| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=mg/kg body weight/day.; EFFECT=mg/kg body weight/day. Biologically significant clinical chemistry changes noted in alkaline phosphatase and alanine aminotransferase indicated possible liver toxicity; however, organ weight determinations and macroscopic and microscopic examination revealed no corresponding findings. The main target organ toxicity in hamsters was dose-related nephrotoxicity (tubular casts, tubular basophilia, tubular dilation). Although the LOEL may be estimated to be 200 mg/kg body weight/day, study investigators determined the NOEL to be 75 mg/kg body weight/day due to increased water consumption and some changes in urinalysis parameters. Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.; CITATION=Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria; CITATION_NUMBERS=[35,200]; REFERENCE=Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria","dose":"mg/kg body weight/day.","duration":"","effect":"mg/kg body weight/day. Biologically significant clinical chemistry changes noted in alkaline phosphatase and alanine aminotransferase indicated possible liver toxicity; however, organ weight determinations and macroscopic and microscopic examination revealed no corresponding findings. The main target organ toxicity in hamsters was dose-related nephrotoxicity (tubular casts, tubular basophilia, tubular dilation). Although the LOEL may be estimated to be 200 mg/kg body weight/day, study investigators determined the NOEL to be 75 mg/kg body weight/day due to increased water consumption and some changes in urinalysis parameters. Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"75","page":25,"route":"","species":"","study_id":"sccp_o_166_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
200 |
mg/kg bw/d |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=200; DOSE=The main target organ toxicity in hamsters was dose-related nephrotoxicity (tubular casts, tubular basophilia, tubular dilation).; EFFECT=sible liver toxicity; however, organ weight determinations and macroscopic and microscopic examination revealed no corresponding findings. The main target organ toxicity in hamsters was dose-related nephrotoxicity (tubular casts, tubular basophilia, tubular dilation). Although the LOEL may be estimated to be 200 mg/kg body weight/day, study investigators determined the NOEL to be 75 mg/kg body weight/day due to increased water consumption and some changes in urinalysis parameters. Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.; CITATION=Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria; CITATION_NUMBERS=[35,200]; REFERENCE=Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria","dose":"The main target organ toxicity in hamsters was dose-related nephrotoxicity (tubular casts, tubular basophilia, tubular dilation).","duration":"","effect":"sible liver toxicity; however, organ weight determinations and macroscopic and microscopic examination revealed no corresponding findings. The main target organ toxicity in hamsters was dose-related nephrotoxicity (tubular casts, tubular basophilia, tubular dilation). Although the LOEL may be estimated to be 200 mg/kg body weight/day, study investigators determined the NOEL to be 75 mg/kg body weight/day due to increased water consumption and some changes in urinalysis parameters. Ref.: 35 Comment of the SCCP The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":25,"route":"","species":"","study_id":"sccp_o_166_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg bw/d |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=e observed in males at ≥350 mg/kg bw/d and females at 900 mg/kg bw/d.; EFFECT=e observed in males at ≥350 mg/kg bw/d and females at 900 mg/kg bw/d. Enlarged dark/thickened lobes correlated with histomorphologic centrilobular hepatocellular hypertrophy, vacuolization, pigment accumulations, necrosis and/or inflammation noted in males at 75 mg/kg bw/d and all animals at 200, 350, 750 mg/kg bw/d. Extramedullary haematopoiesis was observed in the spleen of higher dose (≥750 mg/kg) animals. No histomorphologic alterations were observed in males at 25 mg/kg bw/d and in females at 75 mg/kg bw/d. A NOAEL could not be determined. Trutter, 1993 (33); GLP: compliant OECD: No.408 consistent Rat (Sprague- Dawley) 0, 1,000, 3,000, or 6,000 ppm via diet (~ 0, 100, 300, or 600 mg/kg bw/d) for 90 days via dietary admixture. Interim sacrifice at Day 45. Conducted pursuant to OECD Guideline No. 408. High doses were accompanied by decreased body weight with gradual decreased food consumption and diet spillage at initiation for all treatments. Treatment-related effects on erythrocyte parameters were observed. Interim necrop; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"e observed in males at ≥350 mg/kg bw/d and females at 900 mg/kg bw/d.","duration":"90 days","effect":"e observed in males at ≥350 mg/kg bw/d and females at 900 mg/kg bw/d. Enlarged dark/thickened lobes correlated with histomorphologic centrilobular hepatocellular hypertrophy, vacuolization, pigment accumulations, necrosis and/or inflammation noted in males at 75 mg/kg bw/d and all animals at 200, 350, 750 mg/kg bw/d. Extramedullary haematopoiesis was observed in the spleen of higher dose (≥750 mg/kg) animals. No histomorphologic alterations were observed in males at 25 mg/kg bw/d and in females at 75 mg/kg bw/d. A NOAEL could not be determined. Trutter, 1993 (33); GLP: compliant OECD: No.408 consistent Rat (Sprague- Dawley) 0, 1,000, 3,000, or 6,000 ppm via diet (~ 0, 100, 300, or 600 mg/kg bw/d) for 90 days via dietary admixture. Interim sacrifice at Day 45. Conducted pursuant to OECD Guideline No. 408. High doses were accompanied by decreased body weight with gradual decreased food consumption and diet spillage at initiation for all treatments. Treatment-related effects on erythrocyte parameters were observed. Interim necrop","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":26,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
ppm |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=Interim necropsy revealed increased liver weight changes in males (mid- and high-dose) and females (high dose only).; EFFECT=t-related effects on erythrocyte parameters were observed. Interim necropsy revealed increased liver weight changes in males (mid- and high-dose) and females (high dose only). At terminal necropsy, liver weight for high-dose males and relative liver weight for both male and female dose groups were increased. Histopathologic examination revealed mild hepatic centrilobular cytomegaly and fatty methomorphosis in high and mid-dose males. These changes were also common to female rats; however, at a lower frequency. The NOAEL was considered to be 1,000 ppm (~100 mg/kg bw/d). Litton Bionetics, 1983 (34); GLP: compliant OECD: No.408 consistent; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Interim necropsy revealed increased liver weight changes in males (mid- and high-dose) and females (high dose only).","duration":"","effect":"t-related effects on erythrocyte parameters were observed. Interim necropsy revealed increased liver weight changes in males (mid- and high-dose) and females (high dose only). At terminal necropsy, liver weight for high-dose males and relative liver weight for both male and female dose groups were increased. Histopathologic examination revealed mild hepatic centrilobular cytomegaly and fatty methomorphosis in high and mid-dose males. These changes were also common to female rats; however, at a lower frequency. The NOAEL was considered to be 1,000 ppm (~100 mg/kg bw/d). Litton Bionetics, 1983 (34); GLP: compliant OECD: No.408 consistent","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":26,"route":"","species":"rat","study_id":"sccp_o_166_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg bw/d |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=Histopathology showed nephrotoxicity (e.g., tubular casts, tubular basophilia, tubular dilation) which was dose-related with respect to incidence and severity; microscopic changes were noted starting at the dose of 350 mg/kg bw/d.; EFFECT=discolour and/or granulated kidneys. Histopathology showed nephrotoxicity (e.g., tubular casts, tubular basophilia, tubular dilation) which was dose-related with respect to incidence and severity; microscopic changes were noted starting at the dose of 350 mg/kg bw/d. Stomach inflammation (gastritis, glandular erosions) was also observed at ≥750 mg/kg bw/d. Based on changes noted in water consumption, which were not considered adverse, the LOEL was determined to be 200 mg/kg bw/d; study investigators determined the NOEL to be 75 mg/kg bw/d. At 750 and 900 mg/kg/day, the kidneys were identified as a target organ based on macroscopic, histopathologic and clinical findings. Clinical chemistry changes also indicated liver effects; however, no microscopic findings were observed. The red blood cell also showed treatment- related effects. At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed. The NOEL was determined by study investigators to be 75 mg/kg bw/day. Schmid et al., 1994 (35); GLP: compliant OECD: No.408 con; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Histopathology showed nephrotoxicity (e.g., tubular casts, tubular basophilia, tubular dilation) which was dose-related with respect to incidence and severity; microscopic changes were noted starting at the dose of 350 mg/kg bw/d.","duration":"","effect":"discolour and/or granulated kidneys. Histopathology showed nephrotoxicity (e.g., tubular casts, tubular basophilia, tubular dilation) which was dose-related with respect to incidence and severity; microscopic changes were noted starting at the dose of 350 mg/kg bw/d. Stomach inflammation (gastritis, glandular erosions) was also observed at ≥750 mg/kg bw/d. Based on changes noted in water consumption, which were not considered adverse, the LOEL was determined to be 200 mg/kg bw/d; study investigators determined the NOEL to be 75 mg/kg bw/d. At 750 and 900 mg/kg/day, the kidneys were identified as a target organ based on macroscopic, histopathologic and clinical findings. Clinical chemistry changes also indicated liver effects; however, no microscopic findings were observed. The red blood cell also showed treatment- related effects. At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed. The NOEL was determined by study investigators to be 75 mg/kg bw/day. Schmid et al., 1994 (35); GLP: compliant OECD: No.408 con","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":27,"route":"","species":"","study_id":"sccp_o_166_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
30 |
mg/kg bw/d |
- |
- |
52 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=ects in Males were observed except at 39 and 52 weeks, when decreased WBC noted in Mid Dose and High Dose groups.; EFFECT=ects in Males were observed except at 39 and 52 weeks, when decreased WBC noted in Mid Dose and High Dose groups. Females showed slight decreases in erythroid parameters at all time points for High Dose group, but only significant up to 26 weeks. Also decreased WBC was observed in High Dose Females at 52 weeks (not significant). Decrease in absolute brain weight and increases in kidney and liver weights (relative to BW) in High Dose animals were significant when Male and Female data combined (data at termination). NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Ref.: 41 Comment In baboon studies conducted at doses up to 300 mg/kg bw/d, both 4/13-week and 1-year investigations showed time-dependent haematology findings. Incidental clinical chemistry changes were observed; however, there was no evidence of hepatic or renal injury accompanying these findings [Ref. 40; 41]. Clinical signs observed in the longer-term study were not observe; CITATION=Ref.: 41 Comment In baboon studies conducted at doses up to 300 mg/kg bw/d, both 4/13-week and 1-year investigations showed time-dependent haematology findings; CITATION_NUMBERS=[41,300,4,13,1]; REFERENCE=Ref.: 41 Comment In baboon studies conducted at doses up to 300 mg/kg bw/d, both 4/13-week and 1-year investigations showed time-dependent haematology findings; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 41 Comment In baboon studies conducted at doses up to 300 mg/kg bw/d, both 4/13-week and 1-year investigations showed time-dependent haematology findings","dose":"ects in Males were observed except at 39 and 52 weeks, when decreased WBC noted in Mid Dose and High Dose groups.","duration":"52 weeks","effect":"ects in Males were observed except at 39 and 52 weeks, when decreased WBC noted in Mid Dose and High Dose groups. Females showed slight decreases in erythroid parameters at all time points for High Dose group, but only significant up to 26 weeks. Also decreased WBC was observed in High Dose Females at 52 weeks (not significant). Decrease in absolute brain weight and increases in kidney and liver weights (relative to BW) in High Dose animals were significant when Male and Female data combined (data at termination). NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Ref.: 41 Comment In baboon studies conducted at doses up to 300 mg/kg bw/d, both 4/13-week and 1-year investigations showed time-dependent haematology findings. Incidental clinical chemistry changes were observed; however, there was no evidence of hepatic or renal injury accompanying these findings [Ref. 40; 41]. Clinical signs observed in the longer-term study were not observe","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":28,"route":"","species":"","study_id":"sccp_o_166_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
150 |
mg/kg bw/d |
rabbit |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; DOSE=25 mg/kg bw/d for 90 days via dietary admixture.; EFFECT=25 mg/kg bw/d for 90 days via dietary admixture. Conducted prior to OECD guidelines, but considered similar in design. Terminal examination revealed no organ weight changes or gross pathology findings. Histopathology examination found no differences in high-dose animals compared to control animals. Incidental microscopic changes noted in high-dose animals included granulomatous infiltrations in lungs in 1 female and 2 males and nephrosis in 1 high-dose female. Overall, triclosan was well tolerated at all doses. No NOAEL was determined in this study, in which the highest dose used did not produce treatment-related effects. Leuschner et al., 1970a (36); Predates GLP and OECD OECD: comparable Rabbit (Albino) 0, 3, 30, 150 mg/kg bw/d for 13 weeks via oral gavage. Conducted prior to OECD guidelines, but considered similar in design. Dose-related mortality was observed at 30 and 150 mg/kg bw/d. At doses of 30 and 150 mg/kg bw/d, neutrophilia and lymphopenia were observed on various observation days but were not consistent throughout; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"25 mg/kg bw/d for 90 days via dietary admixture.","duration":"90 days","effect":"25 mg/kg bw/d for 90 days via dietary admixture. Conducted prior to OECD guidelines, but considered similar in design. Terminal examination revealed no organ weight changes or gross pathology findings. Histopathology examination found no differences in high-dose animals compared to control animals. Incidental microscopic changes noted in high-dose animals included granulomatous infiltrations in lungs in 1 female and 2 males and nephrosis in 1 high-dose female. Overall, triclosan was well tolerated at all doses. No NOAEL was determined in this study, in which the highest dose used did not produce treatment-related effects. Leuschner et al., 1970a (36); Predates GLP and OECD OECD: comparable Rabbit (Albino) 0, 3, 30, 150 mg/kg bw/d for 13 weeks via oral gavage. Conducted prior to OECD guidelines, but considered similar in design. Dose-related mortality was observed at 30 and 150 mg/kg bw/d. At doses of 30 and 150 mg/kg bw/d, neutrophilia and lymphopenia were observed on various observation days but were not consistent throughout","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":29,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
3 |
mg/kg bw/d |
rabbit |
- |
91 days |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=3; DOSE=1 rabbit was observed at 30 mg/kg bw/d.; EFFECT=1 rabbit was observed at 30 mg/kg bw/d. Limited organ weight determinations showed no treatment-related findings. Gross macroscopic findings in the lung corresponded with histopathologic lung lesions, oedema in 30 and 150 mg/kg bw/d treated animals and lung necrosis in 2 high-dose animals. No such histomorphology changes were noted in control or 3 mg/kg bw/d animals. Based on findings of neutrophilia and lymphopenia at 30 mg/kg bw/d and absence of histomorphologic alterations, 3 mg/kg bw/d was determined to be the NOAEL. However, the study authors stated that the relationship of the lung lesions, infection, oedema and sometimes necrosis observed at the 2 highest doses to test article administration is unclear. Dosing accidents or regurgitation with resultant pulmonary infection was suggested. Paterson, 1969 (37); Predates GLP and OECD OECD: comparable Dog (Beagle) 0, 25, 50, 100 or 200 mg/kg bw/d via gelatine capsules for 91 days. Conducted prior to OECD guidelines, but considered similar in design, with the exception that cli; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"1 rabbit was observed at 30 mg/kg bw/d.","duration":"91 days","effect":"1 rabbit was observed at 30 mg/kg bw/d. Limited organ weight determinations showed no treatment-related findings. Gross macroscopic findings in the lung corresponded with histopathologic lung lesions, oedema in 30 and 150 mg/kg bw/d treated animals and lung necrosis in 2 high-dose animals. No such histomorphology changes were noted in control or 3 mg/kg bw/d animals. Based on findings of neutrophilia and lymphopenia at 30 mg/kg bw/d and absence of histomorphologic alterations, 3 mg/kg bw/d was determined to be the NOAEL. However, the study authors stated that the relationship of the lung lesions, infection, oedema and sometimes necrosis observed at the 2 highest doses to test article administration is unclear. Dosing accidents or regurgitation with resultant pulmonary infection was suggested. Paterson, 1969 (37); Predates GLP and OECD OECD: comparable Dog (Beagle) 0, 25, 50, 100 or 200 mg/kg bw/d via gelatine capsules for 91 days. Conducted prior to OECD guidelines, but considered similar in design, with the exception that cli","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"3","page":29,"route":"","species":"rabbit","study_id":"sccp_o_166_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
25 |
mg/kg bw/d |
dog |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; DOSE=d adrenal weights for 100 and 200 mg/kg bw/d animals.; EFFECT=d adrenal weights for 100 and 200 mg/kg bw/d animals. Bile retention, necrosis, pathological fat and unusual Kupffer cell activation were observed histopathologically in the liver. In animals which showed severe liver damage, the bone marrow was hyperplastic. In 2 dogs given 200 mg/kg bw/d and one dog at 100 mg/kg bw/d, focal interstitial nephritis was observed. Convoluted epithelium of the kidney was observed in 2 dogs given 25 mg/kg bw/d but not observed at any other dose. Based on the findings in this study, no NOAEL was determined. Paterson, 1967 (38); Predates GLP and OECD OECD: comparable; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"d adrenal weights for 100 and 200 mg/kg bw/d animals.","duration":"","effect":"d adrenal weights for 100 and 200 mg/kg bw/d animals. Bile retention, necrosis, pathological fat and unusual Kupffer cell activation were observed histopathologically in the liver. In animals which showed severe liver damage, the bone marrow was hyperplastic. In 2 dogs given 200 mg/kg bw/d and one dog at 100 mg/kg bw/d, focal interstitial nephritis was observed. Convoluted epithelium of the kidney was observed in 2 dogs given 25 mg/kg bw/d but not observed at any other dose. Based on the findings in this study, no NOAEL was determined. Paterson, 1967 (38); Predates GLP and OECD OECD: comparable","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":29,"route":"","species":"dog","study_id":"sccp_o_166_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg bw/d |
- |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=Haematology, clinical chemistry and urinalysis evaluations were limited to high-dose group animals.; EFFECT=bw/d via diet for 90 days. Conducted prior to OECD guidelines, but considered similar in design. Occasional pasty to thin faeces were noted in all groups. Haematology, clinical chemistry and urinalysis evaluations were limited to high-dose group animals. Macroscopic evaluations found no gross pathology for any organ. Organ weight measurements showed no changes in relative or absolute weights. Histopathologic evaluation of all major organs from all animals showed no difference among treated and control animals. No NOAEL was determined in this study, in which the highest dose used did not produce treatment-related effects. Leuschner et al., 1970b (39); Predates GLP and OECD OECD: comparable Baboons (papio cynocephalus and anubis) 4-week dosing: 0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules. 13-week dosing: 0 or 3 mg/kg bw/d via gelatine capsules. Conducted prior to OECD guidelines, but considered comparable in design (but limited in number of parameters evaluated). Blood chemistry revealed no haematology changes. Urinal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Haematology, clinical chemistry and urinalysis evaluations were limited to high-dose group animals.","duration":"90 days","effect":"bw/d via diet for 90 days. Conducted prior to OECD guidelines, but considered similar in design. Occasional pasty to thin faeces were noted in all groups. Haematology, clinical chemistry and urinalysis evaluations were limited to high-dose group animals. Macroscopic evaluations found no gross pathology for any organ. Organ weight measurements showed no changes in relative or absolute weights. Histopathologic evaluation of all major organs from all animals showed no difference among treated and control animals. No NOAEL was determined in this study, in which the highest dose used did not produce treatment-related effects. Leuschner et al., 1970b (39); Predates GLP and OECD OECD: comparable Baboons (papio cynocephalus and anubis) 4-week dosing: 0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules. 13-week dosing: 0 or 3 mg/kg bw/d via gelatine capsules. Conducted prior to OECD guidelines, but considered comparable in design (but limited in number of parameters evaluated). Blood chemistry revealed no haematology changes. Urinal","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":30,"route":"oral","species":"","study_id":"sccp_o_166_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/d |
- |
- |
4 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=r 4 weeks and after 13 weeks showed no organ weight differences among treated and controls.; EFFECT=r 4 weeks and after 13 weeks showed no organ weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from this study due to insufficient number of animals evaluated. A NOAEL was not determined for this study. Noel et al., 1969 (40); Predates GLP and OECD OECD: comparable Baboons (papio) 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"r 4 weeks and after 13 weeks showed no organ weight differences among treated and controls.","duration":"4 weeks","effect":"r 4 weeks and after 13 weeks showed no organ weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from this study due to insufficient number of animals evaluated. A NOAEL was not determined for this study. Noel et al., 1969 (40); Predates GLP and OECD OECD: comparable Baboons (papio) 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":30,"route":"","species":"","study_id":"sccp_o_166_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/d |
- |
- |
4 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=gan weight differences among treated and controls.; EFFECT=gan weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from this study due to insufficient number of animals evaluated. A NOAEL was not determined for this study. Noel et al., 1969 (40); Predates GLP and OECD OECD: comparable Baboons (papio) 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29 and 52 in mid and high-dose groups. In f; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"gan weight differences among treated and controls.","duration":"4 weeks","effect":"gan weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from this study due to insufficient number of animals evaluated. A NOAEL was not determined for this study. Noel et al., 1969 (40); Predates GLP and OECD OECD: comparable Baboons (papio) 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29 and 52 in mid and high-dose groups. In f","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":30,"route":"","species":"","study_id":"sccp_o_166_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
80 |
mg/kg bw/d |
rat |
dermal |
28-day |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=80; DOSE=e and satellite male rats and to a lesser extent in mid-dose females and males.; EFFECT=e and satellite male rats and to a lesser extent in mid-dose females and males. Histopathology examinations observed eschar and desquamation, hyperplasia/hyperkeratosis of epidermis, dermal inflammation and focal necrosis observed at all doses. Reversal of the dermal effects was seen during the 28-day recovery period. Microscopic changes in the urinary bladder of 3 males were observed. Coagulative necrosis of hepatocytes was also observed. Both findings lacked a dose-response. With respect to general toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the highest dose tested). No NOAEL for dermal toxicity was determined. Trimmer, 1994 (11); GLP: compliant OECD: compliant; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"e and satellite male rats and to a lesser extent in mid-dose females and males.","duration":"28-day","effect":"e and satellite male rats and to a lesser extent in mid-dose females and males. Histopathology examinations observed eschar and desquamation, hyperplasia/hyperkeratosis of epidermis, dermal inflammation and focal necrosis observed at all doses. Reversal of the dermal effects was seen during the 28-day recovery period. Microscopic changes in the urinary bladder of 3 males were observed. Coagulative necrosis of hepatocytes was also observed. Both findings lacked a dose-response. With respect to general toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the highest dose tested). No NOAEL for dermal toxicity was determined. Trimmer, 1994 (11); GLP: compliant OECD: compliant","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":31,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
80 |
mg/kg bw/d |
- |
dermal |
28-day |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=80; DOSE=Both findings lacked a dose-response.; EFFECT=d males. Histopathology examinations observed eschar and desquamation, hyperplasia/hyperkeratosis of epidermis, dermal inflammation and focal necrosis observed at all doses. Reversal of the dermal effects was seen during the 28-day recovery period. Microscopic changes in the urinary bladder of 3 males were observed. Coagulative necrosis of hepatocytes was also observed. Both findings lacked a dose-response. With respect to general toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the highest dose tested). No NOAEL for dermal toxicity was determined. Trimmer, 1994 (11); GLP: compliant OECD: compliant; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Both findings lacked a dose-response.","duration":"28-day","effect":"d males. Histopathology examinations observed eschar and desquamation, hyperplasia/hyperkeratosis of epidermis, dermal inflammation and focal necrosis observed at all doses. Reversal of the dermal effects was seen during the 28-day recovery period. Microscopic changes in the urinary bladder of 3 males were observed. Coagulative necrosis of hepatocytes was also observed. Both findings lacked a dose-response. With respect to general toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the highest dose tested). No NOAEL for dermal toxicity was determined. Trimmer, 1994 (11); GLP: compliant OECD: compliant","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":31,"route":"dermal","species":"","study_id":"sccp_o_166_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10 |
mg/kg bw/d |
rat |
oral |
52-week |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=10; DOSE=6, 10, 17, 32, 42 in males and 0, 1, 3, 6, 20 in females at doses of 0, 10, 30, 100, and 200 mg/kg bw/d, respectively.; EFFECT=liver adenomas and carcinomas, with increased incidence in males vs. females. Incidences of mice bearing at least 1 hepatic tumour (i.e., combined adenoma and carcinoma data) were: 6, 10, 17, 32, 42 in males and 0, 1, 3, 6, 20 in females at doses of 0, 10, 30, 100, and 200 mg/kg bw/d, respectively. In summary, effects in the liver, serum cholesterol decreases (males and females) and hepatocellular hypertrophy (males only) were observed at the lowest dose of 10 mg/kg bw/d; investigators concluded that there was no NOEL based on liver changes at all dose levels. Pharmaco LSR, 1995 (66); GLP- compliant OECD: No. 451 consistent Rat (Sprague- Dawley Oral (diet) doses of 0, 12, 40, or 127 mg/kg bw/d in males and 0, 17, 56, or 190 mg/kg bw/d in females 60/sex/ dose + 10/sex/ dose or 20/sex/ control group (52-week interim) 20/sex in additional high-dose 104 weeks Increased food intake was found in high-dose males. Mean body weight decreases were observed to be transient during the study except for consistent significant decreases of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"6, 10, 17, 32, 42 in males and 0, 1, 3, 6, 20 in females at doses of 0, 10, 30, 100, and 200 mg/kg bw/d, respectively.","duration":"52-week","effect":"liver adenomas and carcinomas, with increased incidence in males vs. females. Incidences of mice bearing at least 1 hepatic tumour (i.e., combined adenoma and carcinoma data) were: 6, 10, 17, 32, 42 in males and 0, 1, 3, 6, 20 in females at doses of 0, 10, 30, 100, and 200 mg/kg bw/d, respectively. In summary, effects in the liver, serum cholesterol decreases (males and females) and hepatocellular hypertrophy (males only) were observed at the lowest dose of 10 mg/kg bw/d; investigators concluded that there was no NOEL based on liver changes at all dose levels. Pharmaco LSR, 1995 (66); GLP- compliant OECD: No. 451 consistent Rat (Sprague- Dawley Oral (diet) doses of 0, 12, 40, or 127 mg/kg bw/d in males and 0, 17, 56, or 190 mg/kg bw/d in females 60/sex/ dose + 10/sex/ dose or 20/sex/ control group (52-week interim) 20/sex in additional high-dose 104 weeks Increased food intake was found in high-dose males. Mean body weight decreases were observed to be transient during the study except for consistent significant decreases of","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":56,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_048"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
ppm |
rat |
oral |
104 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=of the treated rats examined histologically at 52 or 104 weeks.; EFFECT=of the treated rats examined histologically at 52 or 104 weeks. Animals in the additional high-dose group killed at 52 weeks (247 or 422 mg/kg bw/d in males and females, respectively) showed similar types of toxicity as the main study animals, excepting that the severity or incidences of events were increased. No tumours were observed in these animals. In summary, the results show that triclosan is not tumourigenic in a 2-year study in rats at doses of up to 127 mg/kg bw/d in males and 190 mg/kg bw/d in females. A NOEL of 1,000 ppm was determined (48 mg/kg bw/d for females and males combined). Hamster (Syrian) Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) Females: 90 weeks Males: 95 weeks Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food consumption in high-dose females. Biochemical chan; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"of the treated rats examined histologically at 52 or 104 weeks.","duration":"104 weeks","effect":"of the treated rats examined histologically at 52 or 104 weeks. Animals in the additional high-dose group killed at 52 weeks (247 or 422 mg/kg bw/d in males and females, respectively) showed similar types of toxicity as the main study animals, excepting that the severity or incidences of events were increased. No tumours were observed in these animals. In summary, the results show that triclosan is not tumourigenic in a 2-year study in rats at doses of up to 127 mg/kg bw/d in males and 190 mg/kg bw/d in females. A NOEL of 1,000 ppm was determined (48 mg/kg bw/d for females and males combined). Hamster (Syrian) Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) Females: 90 weeks Males: 95 weeks Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food consumption in high-dose females. Biochemical chan","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":57,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_049"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
ppm |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=Increased incidences of liver tumours were observed at doses of 30 mg/kg body weight/day and higher in mice.; EFFECT=s and hepatic tumours in mice, but little evidence of toxicity and no tumours in rats. Hamsters showed increased liver toxicity relative to the rat, but no tumours. No NOAEL could be determined for the mouse, based on findings of liver effects at all doses (effects of hepatocyte hypertrophy and decreased plasma cholesterol). Increased incidences of liver tumours were observed at doses of 30 mg/kg body weight/day and higher in mice. It should be noted that triclosan is a peroxisome proliferator in mouse liver. The NOEL for the rat study was determined by study investigators to be the mid-dose of 1,000 ppm, or ~48 mg/kg body weight/day for males and females combined, based on the finding of hepatocyte changes in the high-dose group of 3,000 ppm (~127 mg/kg body weight/day in males and 190 mg/kg body weight/day in females). Although absolute adrenal weights were elevated at the 1,000 ppm dose in rats, this change was not considered to be adverse for a number of reasons, including a lack of change in relative adrenal weights, a lac; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Increased incidences of liver tumours were observed at doses of 30 mg/kg body weight/day and higher in mice.","duration":"","effect":"s and hepatic tumours in mice, but little evidence of toxicity and no tumours in rats. Hamsters showed increased liver toxicity relative to the rat, but no tumours. No NOAEL could be determined for the mouse, based on findings of liver effects at all doses (effects of hepatocyte hypertrophy and decreased plasma cholesterol). Increased incidences of liver tumours were observed at doses of 30 mg/kg body weight/day and higher in mice. It should be noted that triclosan is a peroxisome proliferator in mouse liver. The NOEL for the rat study was determined by study investigators to be the mid-dose of 1,000 ppm, or ~48 mg/kg body weight/day for males and females combined, based on the finding of hepatocyte changes in the high-dose group of 3,000 ppm (~127 mg/kg body weight/day in males and 190 mg/kg body weight/day in females). Although absolute adrenal weights were elevated at the 1,000 ppm dose in rats, this change was not considered to be adverse for a number of reasons, including a lack of change in relative adrenal weights, a lac","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":58,"route":"","species":"rat","study_id":"sccp_o_166_noael_053"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=combined, based on the finding of hepatocyte changes in the high-dose group of 3,000 ppm (~127 mg/kg body weight/day in males and 190 mg/kg body weight/day in females).; EFFECT=combined, based on the finding of hepatocyte changes in the high-dose group of 3,000 ppm (~127 mg/kg body weight/day in males and 190 mg/kg body weight/day in females). Although absolute adrenal weights were elevated at the 1,000 ppm dose in rats, this change was not considered to be adverse for a number of reasons, including a lack of change in relative adrenal weights, a lack of change in adrenal weights in the high-dose group, and the absence of accompanying histopathological changes in the adrenal glands. The NOAEL for the hamster study was determined to be the mid-dose of 75 mg/kg body weight/day. Although the values for certain haematologic parameters were significantly altered at doses of 12 and 75 mg/kg body weight/day, the erythroid changes were slight (on the order of 5 to 10%), and not considered to be adverse effects per se. An increase in triglycerides (40 to 50%) was not considered to be an adverse effect, as the increase was not accompanied by any changes in liver weight or histopathology. The NOAEL values for the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"combined, based on the finding of hepatocyte changes in the high-dose group of 3,000 ppm (~127 mg/kg body weight/day in males and 190 mg/kg body weight/day in females).","duration":"","effect":"combined, based on the finding of hepatocyte changes in the high-dose group of 3,000 ppm (~127 mg/kg body weight/day in males and 190 mg/kg body weight/day in females). Although absolute adrenal weights were elevated at the 1,000 ppm dose in rats, this change was not considered to be adverse for a number of reasons, including a lack of change in relative adrenal weights, a lack of change in adrenal weights in the high-dose group, and the absence of accompanying histopathological changes in the adrenal glands. The NOAEL for the hamster study was determined to be the mid-dose of 75 mg/kg body weight/day. Although the values for certain haematologic parameters were significantly altered at doses of 12 and 75 mg/kg body weight/day, the erythroid changes were slight (on the order of 5 to 10%), and not considered to be adverse effects per se. An increase in triglycerides (40 to 50%) was not considered to be an adverse effect, as the increase was not accompanied by any changes in liver weight or histopathology. The NOAEL values for the","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"75","page":58,"route":"","species":"rat","study_id":"sccp_o_166_noael_054"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
40 |
% |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=40 to 50; DOSE=The NOAEL for the hamster study was determined to be the mid-dose of 75 mg/kg body weight/day.; EFFECT=al glands. The NOAEL for the hamster study was determined to be the mid-dose of 75 mg/kg body weight/day. Although the values for certain haematologic parameters were significantly altered at doses of 12 and 75 mg/kg body weight/day, the erythroid changes were slight (on the order of 5 to 10%), and not considered to be adverse effects per se. An increase in triglycerides (40 to 50%) was not considered to be an adverse effect, as the increase was not accompanied by any changes in liver weight or histopathology. The NOAEL values for the three rodent lifetime cancer bioassays are summarized in Table 17.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The NOAEL for the hamster study was determined to be the mid-dose of 75 mg/kg body weight/day.","duration":"","effect":"al glands. The NOAEL for the hamster study was determined to be the mid-dose of 75 mg/kg body weight/day. Although the values for certain haematologic parameters were significantly altered at doses of 12 and 75 mg/kg body weight/day, the erythroid changes were slight (on the order of 5 to 10%), and not considered to be adverse effects per se. An increase in triglycerides (40 to 50%) was not considered to be an adverse effect, as the increase was not accompanied by any changes in liver weight or histopathology. The NOAEL values for the three rodent lifetime cancer bioassays are summarized in Table 17.","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"40 to 50","page":58,"route":"","species":"","study_id":"sccp_o_166_noael_055"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
ppm |
rat |
- |
0 to Day |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=ity and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested.; EFFECT=ity and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested. 3.3.8.1.2 Post-Natal Parameters In the two-generation study that examined post-natal development in rats, the primary findings were a slight decrease in mean foetal body weights and a slight decrease in the Day 0 to Day 4 survival in the F1 and F2 generations at the high dose of 3,000 ppm (~203 mg/kg body weight/day) [Morseth, 1988 (69)]. Thus, the foetal and post-natal NOEL for this study was determined to be 1,000 ppm (~65 mg/kg body weight/day using; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"ity and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested.","duration":"0 to Day","effect":"ity and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested. 3.3.8.1.2 Post-Natal Parameters In the two-generation study that examined post-natal development in rats, the primary findings were a slight decrease in mean foetal body weights and a slight decrease in the Day 0 to Day 4 survival in the F1 and F2 generations at the high dose of 3,000 ppm (~203 mg/kg body weight/day) [Morseth, 1988 (69)]. Thus, the foetal and post-natal NOEL for this study was determined to be 1,000 ppm (~65 mg/kg body weight/day using","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":60,"route":"","species":"rat","study_id":"sccp_o_166_noael_066"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
160 |
mg/kg bw/day |
mouse |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=160; DOSE=mg/kg bw/d, absolute liver weights and relative liver weights (relative to terminal body weights and to brain weights) were increased.; EFFECT=mg/kg bw/d, absolute liver weights and relative liver weights (relative to terminal body weights and to brain weights) were increased. Foetal Parameters: Foetal body weight data were lower for the 40, 80, and 160 mg/kg bw/d groups than for the vehicle control group. Litter averages for resorptions (early and late resorptions, percentage of resorbed conceptuses and the number of dams with resorptions) were increased at 160 mg/kg bw/day. There were no other remarkable findings. Study investigators did not determine NOEL values for this study. Argus Research Laboratories, 1992a (70) GLP-compliant OECD: not applicable for a dose range finding study Mouse (Crl:CD®- 1(ICR)BR) 0, 10, 25, 75, or 350 mg/kg bw/d in the diet (Days 6-15 of gestation) Maternal Parameters: Body weights and body weight gains were increased in the 350 mg/kg bw/d group. Absolute liver weights and relative liver weights (relative to terminal body weights and to brain weights) were significantly increased in the 75 and 350 mg/kg bw/d dose groups. The 350 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"mg/kg bw/d, absolute liver weights and relative liver weights (relative to terminal body weights and to brain weights) were increased.","duration":"","effect":"mg/kg bw/d, absolute liver weights and relative liver weights (relative to terminal body weights and to brain weights) were increased. Foetal Parameters: Foetal body weight data were lower for the 40, 80, and 160 mg/kg bw/d groups than for the vehicle control group. Litter averages for resorptions (early and late resorptions, percentage of resorbed conceptuses and the number of dams with resorptions) were increased at 160 mg/kg bw/day. There were no other remarkable findings. Study investigators did not determine NOEL values for this study. Argus Research Laboratories, 1992a (70) GLP-compliant OECD: not applicable for a dose range finding study Mouse (Crl:CD®- 1(ICR)BR) 0, 10, 25, 75, or 350 mg/kg bw/d in the diet (Days 6-15 of gestation) Maternal Parameters: Body weights and body weight gains were increased in the 350 mg/kg bw/d group. Absolute liver weights and relative liver weights (relative to terminal body weights and to brain weights) were significantly increased in the 75 and 350 mg/kg bw/d dose groups. The 350 mg/kg","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"160","page":61,"route":"oral","species":"mouse","study_id":"sccp_o_166_noael_072"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=25 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 25; DOSE=bw/d) Major Findings1 Reference, GLP and OECD Status mouse in the 75 mg/kg bw/d dose group.; EFFECT=bw/d) Major Findings1 Reference, GLP and OECD Status mouse in the 75 mg/kg bw/d dose group. Foetal Parameters: Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group. There were reversible delays in ossification caused by the test article in the 75 and 350 mg/kg bw/d dosage groups, including skull ossification and reductions in the average numbers of ossified forepaw phalanges and hind paw phalanges. There were no other remarkable findings. Maternal NOEL = 25 mg/kg bw/d (based on tan- coloured livers and increased liver weights) Foetal NOEL = 25 mg/kg bw/d (based on decreased foetal body weights and delayed ossification) OECD: consistent with “Teratogenicity” guideline Rat (Charles River CD® Sprague- Dawley derived) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"bw/d) Major Findings1 Reference, GLP and OECD Status mouse in the 75 mg/kg bw/d dose group.","duration":"","effect":"bw/d) Major Findings1 Reference, GLP and OECD Status mouse in the 75 mg/kg bw/d dose group. Foetal Parameters: Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group. There were reversible delays in ossification caused by the test article in the 75 and 350 mg/kg bw/d dosage groups, including skull ossification and reductions in the average numbers of ossified forepaw phalanges and hind paw phalanges. There were no other remarkable findings. Maternal NOEL = 25 mg/kg bw/d (based on tan- coloured livers and increased liver weights) Foetal NOEL = 25 mg/kg bw/d (based on decreased foetal body weights and delayed ossification) OECD: consistent with “Teratogenicity” guideline Rat (Charles River CD® Sprague- Dawley derived) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_073"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=25 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 25; DOSE=Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group.; EFFECT=oup. Foetal Parameters: Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group. There were reversible delays in ossification caused by the test article in the 75 and 350 mg/kg bw/d dosage groups, including skull ossification and reductions in the average numbers of ossified forepaw phalanges and hind paw phalanges. There were no other remarkable findings. Maternal NOEL = 25 mg/kg bw/d (based on tan- coloured livers and increased liver weights) Foetal NOEL = 25 mg/kg bw/d (based on decreased foetal body weights and delayed ossification) OECD: consistent with “Teratogenicity” guideline Rat (Charles River CD® Sprague- Dawley derived) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high dose were due to the weight loss in a single dam. There were no other remarkable findin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group.","duration":"","effect":"oup. Foetal Parameters: Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group. There were reversible delays in ossification caused by the test article in the 75 and 350 mg/kg bw/d dosage groups, including skull ossification and reductions in the average numbers of ossified forepaw phalanges and hind paw phalanges. There were no other remarkable findings. Maternal NOEL = 25 mg/kg bw/d (based on tan- coloured livers and increased liver weights) Foetal NOEL = 25 mg/kg bw/d (based on decreased foetal body weights and delayed ossification) OECD: consistent with “Teratogenicity” guideline Rat (Charles River CD® Sprague- Dawley derived) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high dose were due to the weight loss in a single dam. There were no other remarkable findin","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_074"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=er suspension (Days 6-15 of gestation) Dose range finding study.; EFFECT=er suspension (Days 6-15 of gestation) Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high dose were due to the weight loss in a single dam. There were no other remarkable findings. Foetal Parameters: Foetal body weight data were lower for all treatment groups vs. controls; however, only the 75 mg/kg bw/d group had foetal body weights outside the low range of historical control data. There were no other remarkable findings. Study investigators did not determine NOEL values for this study. Bio/dynamics, 1992a (72) GLP-compliant OECD: not applicable for a dose range finding study Rat (Charles River CD® Sprague- Dawley derived) 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"er suspension (Days 6-15 of gestation) Dose range finding study.","duration":"","effect":"er suspension (Days 6-15 of gestation) Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high dose were due to the weight loss in a single dam. There were no other remarkable findings. Foetal Parameters: Foetal body weight data were lower for all treatment groups vs. controls; however, only the 75 mg/kg bw/d group had foetal body weights outside the low range of historical control data. There were no other remarkable findings. Study investigators did not determine NOEL values for this study. Bio/dynamics, 1992a (72) GLP-compliant OECD: not applicable for a dose range finding study Rat (Charles River CD® Sprague- Dawley derived) 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findin","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_075"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=50 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 50; DOSE=There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs.; EFFECT=vage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline Rat (Colworth Wistar) 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs.","duration":"","effect":"vage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline Rat (Colworth Wistar) 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_076"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=50 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 50; DOSE=There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs.; EFFECT=-15 of gestation) Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline Rat (Colworth Wistar) 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease v; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs.","duration":"","effect":"-15 of gestation) Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline Rat (Colworth Wistar) 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease v","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_077"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg bw/d |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs.; EFFECT=via oral gavage in corn oil (Days 6-15 of gestation) Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). Denning et al., 1992 (74); GLP-compliant2 OECD: comparable Rabbit (New Zealand White) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water Dose range-finding study. Maternal Parameters: There were slight mean maternal bod; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs.","duration":"","effect":"via oral gavage in corn oil (Days 6-15 of gestation) Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). Denning et al., 1992 (74); GLP-compliant2 OECD: comparable Rabbit (New Zealand White) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water Dose range-finding study. Maternal Parameters: There were slight mean maternal bod","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":62,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_078"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg bw/d |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs.; EFFECT=s: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). Denning et al., 1992 (74); GLP-compliant2 OECD: comparable Rabbit (New Zealand White) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water Dose range-finding study. Maternal Parameters: There were slight mean maternal body weight losses and lower terminal body weights of the does treated wit; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs.","duration":"","effect":"s: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). Denning et al., 1992 (74); GLP-compliant2 OECD: comparable Rabbit (New Zealand White) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water Dose range-finding study. Maternal Parameters: There were slight mean maternal body weight losses and lower terminal body weights of the does treated wit","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":62,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_079"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/d |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects).; EFFECT=y weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). Denning et al., 1992 (74); GLP-compliant2 OECD: comparable Rabbit (New Zealand White) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water Dose range-finding study. Maternal Parameters: There were slight mean maternal body weight losses and lower terminal body weights of the does treated with 75 mg/kg bw/d, as well as decreased food consumption as measured on Days 6, 8-11, 13, and 16, but not on Days 7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects).","duration":"","effect":"y weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). Denning et al., 1992 (74); GLP-compliant2 OECD: comparable Rabbit (New Zealand White) 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water Dose range-finding study. Maternal Parameters: There were slight mean maternal body weight losses and lower terminal body weights of the does treated with 75 mg/kg bw/d, as well as decreased food consumption as measured on Days 6, 8-11, 13, and 16, but not on Days 7","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":62,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_080"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
150 |
mg/kg bw/d |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; DOSE=SCCP/1192/08 Opinion on triclosan 63 Species (Strain) Dosing Regimen (mg/kg bw/d) Major Findings1 Reference, GLP and OECD Status suspension (Days 6 to 18 of gestation) Study investigators did not determine NOEL values for this study. finding study Rabbit (New Zealand White) 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellul...; EFFECT=SCCP/1192/08 Opinion on triclosan 63 Species (Strain) Dosing Regimen (mg/kg bw/d) Major Findings1 Reference, GLP and OECD Status suspension (Days 6 to 18 of gestation) Study investigators did not determine NOEL values for this study. finding study Rabbit (New Zealand White) 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"SCCP/1192/08 Opinion on triclosan 63 Species (Strain) Dosing Regimen (mg/kg bw/d) Major Findings1 Reference, GLP and OECD Status suspension (Days 6 to 18 of gestation) Study investigators did not determine NOEL values for this study. finding study Rabbit (New Zealand White) 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellul...","duration":"","effect":"SCCP/1192/08 Opinion on triclosan 63 Species (Strain) Dosing Regimen (mg/kg bw/d) Major Findings1 Reference, GLP and OECD Status suspension (Days 6 to 18 of gestation) Study investigators did not determine NOEL values for this study. finding study Rabbit (New Zealand White) 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":63,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_081"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=50 |
mg/kg bw/d |
- |
- |
1992d |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 50; DOSE=There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14).; EFFECT=er suspension (Days 6-18 of gestation) Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline 1 Being consistent with industry standards, statistical analyses were conducted for definitive, but not range-finding, studies. Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14).","duration":"1992d","effect":"er suspension (Days 6-18 of gestation) Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline 1 Being consistent with industry standards, statistical analyses were conducted for definitive, but not range-finding, studies. Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":63,"route":"","species":"","study_id":"sccp_o_166_noael_082"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=150 |
mg/kg bw/d |
rat |
- |
1992d |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 150; DOSE=ean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14).; EFFECT=ean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline 1 Being consistent with industry standards, statistical analyses were conducted for definitive, but not range-finding, studies. Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al. [1992 (74)] in Colworth Wistar rats was assumed to contain GLP; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"ean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14).","duration":"1992d","effect":"ean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline 1 Being consistent with industry standards, statistical analyses were conducted for definitive, but not range-finding, studies. Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al. [1992 (74)] in Colworth Wistar rats was assumed to contain GLP","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 150","page":63,"route":"","species":"rat","study_id":"sccp_o_166_noael_083"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1.59 |
% |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1.59; DOSE=LP: not specified OECD: not specified Rat (Wistar) 0, 100, 200, or 400 mg/kg bw/d via oral gavage in olive oil (Days 7-17 of gestation) Maternal Parameters:; EFFECT=LP: not specified OECD: not specified Rat (Wistar) 0, 100, 200, or 400 mg/kg bw/d via oral gavage in olive oil (Days 7-17 of gestation) Maternal Parameters: Clinical signs of piloerection, incontinence, and diarrhoea were observed at the high dose, together with a decrease in food consumption during the dosing period. Foetal Parameters: There was a significant increase in numbers of foetal deaths at the high dose of 400 mg/kg bw/d (7.05% mortality vs. 1.59% in the controls). Study investigators did not determine NOEL values for this study. However, the data indicate that Maternal and Foetal NOELs of 200 mg/kg bw/d would be appropriate, based on the absence of any significant maternal and foetal effects at this dose level. Kawashima et al., 1987 (77) GLP: not specified OECD: not specified; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"LP: not specified OECD: not specified Rat (Wistar) 0, 100, 200, or 400 mg/kg bw/d via oral gavage in olive oil (Days 7-17 of gestation) Maternal Parameters:","duration":"","effect":"LP: not specified OECD: not specified Rat (Wistar) 0, 100, 200, or 400 mg/kg bw/d via oral gavage in olive oil (Days 7-17 of gestation) Maternal Parameters: Clinical signs of piloerection, incontinence, and diarrhoea were observed at the high dose, together with a decrease in food consumption during the dosing period. Foetal Parameters: There was a significant increase in numbers of foetal deaths at the high dose of 400 mg/kg bw/d (7.05% mortality vs. 1.59% in the controls). Study investigators did not determine NOEL values for this study. However, the data indicate that Maternal and Foetal NOELs of 200 mg/kg bw/d would be appropriate, based on the absence of any significant maternal and foetal effects at this dose level. Kawashima et al., 1987 (77) GLP: not specified OECD: not specified","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"1.59","page":65,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_096"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:se) 50 50 Decreases in food consumption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, in; DOSE=se) 50 50 Decreases in food consumption in high- dose dams.; EFFECT=se) 50 50 Decreases in food consumption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"se) 50 50 Decreases in food consumption in high- dose dams.","duration":"","effect":"se) 50 50 Decreases in food consumption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, in","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:se) 50 50 Decreases in food consumption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, in","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_109"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:mption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and i; DOSE=mption in high- dose dams.; EFFECT=mption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"mption in high- dose dams.","duration":"","effect":"mption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and i","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:mption in high- dose dams. Reversible, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and i","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_110"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:le, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and intraduodenal routes of administrat; DOSE=le, delayed ossification in foetuses at same dose.; EFFECT=le, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and intraduodenal routes of administrat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"le, delayed ossification in foetuses at same dose.","duration":"","effect":"le, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and intraduodenal routes of administrat","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:le, delayed ossification in foetuses at same dose. Rat Oral (gavage; corn oil) 100 300 Decreases in body weight and diarrhoea in high-dose dams. No remarkable foetal effects. Rabbit Oral (gavage) 50 150 Decreases in body weight and food consumption in high-dose dams. No remarkable foetal effects. Pre- and Post-Natal Effects Rat Diet 652 Slight decreases in foetal body weights and in mean number of live pups at the highest dose. 1 In all cases, the NOEL values were taken to be the NOAEL values for the study as only NOEL values were determined. 2 Male and female doses combined 3.3.9. Toxicokinetics More than 30 non-clinical pharmacokinetics and/or toxicokinetics studies investigating absorption, distribution, metabolism, and excretion of triclosan have been reviewed for this dossier. The kinetics of triclosan and its metabolites have been studied in mice, rats, hamsters, guinea pigs, rabbits, dogs, and monkeys. In these studies, the oral, intravenous, dermal, intraperitoneal, intravaginal, and intraduodenal routes of administrat","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_111"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg |
rat |
oral |
2-week |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=No histopathological changes were observed in the brain or sciatic nerve of treated or control animals.; EFFECT=Brain A 2-week neurotoxicity study was conducted with triclosan in the rat [Ciba-Geigy, 1973a (163)], the main findings of which are provided in Table 43. No histopathological changes were observed in the brain or sciatic nerve of treated or control animals. There were no differences in brain weights between treated and control animals. Clinical signs included decreased movement and muscular tone, polydipsia, and polyuria at dose levels of 300 mg/kg body weight/day and higher. The results of this study indicate a NOEL of 100 mg/kg body weight/day for triclosan in the rat. There was no evidence of neuropathology at any dose level, as examined in the brain and sciatic nerve tissues. The investigators concluded that triclosan produces no specific neurotoxic effects in the rat; however, the reasons for observations of clinical signs consistent with possible neurotoxicity (e.g., hypoactivity, decreased muscular tone) are unclear. Table 43: Findings from a Two-Week Oral Neurotoxicity Study with Triclosan in the Rat Species (Strain); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"No histopathological changes were observed in the brain or sciatic nerve of treated or control animals.","duration":"2-week","effect":"Brain A 2-week neurotoxicity study was conducted with triclosan in the rat [Ciba-Geigy, 1973a (163)], the main findings of which are provided in Table 43. No histopathological changes were observed in the brain or sciatic nerve of treated or control animals. There were no differences in brain weights between treated and control animals. Clinical signs included decreased movement and muscular tone, polydipsia, and polyuria at dose levels of 300 mg/kg body weight/day and higher. The results of this study indicate a NOEL of 100 mg/kg body weight/day for triclosan in the rat. There was no evidence of neuropathology at any dose level, as examined in the brain and sciatic nerve tissues. The investigators concluded that triclosan produces no specific neurotoxic effects in the rat; however, the reasons for observations of clinical signs consistent with possible neurotoxicity (e.g., hypoactivity, decreased muscular tone) are unclear. Table 43: Findings from a Two-Week Oral Neurotoxicity Study with Triclosan in the Rat Species (Strain)","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":106,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_112"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg bw/day |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=sed body weights in high- dose group.; EFFECT=sed body weights in high- dose group. Dose-dependent inhibition of movement, decreased muscular tone, polydipsia and polyuria at dose levels of 300 mg/kg bw/day and higher. Clinical signs were most severe in the high-dose group and also included spastic respiration for several animals. No difference in brain weights between treated and controls (no other organ weights were measured). No histopathological changes in the brain or sciatic nerve of treated or control animals were observed (no other tissues evaluated). NOEL: 100 mg/kg bw/day Ciba-Geigy, 1973a (163) Predates GLP and OECD 3.3.12.2 Effects of Triclosan in Kidney The nephrotoxic effects of triclosan have been investigated in a non-GLP study (published report) [Chow et al., 1977 (164)], described in Table 44 by means of in vitro and in vivo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"sed body weights in high- dose group.","duration":"","effect":"sed body weights in high- dose group. Dose-dependent inhibition of movement, decreased muscular tone, polydipsia and polyuria at dose levels of 300 mg/kg bw/day and higher. Clinical signs were most severe in the high-dose group and also included spastic respiration for several animals. No difference in brain weights between treated and controls (no other organ weights were measured). No histopathological changes in the brain or sciatic nerve of treated or control animals were observed (no other tissues evaluated). NOEL: 100 mg/kg bw/day Ciba-Geigy, 1973a (163) Predates GLP and OECD 3.3.12.2 Effects of Triclosan in Kidney The nephrotoxic effects of triclosan have been investigated in a non-GLP study (published report) [Chow et al., 1977 (164)], described in Table 44 by means of in vitro and in vivo","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":106,"route":"","species":"","study_id":"sccp_o_166_noael_113"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
12 |
mg/kg bw/day |
rat |
- |
13 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab.; EFFECT=losan) and a deodorant (0.39% triclosan) for 13 weeks. The results of this study indicated that all subjects reached a stable plateau plasma level after 3 weeks of use of the toothpaste, deodorant, and soap. The results showed plasma levels of: 19-23 ppb (exposure to toothpaste only), and 29-31 ppb (exposure to toothpaste, deodorant, and soap). 3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab. 27) to derive plasma level based MoS. Types of Products Used SED (mg/kg bw/d) MoS Based on Rat NOAEL of 12 mg/kg bw/d MoS Based on Plasma Levels Toothpaste 0.0234 513 1408 Toothpaste, deodorant stick, and hand soap 0.0315 381 939 Common-Use Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick) 0.0583 206 Not done (no human plasma data available) All Products 0.15 – 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab.","duration":"13 weeks","effect":"losan) and a deodorant (0.39% triclosan) for 13 weeks. The results of this study indicated that all subjects reached a stable plateau plasma level after 3 weeks of use of the toothpaste, deodorant, and soap. The results showed plasma levels of: 19-23 ppb (exposure to toothpaste only), and 29-31 ppb (exposure to toothpaste, deodorant, and soap). 3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab. 27) to derive plasma level based MoS. Types of Products Used SED (mg/kg bw/d) MoS Based on Rat NOAEL of 12 mg/kg bw/d MoS Based on Plasma Levels Toothpaste 0.0234 513 1408 Toothpaste, deodorant stick, and hand soap 0.0315 381 939 Common-Use Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick) 0.0583 206 Not done (no human plasma data available) All Products 0.15 – 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12","page":119,"route":"","species":"rat","study_id":"sccp_o_166_noael_114"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
12 |
mg/kg bw/d |
rat |
- |
3 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab.; EFFECT=u plasma level after 3 weeks of use of the toothpaste, deodorant, and soap. The results showed plasma levels of: 19-23 ppb (exposure to toothpaste only), and 29-31 ppb (exposure to toothpaste, deodorant, and soap). 3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab. 27) to derive plasma level based MoS. Types of Products Used SED (mg/kg bw/d) MoS Based on Rat NOAEL of 12 mg/kg bw/d MoS Based on Plasma Levels Toothpaste 0.0234 513 1408 Toothpaste, deodorant stick, and hand soap 0.0315 381 939 Common-Use Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick) 0.0583 206 Not done (no human plasma data available) All Products 0.15 – 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash, body lotion, face powder, blemish concealer) 0.2449 49 Not done (no human plasma data available) All Products 0.3% triclosan (to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab.","duration":"3 weeks","effect":"u plasma level after 3 weeks of use of the toothpaste, deodorant, and soap. The results showed plasma levels of: 19-23 ppb (exposure to toothpaste only), and 29-31 ppb (exposure to toothpaste, deodorant, and soap). 3.3.13.2 Safety Assessment The human plasma levels can be compared to the plasma level (of 28,160 ng/ml) reported in studies with rats that received triclosan doses at the NOAEL of 12 mg/kg bw/day (see Tab. 27) to derive plasma level based MoS. Types of Products Used SED (mg/kg bw/d) MoS Based on Rat NOAEL of 12 mg/kg bw/d MoS Based on Plasma Levels Toothpaste 0.0234 513 1408 Toothpaste, deodorant stick, and hand soap 0.0315 381 939 Common-Use Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick) 0.0583 206 Not done (no human plasma data available) All Products 0.15 – 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash, body lotion, face powder, blemish concealer) 0.2449 49 Not done (no human plasma data available) All Products 0.3% triclosan (to","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"12","page":119,"route":"","species":"rat","study_id":"sccp_o_166_noael_115"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
30 |
mg/kg/day |
human |
oral |
chronic |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=Because of some uncertainties in converting spot urine concentrations to estimated dose, three conversion methods were used.; EFFECT=animals make human data the first choice for the safety evaluation of triclosan-containing consumer products. Other aspects Recently, the US EPA (2008) utilized population-based biological monitoring data for triclosan (available from the NHANES study) to assess the co-occurrence of uses to develop an aggregate exposure assessment. Because of some uncertainties in converting spot urine concentrations to estimated dose, three conversion methods were used. Calculated exposure was then compared to the selected oral NOAEL of 30 mg/kg/day (from the chronic toxicity study in baboons). Based on the results at the mean and 99th percentile, the aggregate risks to triclosan from all (personal care and other consumer products) uses did not trigger a risk of concern. The mean MOEs ranged from 4,700 to 19,000. The MOEs at the 99th percentile ranged from 260 to 1,500 [US EPA 2008, AR9]. Exposure estimates based on biological monitoring data from the US are considered by SCCP as useful additional information in their overall evaluation on the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Because of some uncertainties in converting spot urine concentrations to estimated dose, three conversion methods were used.","duration":"chronic","effect":"animals make human data the first choice for the safety evaluation of triclosan-containing consumer products. Other aspects Recently, the US EPA (2008) utilized population-based biological monitoring data for triclosan (available from the NHANES study) to assess the co-occurrence of uses to develop an aggregate exposure assessment. Because of some uncertainties in converting spot urine concentrations to estimated dose, three conversion methods were used. Calculated exposure was then compared to the selected oral NOAEL of 30 mg/kg/day (from the chronic toxicity study in baboons). Based on the results at the mean and 99th percentile, the aggregate risks to triclosan from all (personal care and other consumer products) uses did not trigger a risk of concern. The mean MOEs ranged from 4,700 to 19,000. The MOEs at the 99th percentile ranged from 260 to 1,500 [US EPA 2008, AR9]. Exposure estimates based on biological monitoring data from the US are considered by SCCP as useful additional information in their overall evaluation on the","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":122,"route":"oral","species":"human","study_id":"sccp_o_166_noael_121"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
30 |
mg/kg/d |
human |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations).; EFFECT=e risks to triclosan from all (personal care and other consumer products) uses did not trigger a risk of concern. The mean MOEs ranged from 4,700 to 19,000. The MOEs at the 99th percentile ranged from 260 to 1,500 [US EPA 2008, AR9]. Exposure estimates based on biological monitoring data from the US are considered by SCCP as useful additional information in their overall evaluation on the safety of triclosan. The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations). The SCCP approach is in line with the evaluation of triclosan by EFSA for its use in food contact materials. - US-EPA has estimated triclosan exposure in the US population on the basis of biomonitoring data from spot urine samples. Although this approach probably reflects exposure from current use concentratio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations).","duration":"","effect":"e risks to triclosan from all (personal care and other consumer products) uses did not trigger a risk of concern. The mean MOEs ranged from 4,700 to 19,000. The MOEs at the 99th percentile ranged from 260 to 1,500 [US EPA 2008, AR9]. Exposure estimates based on biological monitoring data from the US are considered by SCCP as useful additional information in their overall evaluation on the safety of triclosan. The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations). The SCCP approach is in line with the evaluation of triclosan by EFSA for its use in food contact materials. - US-EPA has estimated triclosan exposure in the US population on the basis of biomonitoring data from spot urine samples. Although this approach probably reflects exposure from current use concentratio","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg/d","noael_value":"30","page":122,"route":"","species":"human","study_id":"sccp_o_166_noael_122"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
12 |
mg/kg/d |
human |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations).; EFFECT=and other consumer products) uses did not trigger a risk of concern. The mean MOEs ranged from 4,700 to 19,000. The MOEs at the 99th percentile ranged from 260 to 1,500 [US EPA 2008, AR9]. Exposure estimates based on biological monitoring data from the US are considered by SCCP as useful additional information in their overall evaluation on the safety of triclosan. The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations). The SCCP approach is in line with the evaluation of triclosan by EFSA for its use in food contact materials. - US-EPA has estimated triclosan exposure in the US population on the basis of biomonitoring data from spot urine samples. Although this approach probably reflects exposure from current use concentrations in various products on the US market, it; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations).","duration":"","effect":"and other consumer products) uses did not trigger a risk of concern. The mean MOEs ranged from 4,700 to 19,000. The MOEs at the 99th percentile ranged from 260 to 1,500 [US EPA 2008, AR9]. Exposure estimates based on biological monitoring data from the US are considered by SCCP as useful additional information in their overall evaluation on the safety of triclosan. The difference in SCCP and US-EPA evaluations of triclosan may be explained as follows: - USA-EPA chose a NOAEL of 30 mg/kg/d whereas SCCP selected a NOAEL of 12 mg/kg/d (based on haemotoxicity) as the critical effect level against which human exposure to triclosan is compared (for subsequent MOE or MOS calculations). The SCCP approach is in line with the evaluation of triclosan by EFSA for its use in food contact materials. - US-EPA has estimated triclosan exposure in the US population on the basis of biomonitoring data from spot urine samples. Although this approach probably reflects exposure from current use concentrations in various products on the US market, it","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg/d","noael_value":"12","page":122,"route":"","species":"human","study_id":"sccp_o_166_noael_123"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
11 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 11: Fin: increase in number | and/or size of | peroxisomes. No NOAEL; EFFECT=Table 11: Fin: increase in number | and/or size of | peroxisomes. No NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 11: Fin: increase in number | and/or size of | peroxisomes. No NOAEL","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 11: Fin: increase in number | and/or size of | peroxisomes. No NOAEL","page":23,"route":"","species":"","study_id":"sccp_o_166_noael_128"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
900 |
mg/kg bw/d |
- |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=900; DOSE=Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture.; EFFECT=Unlabeled table on page 27: Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture. Interim sacrifice at Week 7. | Conducted pursuant to OECD Guideline No. 408. Decreased body weight gains were observed at ≥750 mg/kg bw/d. Food consumption was decreased in males at 900 mg/kg bw/d and females at ≥350 mg/kg bw/d. Water consumption was increased at all groups given 200 mg/kg bw/d and higher. Increased coagulation times, changes in red cell morphology and red cell indices in high-dose animals (≥750 mg/kg bw/d). Slightly increased alanine aminotransferase levels in females at the highest dose, and in both sexes increased cholesterol at the highest dose. At ≥750 mg/kg bw/d, decreased levels of alkaline phosphatase were observed. At 900 mg/kg bw/d, decreased gamma glutamyltransferase was observed. Urinalysis revealed polyuria, haemoglobinuria and haematouria in all animals given ≥350 mg/kg bw/d. Interim and terminal necropsy revealed no change in any major organ weight in females. In males, increased absolute and relative kidney weights at 750...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture.","duration":"13 weeks","effect":"Unlabeled table on page 27: Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture. Interim sacrifice at Week 7. | Conducted pursuant to OECD Guideline No. 408. Decreased body weight gains were observed at ≥750 mg/kg bw/d. Food consumption was decreased in males at 900 mg/kg bw/d and females at ≥350 mg/kg bw/d. Water consumption was increased at all groups given 200 mg/kg bw/d and higher. Increased coagulation times, changes in red cell morphology and red cell indices in high-dose animals (≥750 mg/kg bw/d). Slightly increased alanine aminotransferase levels in females at the highest dose, and in both sexes increased cholesterol at the highest dose. At ≥750 mg/kg bw/d, decreased levels of alkaline phosphatase were observed. At 900 mg/kg bw/d, decreased gamma glutamyltransferase was observed. Urinalysis revealed polyuria, haemoglobinuria and haematouria in all animals given ≥350 mg/kg bw/d. Interim and terminal necropsy revealed no change in any major organ weight in females. In males, increased absolute and relative kidney weights at 750...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"900","page":27,"route":"oral","species":"","study_id":"sccp_o_166_noael_131"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
750 |
mg/kg bw/d |
- |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=750; DOSE=Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture.; EFFECT=Unlabeled table on page 27: Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture. Interim sacrifice at Week 7. | Conducted pursuant to OECD Guideline No. 408. Decreased body weight gains were observed at ≥750 mg/kg bw/d. Food consumption was decreased in males at 900 mg/kg bw/d and females at ≥350 mg/kg bw/d. Water consumption was increased at all groups given 200 mg/kg bw/d and higher. Increased coagulation times, changes in red cell morphology and red cell indices in high-dose animals (≥750 mg/kg bw/d). Slightly increased alanine aminotransferase levels in females at the highest dose, and in both sexes increased cholesterol at the highest dose. At ≥750 mg/kg bw/d, decreased levels of alkaline phosphatase were observed. At 900 mg/kg bw/d, decreased gamma glutamyltransferase was observed. Urinalysis revealed polyuria, haemoglobinuria and haematouria in all animals given ≥350 mg/kg bw/d. Interim and terminal necropsy revealed no change in any major organ weight in females. In males, increased absolute and relative kidney weights at 750...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture.","duration":"13 weeks","effect":"Unlabeled table on page 27: Hamster (Syrian Golden) | 0, 75, 200, 350, 750 or 900 mg/kg bw/d for 13 weeks via dietary admixture. Interim sacrifice at Week 7. | Conducted pursuant to OECD Guideline No. 408. Decreased body weight gains were observed at ≥750 mg/kg bw/d. Food consumption was decreased in males at 900 mg/kg bw/d and females at ≥350 mg/kg bw/d. Water consumption was increased at all groups given 200 mg/kg bw/d and higher. Increased coagulation times, changes in red cell morphology and red cell indices in high-dose animals (≥750 mg/kg bw/d). Slightly increased alanine aminotransferase levels in females at the highest dose, and in both sexes increased cholesterol at the highest dose. At ≥750 mg/kg bw/d, decreased levels of alkaline phosphatase were observed. At 900 mg/kg bw/d, decreased gamma glutamyltransferase was observed. Urinalysis revealed polyuria, haemoglobinuria and haematouria in all animals given ≥350 mg/kg bw/d. Interim and terminal necropsy revealed no change in any major organ weight in females. In males, increased absolute and relative kidney weights at 750...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"750","page":27,"route":"oral","species":"","study_id":"sccp_o_166_noael_132"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
25 |
mg/kg bw/d |
dog |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; DOSE=Dog (Beagle) | 0, 5, 12.5 or 25 mg/kg bw/d via diet for 90 days. | Conducted prior to OECD guidelines, but considered similar in design.; EFFECT=Unlabeled table on page 30: Dog (Beagle) | 0, 5, 12.5 or 25 mg/kg bw/d via diet for 90 days. | Conducted prior to OECD guidelines, but considered similar in design. Occasional pasty to thin faeces were noted in all groups. Haematology, clinical chemistry and urinalysis evaluations were limited to high-dose group animals. Macroscopic evaluations found no gross pathology for any organ. Organ weight measurements showed no changes in relative or absolute weights. Histopathologic evaluation of all major organs from all animals showed no difference among treated and control animals. No NOAEL was determined in this study, in which the highest dose used did not produce treatment-related effects. | Leuschner et al., 1970b (39); Predates GLP and OECD OECD: comparable; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Dog (Beagle) | 0, 5, 12.5 or 25 mg/kg bw/d via diet for 90 days. | Conducted prior to OECD guidelines, but considered similar in design.","duration":"90 days","effect":"Unlabeled table on page 30: Dog (Beagle) | 0, 5, 12.5 or 25 mg/kg bw/d via diet for 90 days. | Conducted prior to OECD guidelines, but considered similar in design. Occasional pasty to thin faeces were noted in all groups. Haematology, clinical chemistry and urinalysis evaluations were limited to high-dose group animals. Macroscopic evaluations found no gross pathology for any organ. Organ weight measurements showed no changes in relative or absolute weights. Histopathologic evaluation of all major organs from all animals showed no difference among treated and control animals. No NOAEL was determined in this study, in which the highest dose used did not produce treatment-related effects. | Leuschner et al., 1970b (39); Predates GLP and OECD OECD: comparable","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":30,"route":"oral","species":"dog","study_id":"sccp_o_166_noael_136"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg bw/d |
- |
- |
4-week |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules.; EFFECT=Unlabeled table on page 30: Baboons (papio cynocephalus and anubis) | 4-week dosing: 0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules. 13-week dosing: 0 or 3 mg/kg bw/d via gelatine capsules. | Conducted prior to OECD guidelines, but considered comparable in design (but limited in number of parameters evaluated). Blood chemistry revealed no haematology changes. Urinalysis showed no changes. Clinical chemistry changes included high plasma urea levels in 2 animals at 30 mg/kg bw/d, 2 animals at 3 mg/kg bw/d, 1 control baboon and increased SGPT in individual male baboons at 1 mg/kg bw/d and 3 mg/kg bw/d. Terminal necropsy after 4 weeks and after 13 weeks showed no organ weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from thi...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules.","duration":"4-week","effect":"Unlabeled table on page 30: Baboons (papio cynocephalus and anubis) | 4-week dosing: 0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules. 13-week dosing: 0 or 3 mg/kg bw/d via gelatine capsules. | Conducted prior to OECD guidelines, but considered comparable in design (but limited in number of parameters evaluated). Blood chemistry revealed no haematology changes. Urinalysis showed no changes. Clinical chemistry changes included high plasma urea levels in 2 animals at 30 mg/kg bw/d, 2 animals at 3 mg/kg bw/d, 1 control baboon and increased SGPT in individual male baboons at 1 mg/kg bw/d and 3 mg/kg bw/d. Terminal necropsy after 4 weeks and after 13 weeks showed no organ weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from thi...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":30,"route":"","species":"","study_id":"sccp_o_166_noael_137"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/d |
- |
- |
1 year |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year.; EFFECT=Unlabeled table on page 30: Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). | Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29 and 52 in mid and high-dose groups. In females, slight decreases in erythroid parameters at all time points were observed for the high-dose group (statistically significant only up to Week 26). Incidental changes in potassium and sodium were observed. Slight changes, both increases and decreases in SGOT and AP were observed; however, not considered treatment-related. No differences were found in urinalysis. At necropsy, decreased absolute brain and increases in kidney and liver weights were observed in high-dose animals. Histopathologic examination found similar histology in both treated and control animals. The NOEL was determined to be 3...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year.","duration":"1 year","effect":"Unlabeled table on page 30: Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). | Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29 and 52 in mid and high-dose groups. In females, slight decreases in erythroid parameters at all time points were observed for the high-dose group (statistically significant only up to Week 26). Incidental changes in potassium and sodium were observed. Slight changes, both increases and decreases in SGOT and AP were observed; however, not considered treatment-related. No differences were found in urinalysis. At necropsy, decreased absolute brain and increases in kidney and liver weights were observed in high-dose animals. Histopathologic examination found similar histology in both treated and control animals. The NOEL was determined to be 3...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":30,"route":"","species":"","study_id":"sccp_o_166_noael_138"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
30 |
mg/kg bw/d |
- |
- |
4-week |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules.; EFFECT=Unlabeled table on page 30: Baboons (papio cynocephalus and anubis) | 4-week dosing: 0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules. 13-week dosing: 0 or 3 mg/kg bw/d via gelatine capsules. | Conducted prior to OECD guidelines, but considered comparable in design (but limited in number of parameters evaluated). Blood chemistry revealed no haematology changes. Urinalysis showed no changes. Clinical chemistry changes included high plasma urea levels in 2 animals at 30 mg/kg bw/d, 2 animals at 3 mg/kg bw/d, 1 control baboon and increased SGPT in individual male baboons at 1 mg/kg bw/d and 3 mg/kg bw/d. Terminal necropsy after 4 weeks and after 13 weeks showed no organ weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from thi...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules.","duration":"4-week","effect":"Unlabeled table on page 30: Baboons (papio cynocephalus and anubis) | 4-week dosing: 0, 1, 10, 30, or 100 mg/kg bw/d via gelatine capsules. 13-week dosing: 0 or 3 mg/kg bw/d via gelatine capsules. | Conducted prior to OECD guidelines, but considered comparable in design (but limited in number of parameters evaluated). Blood chemistry revealed no haematology changes. Urinalysis showed no changes. Clinical chemistry changes included high plasma urea levels in 2 animals at 30 mg/kg bw/d, 2 animals at 3 mg/kg bw/d, 1 control baboon and increased SGPT in individual male baboons at 1 mg/kg bw/d and 3 mg/kg bw/d. Terminal necropsy after 4 weeks and after 13 weeks showed no organ weight differences among treated and controls. No gross macroscopic findings were observed. After 4 weeks of treatment, minor changes such as dark nodules in the large intestine wall at ≥10 mg/kg bw/d. Adhesion in lung surface and rib cage, slight thickening of capsule of the liver in 10 mg/kg bw/d female and 1 mg/kg bw/d male, and control male and female were observed. Limited conclusions can be derived from thi...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":30,"route":"","species":"","study_id":"sccp_o_166_noael_139"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
30 |
mg/kg bw/d |
- |
- |
1 year |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year.; EFFECT=Unlabeled table on page 30: Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). | Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29 and 52 in mid and high-dose groups. In females, slight decreases in erythroid parameters at all time points were observed for the high-dose group (statistically significant only up to Week 26). Incidental changes in potassium and sodium were observed. Slight changes, both increases and decreases in SGOT and AP were observed; however, not considered treatment-related. No differences were found in urinalysis. At necropsy, decreased absolute brain and increases in kidney and liver weights were observed in high-dose animals. Histopathologic examination found similar histology in both treated and control animals. The NOEL was determined to be 3...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year.","duration":"1 year","effect":"Unlabeled table on page 30: Baboons (papio) | 0, 30, 100, or 300 mg/kg bw/d via capsules daily for 1 year. Necropsies were scheduled at 6 months, 12 months, and 13 months (28 days post-treatment). | Conducted prior to OECD guidelines, but considered similar in design (but limited in number of parameters evaluated). Vomiting and diarrhoea occurred at mid and high-doses. Haematology parameters showed decreased white blood cells in males at Week 29 and 52 in mid and high-dose groups. In females, slight decreases in erythroid parameters at all time points were observed for the high-dose group (statistically significant only up to Week 26). Incidental changes in potassium and sodium were observed. Slight changes, both increases and decreases in SGOT and AP were observed; however, not considered treatment-related. No differences were found in urinalysis. At necropsy, decreased absolute brain and increases in kidney and liver weights were observed in high-dose animals. Histopathologic examination found similar histology in both treated and control animals. The NOEL was determined to be 3...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":30,"route":"","species":"","study_id":"sccp_o_166_noael_140"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
30 |
mg/kg bw/d |
- |
oral |
1 year |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=Long term (1 year) oral toxicity study in baboons | NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study.; EFFECT=Unlabeled table on page 34: Long term (1 year) oral toxicity study in baboons | NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Long term (1 year) oral toxicity study in baboons | NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study.","duration":"1 year","effect":"Unlabeled table on page 34: Long term (1 year) oral toxicity study in baboons | NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study.","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":34,"route":"oral","species":"","study_id":"sccp_o_166_noael_146"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
422 |
mg/kg bw/d |
rat |
- |
52 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=422; DOSE=Unlabeled table on page 57: group (247 or 422 mg/kg bw/d in males and females) at 52 weeks | weeks.; EFFECT=Unlabeled table on page 57: group (247 or 422 mg/kg bw/d in males and females) at 52 weeks | weeks. No other histological lesions, either neoplastic or non-neoplastic, were observed that were considered to be treatment-related. Specifically, there were no treatment-related tumours, including hepatic tumours, in any of the treated rats examined histologically at 52 or 104 weeks. Animals in the additional high-dose group killed at 52 weeks (247 or 422 mg/kg bw/d in males and females, respectively) showed similar types of toxicity as the main study animals, excepting that the severity or incidences of events were increased. No tumours were observed in these animals. In summary, the results show that triclosan is not tumourigenic in a 2-year study in rats at doses of up to 127 mg/kg bw/d in males and 190 mg/kg bw/d in females. A NOEL of 1,000 ppm was determined (48 mg/kg bw/d for females and males combined).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Unlabeled table on page 57: group (247 or 422 mg/kg bw/d in males and females) at 52 weeks | weeks.","duration":"52 weeks","effect":"Unlabeled table on page 57: group (247 or 422 mg/kg bw/d in males and females) at 52 weeks | weeks. No other histological lesions, either neoplastic or non-neoplastic, were observed that were considered to be treatment-related. Specifically, there were no treatment-related tumours, including hepatic tumours, in any of the treated rats examined histologically at 52 or 104 weeks. Animals in the additional high-dose group killed at 52 weeks (247 or 422 mg/kg bw/d in males and females, respectively) showed similar types of toxicity as the main study animals, excepting that the severity or incidences of events were increased. No tumours were observed in these animals. In summary, the results show that triclosan is not tumourigenic in a 2-year study in rats at doses of up to 127 mg/kg bw/d in males and 190 mg/kg bw/d in females. A NOEL of 1,000 ppm was determined (48 mg/kg bw/d for females and males combined).","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"422","page":57,"route":"","species":"rat","study_id":"sccp_o_166_noael_151"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
250 |
mg/kg bw/d |
- |
oral |
52- week |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=250; DOSE=Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females:; EFFECT=Unlabeled table on page 57: Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females: 90 weeks Males: 95 weeks | Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food consumption in high-dose females. Biochemical changes observed at termination included increases (<50%) in blood urea nitrogen in high-dose hamsters and in triglycerides in mid- and high-dose males. Haematological changes observed included slight (<15%), but significant decreases in erythroid parameters in mid- and high-dose animals, increased white blood cells in high-dose animals, and increased lymphocytes in high-dose females at termination. Significant observations at 52 weeks (interim) were mainly renal changes in high-dose animals. At termination, renal nephropathy was observed in animals of all dose groups, with increased incidence and severity at the high...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females:","duration":"52- week","effect":"Unlabeled table on page 57: Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females: 90 weeks Males: 95 weeks | Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food consumption in high-dose females. Biochemical changes observed at termination included increases (<50%) in blood urea nitrogen in high-dose hamsters and in triglycerides in mid- and high-dose males. Haematological changes observed included slight (<15%), but significant decreases in erythroid parameters in mid- and high-dose animals, increased white blood cells in high-dose animals, and increased lymphocytes in high-dose females at termination. Significant observations at 52 weeks (interim) were mainly renal changes in high-dose animals. At termination, renal nephropathy was observed in animals of all dose groups, with increased incidence and severity at the high...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":57,"route":"oral","species":"","study_id":"sccp_o_166_noael_152"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
38 |
% |
- |
oral |
52- week |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=38-58; DOSE=Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females:; EFFECT=Unlabeled table on page 57: Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females: 90 weeks Males: 95 weeks | Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food consumption in high-dose females. Biochemical changes observed at termination included increases (<50%) in blood urea nitrogen in high-dose hamsters and in triglycerides in mid- and high-dose males. Haematological changes observed included slight (<15%), but significant decreases in erythroid parameters in mid- and high-dose animals, increased white blood cells in high-dose animals, and increased lymphocytes in high-dose females at termination. Significant observations at 52 weeks (interim) were mainly renal changes in high-dose animals. At termination, renal nephropathy was observed in animals of all dose groups, with increased incidence and severity at the high...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females:","duration":"52- week","effect":"Unlabeled table on page 57: Hamster (Syrian) | Oral (diet) doses of 0, 12, 75, or 250 mg/kg bw/d 60/sex/ dose + 10/sex/ dose (52- week interim) | Females: 90 weeks Males: 95 weeks | Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food consumption in high-dose females. Biochemical changes observed at termination included increases (<50%) in blood urea nitrogen in high-dose hamsters and in triglycerides in mid- and high-dose males. Haematological changes observed included slight (<15%), but significant decreases in erythroid parameters in mid- and high-dose animals, increased white blood cells in high-dose animals, and increased lymphocytes in high-dose females at termination. Significant observations at 52 weeks (interim) were mainly renal changes in high-dose animals. At termination, renal nephropathy was observed in animals of all dose groups, with increased incidence and severity at the high...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"38-58","page":57,"route":"oral","species":"","study_id":"sccp_o_166_noael_153"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
17 |
- |
mouse |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 17: Summ: Mouse | 10 | No overall NOAEL | due to hepatotoxic ef | fects; EFFECT=Table 17: Summ: Mouse | 10 | No overall NOAEL | due to hepatotoxic ef | fects; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: Mouse | 10 | No overall NOAEL | due to hepatotoxic ef | fects","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 17: Summ: Mouse | 10 | No overall NOAEL | due to hepatotoxic ef | fects","page":59,"route":"","species":"mouse","study_id":"sccp_o_166_noael_154"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
17 |
- |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 17: Summ: Rat | ~48 (NOAEL)1 | NOAEL based on s | ystemic toxicity. The | re was no; EFFECT=Table 17: Summ: Rat | ~48 (NOAEL)1 | NOAEL based on s | ystemic toxicity. The | re was no; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: Rat | ~48 (NOAEL)1 | NOAEL based on s | ystemic toxicity. The | re was no","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 17: Summ: Rat | ~48 (NOAEL)1 | NOAEL based on s | ystemic toxicity. The | re was no","page":59,"route":"","species":"rat","study_id":"sccp_o_166_noael_155"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
17 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 17: Summ: Hamster | 75 | NOAEL based on s | ystemic toxicity. The | re was no; EFFECT=Table 17: Summ: Hamster | 75 | NOAEL based on s | ystemic toxicity. The | re was no; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: Hamster | 75 | NOAEL based on s | ystemic toxicity. The | re was no","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 17: Summ: Hamster | 75 | NOAEL based on s | ystemic toxicity. The | re was no","page":59,"route":"","species":"","study_id":"sccp_o_166_noael_156"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
ppm |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=1 1,000 ppm ~48 mg/k | g body | weight/day for males a | nd fe | males, combined.; EFFECT=Table 17: Summ: 1 1,000 ppm ~48 mg/k | g body | weight/day for males a | nd fe | males, combined.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"1 1,000 ppm ~48 mg/k | g body | weight/day for males a | nd fe | males, combined.","duration":"","effect":"Table 17: Summ: 1 1,000 ppm ~48 mg/k | g body | weight/day for males a | nd fe | males, combined.","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":59,"route":"","species":"","study_id":"sccp_o_166_noael_157"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
988 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=988 (69)]. Th; EFFECT=Table 17: Summ: reproduction and | post-n | atal data [Morset | h, 1 | 988 (69)]. Th | e study was co | nsistent with; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: reproduction and | post-n | atal data [Morset | h, 1 | 988 (69)]. Th | e study was co | nsistent with","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"988 (69)]. Th","page":59,"route":"","species":"","study_id":"sccp_o_166_noael_159"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1992 |
- |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=et al., 1992 (7; EFFECT=Table 17: Summ: Wistar rats provid | ed pos | t-natal data [Denn | ing | et al., 1992 (7 | 4)]. This study | was generally; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: Wistar rats provid | ed pos | t-natal data [Denn | ing | et al., 1992 (7 | 4)]. This study | was generally","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"et al., 1992 (7","page":59,"route":"","species":"rat","study_id":"sccp_o_166_noael_160"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
9 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=9)], that matu; EFFECT=Table 17: Summ: [i.e., as for the | study | by Morseth, 1988 | (6 | 9)], that matu | ration and ferti | lity were not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: [i.e., as for the | study | by Morseth, 1988 | (6 | 9)], that matu | ration and ferti | lity were not","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"9)], that matu","page":59,"route":"","species":"","study_id":"sccp_o_166_noael_161"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
229 |
mg/kg bw/d |
rat |
oral |
10 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=229; DOSE=73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing.; EFFECT=Unlabeled table on page 60: 73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing. Both males and females were dosed starting 10 weeks prior to mating. The rats received the appropriate control or test diet throughout the growth, mating, gestation, and lactation phases, or until terminal sacrifice. | Post-natal Parameters: F Generation: Post-natal survival from Day 0 to Day 4 (i.e., 1 viability index) was slightly reduced in the high-dose group (90, 94, 96, and 82% in the control, 300, 1,000, and 3,000 ppm groups, respectively). Adjusted mean body weights of pups in the high-dose group were generally lower than controls throughout the Day 0 to 21 lactation period. With regard to development, mean body weights of high-dose pups were lower than controls during Weeks 0 to 12. Mean body weights were slightly decreased in low- dose group females vs. controls during Weeks 4-8 and 11. Overall, the most common findings were dilated pelvises of the kidney that showed a slight increase in incidence at the high dose in pups, but no differe...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing.","duration":"10 weeks","effect":"Unlabeled table on page 60: 73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing. Both males and females were dosed starting 10 weeks prior to mating. The rats received the appropriate control or test diet throughout the growth, mating, gestation, and lactation phases, or until terminal sacrifice. | Post-natal Parameters: F Generation: Post-natal survival from Day 0 to Day 4 (i.e., 1 viability index) was slightly reduced in the high-dose group (90, 94, 96, and 82% in the control, 300, 1,000, and 3,000 ppm groups, respectively). Adjusted mean body weights of pups in the high-dose group were generally lower than controls throughout the Day 0 to 21 lactation period. With regard to development, mean body weights of high-dose pups were lower than controls during Weeks 0 to 12. Mean body weights were slightly decreased in low- dose group females vs. controls during Weeks 4-8 and 11. Overall, the most common findings were dilated pelvises of the kidney that showed a slight increase in incidence at the high dose in pups, but no differe...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"229","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_162"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=Rat (Colworth Wistar) | Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation | [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters:; EFFECT=Unlabeled table on page 60: Rat (Colworth Wistar) | Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation | [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data indicate that a Foetal and Post-Natal NOEL of 300 mg/kg bw/d would be appropriate, based on the lack of foetal and pup effects at this dose. | Denning et al., 1992 (70); GLP- compliant2 OECD: comparable; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rat (Colworth Wistar) | Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation | [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters:","duration":"","effect":"Unlabeled table on page 60: Rat (Colworth Wistar) | Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation | [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data indicate that a Foetal and Post-Natal NOEL of 300 mg/kg bw/d would be appropriate, based on the lack of foetal and pup effects at this dose. | Denning et al., 1992 (70); GLP- compliant2 OECD: comparable","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_163"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
82 |
% |
rat |
oral |
10 weeks |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=82; DOSE=73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing.; EFFECT=Unlabeled table on page 60: 73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing. Both males and females were dosed starting 10 weeks prior to mating. The rats received the appropriate control or test diet throughout the growth, mating, gestation, and lactation phases, or until terminal sacrifice. | Post-natal Parameters: F Generation: Post-natal survival from Day 0 to Day 4 (i.e., 1 viability index) was slightly reduced in the high-dose group (90, 94, 96, and 82% in the control, 300, 1,000, and 3,000 ppm groups, respectively). Adjusted mean body weights of pups in the high-dose group were generally lower than controls throughout the Day 0 to 21 lactation period. With regard to development, mean body weights of high-dose pups were lower than controls during Weeks 0 to 12. Mean body weights were slightly decreased in low- dose group females vs. controls during Weeks 4-8 and 11. Overall, the most common findings were dilated pelvises of the kidney that showed a slight increase in incidence at the high dose in pups, but no differe...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing.","duration":"10 weeks","effect":"Unlabeled table on page 60: 73, and 229 mg/kg bw/d in females, based on food consumption and body weight data after 10 weeks of dosing. Both males and females were dosed starting 10 weeks prior to mating. The rats received the appropriate control or test diet throughout the growth, mating, gestation, and lactation phases, or until terminal sacrifice. | Post-natal Parameters: F Generation: Post-natal survival from Day 0 to Day 4 (i.e., 1 viability index) was slightly reduced in the high-dose group (90, 94, 96, and 82% in the control, 300, 1,000, and 3,000 ppm groups, respectively). Adjusted mean body weights of pups in the high-dose group were generally lower than controls throughout the Day 0 to 21 lactation period. With regard to development, mean body weights of high-dose pups were lower than controls during Weeks 0 to 12. Mean body weights were slightly decreased in low- dose group females vs. controls during Weeks 4-8 and 11. Overall, the most common findings were dilated pelvises of the kidney that showed a slight increase in incidence at the high dose in pups, but no differe...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"82","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_164"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg bw/d |
mouse |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=Unlabeled table on page 62: mouse in the 75 mg/kg bw/d dose group.; EFFECT=Unlabeled table on page 62: mouse in the 75 mg/kg bw/d dose group. Foetal Parameters: Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group. There were reversible delays in ossification caused by the test article in the 75 and 350 mg/kg bw/d dosage groups, including skull ossification and reductions in the average numbers of ossified forepaw phalanges and hind paw phalanges. There were no other remarkable findings. Maternal NOEL = 25 mg/kg bw/d (based on tan- coloured livers and increased liver weights) Foetal NOEL = 25 mg/kg bw/d (based on decreased foetal body weights and delayed ossification) | OECD: consistent with “Teratogenicity” guideline; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Unlabeled table on page 62: mouse in the 75 mg/kg bw/d dose group.","duration":"","effect":"Unlabeled table on page 62: mouse in the 75 mg/kg bw/d dose group. Foetal Parameters: Foetal body weight data were slightly lower for the 75 and 350 mg/kg bw/d groups compared to the vehicle control group. There were reversible delays in ossification caused by the test article in the 75 and 350 mg/kg bw/d dosage groups, including skull ossification and reductions in the average numbers of ossified forepaw phalanges and hind paw phalanges. There were no other remarkable findings. Maternal NOEL = 25 mg/kg bw/d (based on tan- coloured livers and increased liver weights) Foetal NOEL = 25 mg/kg bw/d (based on decreased foetal body weights and delayed ossification) | OECD: consistent with “Teratogenicity” guideline","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":62,"route":"","species":"mouse","study_id":"sccp_o_166_noael_166"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=Rat (Charles River CD® Sprague- Dawley derived) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Dose range finding study.; EFFECT=Unlabeled table on page 62: Rat (Charles River CD® Sprague- Dawley derived) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high dose were due to the weight loss in a single dam. There were no other remarkable findings. Foetal Parameters: Foetal body weight data were lower for all treatment groups vs. controls; however, only the 75 mg/kg bw/d group had foetal body weights outside the low range of historical control data. There were no other remarkable findings. Study investigators did not determine NOEL values for this study. | Bio/dynamics, 1992a (72) GLP-compliant OECD: not applicable for a dose range finding study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rat (Charles River CD® Sprague- Dawley derived) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Dose range finding study.","duration":"","effect":"Unlabeled table on page 62: Rat (Charles River CD® Sprague- Dawley derived) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Dose range finding study. Maternal Parameters: The lower maternal body weights that occurred at the high dose were due to the weight loss in a single dam. There were no other remarkable findings. Foetal Parameters: Foetal body weight data were lower for all treatment groups vs. controls; however, only the 75 mg/kg bw/d group had foetal body weights outside the low range of historical control data. There were no other remarkable findings. Study investigators did not determine NOEL values for this study. | Bio/dynamics, 1992a (72) GLP-compliant OECD: not applicable for a dose range finding study","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_167"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
150 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; DOSE=Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters:; EFFECT=Unlabeled table on page 62: Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) | Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters:","duration":"","effect":"Unlabeled table on page 62: Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) | Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_168"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=Rat (Colworth Wistar) | 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) | Maternal Parameters:; EFFECT=Unlabeled table on page 62: Rat (Colworth Wistar) | 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) | Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). | Denning et al., 1992 (74); GLP-compliant2 OECD: comparable; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rat (Colworth Wistar) | 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) | Maternal Parameters:","duration":"","effect":"Unlabeled table on page 62: Rat (Colworth Wistar) | 0, 30, 100, 300 mg/kg bw/d via oral gavage in corn oil (Days 6-15 of gestation) | Maternal Parameters: At the 300 mg/kg bw/d dose level, slight maternal toxicity was manifested as transient diarrhoea, retarded body weight gain (e.g., 9.4 vs. 13.0 g for controls during the period of Days 6 to 10), and reduced food consumption (5-15% decrease vs. controls), and increased water intake (<10% increase vs. controls). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings. Study investigators did not determine NOEL values for this study. However, the data indicate that a Maternal NOEL of 100 mg/kg bw/d would be appropriate, based on decreased body weights and slight diarrhoea, with a Foetal NOEL of 300 mg/kg bw/d (based on a lack of foetal effects). | Denning et al., 1992 (74); GLP-compliant2 OECD: comparable","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_169"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=50 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 50; DOSE=Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters:; EFFECT=Unlabeled table on page 62: Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) | Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters:","duration":"","effect":"Unlabeled table on page 62: Rat (Charles River CD® Sprague- Dawley derived) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage, in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-15 of gestation) | Maternal Parameters: There was a slight but significant decrease in food consumption from Days 6 through 11 of gestation at the high dose (70±7 vs. 76±5 g/kg bw/d in controls). There were no other remarkable findings. Foetal Parameters: Foetal development showed retarded ossification at the high dose (cranium, vertebrae, sternebrae, metacarpals, and pelvic girdle). There were no other remarkable findings. Maternal NOEL = 50 mg/kg bw/d (based on decreased food consumption at the high dose) Foetal NOEL = 50 mg/kg bw/d (based on delayed ossification at the high dose) | Bio/dynamics, 1992b (73) GLP-compliant OECD: consistent with “Teratogenicity” guideline","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":62,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_170"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
mg/kg bw/d |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=Rabbit (New Zealand White) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water | Dose range-finding study.; EFFECT=Unlabeled table on page 62: Rabbit (New Zealand White) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water | Dose range-finding study. Maternal Parameters: There were slight mean maternal body weight losses and lower terminal body weights of the does treated with 75 mg/kg bw/d, as well as decreased food consumption as measured on Days 6, 8-11, 13, and 16, but not on Days 7 and 18, for this dose group. There were no other remarkable findings. Foetal Parameters: There were no remarkable findings | Bio/dynamics, 1992c (77) GLP-compliant OECD: not applicable for a dose range; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rabbit (New Zealand White) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water | Dose range-finding study.","duration":"","effect":"Unlabeled table on page 62: Rabbit (New Zealand White) | 0, 5, 10, 25, 50, or 75 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water | Dose range-finding study. Maternal Parameters: There were slight mean maternal body weight losses and lower terminal body weights of the does treated with 75 mg/kg bw/d, as well as decreased food consumption as measured on Days 6, 8-11, 13, and 16, but not on Days 7 and 18, for this dose group. There were no other remarkable findings. Foetal Parameters: There were no remarkable findings | Bio/dynamics, 1992c (77) GLP-compliant OECD: not applicable for a dose range","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":62,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_171"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
63 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Unlabeled table on page 63: suspension (Days 6 to 18 of gestation) | Study investigators did not determine NOEL values for this study. | finding study; EFFECT=Unlabeled table on page 63: suspension (Days 6 to 18 of gestation) | Study investigators did not determine NOEL values for this study. | finding study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 63: suspension (Days 6 to 18 of gestation) | Study investigators did not determine NOEL values for this study. | finding study","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 63: suspension (Days 6 to 18 of gestation) | Study investigators did not determine NOEL values for this study. | finding study","page":63,"route":"","species":"","study_id":"sccp_o_166_noael_172"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
150 |
mg/kg bw/d |
rabbit |
oral |
1992d |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; DOSE=Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters:; EFFECT=Unlabeled table on page 63: Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) | Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters:","duration":"1992d","effect":"Unlabeled table on page 63: Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) | Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":63,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_173"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5.1 |
% |
rabbit |
oral |
1992d |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=5.1; DOSE=Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters:; EFFECT=Unlabeled table on page 63: Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) | Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters:","duration":"1992d","effect":"Unlabeled table on page 63: Rabbit (New Zealand White) | 0, 15, 50, or 150 mg/kg bw/d via oral gavage in 1% carboxymethyl- cellulose in a 20% glycerine in water suspension (Days 6-18 of gestation) | Maternal Parameters: There were slight decreases in mean maternal body weight (-5.1% at Day 10 to -7.9% at Day 16, with significant decreases on Days 14 and 16) and occasional decreased body weight gains during the dosing period at the high dose, as well as decreased food consumption for this dose group (from -7.05 at Day 11 to -41.4% at Day 14). There were no other remarkable findings. Foetal Parameters: There were no remarkable findings at any of the doses tested. Maternal NOEL = 50 mg/kg bw/d (based on decreased maternal body weights and food consumption) Foetal NOEL = 150 mg/kg bw/d (based on the absence of effects at the highest dose tested) | Bio/dynamics, 1992d (78) GLP-compliant OECD: consistent with “Teratogenicity” guideline","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"5.1","page":63,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_174"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
80 |
mg/kg bw/d |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=80; DOSE=Rat (Wistar) and Hamster (Syrian) | 0, or 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD 50 dose in a pilot study (approximately 4, 8, 16, 40, and 80 mg/kg bw/d based on the LD of 4 50 g/kg bw in rats – doses in hamsters were similarly 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD dose).; EFFECT=Unlabeled table on page 66: Rat (Wistar) and Hamster (Syrian) | 0, or 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD 50 dose in a pilot study (approximately 4, 8, 16, 40, and 80 mg/kg bw/d based on the LD of 4 50 g/kg bw in rats – doses in hamsters were similarly 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD dose). 50 Animals were treated during gestational Days 6-15 (rats) or Days 6-10 (hamsters). | Limited numbers and types of parameters were assessed (dams: body weight, clinical signs, mortality; foetuses: body weights, placental weights, foetal length, foetal tail length, number of foetuses, number of males, numbers of resorptions, gross abnormalities). Maternal Parameters (Rat): There were no remarkable findings. Foetal Parameters (Rat): A significant decrease in number of live foetuses and number of males was reported in the 1/1000 (lowest dose) group vs. controls. However, this was not considered to be treatment-related based on a lack of dose relationship. Also, the decrease in number of foetuses did not appear to be due to an increase in resorptions but could have reflec...; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Rat (Wistar) and Hamster (Syrian) | 0, or 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD 50 dose in a pilot study (approximately 4, 8, 16, 40, and 80 mg/kg bw/d based on the LD of 4 50 g/kg bw in rats – doses in hamsters were similarly 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD dose).","duration":"","effect":"Unlabeled table on page 66: Rat (Wistar) and Hamster (Syrian) | 0, or 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD 50 dose in a pilot study (approximately 4, 8, 16, 40, and 80 mg/kg bw/d based on the LD of 4 50 g/kg bw in rats – doses in hamsters were similarly 1/1000, 1/500, 1/250, 1/100, or 1/50 of the LD dose). 50 Animals were treated during gestational Days 6-15 (rats) or Days 6-10 (hamsters). | Limited numbers and types of parameters were assessed (dams: body weight, clinical signs, mortality; foetuses: body weights, placental weights, foetal length, foetal tail length, number of foetuses, number of males, numbers of resorptions, gross abnormalities). Maternal Parameters (Rat): There were no remarkable findings. Foetal Parameters (Rat): A significant decrease in number of live foetuses and number of males was reported in the 1/1000 (lowest dose) group vs. controls. However, this was not considered to be treatment-related based on a lack of dose relationship. Also, the decrease in number of foetuses did not appear to be due to an increase in resorptions but could have reflec...","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":66,"route":"","species":"rat","study_id":"sccp_o_166_noael_176"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
21 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 21: Summ: Species Rout | e of | Maternal | Fo | etal NOAEL | Comment; EFFECT=Table 21: Summ: Species Rout | e of | Maternal | Fo | etal NOAEL | Comment; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Species Rout | e of | Maternal | Fo | etal NOAEL | Comment","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: Summ: Species Rout | e of | Maternal | Fo | etal NOAEL | Comment","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_177"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
21 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 21: Summ: Adminis | tration | NOAEL | (NOEL)1; EFFECT=Table 21: Summ: Adminis | tration | NOAEL | (NOEL)1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Adminis | tration | NOAEL | (NOEL)1","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: Summ: Adminis | tration | NOAEL | (NOEL)1","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_178"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
21 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 21: Summ: (NOEL)1 | (mg/kg; EFFECT=Table 21: Summ: (NOEL)1 | (mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: (NOEL)1 | (mg/kg","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: Summ: (NOEL)1 | (mg/kg","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_179"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
21 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 21: Summ: 1 In all cases, the NOE | L values we | re taken to be | the NO | AEL values for t | he study as on | ly NOEL valu | es were; EFFECT=Table 21: Summ: 1 In all cases, the NOE | L values we | re taken to be | the NO | AEL values for t | he study as on | ly NOEL valu | es were; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: 1 In all cases, the NOE | L values we | re taken to be | the NO | AEL values for t | he study as on | ly NOEL valu | es were","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: Summ: 1 In all cases, the NOE | L values we | re taken to be | the NO | AEL values for t | he study as on | ly NOEL valu | es were","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_180"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=(NOEL)1; EFFECT=Table 21: Summ: Adminis | tration | NOAEL | (NOEL)1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Adminis | tration | NOAEL | (NOEL)1","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"(NOEL)1","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_181"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=(NOEL)1; EFFECT=Table 21: Summ: (NOEL)1 | (mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: (NOEL)1 | (mg/kg","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"(NOEL)1","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_182"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
25 |
- |
mouse |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; EFFECT=Table 21: Summ: Mouse Diet | 25 | 25 | Maternal liver | effects noted | in 2 higher; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Mouse Diet | 25 | 25 | Maternal liver | effects noted | in 2 higher","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"25","page":69,"route":"oral","species":"mouse","study_id":"sccp_o_166_noael_183"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; EFFECT=Table 21: Summ: Rat Oral (gav | age; | 50 | 50 | Decreases in f | ood consump | tion in high-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Rat Oral (gav | age; | 50 | 50 | Decreases in f | ood consump | tion in high-","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"50","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_184"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; EFFECT=Table 21: Summ: Rat Oral (gav | age; | 100 | 300 | Decreases in | body weight a | nd diarrhoea in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Rat Oral (gav | age; | 100 | 300 | Decreases in | body weight a | nd diarrhoea in","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"100","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_185"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; EFFECT=Table 21: Summ: Rat Oral (gav | age; | 100 | 300 | Decreases in | body weight a | nd diarrhoea in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Rat Oral (gav | age; | 100 | 300 | Decreases in | body weight a | nd diarrhoea in","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"300","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_186"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
- |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; EFFECT=Table 21: Summ: Rabbit Oral (gav | age) | 50 | 150 | Decreases in | body weight a | nd food; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Rabbit Oral (gav | age) | 50 | 150 | Decreases in | body weight a | nd food","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"50","page":69,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_187"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
150 |
- |
rabbit |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; EFFECT=Table 21: Summ: Rabbit Oral (gav | age) | 50 | 150 | Decreases in | body weight a | nd food; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Rabbit Oral (gav | age) | 50 | 150 | Decreases in | body weight a | nd food","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"150","page":69,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_188"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
3 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=nd 3H-labelle; EFFECT=Table 21: Summ: Unlabelled triclosa | n, 14C-lab | elled triclos | an, a | nd 3H-labelle | d triclosan | have been | used to study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 21: Summ: Unlabelled triclosa | n, 14C-lab | elled triclos | an, a | nd 3H-labelle | d triclosan | have been | used to study","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"nd 3H-labelle","page":69,"route":"","species":"","study_id":"sccp_o_166_noael_189"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
100 |
mg/kg |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=Findings from a Two-Week Oral Neurotoxicity Study with Triclosan in the Rat: mg/kg body wei | ght/day an | d higher.; EFFECT=Table 43: Findings from a Two-Week Oral Neurotoxicity Study with Triclosan in the Rat: mg/kg body wei | ght/day an | d higher. The r | esults of this st | udy indicate a NOEL | of 100 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from a Two-Week Oral Neurotoxicity Study with Triclosan in the Rat: mg/kg body wei | ght/day an | d higher.","duration":"","effect":"Table 43: Findings from a Two-Week Oral Neurotoxicity Study with Triclosan in the Rat: mg/kg body wei | ght/day an | d higher. The r | esults of this st | udy indicate a NOEL | of 100 mg/kg","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":106,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_190"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
12 |
mg/kg bw/d |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=Types of Products Used | SED (mg/kg bw/d) | MoS Based on Rat NOAEL of 12 mg/kg bw/d | MoS Based on Plasma Levels; EFFECT=Unlabeled table on page 119: Types of Products Used | SED (mg/kg bw/d) | MoS Based on Rat NOAEL of 12 mg/kg bw/d | MoS Based on Plasma Levels; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Types of Products Used | SED (mg/kg bw/d) | MoS Based on Rat NOAEL of 12 mg/kg bw/d | MoS Based on Plasma Levels","duration":"","effect":"Unlabeled table on page 119: Types of Products Used | SED (mg/kg bw/d) | MoS Based on Rat NOAEL of 12 mg/kg bw/d | MoS Based on Plasma Levels","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"12","page":119,"route":"","species":"rat","study_id":"sccp_o_166_noael_191"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
513 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=513; EFFECT=Unlabeled table on page 119: Toothpaste | 0.0234 | 513 | 1408; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 119: Toothpaste | 0.0234 | 513 | 1408","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"513","page":119,"route":"","species":"","study_id":"sccp_o_166_noael_192"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
381 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=381; EFFECT=Unlabeled table on page 119: Toothpaste, deodorant stick, and hand soap | 0.0315 | 381 | 939; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 119: Toothpaste, deodorant stick, and hand soap | 0.0315 | 381 | 939","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"381","page":119,"route":"","species":"","study_id":"sccp_o_166_noael_193"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.3 |
% |
human |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=0.3; EFFECT=Unlabeled table on page 119: Common-Use Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick) | 0.0583 | 206 | Not done (no human plasma data available); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 119: Common-Use Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick) | 0.0583 | 206 | Not done (no human plasma data available)","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"0.3","page":119,"route":"","species":"human","study_id":"sccp_o_166_noael_194"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.3 |
% |
human |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=0.3; EFFECT=Unlabeled table on page 119: All Products 0.15 – 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash, body lotion, face powder, blemish concealer) | 0.2449 | 49 | Not done (no human plasma data available); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 119: All Products 0.15 – 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash, body lotion, face powder, blemish concealer) | 0.2449 | 49 | Not done (no human plasma data available)","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"0.3","page":119,"route":"","species":"human","study_id":"sccp_o_166_noael_195"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.3 |
% |
human |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=0.3; EFFECT=Unlabeled table on page 119: All Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash, body lotion, face powder, blemish concealer) | 0.3795 | 32 | Not done (no human plasma data available); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 119: All Products 0.3% triclosan (toothpaste, hand soap, body soap/shower gel, deodorant stick, mouthwash, body lotion, face powder, blemish concealer) | 0.3795 | 32 | Not done (no human plasma data available)","endpoint":"","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"0.3","page":119,"route":"","species":"human","study_id":"sccp_o_166_noael_196"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
10 |
mg/kg bw/d |
rat |
oral |
104-week |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=10; DOSE=Females of high Mid Dose and High Dose groups compared to control.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=Females of high Mid Dose and High Dose groups compared to control. Slight increase in testicular germinal epithelium degeneration/atrophy was observed at High Dose (only controls and High Dose examined). No treatment-related histopathological changes other than in liver. Hepatocyte hypertrophy was present in all animals except Low Dose Females. Brown pigment in hepatocytes in higher dose rats was found to be lipofuscin and iron. The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Ref.: 66 Long Term Toxicity/Carcinogenicity study – 104-week (Rat) Animals were dosed daily via the diet at concentrations of 0, 300 (Low Dose), 1,000 (Mid Dose), 3,000 (High Dose) ppm in 104-week study. An extra group of rats was given a “toxic” dose of 6,000 ppm and killed at 52 weeks. Doses were calculated weekly based on food intake and weekly mean BW. At 52 weeks, calculated doses were 0, 12, 40, and 127 mg/kg bw/d (Males) and 0, 17, 56, and 19; CITATION=Ref.: 66 Long Term Toxicity/Carcinogenicity study – 104-week (Rat) Animals were dosed daily via the diet at concentrations of 0, 300 (Low Dose), 1,000 (Mid Dose), 3,000 (High Dose) ppm i; CITATION_NUMBERS=[66,104,300,1,3]; REFERENCE=Ref.: 66 Long Term Toxicity/Carcinogenicity study – 104-week (Rat) Animals were dosed daily via the diet at concentrations of 0, 300 (Low Dose), 1,000 (Mid Dose), 3,000 (High Dose) ppm i; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 66 Long Term Toxicity/Carcinogenicity study – 104-week (Rat) Animals were dosed daily via the diet at concentrations of 0, 300 (Low Dose), 1,000 (Mid Dose), 3,000 (High Dose) ppm i","dose":"Females of high Mid Dose and High Dose groups compared to control.","duration":"104-week","effect":"Females of high Mid Dose and High Dose groups compared to control. Slight increase in testicular germinal epithelium degeneration/atrophy was observed at High Dose (only controls and High Dose examined). No treatment-related histopathological changes other than in liver. Hepatocyte hypertrophy was present in all animals except Low Dose Females. Brown pigment in hepatocytes in higher dose rats was found to be lipofuscin and iron. The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Ref.: 66 Long Term Toxicity/Carcinogenicity study – 104-week (Rat) Animals were dosed daily via the diet at concentrations of 0, 300 (Low Dose), 1,000 (Mid Dose), 3,000 (High Dose) ppm in 104-week study. An extra group of rats was given a “toxic” dose of 6,000 ppm and killed at 52 weeks. Doses were calculated weekly based on food intake and weekly mean BW. At 52 weeks, calculated doses were 0, 12, 40, and 127 mg/kg bw/d (Males) and 0, 17, 56, and 19","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"10","page":33,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
~48 |
mg/kg/d |
rat |
oral |
13 weeks |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=~48; DOSE=es) and decreased brain weight (High Dose Males); increased absolute and relative ovary weight (High Dose Females), decreased relative spleen weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females).; EFFECT=es) and decreased brain weight (High Dose Males); increased absolute and relative ovary weight (High Dose Females), decreased relative spleen weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females). Morphology revealed hepatocyte hypertrophy and hepatocytic inclusions (hyaline-staining, round-shaped) in Male rats: significant – High Dose (13 weeks), 6,000 ppm (52 weeks). No other histological lesions were considered to be treatment-related. The study authors considered the NOAEL as ~48 mg/kg/d for both sexes, combined (~56 mg/kg bw/d in Females and ~40 mg/kg bw/d in Males). Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity/Carcinogenicity study – 95 Weeks (Hamster) The animals were administered 0, 12, 75, or 250 mg/kg bw/d FAT 80’023/S. in the diet for 90 weeks. Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body; CITATION=Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females); CITATION_NUMBERS=[67,12]; REFERENCE=Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females); DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females)","dose":"es) and decreased brain weight (High Dose Males); increased absolute and relative ovary weight (High Dose Females), decreased relative spleen weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females).","duration":"13 weeks","effect":"es) and decreased brain weight (High Dose Males); increased absolute and relative ovary weight (High Dose Females), decreased relative spleen weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females). Morphology revealed hepatocyte hypertrophy and hepatocytic inclusions (hyaline-staining, round-shaped) in Male rats: significant – High Dose (13 weeks), 6,000 ppm (52 weeks). No other histological lesions were considered to be treatment-related. The study authors considered the NOAEL as ~48 mg/kg/d for both sexes, combined (~56 mg/kg bw/d in Females and ~40 mg/kg bw/d in Males). Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity/Carcinogenicity study – 95 Weeks (Hamster) The animals were administered 0, 12, 75, or 250 mg/kg bw/d FAT 80’023/S. in the diet for 90 weeks. Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg/d","noael_value":"~48","page":33,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
12 |
mg/kg bw/d |
rat |
oral |
13 weeks |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=n weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females).; EFFECT=n weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females). Morphology revealed hepatocyte hypertrophy and hepatocytic inclusions (hyaline-staining, round-shaped) in Male rats: significant – High Dose (13 weeks), 6,000 ppm (52 weeks). No other histological lesions were considered to be treatment-related. The study authors considered the NOAEL as ~48 mg/kg/d for both sexes, combined (~56 mg/kg bw/d in Females and ~40 mg/kg bw/d in Males). Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity/Carcinogenicity study – 95 Weeks (Hamster) The animals were administered 0, 12, 75, or 250 mg/kg bw/d FAT 80’023/S. in the diet for 90 weeks. Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food; CITATION=Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females); CITATION_NUMBERS=[67,12]; REFERENCE=Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females); DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females)","dose":"n weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females).","duration":"13 weeks","effect":"n weight (High Dose Females), and decreased absolute and relative spleen weights (Mid Dose Females). Morphology revealed hepatocyte hypertrophy and hepatocytic inclusions (hyaline-staining, round-shaped) in Male rats: significant – High Dose (13 weeks), 6,000 ppm (52 weeks). No other histological lesions were considered to be treatment-related. The study authors considered the NOAEL as ~48 mg/kg/d for both sexes, combined (~56 mg/kg bw/d in Females and ~40 mg/kg bw/d in Males). Ref.: 67 Comment SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity/Carcinogenicity study – 95 Weeks (Hamster) The animals were administered 0, 12, 75, or 250 mg/kg bw/d FAT 80’023/S. in the diet for 90 weeks. Survival was significantly decreased in males and was generally poor (38-58%) in females at 90 weeks. Body weight gain was significantly decreased in all high-dose hamsters and was accompanied by a slight (3%), but significant decrease in food","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"12","page":33,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
10 |
mg/kg bw/d |
rat |
oral |
1 year |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=10; DOSE=ronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=ronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"ronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.","duration":"1 year","effect":"ronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"10","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
48 |
mg/kg/d |
rat |
oral |
1 year |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=48; DOSE=Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=d haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study.","duration":"1 year","effect":"d haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg/d","noael_value":"48","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
12 |
mg/kg bw/d |
rat |
- |
18 Months |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=f any effect, including diarrhoea, in baboons at the low dose level in this study.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=f any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"f any effect, including diarrhoea, in baboons at the low dose level in this study.","duration":"18 Months","effect":"f any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"12","page":34,"route":"","species":"rat","study_id":"sccp_o_166_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
75 |
mg/kg bw/d |
rat |
- |
104-week |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver.; EFFECT=liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver.","duration":"104-week","effect":"liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females). Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) The NOAEL was set as 75 mg/kg bw/d.","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"","species":"rat","study_id":"sccp_o_166_noael_047"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
=75 |
mg/kg bw/d |
rat |
- |
90 weeks |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT==75; DOSE=e few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs.; EFFECT=e few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). There were no tumours considered to be treatment-related. In summary, triclosan had little to no effect in hamsters at 12 and 75 mg/kg bw/d, and toxic effects at 250 mg/kg bw/d that resulted in the general deterioration of high- dose males after Week 80. Overall results show that triclosan is not tumourigenic in hamsters at doses of up to 250 mg/kg bw/d. However, survival in females at 90 weeks was poor. NOAEL=75 mg/kg bw/d. Huntingdon Life Sciences, 1999 (68); GLP- compliant OECD: No. 451 consistent 1 Findings reported in table are significant compared to controls unless otherwise noted in text. Doses tested in the 3 carcinogenicity assays were comparable, ranging from 10 to 200 mg/kg body weight/day in mice, 12 to 127 mg/kg body weight/day (for males) and 17 to 190 mg/kg body weight/day (for females) in rats, and 12 to 250 mg/kg body weight/day in hamsters. Survival was not altered by triclosan treatment in the rat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"e few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs.","duration":"90 weeks","effect":"e few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). There were no tumours considered to be treatment-related. In summary, triclosan had little to no effect in hamsters at 12 and 75 mg/kg bw/d, and toxic effects at 250 mg/kg bw/d that resulted in the general deterioration of high- dose males after Week 80. Overall results show that triclosan is not tumourigenic in hamsters at doses of up to 250 mg/kg bw/d. However, survival in females at 90 weeks was poor. NOAEL=75 mg/kg bw/d. Huntingdon Life Sciences, 1999 (68); GLP- compliant OECD: No. 451 consistent 1 Findings reported in table are significant compared to controls unless otherwise noted in text. Doses tested in the 3 carcinogenicity assays were comparable, ranging from 10 to 200 mg/kg body weight/day in mice, 12 to 127 mg/kg body weight/day (for males) and 17 to 190 mg/kg body weight/day (for females) in rats, and 12 to 250 mg/kg body weight/day in hamsters. Survival was not altered by triclosan treatment in the rat","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"=75","page":57,"route":"","species":"rat","study_id":"sccp_o_166_noael_050"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
30 |
mg/kg |
rat |
- |
- |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=s and hepatocellular carcinomas, depending on dose level.; EFFECT=s and hepatocellular carcinomas, depending on dose level. Signs of liver effects, increases in cholesterol (both sexes) and hypertrophy (males only) were seen at the lowest dose of 10 mg/kg body weight/day. Hypertrophy was seen in mice of both sexes at 30 mg/kg body weight/day, and increases in liver function enzyme levels were seen in mice of both sexes at doses of 100 and 200 mg/kg body weight/day. Increases in numbers of hepatic tumours were observed at doses of 30 mg/kg body weight/day and higher. Summary and NOAEL Values from the Rodent Carcinogenicity Studies Three rodent lifetime bioassays have been conducted to evaluate the carcinogenic potential of triclosan. Triclosan produced hepatic effects and hepatic tumours in mice, but little evidence of toxicity and no tumours in rats. Hamsters showed increased liver toxicity relative to the rat, but no tumours. No NOAEL could be determined for the mouse, based on findings of liver effects at all doses (effects of hepatocyte hypertrophy and decreased plasma cholesterol). Increa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"s and hepatocellular carcinomas, depending on dose level.","duration":"","effect":"s and hepatocellular carcinomas, depending on dose level. Signs of liver effects, increases in cholesterol (both sexes) and hypertrophy (males only) were seen at the lowest dose of 10 mg/kg body weight/day. Hypertrophy was seen in mice of both sexes at 30 mg/kg body weight/day, and increases in liver function enzyme levels were seen in mice of both sexes at doses of 100 and 200 mg/kg body weight/day. Increases in numbers of hepatic tumours were observed at doses of 30 mg/kg body weight/day and higher. Summary and NOAEL Values from the Rodent Carcinogenicity Studies Three rodent lifetime bioassays have been conducted to evaluate the carcinogenic potential of triclosan. Triclosan produced hepatic effects and hepatic tumours in mice, but little evidence of toxicity and no tumours in rats. Hamsters showed increased liver toxicity relative to the rat, but no tumours. No NOAEL could be determined for the mouse, based on findings of liver effects at all doses (effects of hepatocyte hypertrophy and decreased plasma cholesterol). Increa","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"30","page":58,"route":"","species":"rat","study_id":"sccp_o_166_noael_051"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
30 |
mg/kg |
rat |
- |
- |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=doses of 100 and 200 mg/kg body weight/day.; EFFECT=doses of 100 and 200 mg/kg body weight/day. Increases in numbers of hepatic tumours were observed at doses of 30 mg/kg body weight/day and higher. Summary and NOAEL Values from the Rodent Carcinogenicity Studies Three rodent lifetime bioassays have been conducted to evaluate the carcinogenic potential of triclosan. Triclosan produced hepatic effects and hepatic tumours in mice, but little evidence of toxicity and no tumours in rats. Hamsters showed increased liver toxicity relative to the rat, but no tumours. No NOAEL could be determined for the mouse, based on findings of liver effects at all doses (effects of hepatocyte hypertrophy and decreased plasma cholesterol). Increased incidences of liver tumours were observed at doses of 30 mg/kg body weight/day and higher in mice. It should be noted that triclosan is a peroxisome proliferator in mouse liver. The NOEL for the rat study was determined by study investigators to be the mid-dose of 1,000 ppm, or ~48 mg/kg body weight/day for males and females combined, based on the findi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"doses of 100 and 200 mg/kg body weight/day.","duration":"","effect":"doses of 100 and 200 mg/kg body weight/day. Increases in numbers of hepatic tumours were observed at doses of 30 mg/kg body weight/day and higher. Summary and NOAEL Values from the Rodent Carcinogenicity Studies Three rodent lifetime bioassays have been conducted to evaluate the carcinogenic potential of triclosan. Triclosan produced hepatic effects and hepatic tumours in mice, but little evidence of toxicity and no tumours in rats. Hamsters showed increased liver toxicity relative to the rat, but no tumours. No NOAEL could be determined for the mouse, based on findings of liver effects at all doses (effects of hepatocyte hypertrophy and decreased plasma cholesterol). Increased incidences of liver tumours were observed at doses of 30 mg/kg body weight/day and higher in mice. It should be noted that triclosan is a peroxisome proliferator in mouse liver. The NOEL for the rat study was determined by study investigators to be the mid-dose of 1,000 ppm, or ~48 mg/kg body weight/day for males and females combined, based on the findi","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"30","page":58,"route":"","species":"rat","study_id":"sccp_o_166_noael_052"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
1192 |
- |
rat |
- |
- |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:SCCP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumo; DOSE=Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested.; EFFECT=SCCP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested.","duration":"","effect":"SCCP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumo","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:SCCP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumo","page":59,"route":"","species":"rat","study_id":"sccp_o_166_noael_056"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
1000 |
ppm |
rat |
- |
- |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested.; EFFECT=SCCP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. 1 1,000 ppm ~48 mg/kg body weight/day for male; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested.","duration":"","effect":"SCCP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. 1 1,000 ppm ~48 mg/kg body weight/day for male","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":59,"route":"","species":"rat","study_id":"sccp_o_166_noael_057"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
10 |
mg/kg bw/d |
mouse |
- |
18 Months |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=10; DOSE=Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) | The LOAEL was 10 mg/kg bw/d based on liver changes.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=Unlabeled table on page 34: Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) | The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) | The LOAEL was 10 mg/kg bw/d based on liver changes.","duration":"18 Months","effect":"Unlabeled table on page 34: Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) | The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver.","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"10","page":34,"route":"","species":"mouse","study_id":"sccp_o_166_noael_147"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
48 |
mg/kg/d |
rat |
- |
104-week |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=48; DOSE=Long Term Toxicity / Carcinogenicity study – 104-week (Rat) | The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males).; EFFECT=Unlabeled table on page 34: Long Term Toxicity / Carcinogenicity study – 104-week (Rat) | The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Long Term Toxicity / Carcinogenicity study – 104-week (Rat) | The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males).","duration":"104-week","effect":"Unlabeled table on page 34: Long Term Toxicity / Carcinogenicity study – 104-week (Rat) | The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Females and ≈ 40 mg/kg bw/d in Males). SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females).","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg/d","noael_value":"48","page":34,"route":"","species":"rat","study_id":"sccp_o_166_noael_148"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
75 |
mg/kg bw/d |
- |
- |
95 Weeks |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) | The NOAEL was set as 75 mg/kg bw/d.; EFFECT=Unlabeled table on page 34: Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) | The NOAEL was set as 75 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) | The NOAEL was set as 75 mg/kg bw/d.","duration":"95 Weeks","effect":"Unlabeled table on page 34: Long Term Toxicity / Carcinogenicity study – 95 Weeks (Hamster) | The NOAEL was set as 75 mg/kg bw/d.","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"","species":"","study_id":"sccp_o_166_noael_149"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
16 |
- |
- |
- |
- |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 16: Findings from GLP Carcinogenicity Studies for Triclosan: concluded that there was no NOEL based on liver; EFFECT=Table 16: Findings from GLP Carcinogenicity Studies for Triclosan: concluded that there was no NOEL based on liver; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 16: Findings from GLP Carcinogenicity Studies for Triclosan: concluded that there was no NOEL based on liver","endpoint":"carcinogenicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 16: Findings from GLP Carcinogenicity Studies for Triclosan: concluded that there was no NOEL based on liver","page":56,"route":"","species":"","study_id":"sccp_o_166_noael_150"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg |
rat |
oral |
Developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet.; EFFECT=SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet. Results from the study in Colworth Wistar rats showed no effect of triclosan on the survival and development of pups from birth to weaning [Denning et al., 1992 (70)]. In this study, the post-natal NOEL was determined to be 300 mg/kg body weight/day for triclosan administered via oral gavage. In summary, taking into account both of the studies containing post-natal data, the lowest post-natal NOAEL is considered to be 65 mg/kg body weight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, ra; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet.","duration":"Developmental","effect":"SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet. Results from the study in Colworth Wistar rats showed no effect of triclosan on the survival and development of pups from birth to weaning [Denning et al., 1992 (70)]. In this study, the post-natal NOEL was determined to be 300 mg/kg body weight/day for triclosan administered via oral gavage. In summary, taking into account both of the studies containing post-natal data, the lowest post-natal NOAEL is considered to be 65 mg/kg body weight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, ra","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":61,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_067"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
65 |
mg/kg |
rat |
oral |
Developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=65; DOSE=SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet.; EFFECT=SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet. Results from the study in Colworth Wistar rats showed no effect of triclosan on the survival and development of pups from birth to weaning [Denning et al., 1992 (70)]. In this study, the post-natal NOEL was determined to be 300 mg/kg body weight/day for triclosan administered via oral gavage. In summary, taking into account both of the studies containing post-natal data, the lowest post-natal NOAEL is considered to be 65 mg/kg body weight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in additi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet.","duration":"Developmental","effect":"SCCP/1192/08 Opinion on triclosan 61 combined male and female doses) for triclosan administered in the diet. Results from the study in Colworth Wistar rats showed no effect of triclosan on the survival and development of pups from birth to weaning [Denning et al., 1992 (70)]. In this study, the post-natal NOEL was determined to be 300 mg/kg body weight/day for triclosan administered via oral gavage. In summary, taking into account both of the studies containing post-natal data, the lowest post-natal NOAEL is considered to be 65 mg/kg body weight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in additi","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"65","page":61,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_068"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
65 |
mg/kg |
rat |
oral |
Developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=65; DOSE=d female doses) for triclosan administered in the diet.; EFFECT=d female doses) for triclosan administered in the diet. Results from the study in Colworth Wistar rats showed no effect of triclosan on the survival and development of pups from birth to weaning [Denning et al., 1992 (70)]. In this study, the post-natal NOEL was determined to be 300 mg/kg body weight/day for triclosan administered via oral gavage. In summary, taking into account both of the studies containing post-natal data, the lowest post-natal NOAEL is considered to be 65 mg/kg body weight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were det; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"d female doses) for triclosan administered in the diet.","duration":"Developmental","effect":"d female doses) for triclosan administered in the diet. Results from the study in Colworth Wistar rats showed no effect of triclosan on the survival and development of pups from birth to weaning [Denning et al., 1992 (70)]. In this study, the post-natal NOEL was determined to be 300 mg/kg body weight/day for triclosan administered via oral gavage. In summary, taking into account both of the studies containing post-natal data, the lowest post-natal NOAEL is considered to be 65 mg/kg body weight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were det","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"65","page":61,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_069"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
3.3 |
- |
rat |
oral |
Developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:ight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, dev; EFFECT=ight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, dev; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Developmental","effect":"ight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, dev","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:ight/day, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, dev","page":61,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_070"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
3.3 |
- |
rat |
oral |
Developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, development,; EFFECT=, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, development,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Developmental","effect":", the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, development,","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:, the post-natal NOEL from the two-generation study using dietary administration of triclosan. 3.3.8.2. Teratogenicity One-Generation Reproduction Toxicology: Developmental Toxicity Studies 3.3.8.2.1 GLP Studies GLP-compliant teratology studies were conducted in mice, rats, and in rabbits using the oral route of administration. All 3 of the main studies were conducted along OECD guidelines. One preliminary range-finding study was conducted for each species, in addition to the definitive investigations. NOEL or NOAEL values were determined for each of the definitive studies in each species. Brief summaries of the pertinent findings from the GLP teratology studies are presented in table 19. Where appropriate, findings of foetal effects were classified either as foetal variations (an alteration that may occur at a relatively high frequency and/or represent a (reversible) retardation or acceleration in development, a transitory alteration, or a permanent alteration not considered to adversely affect survival, growth, development,","page":61,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_071"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
25 |
mg/kg |
rat |
oral |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; DOSE=Maternal toxicity was observed at doses greater than 25 mg/kg body weight/day, including liver effects (i.e., increased liver weights and tan-coloured livers).; EFFECT=stered in the diet on Days 6 to 15 of gestation. Maternal toxicity was observed at doses greater than 25 mg/kg body weight/day, including liver effects (i.e., increased liver weights and tan-coloured livers). Triclosan was not teratogenic in either the dose range finding or the definitive study. Foetal effects (classified as foetal variations) included slightly decreased body weights at the two higher doses that also caused maternal toxicity, as well as reversible delays in ossification at the same doses. A foetal NOEL of 25 mg/kg body weight/day was determined based upon decreases in foetal body weights and delayed ossification at higher dose levels in the definitive study. GLP Studies in the Rat In rats, triclosan has been investigated in 1 range-finding and 2 definitive teratology studies [Bio/dynamics, 1992a (73); Bio/dynamics, 1992b (74); Denning et al., 1992 (70)]. The study in Colworth Wistar rats [Denning et al., 1992 (70)], although lacking a formal statement of GLP compliance, included a statement of Quality Assurance; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Maternal toxicity was observed at doses greater than 25 mg/kg body weight/day, including liver effects (i.e., increased liver weights and tan-coloured livers).","duration":"","effect":"stered in the diet on Days 6 to 15 of gestation. Maternal toxicity was observed at doses greater than 25 mg/kg body weight/day, including liver effects (i.e., increased liver weights and tan-coloured livers). Triclosan was not teratogenic in either the dose range finding or the definitive study. Foetal effects (classified as foetal variations) included slightly decreased body weights at the two higher doses that also caused maternal toxicity, as well as reversible delays in ossification at the same doses. A foetal NOEL of 25 mg/kg body weight/day was determined based upon decreases in foetal body weights and delayed ossification at higher dose levels in the definitive study. GLP Studies in the Rat In rats, triclosan has been investigated in 1 range-finding and 2 definitive teratology studies [Bio/dynamics, 1992a (73); Bio/dynamics, 1992b (74); Denning et al., 1992 (70)]. The study in Colworth Wistar rats [Denning et al., 1992 (70)], although lacking a formal statement of GLP compliance, included a statement of Quality Assurance","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"25","page":63,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_084"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg |
rat |
oral |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=The dams showed evidence of maternal toxicity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals.; EFFECT=lcellulose [Bio/dynamics, 1992b (73)]. The dams showed evidence of maternal toxicity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals. There was no evidence of any teratogenic effect of triclosan. Foetal effects (foetal variations) were manifest as delayed ossification at the high dose of 150 mg/kg body weight/day, and with maternal toxicity occurring at the same dose. Based on observations of delayed ossification at the high dose, the foetal NOEL in this study was determined to be 50 mg/kg body weight/day. The maternal NOEL was also 50 mg/kg body weight/day. The 1992 study by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delay; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The dams showed evidence of maternal toxicity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals.","duration":"","effect":"lcellulose [Bio/dynamics, 1992b (73)]. The dams showed evidence of maternal toxicity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals. There was no evidence of any teratogenic effect of triclosan. Foetal effects (foetal variations) were manifest as delayed ossification at the high dose of 150 mg/kg body weight/day, and with maternal toxicity occurring at the same dose. Based on observations of delayed ossification at the high dose, the foetal NOEL in this study was determined to be 50 mg/kg body weight/day. The maternal NOEL was also 50 mg/kg body weight/day. The 1992 study by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delay","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":64,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_085"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg |
rat |
oral |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=icity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals.; EFFECT=icity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals. There was no evidence of any teratogenic effect of triclosan. Foetal effects (foetal variations) were manifest as delayed ossification at the high dose of 150 mg/kg body weight/day, and with maternal toxicity occurring at the same dose. Based on observations of delayed ossification at the high dose, the foetal NOEL in this study was determined to be 50 mg/kg body weight/day. The maternal NOEL was also 50 mg/kg body weight/day. The 1992 study by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delayed body weight gain, and reduced food consumption, as well as transient diarrho; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"icity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals.","duration":"","effect":"icity in the form of slight, but significant, decreases in food consumption from Days 6 to 11 of gestation in high-dose animals. There was no evidence of any teratogenic effect of triclosan. Foetal effects (foetal variations) were manifest as delayed ossification at the high dose of 150 mg/kg body weight/day, and with maternal toxicity occurring at the same dose. Based on observations of delayed ossification at the high dose, the foetal NOEL in this study was determined to be 50 mg/kg body weight/day. The maternal NOEL was also 50 mg/kg body weight/day. The 1992 study by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delayed body weight gain, and reduced food consumption, as well as transient diarrho","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":64,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_086"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
100 |
mg/kg |
rat |
oral |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=dy by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters.; EFFECT=dy by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delayed body weight gain, and reduced food consumption, as well as transient diarrhoea, at the highest dose, resulting in a maternal NOEL of 100 mg/kg body weight/day. Based on the absence of foetal effects at any of the doses tested, the foetal NOEL for this study was determined to be 300 mg/kg body weight/day. In summary, triclosan showed no teratogenic effects at any of the doses in either of the GLP studies in rats. The only embryo or foetal toxic effect observed was classified as a foetal variation (delayed ossification) in the 1% carboxymethylcellulose vehicle study at the dose of 150 mg/kg body weight/day, a dose that was associated with evi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"dy by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters.","duration":"","effect":"dy by Denning et al. was conducted in Colworth Wistar rats at doses of 0, 30, 100, or 300 mg triclosan/kg body weight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delayed body weight gain, and reduced food consumption, as well as transient diarrhoea, at the highest dose, resulting in a maternal NOEL of 100 mg/kg body weight/day. Based on the absence of foetal effects at any of the doses tested, the foetal NOEL for this study was determined to be 300 mg/kg body weight/day. In summary, triclosan showed no teratogenic effects at any of the doses in either of the GLP studies in rats. The only embryo or foetal toxic effect observed was classified as a foetal variation (delayed ossification) in the 1% carboxymethylcellulose vehicle study at the dose of 150 mg/kg body weight/day, a dose that was associated with evi","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":64,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_087"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg |
rat |
oral |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=ight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters.; EFFECT=ight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delayed body weight gain, and reduced food consumption, as well as transient diarrhoea, at the highest dose, resulting in a maternal NOEL of 100 mg/kg body weight/day. Based on the absence of foetal effects at any of the doses tested, the foetal NOEL for this study was determined to be 300 mg/kg body weight/day. In summary, triclosan showed no teratogenic effects at any of the doses in either of the GLP studies in rats. The only embryo or foetal toxic effect observed was classified as a foetal variation (delayed ossification) in the 1% carboxymethylcellulose vehicle study at the dose of 150 mg/kg body weight/day, a dose that was associated with evidence of maternal toxicity (significantly decreased food consumption). The findings of maternal toxicity at the h; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"ight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters.","duration":"","effect":"ight/day administered via oral gavage in corn oil, and examined both embryo/foetal and post-natal parameters. The results from this study demonstrated no foetal effects in terms of anomalies, body weights, numbers of live foetuses, etc. Maternal toxicity was in the form of delayed body weight gain, and reduced food consumption, as well as transient diarrhoea, at the highest dose, resulting in a maternal NOEL of 100 mg/kg body weight/day. Based on the absence of foetal effects at any of the doses tested, the foetal NOEL for this study was determined to be 300 mg/kg body weight/day. In summary, triclosan showed no teratogenic effects at any of the doses in either of the GLP studies in rats. The only embryo or foetal toxic effect observed was classified as a foetal variation (delayed ossification) in the 1% carboxymethylcellulose vehicle study at the dose of 150 mg/kg body weight/day, a dose that was associated with evidence of maternal toxicity (significantly decreased food consumption). The findings of maternal toxicity at the h","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":64,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_088"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg |
rat |
oral |
1992d |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day.; EFFECT=(It should be noted that the observed decreases in food consumption followed the administration of triclosan by oral gavage, and therefore would not likely have been due to any decreased palatability of the diet.) Hepatotoxic effects were not noted in the dams in any of the studies. No embryo or foetal toxic effects were seen at any of the doses in the corn oil study. None of the studies showed evidence of any teratogenic effects of triclosan. Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day. GLP Studies in the Rabbit In rabbits, triclosan has been investigated in one range-finding and one definitive teratology study [Bio/dynamics, 1992c (75), Bio/dynamics, 1992d (76)]. Based on the reports, the studies were generally consistent with the OECD (Teratogenicity) and ICH (Embryo-foetal development, Stage C) guidelines, with; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day.","duration":"1992d","effect":"(It should be noted that the observed decreases in food consumption followed the administration of triclosan by oral gavage, and therefore would not likely have been due to any decreased palatability of the diet.) Hepatotoxic effects were not noted in the dams in any of the studies. No embryo or foetal toxic effects were seen at any of the doses in the corn oil study. None of the studies showed evidence of any teratogenic effects of triclosan. Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day. GLP Studies in the Rabbit In rabbits, triclosan has been investigated in one range-finding and one definitive teratology study [Bio/dynamics, 1992c (75), Bio/dynamics, 1992d (76)]. Based on the reports, the studies were generally consistent with the OECD (Teratogenicity) and ICH (Embryo-foetal development, Stage C) guidelines, with","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":64,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_089"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg |
rat |
oral |
1992d |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day.; EFFECT=t likely have been due to any decreased palatability of the diet.) Hepatotoxic effects were not noted in the dams in any of the studies. No embryo or foetal toxic effects were seen at any of the doses in the corn oil study. None of the studies showed evidence of any teratogenic effects of triclosan. Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day. GLP Studies in the Rabbit In rabbits, triclosan has been investigated in one range-finding and one definitive teratology study [Bio/dynamics, 1992c (75), Bio/dynamics, 1992d (76)]. Based on the reports, the studies were generally consistent with the OECD (Teratogenicity) and ICH (Embryo-foetal development, Stage C) guidelines, with the major exception being that the placenta was not grossly examined. Triclosan was orally administered by gavage in a vehicle of 1% carboxymethylce; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day.","duration":"1992d","effect":"t likely have been due to any decreased palatability of the diet.) Hepatotoxic effects were not noted in the dams in any of the studies. No embryo or foetal toxic effects were seen at any of the doses in the corn oil study. None of the studies showed evidence of any teratogenic effects of triclosan. Taking into account both of the GLP rat teratology studies, the foetal NOEL is considered to be 50 mg/kg body weight/day in rats given triclosan via oral gavage in a 1% carboxymethylcellulose vehicle, with the maternal NOEL being also 50 mg/kg body weight/day. GLP Studies in the Rabbit In rabbits, triclosan has been investigated in one range-finding and one definitive teratology study [Bio/dynamics, 1992c (75), Bio/dynamics, 1992d (76)]. Based on the reports, the studies were generally consistent with the OECD (Teratogenicity) and ICH (Embryo-foetal development, Stage C) guidelines, with the major exception being that the placenta was not grossly examined. Triclosan was orally administered by gavage in a vehicle of 1% carboxymethylce","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":64,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_090"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
150 |
mg/kg |
rabbit |
oral |
1992d |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; DOSE=The does were treated from Days 6 to 18 of gestation.; EFFECT=ter suspension. The does were treated from Days 6 to 18 of gestation. Doses of 0, 15, 50, or 150 mg/kg body weight/day were administered in the definitive oral gavage study in rabbits [Bio/dynamics, 1992d (76)]. The does showed evidence of significant maternal toxicity in the form of decreased body weights, body weight gains, and food consumption at the high dose. There was no evidence of embryo or foetal toxicity or of teratogenic effect of triclosan. Based on the lack of foetal effects in this study, the foetal NOEL was determined to be 150 mg/kg body weight/day administered by gavage, with the maternal NOEL being 50 mg/kg body weight/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The does were treated from Days 6 to 18 of gestation.","duration":"1992d","effect":"ter suspension. The does were treated from Days 6 to 18 of gestation. Doses of 0, 15, 50, or 150 mg/kg body weight/day were administered in the definitive oral gavage study in rabbits [Bio/dynamics, 1992d (76)]. The does showed evidence of significant maternal toxicity in the form of decreased body weights, body weight gains, and food consumption at the high dose. There was no evidence of embryo or foetal toxicity or of teratogenic effect of triclosan. Based on the lack of foetal effects in this study, the foetal NOEL was determined to be 150 mg/kg body weight/day administered by gavage, with the maternal NOEL being 50 mg/kg body weight/day.","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":64,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_091"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg |
rabbit |
oral |
1992d |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=150 mg/kg body weight/day were administered in the definitive oral gavage study in rabbits [Bio/dynamics, 1992d (76)].; EFFECT=150 mg/kg body weight/day were administered in the definitive oral gavage study in rabbits [Bio/dynamics, 1992d (76)]. The does showed evidence of significant maternal toxicity in the form of decreased body weights, body weight gains, and food consumption at the high dose. There was no evidence of embryo or foetal toxicity or of teratogenic effect of triclosan. Based on the lack of foetal effects in this study, the foetal NOEL was determined to be 150 mg/kg body weight/day administered by gavage, with the maternal NOEL being 50 mg/kg body weight/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"150 mg/kg body weight/day were administered in the definitive oral gavage study in rabbits [Bio/dynamics, 1992d (76)].","duration":"1992d","effect":"150 mg/kg body weight/day were administered in the definitive oral gavage study in rabbits [Bio/dynamics, 1992d (76)]. The does showed evidence of significant maternal toxicity in the form of decreased body weights, body weight gains, and food consumption at the high dose. There was no evidence of embryo or foetal toxicity or of teratogenic effect of triclosan. Based on the lack of foetal effects in this study, the foetal NOEL was determined to be 150 mg/kg body weight/day administered by gavage, with the maternal NOEL being 50 mg/kg body weight/day.","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":64,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_092"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
150 |
mg/kg |
mouse |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=150; DOSE=Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study.; EFFECT=SCCP/1192/08 Opinion on triclosan 65 In summary, triclosan showed no teratogenic and no embryotoxic effects at any of the doses in the definitive GLP study conducted in rabbits. Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study. Hepatotoxic effects were not observed in any of the dams. The foetal NOEL is considered to be 150 mg/kg body weight/day in rabbits given triclosan via oral gavage, with the maternal NOEL being 50 mg/kg body weight/day. Non-GLP Studies Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan, including findings from a genotoxicity study in mice that examined embryo/foetal toxicity following triclosan administered via the intraperitoneal route of administration. Table 20: Findings from non-GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C) Stu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study.","duration":"developmental","effect":"SCCP/1192/08 Opinion on triclosan 65 In summary, triclosan showed no teratogenic and no embryotoxic effects at any of the doses in the definitive GLP study conducted in rabbits. Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study. Hepatotoxic effects were not observed in any of the dams. The foetal NOEL is considered to be 150 mg/kg body weight/day in rabbits given triclosan via oral gavage, with the maternal NOEL being 50 mg/kg body weight/day. Non-GLP Studies Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan, including findings from a genotoxicity study in mice that examined embryo/foetal toxicity following triclosan administered via the intraperitoneal route of administration. Table 20: Findings from non-GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C) Stu","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":65,"route":"oral","species":"mouse","study_id":"sccp_o_166_noael_093"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg |
mouse |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study.; EFFECT=SCCP/1192/08 Opinion on triclosan 65 In summary, triclosan showed no teratogenic and no embryotoxic effects at any of the doses in the definitive GLP study conducted in rabbits. Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study. Hepatotoxic effects were not observed in any of the dams. The foetal NOEL is considered to be 150 mg/kg body weight/day in rabbits given triclosan via oral gavage, with the maternal NOEL being 50 mg/kg body weight/day. Non-GLP Studies Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan, including findings from a genotoxicity study in mice that examined embryo/foetal toxicity following triclosan administered via the intraperitoneal route of administration. Table 20: Findings from non-GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C) Studies for Triclosan Species (Strain) Dosing Regimen (mg/kg bw/d) Major Findings1 Reference, GLP and OECD Status M; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study.","duration":"developmental","effect":"SCCP/1192/08 Opinion on triclosan 65 In summary, triclosan showed no teratogenic and no embryotoxic effects at any of the doses in the definitive GLP study conducted in rabbits. Findings of maternal toxicity (decreases in maternal body weight gains) at the high dose indicated that dose levels were adequately high in the study. Hepatotoxic effects were not observed in any of the dams. The foetal NOEL is considered to be 150 mg/kg body weight/day in rabbits given triclosan via oral gavage, with the maternal NOEL being 50 mg/kg body weight/day. Non-GLP Studies Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan, including findings from a genotoxicity study in mice that examined embryo/foetal toxicity following triclosan administered via the intraperitoneal route of administration. Table 20: Findings from non-GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C) Studies for Triclosan Species (Strain) Dosing Regimen (mg/kg bw/d) Major Findings1 Reference, GLP and OECD Status M","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":65,"route":"oral","species":"mouse","study_id":"sccp_o_166_noael_094"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
19 |
- |
- |
- |
Developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 19: Findings from GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C): Study investigators did not determine NOEL values for this; EFFECT=Table 19: Findings from GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C): Study investigators did not determine NOEL values for this; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Developmental","effect":"Table 19: Findings from GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C): Study investigators did not determine NOEL values for this","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 19: Findings from GLP Teratology/Developmental Toxicity (Segment 2, ICH Stage C): Study investigators did not determine NOEL values for this","page":61,"route":"","species":"","study_id":"sccp_o_166_noael_165"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
20 |
- |
- |
- |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan,: Study investigators did not determine NOEL values for this; EFFECT=Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan,: Study investigators did not determine NOEL values for this; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"developmental","effect":"Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan,: Study investigators did not determine NOEL values for this","endpoint":"developmental toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 20 presents summaries of the non-GLP developmental toxicity studies for triclosan,: Study investigators did not determine NOEL values for this","page":65,"route":"","species":"","study_id":"sccp_o_166_noael_175"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
300 |
- |
rabbit |
oral |
91-Day |
genotoxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:n Rabbits. Irgasan DP 300. GP 41 353. Ciba-Geigy UK. Stamford Lodge, Wilmslow, England. March 31, 1969 38. Paterson, R.A 91-Day oral toxicity study in dogs. Irgasan DP300. Ciba Geigy: Conducted by Paterson, R.A. Geigy, UK. Wilmslow, England for Buxtorf, A. Geigy, Basel, Switzerland. December 21, 1967 39. Leuschner F., Leuschner A., Schwerdtfeger W., Dontenwill W. 90 Days oral toxicity study in Beagle dogs with CH 3565. Laboratorium Fur Pharmakologie Und Toxikologie. Privatdozent Dr. F. Leuschner. July 10, 1970 40. Noel, P.R.B., Mawdesley-Thomas, L.E., Squires, P.F., Street, A.E. Oral toxicity study in baboons. Repeated dosage for 4 and 13 weeks. Irgasan DP 300. GP 41353. Huntingdon Research Centre, England. April 17, 1969 41. Ciba-Geigy. 1 Year oral toxicity study in baboons with compound FAT 80 023/A (GP 4153, Triclosan). 169/75/S.L. Geigy Pharmaceuticals, Toxicology Department, Wilmslow, Cheshire. July 28, 1975 42. Arni, P., Müller, D. Salmonella/Mammalian-Microsome Mutagenicity Test with FAT 80 023/A (Test for mutagenic prope; EFFECT=n Rabbits. Irgasan DP 300. GP 41 353. Ciba-Geigy UK. Stamford Lodge, Wilmslow, England. March 31, 1969 38. Paterson, R.A 91-Day oral toxicity study in dogs. Irgasan DP300. Ciba Geigy: Conducted by Paterson, R.A. Geigy, UK. Wilmslow, England for Buxtorf, A. Geigy, Basel, Switzerland. December 21, 1967 39. Leuschner F., Leuschner A., Schwerdtfeger W., Dontenwill W. 90 Days oral toxicity study in Beagle dogs with CH 3565. Laboratorium Fur Pharmakologie Und Toxikologie. Privatdozent Dr. F. Leuschner. July 10, 1970 40. Noel, P.R.B., Mawdesley-Thomas, L.E., Squires, P.F., Street, A.E. Oral toxicity study in baboons. Repeated dosage for 4 and 13 weeks. Irgasan DP 300. GP 41353. Huntingdon Research Centre, England. April 17, 1969 41. Ciba-Geigy. 1 Year oral toxicity study in baboons with compound FAT 80 023/A (GP 4153, Triclosan). 169/75/S.L. Geigy Pharmaceuticals, Toxicology Department, Wilmslow, Cheshire. July 28, 1975 42. Arni, P., Müller, D. Salmonella/Mammalian-Microsome Mutagenicity Test with FAT 80 023/A (Test for mutagenic prope; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"91-Day","effect":"n Rabbits. Irgasan DP 300. GP 41 353. Ciba-Geigy UK. Stamford Lodge, Wilmslow, England. March 31, 1969 38. Paterson, R.A 91-Day oral toxicity study in dogs. Irgasan DP300. Ciba Geigy: Conducted by Paterson, R.A. Geigy, UK. Wilmslow, England for Buxtorf, A. Geigy, Basel, Switzerland. December 21, 1967 39. Leuschner F., Leuschner A., Schwerdtfeger W., Dontenwill W. 90 Days oral toxicity study in Beagle dogs with CH 3565. Laboratorium Fur Pharmakologie Und Toxikologie. Privatdozent Dr. F. Leuschner. July 10, 1970 40. Noel, P.R.B., Mawdesley-Thomas, L.E., Squires, P.F., Street, A.E. Oral toxicity study in baboons. Repeated dosage for 4 and 13 weeks. Irgasan DP 300. GP 41353. Huntingdon Research Centre, England. April 17, 1969 41. Ciba-Geigy. 1 Year oral toxicity study in baboons with compound FAT 80 023/A (GP 4153, Triclosan). 169/75/S.L. Geigy Pharmaceuticals, Toxicology Department, Wilmslow, Cheshire. July 28, 1975 42. Arni, P., Müller, D. Salmonella/Mammalian-Microsome Mutagenicity Test with FAT 80 023/A (Test for mutagenic prope","endpoint":"genotoxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:n Rabbits. Irgasan DP 300. GP 41 353. Ciba-Geigy UK. Stamford Lodge, Wilmslow, England. March 31, 1969 38. Paterson, R.A 91-Day oral toxicity study in dogs. Irgasan DP300. Ciba Geigy: Conducted by Paterson, R.A. Geigy, UK. Wilmslow, England for Buxtorf, A. Geigy, Basel, Switzerland. December 21, 1967 39. Leuschner F., Leuschner A., Schwerdtfeger W., Dontenwill W. 90 Days oral toxicity study in Beagle dogs with CH 3565. Laboratorium Fur Pharmakologie Und Toxikologie. Privatdozent Dr. F. Leuschner. July 10, 1970 40. Noel, P.R.B., Mawdesley-Thomas, L.E., Squires, P.F., Street, A.E. Oral toxicity study in baboons. Repeated dosage for 4 and 13 weeks. Irgasan DP 300. GP 41353. Huntingdon Research Centre, England. April 17, 1969 41. Ciba-Geigy. 1 Year oral toxicity study in baboons with compound FAT 80 023/A (GP 4153, Triclosan). 169/75/S.L. Geigy Pharmaceuticals, Toxicology Department, Wilmslow, Cheshire. July 28, 1975 42. Arni, P., Müller, D. Salmonella/Mammalian-Microsome Mutagenicity Test with FAT 80 023/A (Test for mutagenic prope","page":125,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_124"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
60 |
mg/kg bw/d |
rat |
dermal |
- |
irritation |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=60; DOSE=Both mouse studies showed similar dose-related dermal and liver findings such as dermal irritation, increased liver weight, coagulative necrosis and centrilobular hypertrophy.; EFFECT=acroscopic and microscopic evaluations were limited). Both mouse studies showed similar dose-related dermal and liver findings such as dermal irritation, increased liver weight, coagulative necrosis and centrilobular hypertrophy. Dose-related dermal findings started at 1.5 mg / animal / day (60 mg/kg bw/d) for triclosan in propylene glycol and at 3.0 mg / animal / day for triclosan in acetone vehicle. Liver effects were observed in animals treated with dermal doses of ≥ 1.5 mg / animal / day (≥ 60 mg/kg bw/d). The NOAEL is 24 mg/kg bw/d. Ref.: 8, 9 In rats, a similar dose range finding study was conducted using an acetone vehicle. Dermally-applied doses of 0.3, 0.6, 1.5, 3.0, or 6.0 mg/day in the rat study correspond to systemic doses of approximately 1.2, 2.4, 6, 12, or 24 mg/kg body weight/day for a 250 g rat (triclosan concentrations of 0.1, 0.2, 0.5, 1, and 2 % in 0.3 mL application volume). Skin irritation such as erythema was observed at 6.0 mg/day, with findings in one female animal at 1.5 mg/day considered to be incident; CITATION=Ref.: 8, 9 In rats, a similar dose range finding study was conducted using an acetone vehicle; CITATION_NUMBERS=[8,9]; REFERENCE=Ref.: 8, 9 In rats, a similar dose range finding study was conducted using an acetone vehicle; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 8, 9 In rats, a similar dose range finding study was conducted using an acetone vehicle","dose":"Both mouse studies showed similar dose-related dermal and liver findings such as dermal irritation, increased liver weight, coagulative necrosis and centrilobular hypertrophy.","duration":"","effect":"acroscopic and microscopic evaluations were limited). Both mouse studies showed similar dose-related dermal and liver findings such as dermal irritation, increased liver weight, coagulative necrosis and centrilobular hypertrophy. Dose-related dermal findings started at 1.5 mg / animal / day (60 mg/kg bw/d) for triclosan in propylene glycol and at 3.0 mg / animal / day for triclosan in acetone vehicle. Liver effects were observed in animals treated with dermal doses of ≥ 1.5 mg / animal / day (≥ 60 mg/kg bw/d). The NOAEL is 24 mg/kg bw/d. Ref.: 8, 9 In rats, a similar dose range finding study was conducted using an acetone vehicle. Dermally-applied doses of 0.3, 0.6, 1.5, 3.0, or 6.0 mg/day in the rat study correspond to systemic doses of approximately 1.2, 2.4, 6, 12, or 24 mg/kg body weight/day for a 250 g rat (triclosan concentrations of 0.1, 0.2, 0.5, 1, and 2 % in 0.3 mL application volume). Skin irritation such as erythema was observed at 6.0 mg/day, with findings in one female animal at 1.5 mg/day considered to be incident","endpoint":"irritation","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"60","page":21,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
24 |
mg/kg |
rat |
dermal |
- |
irritation |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=24; DOSE=10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application.; EFFECT=change in organ weight was observed and no histopathology was associated with the gross pathology findings. Ref.: 10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application. In addition, liver-related effects such as increased organ weight associated with centrilobular hypertrophy were observed in both mouse studies but not in the rat, indicating a species difference in response to triclosan. The NOAEL was determined to be 0.6 mg/day (24 mg/kg body weight/day) in both mouse studies, based on liver effects observed at doses of ≥ 1.5 mg / animal / day. The NOAEL in the rat study was determined to be 3.0 mg / animal / day (12 mg/kg bw/day), based on dermal irritation at the highest dose of 6.0 mg / animal / day.; CITATION=Ref.: 10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application; CITATION_NUMBERS=[10,3]; REFERENCE=Ref.: 10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application","dose":"10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application.","duration":"","effect":"change in organ weight was observed and no histopathology was associated with the gross pathology findings. Ref.: 10 In summary, these 3 rodent dermal studies revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application. In addition, liver-related effects such as increased organ weight associated with centrilobular hypertrophy were observed in both mouse studies but not in the rat, indicating a species difference in response to triclosan. The NOAEL was determined to be 0.6 mg/day (24 mg/kg body weight/day) in both mouse studies, based on liver effects observed at doses of ≥ 1.5 mg / animal / day. The NOAEL in the rat study was determined to be 3.0 mg / animal / day (12 mg/kg bw/day), based on dermal irritation at the highest dose of 6.0 mg / animal / day.","endpoint":"irritation","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"24","page":21,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
12 |
mg/kg bw/day |
rat |
dermal |
- |
irritation |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application.; EFFECT=revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application. In addition, liver-related effects such as increased organ weight associated with centrilobular hypertrophy were observed in both mouse studies but not in the rat, indicating a species difference in response to triclosan. The NOAEL was determined to be 0.6 mg/day (24 mg/kg body weight/day) in both mouse studies, based on liver effects observed at doses of ≥ 1.5 mg / animal / day. The NOAEL in the rat study was determined to be 3.0 mg / animal / day (12 mg/kg bw/day), based on dermal irritation at the highest dose of 6.0 mg / animal / day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application.","duration":"","effect":"revealed a similar pattern of toxicity with respect to dose-related dermal irritation and hyperkeratosis at the site of application. In addition, liver-related effects such as increased organ weight associated with centrilobular hypertrophy were observed in both mouse studies but not in the rat, indicating a species difference in response to triclosan. The NOAEL was determined to be 0.6 mg/day (24 mg/kg body weight/day) in both mouse studies, based on liver effects observed at doses of ≥ 1.5 mg / animal / day. The NOAEL in the rat study was determined to be 3.0 mg / animal / day (12 mg/kg bw/day), based on dermal irritation at the highest dose of 6.0 mg / animal / day.","endpoint":"irritation","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12","page":21,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
24 |
mg/kg bw |
mouse |
dermal |
14 days |
irritation |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=24; DOSE=The liver showed dose-related increase in absolute and relative liver weight in females at 1.5 and in both sexes at 3.0 and 6.0 mg/d.; EFFECT=0, 0.3, 0.6, 1.5, 3, and 6%) Dermal irritation such as erythema was observed at the site of application. Oedema, fissuring, eschar was observed at the 2 highest doses which correlated with hyperkeratosis. Acanthosis was also observed in males at 1.5 mg/d. The liver showed dose-related increase in absolute and relative liver weight in females at 1.5 and in both sexes at 3.0 and 6.0 mg/d. This increase associated with centrilobular hypertrophy. Mononuclear infiltrate was also observed but only at the high dose. The NOAEL is considered to be 0.6 mg/d. This corresponds to 24 mg/kg bw per day Burns, 1997a (8) GLP: compliant OECD: comparable Mouse (CD-1) 0, 0.3, 0.6, 1.5, 3.0, or 6.0 mg/animal/d in propylene glycol for 14 days, in a volume of 100 µL, applied to 2x3 cm2 area on the dorsal area once daily (triclosan concentrations of 0, 0.3, 0.6, 1.5, 3, and 6%) Dose-related dermal irritation was observed at the site of application starting at 1.5 mg/d. Dose-related increases in absolute and relative liver weights in both sexes at 6.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The liver showed dose-related increase in absolute and relative liver weight in females at 1.5 and in both sexes at 3.0 and 6.0 mg/d.","duration":"14 days","effect":"0, 0.3, 0.6, 1.5, 3, and 6%) Dermal irritation such as erythema was observed at the site of application. Oedema, fissuring, eschar was observed at the 2 highest doses which correlated with hyperkeratosis. Acanthosis was also observed in males at 1.5 mg/d. The liver showed dose-related increase in absolute and relative liver weight in females at 1.5 and in both sexes at 3.0 and 6.0 mg/d. This increase associated with centrilobular hypertrophy. Mononuclear infiltrate was also observed but only at the high dose. The NOAEL is considered to be 0.6 mg/d. This corresponds to 24 mg/kg bw per day Burns, 1997a (8) GLP: compliant OECD: comparable Mouse (CD-1) 0, 0.3, 0.6, 1.5, 3.0, or 6.0 mg/animal/d in propylene glycol for 14 days, in a volume of 100 µL, applied to 2x3 cm2 area on the dorsal area once daily (triclosan concentrations of 0, 0.3, 0.6, 1.5, 3, and 6%) Dose-related dermal irritation was observed at the site of application starting at 1.5 mg/d. Dose-related increases in absolute and relative liver weights in both sexes at 6.","endpoint":"irritation","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"24","page":22,"route":"dermal","species":"mouse","study_id":"sccp_o_166_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
24 |
mg/kg bw |
rat |
dermal |
14 days |
irritation |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=24; DOSE=ys, in a volume of 100 µL, applied to 2x3 cm2 area on the dorsal area once daily (triclosan concentrations of 0, 0.3, 0.6, 1.5, 3, and 6%) Dose-related dermal irritation was observed at the site of application starting at 1.5 mg/d.; EFFECT=ys, in a volume of 100 µL, applied to 2x3 cm2 area on the dorsal area once daily (triclosan concentrations of 0, 0.3, 0.6, 1.5, 3, and 6%) Dose-related dermal irritation was observed at the site of application starting at 1.5 mg/d. Dose-related increases in absolute and relative liver weights in both sexes at 6.0 mg/d and in males at 0.3, 1.5 and 3.0 mg/d. Centrilobular hypertrophy at doses ≥1.5 mg/d. The statistical increase in male liver weights at 0.3 mg/d was not correlated with any histopathology changes. The NOAEL is considered to be 0.6 mg/d. This corresponds to 24 mg/kg bw per day Burns, 1996 (9); GLP: compliant OECD: comparable Rat (Crl:CDBR) 0, 0.3, 0.6, 1.5, 3.0, or 6.0 mg/animal/d in acetone for 14 days, in a volume of 300 µL, applied to 2x3 cm2 on the dorsal area once daily (triclosan concentrations of 0.1, 0.2, 0.5, 1, and 2%) Dose-related skin irritation such as erythema was observed at 6.0 mg/d, with findings in 1 animal at 1.5 mg/d considered incidental. Other related signs of skin irritation such as eschar, oe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"ys, in a volume of 100 µL, applied to 2x3 cm2 area on the dorsal area once daily (triclosan concentrations of 0, 0.3, 0.6, 1.5, 3, and 6%) Dose-related dermal irritation was observed at the site of application starting at 1.5 mg/d.","duration":"14 days","effect":"ys, in a volume of 100 µL, applied to 2x3 cm2 area on the dorsal area once daily (triclosan concentrations of 0, 0.3, 0.6, 1.5, 3, and 6%) Dose-related dermal irritation was observed at the site of application starting at 1.5 mg/d. Dose-related increases in absolute and relative liver weights in both sexes at 6.0 mg/d and in males at 0.3, 1.5 and 3.0 mg/d. Centrilobular hypertrophy at doses ≥1.5 mg/d. The statistical increase in male liver weights at 0.3 mg/d was not correlated with any histopathology changes. The NOAEL is considered to be 0.6 mg/d. This corresponds to 24 mg/kg bw per day Burns, 1996 (9); GLP: compliant OECD: comparable Rat (Crl:CDBR) 0, 0.3, 0.6, 1.5, 3.0, or 6.0 mg/animal/d in acetone for 14 days, in a volume of 300 µL, applied to 2x3 cm2 on the dorsal area once daily (triclosan concentrations of 0.1, 0.2, 0.5, 1, and 2%) Dose-related skin irritation such as erythema was observed at 6.0 mg/d, with findings in 1 animal at 1.5 mg/d considered incidental. Other related signs of skin irritation such as eschar, oe","endpoint":"irritation","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"24","page":22,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
12 |
mg/kg bw/d |
rat |
oral |
- |
irritation |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=General toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs.; EFFECT=ussion Physico-chemical properties Trichlosan is a phenol and a weak acid (pKa 8.1). This and its partition coefficient (logPo/w 4.8) facilitate transfer of the protonated (non-ionized) form of triclosan across lipid membranes. General toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs. SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females) in the long term toxicity study in rats. Irritation / sensitisation The irritation/corrosivity data from either irritation studies in the hamster, guinea pig, and rabbit, or skin toxicity studies conducted in the mouse, rat, monkey, and dog suggest that triclosan may cause slight reversible skin irritation at concentrations of 0.5 to 5% under experimental conditions. Triclosan at concentrations of 1 to 10%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"General toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs.","duration":"","effect":"ussion Physico-chemical properties Trichlosan is a phenol and a weak acid (pKa 8.1). This and its partition coefficient (logPo/w 4.8) facilitate transfer of the protonated (non-ionized) form of triclosan across lipid membranes. General toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs. SCCP considers the NOAEL as 12 mg/kg bw/d due to haematoxicity and decreased absolute and relative spleen weights (Mid Dose Females) in the long term toxicity study in rats. Irritation / sensitisation The irritation/corrosivity data from either irritation studies in the hamster, guinea pig, and rabbit, or skin toxicity studies conducted in the mouse, rat, monkey, and dog suggest that triclosan may cause slight reversible skin irritation at concentrations of 0.5 to 5% under experimental conditions. Triclosan at concentrations of 1 to 10%","endpoint":"irritation","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"12","page":120,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_116"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
12 |
mg/kg bw |
rat |
inhalation |
21 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=Histopathology of the erythema, scaling and eschar showed acanthosis and hyperkeratosis at the highest dose.; EFFECT=lated skin irritation such as erythema was observed at 6.0 mg/d, with findings in 1 animal at 1.5 mg/d considered incidental. Other related signs of skin irritation such as eschar, oedema were also noted. Histopathology of the erythema, scaling and eschar showed acanthosis and hyperkeratosis at the highest dose. Gross pathology revealed dark areas of the liver noted in a few treated animals (not dose-related); however, no change in organ weight was observed and no histopathology accompanied this gross finding. The NOAEL was estimated by investigators to be 3.0 mg/animal/d equivalent to 12 mg/kg bw per day. Burns, 1997b (10); GLP: compliant OECD: comparable 3.3.5.2. Repeated dose (21 days) inhalation toxicity The inhalation toxicity of triclosan after 14 days of repeated dose administration was evaluated in the rat. This study was performed prior to GLP regulations and the establishment of OECD guidelines In this study, groups of 10 male and 10 female rats were initially exposed to triclosan at concentrations ranging from 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Histopathology of the erythema, scaling and eschar showed acanthosis and hyperkeratosis at the highest dose.","duration":"21 days","effect":"lated skin irritation such as erythema was observed at 6.0 mg/d, with findings in 1 animal at 1.5 mg/d considered incidental. Other related signs of skin irritation such as eschar, oedema were also noted. Histopathology of the erythema, scaling and eschar showed acanthosis and hyperkeratosis at the highest dose. Gross pathology revealed dark areas of the liver noted in a few treated animals (not dose-related); however, no change in organ weight was observed and no histopathology accompanied this gross finding. The NOAEL was estimated by investigators to be 3.0 mg/animal/d equivalent to 12 mg/kg bw per day. Burns, 1997b (10); GLP: compliant OECD: comparable 3.3.5.2. Repeated dose (21 days) inhalation toxicity The inhalation toxicity of triclosan after 14 days of repeated dose administration was evaluated in the rat. This study was performed prior to GLP regulations and the establishment of OECD guidelines In this study, groups of 10 male and 10 female rats were initially exposed to triclosan at concentrations ranging from 5","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"12","page":22,"route":"inhalation","species":"rat","study_id":"sccp_o_166_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
169 |
mg/kg |
mouse |
oral |
28 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=169; DOSE=Slight focal inflammation of the mucous membranes was observed in high-dose animals at the end of the study.; EFFECT=SCCP/1192/08 Opinion on triclosan 23 observed. Slight focal inflammation of the mucous membranes was observed in high-dose animals at the end of the study. The NOAEL for inhaled triclosan was determined in this study to be 50 mg/m3, the lowest dose tested. Ref.: 32 3.3.5.3. Repeated dose (28 days) oral toxicity study in mice A GLP-compliant 28-day repeated dose oral toxicity study of triclosan was conducted in the mouse, using OECD Guideline 407 for the design of the study. In this mouse study, the significant findings were in the liver, which showed reversible hepatocellular hypertrophy and focal necrosis in mice that received the high dose (136 and 169 mg/kg body weight/da; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 32 3","dose":"Slight focal inflammation of the mucous membranes was observed in high-dose animals at the end of the study.","duration":"28 days","effect":"SCCP/1192/08 Opinion on triclosan 23 observed. Slight focal inflammation of the mucous membranes was observed in high-dose animals at the end of the study. The NOAEL for inhaled triclosan was determined in this study to be 50 mg/m3, the lowest dose tested. Ref.: 32 3.3.5.3. Repeated dose (28 days) oral toxicity study in mice A GLP-compliant 28-day repeated dose oral toxicity study of triclosan was conducted in the mouse, using OECD Guideline 407 for the design of the study. In this mouse study, the significant findings were in the liver, which showed reversible hepatocellular hypertrophy and focal necrosis in mice that received the high dose (136 and 169 mg/kg body weight/da","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"169","page":23,"route":"oral","species":"mouse","study_id":"sccp_o_166_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
ppm |
rat |
oral |
14-day |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=Low-dose animals showed no histological changes or changes in haematology or blood chemistry (except for a slight, not significant increase in liver function enzymes in males of the low-dose group).; EFFECT=cases. Some Kupffer cells in the area contained a pigment that was assumed to be iron. These changes were reversed in 14-day recovery period. Low-dose animals showed no histological changes or changes in haematology or blood chemistry (except for a slight, not significant increase in liver function enzymes in males of the low-dose group). Electron microscopy of selected livers of high-dose animals showed reversible proliferation of smooth endoplasmic reticulum and increase in number and/or size of peroxisomes. No NOAEL was determined by investigators; however, it should be noted that no adverse effects were observed at the low dose (50 ppm). Ciba-Geigy, 1987 (31); GLP: compliant OECD: No.407 consistent Comment A reversible decrease in phosphate was observed in females of both doses and liver enzymes were slightly increased but not significant in low dose males. 3.3.5.4. Sub-chronic (90 days) oral toxicity studies The safety of triclosan has been evaluated in sub-chronic oral toxicity studies in mice, rats, hamsters, rabbits; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Low-dose animals showed no histological changes or changes in haematology or blood chemistry (except for a slight, not significant increase in liver function enzymes in males of the low-dose group).","duration":"14-day","effect":"cases. Some Kupffer cells in the area contained a pigment that was assumed to be iron. These changes were reversed in 14-day recovery period. Low-dose animals showed no histological changes or changes in haematology or blood chemistry (except for a slight, not significant increase in liver function enzymes in males of the low-dose group). Electron microscopy of selected livers of high-dose animals showed reversible proliferation of smooth endoplasmic reticulum and increase in number and/or size of peroxisomes. No NOAEL was determined by investigators; however, it should be noted that no adverse effects were observed at the low dose (50 ppm). Ciba-Geigy, 1987 (31); GLP: compliant OECD: No.407 consistent Comment A reversible decrease in phosphate was observed in females of both doses and liver enzymes were slightly increased but not significant in low dose males. 3.3.5.4. Sub-chronic (90 days) oral toxicity studies The safety of triclosan has been evaluated in sub-chronic oral toxicity studies in mice, rats, hamsters, rabbits","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"50","page":23,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
75 |
mg/kg bw/day |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=In addition to liver findings, increased extramedullary haematopoiesis was observed in the spleen of animals at 750 and 900 mg/kg bw/day and, at doses of 200 mg/kg body weight/day and higher, hyperplasia in male glandular stomachs and inflammation in female kidneys occurred.; EFFECT=ses of hepatocellular hypertrophy, hepatocytes were individualized, although the overall hepatic architecture was still intact. In addition to liver findings, increased extramedullary haematopoiesis was observed in the spleen of animals at 750 and 900 mg/kg bw/day and, at doses of 200 mg/kg body weight/day and higher, hyperplasia in male glandular stomachs and inflammation in female kidneys occurred. No histomorphologic alterations were observed in males at 25 mg/kg bw/day or in females at 25 or 75 mg/kg bw/day. A NOAEL was not established from this study since treatment- related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose. Ref.: 33 Subchronic oral toxicity study in rats In a 90-day GLP toxicity study in rats that served as a dose range-finding study for a 2-year oral carcinogenicity study, triclosan (FAT 80’023) was administered to Sprague-Dawley rats (25/sex/group) via the diet at concentrations of 0, 1000, 3000, or 6000 ppm (approximately 0, 100,; CITATION=Ref.: 33 Subchronic oral toxicity study in rats In a 90-day GLP toxicity study in rats that served as a dose range-finding study for a 2-year oral carcinogenicity study, triclosan (FAT 8; CITATION_NUMBERS=[33,90,2,8]; REFERENCE=Ref.: 33 Subchronic oral toxicity study in rats In a 90-day GLP toxicity study in rats that served as a dose range-finding study for a 2-year oral carcinogenicity study, triclosan (FAT 8; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 33 Subchronic oral toxicity study in rats In a 90-day GLP toxicity study in rats that served as a dose range-finding study for a 2-year oral carcinogenicity study, triclosan (FAT 8","dose":"In addition to liver findings, increased extramedullary haematopoiesis was observed in the spleen of animals at 750 and 900 mg/kg bw/day and, at doses of 200 mg/kg body weight/day and higher, hyperplasia in male glandular stomachs and inflammation in female kidneys occurred.","duration":"Subchronic","effect":"ses of hepatocellular hypertrophy, hepatocytes were individualized, although the overall hepatic architecture was still intact. In addition to liver findings, increased extramedullary haematopoiesis was observed in the spleen of animals at 750 and 900 mg/kg bw/day and, at doses of 200 mg/kg body weight/day and higher, hyperplasia in male glandular stomachs and inflammation in female kidneys occurred. No histomorphologic alterations were observed in males at 25 mg/kg bw/day or in females at 25 or 75 mg/kg bw/day. A NOAEL was not established from this study since treatment- related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose. Ref.: 33 Subchronic oral toxicity study in rats In a 90-day GLP toxicity study in rats that served as a dose range-finding study for a 2-year oral carcinogenicity study, triclosan (FAT 80’023) was administered to Sprague-Dawley rats (25/sex/group) via the diet at concentrations of 0, 1000, 3000, or 6000 ppm (approximately 0, 100,","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":24,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
ppm |
- |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).; EFFECT=SCCP/1192/08 Opinion on triclosan 25 histomorphologic changes were observed in the spleen. The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Ref.: 34 Subchronic oral toxicity study in hamsters In the 13-week GLP hamster study, triclosan (FAT 80’023) was administered to Syrian Golden Hamsters (15/sex/treatment group; 20/sex/control, 10/sex/group for interim sacrifice at 7 weeks) via the diet at doses of 0, 75, 200, 350, 750, or 900 mg/kg body weight/day. Treatment was not associated with any mortality or clinical signs. Decreased body weight gain was observed at 750 and 900 mg/kg body weigh; CITATION=Ref.: 34 Subchronic oral toxicity study in hamsters In the 13-week GLP hamster study, triclosan (FAT 80’023) was administered to Syrian Golden Hamsters (15/sex/treatment group; CITATION_NUMBERS=[34,13,80,23,15]; REFERENCE=Ref.: 34 Subchronic oral toxicity study in hamsters In the 13-week GLP hamster study, triclosan (FAT 80’023) was administered to Syrian Golden Hamsters (15/sex/treatment group; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 34 Subchronic oral toxicity study in hamsters In the 13-week GLP hamster study, triclosan (FAT 80’023) was administered to Syrian Golden Hamsters (15/sex/treatment group","dose":"The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).","duration":"Subchronic","effect":"SCCP/1192/08 Opinion on triclosan 25 histomorphologic changes were observed in the spleen. The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Ref.: 34 Subchronic oral toxicity study in hamsters In the 13-week GLP hamster study, triclosan (FAT 80’023) was administered to Syrian Golden Hamsters (15/sex/treatment group; 20/sex/control, 10/sex/group for interim sacrifice at 7 weeks) via the diet at doses of 0, 75, 200, 350, 750, or 900 mg/kg body weight/day. Treatment was not associated with any mortality or clinical signs. Decreased body weight gain was observed at 750 and 900 mg/kg body weigh","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":25,"route":"oral","species":"","study_id":"sccp_o_166_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
75 |
mg/kg bw/day |
rabbit |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=ion, which were not considered adverse, the LOEL was determined to be 200 mg/kg bw/d; study investigators determined the NOEL to be 75 mg/kg bw/d.; EFFECT=ion, which were not considered adverse, the LOEL was determined to be 200 mg/kg bw/d; study investigators determined the NOEL to be 75 mg/kg bw/d. At 750 and 900 mg/kg/day, the kidneys were identified as a target organ based on macroscopic, histopathologic and clinical findings. Clinical chemistry changes also indicated liver effects; however, no microscopic findings were observed. The red blood cell also showed treatment- related effects. At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed. The NOEL was determined by study investigators to be 75 mg/kg bw/day. Schmid et al., 1994 (35); GLP: compliant OECD: No.408 consistent Subchronic oral toxicity study in rabbits The results of 2 studies in rabbits were inconsistent; in 1 study, triclosan was reported to be well-tolerated, with no treatment-related effects up to the dose level of 125 mg/kg bw/day, whereas in a second study, the NOAEL was determined to be 3 mg/kg bw/day, as animals given doses of 30 or 150 mg/kg bw/day showed pulmonary infections. Howev; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"ion, which were not considered adverse, the LOEL was determined to be 200 mg/kg bw/d; study investigators determined the NOEL to be 75 mg/kg bw/d.","duration":"Subchronic","effect":"ion, which were not considered adverse, the LOEL was determined to be 200 mg/kg bw/d; study investigators determined the NOEL to be 75 mg/kg bw/d. At 750 and 900 mg/kg/day, the kidneys were identified as a target organ based on macroscopic, histopathologic and clinical findings. Clinical chemistry changes also indicated liver effects; however, no microscopic findings were observed. The red blood cell also showed treatment- related effects. At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed. The NOEL was determined by study investigators to be 75 mg/kg bw/day. Schmid et al., 1994 (35); GLP: compliant OECD: No.408 consistent Subchronic oral toxicity study in rabbits The results of 2 studies in rabbits were inconsistent; in 1 study, triclosan was reported to be well-tolerated, with no treatment-related effects up to the dose level of 125 mg/kg bw/day, whereas in a second study, the NOAEL was determined to be 3 mg/kg bw/day, as animals given doses of 30 or 150 mg/kg bw/day showed pulmonary infections. Howev","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":27,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
3 |
mg/kg bw/day |
rabbit |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=3; DOSE=At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed.; EFFECT=cell also showed treatment- related effects. At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed. The NOEL was determined by study investigators to be 75 mg/kg bw/day. Schmid et al., 1994 (35); GLP: compliant OECD: No.408 consistent Subchronic oral toxicity study in rabbits The results of 2 studies in rabbits were inconsistent; in 1 study, triclosan was reported to be well-tolerated, with no treatment-related effects up to the dose level of 125 mg/kg bw/day, whereas in a second study, the NOAEL was determined to be 3 mg/kg bw/day, as animals given doses of 30 or 150 mg/kg bw/day showed pulmonary infections. However, it should be noted that study investigators stated that the relationship of the lung findings to triclosan was unclear. Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical chemistry, macroscopic and microscopic findings at all doses tested, including some effe; CITATION=Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical ch; CITATION_NUMBERS=[36,37,1,2]; REFERENCE=Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical ch; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical ch","dose":"At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed.","duration":"Subchronic","effect":"cell also showed treatment- related effects. At 350 mg/kg/day, microscopic findings of nephrotoxicity were observed. The NOEL was determined by study investigators to be 75 mg/kg bw/day. Schmid et al., 1994 (35); GLP: compliant OECD: No.408 consistent Subchronic oral toxicity study in rabbits The results of 2 studies in rabbits were inconsistent; in 1 study, triclosan was reported to be well-tolerated, with no treatment-related effects up to the dose level of 125 mg/kg bw/day, whereas in a second study, the NOAEL was determined to be 3 mg/kg bw/day, as animals given doses of 30 or 150 mg/kg bw/day showed pulmonary infections. However, it should be noted that study investigators stated that the relationship of the lung findings to triclosan was unclear. Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical chemistry, macroscopic and microscopic findings at all doses tested, including some effe","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":27,"route":"oral","species":"rabbit","study_id":"sccp_o_166_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg bw/day |
dog |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; DOSE=or 150 mg/kg bw/day showed pulmonary infections.; EFFECT=or 150 mg/kg bw/day showed pulmonary infections. However, it should be noted that study investigators stated that the relationship of the lung findings to triclosan was unclear. Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical chemistry, macroscopic and microscopic findings at all doses tested, including some effects at the lowest dose tested of 25 mg/kg bw/day. As a result, no NOAEL was determined for the study. Ref.: 38; CITATION=Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical ch; CITATION_NUMBERS=[36,37,1,2]; REFERENCE=Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical ch; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical ch","dose":"or 150 mg/kg bw/day showed pulmonary infections.","duration":"Subchronic","effect":"or 150 mg/kg bw/day showed pulmonary infections. However, it should be noted that study investigators stated that the relationship of the lung findings to triclosan was unclear. Ref.: 36, 37 Subchronic oral toxicity study in dogs, study 1 Inconsistency also was found in a comparison of 2 sub-chronic dog studies, the first of which showed haematology, clinical chemistry, macroscopic and microscopic findings at all doses tested, including some effects at the lowest dose tested of 25 mg/kg bw/day. As a result, no NOAEL was determined for the study. Ref.: 38","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":27,"route":"oral","species":"dog","study_id":"sccp_o_166_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
30 |
mg/kg bw/d |
rat |
dermal |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=points were observed for the high-dose group (statistically significant only up to Week 26).; EFFECT=points were observed for the high-dose group (statistically significant only up to Week 26). Incidental changes in potassium and sodium were observed. Slight changes, both increases and decreases in SGOT and AP were observed; however, not considered treatment-related. No differences were found in urinalysis. At necropsy, decreased absolute brain and increases in kidney and liver weights were observed in high-dose animals. Histopathologic examination found similar histology in both treated and control animals. The NOEL was determined to be 30 mg/kg bw/d. Ciba-Geigy, 1975a (41); Predates GLP and OECD OECD: comparable 3.3.5.5. Sub-Chronic Dermal Toxicity The sub-chronic dermal toxicity of triclosan has been investigated in rats, dogs, and monkeys. The studies conducted in weanling dogs and newborn Rhesus monkeys were not GLP-compliant and not conducted pursuant to OECD guidelines. The pertinent details from these studies are summarized in Tables 14 (GLP rat study) and 15 (non-GLP, non-OECD studies). Sub-Chronic Dermal Toxici; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"points were observed for the high-dose group (statistically significant only up to Week 26).","duration":"Sub-Chronic","effect":"points were observed for the high-dose group (statistically significant only up to Week 26). Incidental changes in potassium and sodium were observed. Slight changes, both increases and decreases in SGOT and AP were observed; however, not considered treatment-related. No differences were found in urinalysis. At necropsy, decreased absolute brain and increases in kidney and liver weights were observed in high-dose animals. Histopathologic examination found similar histology in both treated and control animals. The NOEL was determined to be 30 mg/kg bw/d. Ciba-Geigy, 1975a (41); Predates GLP and OECD OECD: comparable 3.3.5.5. Sub-Chronic Dermal Toxicity The sub-chronic dermal toxicity of triclosan has been investigated in rats, dogs, and monkeys. The studies conducted in weanling dogs and newborn Rhesus monkeys were not GLP-compliant and not conducted pursuant to OECD guidelines. The pertinent details from these studies are summarized in Tables 14 (GLP rat study) and 15 (non-GLP, non-OECD studies). Sub-Chronic Dermal Toxici","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":30,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
=80 |
mg/kg/day |
rat |
dermal |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 80; DOSE=Dermal observations of erythema and/or showed oedema in all treated groups.; EFFECT=was for at least 6 hours. Dermal observations of erythema and/or showed oedema in all treated groups. No treatment-related changes were found in ophthalmoscopic examinations and in water consumption and body weight. Occult blood was observed in the urine of high-dose and satellite male rats and to a lesser extent in mid-dose males and females. Isolated changes were observed in erythrocyte parameters in high dose animals. Small but statistically significant changes were observed in some serum chemistry parameters. NOAEL = 80 mg/kg/day (excluding dermal irritation) Ref.: 11 Sub-Chronic Dermal Toxicity (90 d) in dogs Weanling dogs exposed to triclosan through dermal application for 90 days of doses ranging from 2 to 200 mg/kg bw/day in a non-GLP study showed no toxicity except for dermal irritation at the highest dose tested. Ref.: 12 Sub-Chronic Dermal Toxicity (90 d) in monkeys The major findings from a 90-day bathing study conducted in newborn Rhesus monkeys showed that repeated exposure to triclosan (0.1% in a soap solution; CITATION=Ref.: 11 Sub-Chronic Dermal Toxicity (90 d) in dogs Weanling dogs exposed to triclosan through dermal application for 90 days of doses ranging from 2 to 200 mg/kg bw/day in a non-GLP stu; CITATION_NUMBERS=[11,90,2,200]; REFERENCE=Ref.: 11 Sub-Chronic Dermal Toxicity (90 d) in dogs Weanling dogs exposed to triclosan through dermal application for 90 days of doses ranging from 2 to 200 mg/kg bw/day in a non-GLP stu; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 11 Sub-Chronic Dermal Toxicity (90 d) in dogs Weanling dogs exposed to triclosan through dermal application for 90 days of doses ranging from 2 to 200 mg/kg bw/day in a non-GLP stu","dose":"Dermal observations of erythema and/or showed oedema in all treated groups.","duration":"Sub-Chronic","effect":"was for at least 6 hours. Dermal observations of erythema and/or showed oedema in all treated groups. No treatment-related changes were found in ophthalmoscopic examinations and in water consumption and body weight. Occult blood was observed in the urine of high-dose and satellite male rats and to a lesser extent in mid-dose males and females. Isolated changes were observed in erythrocyte parameters in high dose animals. Small but statistically significant changes were observed in some serum chemistry parameters. NOAEL = 80 mg/kg/day (excluding dermal irritation) Ref.: 11 Sub-Chronic Dermal Toxicity (90 d) in dogs Weanling dogs exposed to triclosan through dermal application for 90 days of doses ranging from 2 to 200 mg/kg bw/day in a non-GLP study showed no toxicity except for dermal irritation at the highest dose tested. Ref.: 12 Sub-Chronic Dermal Toxicity (90 d) in monkeys The major findings from a 90-day bathing study conducted in newborn Rhesus monkeys showed that repeated exposure to triclosan (0.1% in a soap solution","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg/day","noael_value":"= 80","page":31,"route":"dermal","species":"rat","study_id":"sccp_o_166_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
75 |
mg/kg bw/d |
- |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=machs (fundic region), along with spermatozoa and germ cell effects at the high dose.; EFFECT=machs (fundic region), along with spermatozoa and germ cell effects at the high dose. One high-dose female showed atypical hyperplasia in the fundic region that was considered to be treatment-related. High-dose females showed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report). Hepatic effects were few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged; CITATION=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; CITATION_NUMBERS=[68]; REFERENCE=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled","dose":"machs (fundic region), along with spermatozoa and germ cell effects at the high dose.","duration":"subchronic","effect":"machs (fundic region), along with spermatozoa and germ cell effects at the high dose. One high-dose female showed atypical hyperplasia in the fundic region that was considered to be treatment-related. High-dose females showed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report). Hepatic effects were few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"oral","species":"","study_id":"sccp_o_166_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
75 |
mg/kg bw/d |
human |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=ects at the high dose.; EFFECT=ects at the high dose. One high-dose female showed atypical hyperplasia in the fundic region that was considered to be treatment-related. High-dose females showed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report). Hepatic effects were few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (7; CITATION=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; CITATION_NUMBERS=[68]; REFERENCE=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled","dose":"ects at the high dose.","duration":"subchronic","effect":"ects at the high dose. One high-dose female showed atypical hyperplasia in the fundic region that was considered to be treatment-related. High-dose females showed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report). Hepatic effects were few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (7","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"oral","species":"human","study_id":"sccp_o_166_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
30 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=ed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report).; EFFECT=ed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report). Hepatic effects were few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOA; CITATION=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; CITATION_NUMBERS=[68]; REFERENCE=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled","dose":"ed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report).","duration":"subchronic","effect":"ed distended gastric glands and a few treated females of all doses showed benign papillomas of the non-glandular region of the stomach (not discussed in report). Hepatic effects were few, with only rarified hepatocytes reported in a few male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOA","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
75 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=male animals (6/60 in high dose vs.; EFFECT=male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studie; CITATION=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; CITATION_NUMBERS=[68]; REFERENCE=Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled; DETAILS_JSON={"cas_number":"3380-34-5","citation":"Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled","dose":"male animals (6/60 in high dose vs.","duration":"subchronic","effect":"male animals (6/60 in high dose vs. 3/121 in controls). The NOAEL was set as 75 mg/kg bw/d. Ref.: 68 Comment on setting a NOAEL In the Table below the derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studie","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
48 |
mg/kg bw/d |
rat |
oral |
95-week |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=48; DOSE=EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.; EFFECT=onic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.","duration":"95-week","effect":"onic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"48","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
48 |
mg/kg bw/d |
rat |
oral |
95-week |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=48; DOSE=AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.; EFFECT=AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.","duration":"95-week","effect":"AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively as a more conservative value, the NOEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"48","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
12 |
mg/kg bw/d |
rat |
oral |
13-week |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights.; EFFECT=mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights.","duration":"13-week","effect":"mg/kg bw/d) due to haematoxicity and decreased absolute and relative spleen weights. Haematoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"12","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
12 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=12; DOSE=The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment.; EFFECT=-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment.","duration":"subchronic","effect":"-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopi","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"12","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
ppm |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment.; EFFECT=erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment.","duration":"Subchronic","effect":"erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long term toxicity study in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
200 |
mg/kg bw/d |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=200; DOSE=Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=y in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.","duration":"Subchronic","effect":"y in rats for risk assessment. Subchronic oral toxicity study in mice A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting t","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"200","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
30 |
mg/kg bw/d |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=30; DOSE=kaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=kaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Fe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"kaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.","duration":"Subchronic","effect":"kaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day. Subchronic oral toxicity study in rats The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day). Subchronic oral toxicity study in hamsters The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria. Long term (1 year) oral toxicity study in baboons NOEL is estimated to be 30 mg/kg bw/d based on the absence of any effect, including diarrhoea, in baboons at the low dose level in this study. Long Term Toxicity / Carcinogenicity study – 18 Months (Mouse) The LOAEL was 10 mg/kg bw/d based on liver changes. This dose level was considered as NOAEL based on haematotoxicity when excepting the target organ liver. Long Term Toxicity / Carcinogenicity study – 104-week (Rat) The study authors considered the NOAEL as ≈ 48 mg/kg/d for both sexes, combined (≈ 56 mg/kg bw/d in Fe","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"30","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
2000 |
- |
mouse |
- |
14 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:tor, as its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver; DOSE=However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver; EFFECT=tor, as its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver","duration":"14 days","effect":"tor, as its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:tor, as its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver","page":68,"route":"","species":"mouse","study_id":"sccp_o_166_noael_102"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
2000 |
- |
mouse |
- |
14 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effect; DOSE=However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effect; EFFECT=its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effect; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effect","duration":"14 days","effect":"its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effect","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:its chemical structure resembles that of known non-steroidal estrogens (e.g., DES, bis-phenol A). In a published, non-GLP study [Foran et al., 2000 (79)], Japanese medaka fry were exposed to concentrations of up to 100 µg triclosan/µL for 14 days, but there was no evidence of any effect of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effect","page":68,"route":"","species":"mouse","study_id":"sccp_o_166_noael_103"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
21 |
- |
mouse |
- |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan; DOSE=However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.; EFFECT=of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.","duration":"developmental","effect":"of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:of triclosan on sex ratios in developing fish. The results of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan","page":68,"route":"","species":"mouse","study_id":"sccp_o_166_noael_104"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
21 |
- |
mouse |
- |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NO; DOSE=However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.; EFFECT=of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NO; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.","duration":"developmental","effect":"of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NO","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:of this experiment were consistent with the findings from GLP studies in mammals indicating that triclosan has no effect on sex ratios or on reproductive maturity. NOAEL (NOEL) values from the definitive GLP studies are summarized in Table 21. The developmental toxicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NO","page":68,"route":"","species":"mouse","study_id":"sccp_o_166_noael_105"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
mg/kg |
rat |
- |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.; EFFECT=xicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NOAEL for reproductive and developmental toxicity is 50 mg/kg body weight/day from the study in rats. Of note, a lack of liver effects at doses up to 300 mg/kg body weight/day was seen in studies in both rats and rabbits, indicating a consistency between these two sp; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.","duration":"developmental","effect":"xicity effects of decreased foetal body weights and delayed ossification in all of the studies were observed at doses that also caused maternal toxicity. Based on the data in Table 21, the mouse NOAEL (both maternal and foetal) could represent an overall NOAEL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NOAEL for reproductive and developmental toxicity is 50 mg/kg body weight/day from the study in rats. Of note, a lack of liver effects at doses up to 300 mg/kg body weight/day was seen in studies in both rats and rabbits, indicating a consistency between these two sp","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":68,"route":"","species":"rat","study_id":"sccp_o_166_noael_106"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
50 |
mg/kg |
rat |
- |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.; EFFECT=EL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NOAEL for reproductive and developmental toxicity is 50 mg/kg body weight/day from the study in rats. Of note, a lack of liver effects at doses up to 300 mg/kg body weight/day was seen in studies in both rats and rabbits, indicating a consistency between these two species.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study.","duration":"developmental","effect":"EL for reproductive and developmental toxicity effects of triclosan. However, as observed in the repeated dose studies, the mouse is uniquely sensitive, showing liver effects at low doses of triclosan, including in the dams in the teratology study. Thus the low NOAEL value for foetal effects that was determined based on the mouse study may be attributed to the sensitivity of the maternal mice to liver effects, and is not due to any direct effect of triclosan on foetuses per se. The next lowest value for an overall NOAEL for reproductive and developmental toxicity is 50 mg/kg body weight/day from the study in rats. Of note, a lack of liver effects at doses up to 300 mg/kg body weight/day was seen in studies in both rats and rabbits, indicating a consistency between these two species.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":68,"route":"","species":"rat","study_id":"sccp_o_166_noael_107"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
350 |
mg/kg |
rat |
- |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=350; DOSE=Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.; EFFECT=not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mice liver. Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also observed in the repeated dose and carcinogenicity studies in mice.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.","duration":"developmental","effect":"not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mice liver. Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also observed in the repeated dose and carcinogenicity studies in mice.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"350","page":121,"route":"","species":"rat","study_id":"sccp_o_166_noael_119"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg |
rat |
- |
developmental |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; DOSE=e toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.; EFFECT=e toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also observed in the repeated dose and carcinogenicity studies in mice.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"e toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.","duration":"developmental","effect":"e toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also observed in the repeated dose and carcinogenicity studies in mice.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"25","page":121,"route":"","species":"rat","study_id":"sccp_o_166_noael_120"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
10 |
- |
- |
dermal |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: once daily | only at the high dose. | The NOAEL is | considered to | be 0.6; DOSE=Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: once daily | only at the high dose. | The NOAEL is | considered to | be 0.6; EFFECT=Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: once daily | only at the high dose. | The NOAEL is | considered to | be 0.6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: once daily | only at the high dose. | The NOAEL is | considered to | be 0.6","duration":"","effect":"Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: once daily | only at the high dose. | The NOAEL is | considered to | be 0.6","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: once daily | only at the high dose. | The NOAEL is | considered to | be 0.6","page":22,"route":"dermal","species":"","study_id":"sccp_o_166_noael_125"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
10 |
- |
- |
dermal |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: applied to 2x3 | c | m2 | histopathology changes | . The NOAEL | is considered | to be | OECD:; DOSE=Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: applied to 2x3 | c | m2 | histopathology changes | .; EFFECT=Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: applied to 2x3 | c | m2 | histopathology changes | . The NOAEL | is considered | to be | OECD:; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: applied to 2x3 | c | m2 | histopathology changes | .","duration":"","effect":"Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: applied to 2x3 | c | m2 | histopathology changes | . The NOAEL | is considered | to be | OECD:","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: applied to 2x3 | c | m2 | histopathology changes | . The NOAEL | is considered | to be | OECD:","page":22,"route":"dermal","species":"","study_id":"sccp_o_166_noael_126"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
10 |
- |
- |
dermal |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: concentrations | o | f | this gross finding. The | NOAEL was e | stimated by; DOSE=Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: concentrations | o | f | this gross finding.; EFFECT=Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: concentrations | o | f | this gross finding. The | NOAEL was e | stimated by; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: concentrations | o | f | this gross finding.","duration":"","effect":"Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: concentrations | o | f | this gross finding. The | NOAEL was e | stimated by","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 10: Findings from GLP Short-Term Repeated Dose Dermal Toxicity Studies for: concentrations | o | f | this gross finding. The | NOAEL was e | stimated by","page":22,"route":"dermal","species":"","study_id":"sccp_o_166_noael_127"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
75 |
mg/kg bw/d |
- |
oral |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=75; DOSE=Findings from GLP Sub-Chronic Oral Toxicity Studies for Triclosan: at 75 mg/kg bw/d.; EFFECT=Table 12: Findings from GLP Sub-Chronic Oral Toxicity Studies for Triclosan: at 75 mg/kg bw/d. A NOAEL could not be determined.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from GLP Sub-Chronic Oral Toxicity Studies for Triclosan: at 75 mg/kg bw/d.","duration":"Sub-Chronic","effect":"Table 12: Findings from GLP Sub-Chronic Oral Toxicity Studies for Triclosan: at 75 mg/kg bw/d. A NOAEL could not be determined.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":26,"route":"oral","species":"","study_id":"sccp_o_166_noael_129"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
ppm |
- |
oral |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=The NOAEL was considered to be 1,000 ppm (~100 mg/kg; EFFECT=Table 12: Findings from GLP Sub-Chronic Oral Toxicity Studies for Triclosan: The NOAEL was considered to be 1,000 ppm (~100 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The NOAEL was considered to be 1,000 ppm (~100 mg/kg","duration":"Sub-Chronic","effect":"Table 12: Findings from GLP Sub-Chronic Oral Toxicity Studies for Triclosan: The NOAEL was considered to be 1,000 ppm (~100 mg/kg","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":26,"route":"oral","species":"","study_id":"sccp_o_166_noael_130"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
13 |
- |
- |
oral |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: doses. No NOAEL was determined in this study, in which the; EFFECT=Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: doses. No NOAEL was determined in this study, in which the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Sub-Chronic","effect":"Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: doses. No NOAEL was determined in this study, in which the","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: doses. No NOAEL was determined in this study, in which the","page":29,"route":"oral","species":"","study_id":"sccp_o_166_noael_133"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
13 |
- |
- |
oral |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: to be the NOAEL. However, the study authors stated that the; EFFECT=Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: to be the NOAEL. However, the study authors stated that the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Sub-Chronic","effect":"Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: to be the NOAEL. However, the study authors stated that the","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: to be the NOAEL. However, the study authors stated that the","page":29,"route":"oral","species":"","study_id":"sccp_o_166_noael_134"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
13 |
- |
- |
oral |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: Based on the findings in this study, no NOAEL was determined.; EFFECT=Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: Based on the findings in this study, no NOAEL was determined.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Sub-Chronic","effect":"Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: Based on the findings in this study, no NOAEL was determined.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: Findings from Non-GLP, Non-OECD Sub-Chronic Oral Toxicity Studies for: Based on the findings in this study, no NOAEL was determined.","page":29,"route":"oral","species":"","study_id":"sccp_o_166_noael_135"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
80 |
mg/kg bw/d |
- |
dermal |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=80; DOSE=Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: were ~0, 0.5, 2, | toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the; EFFECT=Table 14: Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: were ~0, 0.5, 2, | toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: were ~0, 0.5, 2, | toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the","duration":"Sub-Chronic","effect":"Table 14: Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: were ~0, 0.5, 2, | toxicity, the NOAEL was determined to be 80 mg/kg bw/d (the","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":31,"route":"dermal","species":"","study_id":"sccp_o_166_noael_141"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
4 |
% |
- |
dermal |
Sub-Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=4; DOSE=Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: and 4% for a | highest dose tested).; EFFECT=Table 14: Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: and 4% for a | highest dose tested). No NOAEL for dermal toxicity was; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: and 4% for a | highest dose tested).","duration":"Sub-Chronic","effect":"Table 14: Findings from GLP Sub-Chronic Dermal Toxicity Studies for Triclosan: and 4% for a | highest dose tested). No NOAEL for dermal toxicity was","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"%","noael_value":"4","page":31,"route":"dermal","species":"","study_id":"sccp_o_166_noael_142"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
25 |
mg/kg |
mouse |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=25; DOSE=Subchronic oral toxicity study in mice | A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.; EFFECT=Unlabeled table on page 34: Subchronic oral toxicity study in mice | A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Subchronic oral toxicity study in mice | A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.","duration":"Subchronic","effect":"Unlabeled table on page 34: Subchronic oral toxicity study in mice | A NOAEL was not established from this study since treatment-related changes in haematology parameters, increased alkaline phosphatase, and decreased cholesterol were observed at the low dose 25 mg/kg body weight/day.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"25","page":34,"route":"oral","species":"mouse","study_id":"sccp_o_166_noael_143"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
ppm |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=Subchronic oral toxicity study in rats | The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).; EFFECT=Unlabeled table on page 34: Subchronic oral toxicity study in rats | The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Subchronic oral toxicity study in rats | The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).","duration":"Subchronic","effect":"Unlabeled table on page 34: Subchronic oral toxicity study in rats | The low dose was not associated with any treatment-related findings; thus, the NOAEL was determined to be 1,000 ppm (~100 mg/kg body weight/day).","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":34,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_144"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
200 |
mg/kg bw/d |
- |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=200; DOSE=Subchronic oral toxicity study in hamsters | The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.; EFFECT=Unlabeled table on page 34: Subchronic oral toxicity study in hamsters | The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Subchronic oral toxicity study in hamsters | The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.","duration":"Subchronic","effect":"Unlabeled table on page 34: Subchronic oral toxicity study in hamsters | The NOAEL is set at 200 mg/kg bw/d based on nephrotoxicity indicated by microscopic findings and polyuria, haemoglobinuria and haematouria.","endpoint":"repeated dose toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":34,"route":"oral","species":"","study_id":"sccp_o_166_noael_145"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested.; EFFECT=CP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. 1 1,000 ppm ~48 mg/kg body weight/day for males and females, combined. Comment According to the EU classification system, triclosan is not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mouse liver. 3.3.8. Reproductive toxicity The reproductive and developmental toxicology of triclosan has been investigated in teratology studies in the mouse, rat, and rabbit, and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested.","duration":"developmental","effect":"CP/1192/08 Opinion on triclosan 59 Table 17: Summary of NOAEL Values from GLP Carcinogenicity Studies for Triclosan in Rodents Species NOAEL (mg/kg bw/day) Comment Mouse 10 (this value is a LOEL for tumour formation only) No overall NOAEL due to hepatotoxic effects observed at the lowest dose tested. There were no tumours observed in other tissues. Rat ~48 (NOAEL)1 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. There was no evidence of hepatotoxicity. Hamster 75 NOAEL based on systemic toxicity. There was no evidence of tumour formation, including in liver. 1 1,000 ppm ~48 mg/kg body weight/day for males and females, combined. Comment According to the EU classification system, triclosan is not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mouse liver. 3.3.8. Reproductive toxicity The reproductive and developmental toxicology of triclosan has been investigated in teratology studies in the mouse, rat, and rabbit, and","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":59,"route":"","species":"rat","study_id":"sccp_o_166_noael_058"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
ppm |
- |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1,000; DOSE=The mean number of live F2 pups on Day 0, viability index (survival to Day 4), and survival to weaning were slightly lower in high-dose animals vs. controls.; EFFECT=reatment groups in adult animals. F2 Generation: The mean number of live F2 pups on Day 0, viability index (survival to Day 4), and survival to weaning were slightly lower in high-dose animals vs. controls. Adjusted mean body weights of high-dose pups were slightly, but significantly lower than controls on Day 0. There were no other remarkable treatment-related findings in the F2 pups, or of mature F2 offspring. Although study investigators considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose. However, the data in the study indicate that a Fertility and Reproduction NOEL of 3,000 ppm (~203 mg/kg bw/day for males and females combined) would be appropriate based on the absence of treatment-related effect in both the F0 and F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 cons; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The mean number of live F2 pups on Day 0, viability index (survival to Day 4), and survival to weaning were slightly lower in high-dose animals vs. controls.","duration":"","effect":"reatment groups in adult animals. F2 Generation: The mean number of live F2 pups on Day 0, viability index (survival to Day 4), and survival to weaning were slightly lower in high-dose animals vs. controls. Adjusted mean body weights of high-dose pups were slightly, but significantly lower than controls on Day 0. There were no other remarkable treatment-related findings in the F2 pups, or of mature F2 offspring. Although study investigators considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose. However, the data in the study indicate that a Fertility and Reproduction NOEL of 3,000 ppm (~203 mg/kg bw/day for males and females combined) would be appropriate based on the absence of treatment-related effect in both the F0 and F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 cons","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"1,000","page":60,"route":"","species":"","study_id":"sccp_o_166_noael_059"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
3000 |
ppm |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=3,000; DOSE=Although study investigators considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose.; EFFECT=pups were slightly, but significantly lower than controls on Day 0. There were no other remarkable treatment-related findings in the F2 pups, or of mature F2 offspring. Although study investigators considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose. However, the data in the study indicate that a Fertility and Reproduction NOEL of 3,000 ppm (~203 mg/kg bw/day for males and females combined) would be appropriate based on the absence of treatment-related effect in both the F0 and F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from bir; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Although study investigators considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose.","duration":"","effect":"pups were slightly, but significantly lower than controls on Day 0. There were no other remarkable treatment-related findings in the F2 pups, or of mature F2 offspring. Although study investigators considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose. However, the data in the study indicate that a Fertility and Reproduction NOEL of 3,000 ppm (~203 mg/kg bw/day for males and females combined) would be appropriate based on the absence of treatment-related effect in both the F0 and F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from bir","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"3,000","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_060"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
65 |
mg/kg bw/day |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=65; DOSE=considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose.; EFFECT=considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose. However, the data in the study indicate that a Fertility and Reproduction NOEL of 3,000 ppm (~203 mg/kg bw/day for males and females combined) would be appropriate based on the absence of treatment-related effect in both the F0 and F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose.","duration":"","effect":"considered the data to be somewhat equivocal, they determined the Overall NOAEL for the study to be 1,000 ppm (~65 mg/kg bw/d for males and females, combined), based on evidence of slightly reduced survival and pup body weights at the high dose. However, the data in the study indicate that a Fertility and Reproduction NOEL of 3,000 ppm (~203 mg/kg bw/day for males and females combined) would be appropriate based on the absence of treatment-related effect in both the F0 and F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data in","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_061"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights).; EFFECT=F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data indicate that a Foetal and Post-Natal NOEL of 300 mg/kg bw/d would be appropriate, based on the lack of foetal and pup effects at this dose. Denning et al., 1992 (70); GLP- compliant2 OECD: comparable 1 Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights).","duration":"","effect":"F1 generations. The Foetal and Post-Natal NOAEL would be 65 mg/kg bw/day (based on pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data indicate that a Foetal and Post-Natal NOEL of 300 mg/kg bw/d would be appropriate, based on the lack of foetal and pup effects at this dose. Denning et al., 1992 (70); GLP- compliant2 OECD: comparable 1 Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduc","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_062"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters:; EFFECT=pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data indicate that a Foetal and Post-Natal NOEL of 300 mg/kg bw/d would be appropriate, based on the lack of foetal and pup effects at this dose. Denning et al., 1992 (70); GLP- compliant2 OECD: comparable 1 Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduction Fertility and reproduction parameters of mating, pregnancy, duration of gestat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters:","duration":"","effect":"pup body weights). OECD: No. 416 consistent Rat (Colworth Wistar) Dams received 0, 30, 100, 300 mg/kg bw/day) via oral gavage, in corn oil on Days 6-15 of gestation [Maternal and Foetal Data are presented in Table 19] Post-natal Parameters: Survival and development of pups from birth to weaning was comparable to controls. There was no significant increase in the number of pups with anomalies. Study investigators did not determine NOEL values for this study. However, the data indicate that a Foetal and Post-Natal NOEL of 300 mg/kg bw/d would be appropriate, based on the lack of foetal and pup effects at this dose. Denning et al., 1992 (70); GLP- compliant2 OECD: comparable 1 Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduction Fertility and reproduction parameters of mating, pregnancy, duration of gestat","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":60,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_063"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
3000 |
ppm |
rat |
- |
0 to Day |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=3,000; DOSE=Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested.; EFFECT=rable 1 Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduction Fertility and reproduction parameters of mating, pregnancy, duration of gestation, and parturition were assessed in the two-generation rat study [Morseth, 1988 (69)]. Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested. 3.3.8.1.2 Post-Natal Parameters In the two-generation study that examined post-natal development in rats, the primary findings were a slight decrease in mean foetal body weights and a slight decrease in the Day 0 to Day 4 survival in the F1 and F2 generations at the high dose of 3,000 ppm (~203 mg/kg body weight/day) [Morseth, 1988 (69)]. Thus, the foet; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested.","duration":"0 to Day","effect":"rable 1 Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduction Fertility and reproduction parameters of mating, pregnancy, duration of gestation, and parturition were assessed in the two-generation rat study [Morseth, 1988 (69)]. Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested. 3.3.8.1.2 Post-Natal Parameters In the two-generation study that examined post-natal development in rats, the primary findings were a slight decrease in mean foetal body weights and a slight decrease in the Day 0 to Day 4 survival in the F1 and F2 generations at the high dose of 3,000 ppm (~203 mg/kg body weight/day) [Morseth, 1988 (69)]. Thus, the foet","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"3,000","page":60,"route":"","species":"rat","study_id":"sccp_o_166_noael_064"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
3000 |
ppm |
rat |
- |
0 to Day |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=3,000; DOSE=Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested.; EFFECT=Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduction Fertility and reproduction parameters of mating, pregnancy, duration of gestation, and parturition were assessed in the two-generation rat study [Morseth, 1988 (69)]. Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested. 3.3.8.1.2 Post-Natal Parameters In the two-generation study that examined post-natal development in rats, the primary findings were a slight decrease in mean foetal body weights and a slight decrease in the Day 0 to Day 4 survival in the F1 and F2 generations at the high dose of 3,000 ppm (~203 mg/kg body weight/day) [Morseth, 1988 (69)]. Thus, the foetal and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested.","duration":"0 to Day","effect":"Statistically and biologically significant findings have been outlined. 2 Based on the presence of a statement of Quality Assurance, the study by Denning et al., [1992 (74)] in Colworth Wistar rats was assumed to contain GLP-quality data. 3.3.8.1.1 Fertility and Reproduction Fertility and reproduction parameters of mating, pregnancy, duration of gestation, and parturition were assessed in the two-generation rat study [Morseth, 1988 (69)]. Based on the absence of effects in F0 and F1 generation rats, the NOAEL (NOEL) for fertility and reproduction was determined to be 3,000 ppm (~203 mg/kg body weight/day using male and female doses, combined), the highest dose tested. 3.3.8.1.2 Post-Natal Parameters In the two-generation study that examined post-natal development in rats, the primary findings were a slight decrease in mean foetal body weights and a slight decrease in the Day 0 to Day 4 survival in the F1 and F2 generations at the high dose of 3,000 ppm (~203 mg/kg body weight/day) [Morseth, 1988 (69)]. Thus, the foetal and","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"ppm","noael_value":"3,000","page":60,"route":"","species":"rat","study_id":"sccp_o_166_noael_065"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
8 |
mg/kg bw |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=8; DOSE=), but no deaths in the 267 animals treated at the 1, 2, 4, and 8 mg/kg doses.; EFFECT=), but no deaths in the 267 animals treated at the 1, 2, 4, and 8 mg/kg doses. Foetal Parameters: The principle endpoints assessed were embryo and post-natal survival. Embryo survival (reductions in litter size) was reduced at the high dose in animals dosed on either Day 9 or Day 10. Post-natal survival was markedly reduced at the high dose. Post- natal survival was slightly decreased at the dose of 8 mg/kg bw (Day 9 or Day 10 treatment), and at the doses of 2 and 4 combined. Study investigators did not determine NOEL values for this study. It should be noted that, due to the design of the study (e.g., lack of evaluation of parameters typically assessed in reproductive toxicity studies), it was not possible to reach any clear interpretation and conclusion of the impact of these data. Russell and Montgomery, 1980 (64) GLP: not specified OECD: not specified Rat (Wistar) 0, 100, 200, or 400 mg/kg bw/d via oral gavage in olive oil (Days 7-17 of gestation) Maternal Parameters: Clinical signs of piloerection, incontinence, and diar; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"), but no deaths in the 267 animals treated at the 1, 2, 4, and 8 mg/kg doses.","duration":"","effect":"), but no deaths in the 267 animals treated at the 1, 2, 4, and 8 mg/kg doses. Foetal Parameters: The principle endpoints assessed were embryo and post-natal survival. Embryo survival (reductions in litter size) was reduced at the high dose in animals dosed on either Day 9 or Day 10. Post-natal survival was markedly reduced at the high dose. Post- natal survival was slightly decreased at the dose of 8 mg/kg bw (Day 9 or Day 10 treatment), and at the doses of 2 and 4 combined. Study investigators did not determine NOEL values for this study. It should be noted that, due to the design of the study (e.g., lack of evaluation of parameters typically assessed in reproductive toxicity studies), it was not possible to reach any clear interpretation and conclusion of the impact of these data. Russell and Montgomery, 1980 (64) GLP: not specified OECD: not specified Rat (Wistar) 0, 100, 200, or 400 mg/kg bw/d via oral gavage in olive oil (Days 7-17 of gestation) Maternal Parameters: Clinical signs of piloerection, incontinence, and diar","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"8","page":65,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_095"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1978 |
- |
mouse |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:in the high-dose group. The significant decrease in number of live foetuses in the low dose group is not considered to be treatment-related due to the lack of a dose relationship. Also, there was no increase in number of resorptions, suggesting that there might have been a decrease in ovulation or implantation rate (could not be confirmed due to lack of corpora lutea data). The decrease in number of live foetuses in the high- dose group was accompanied by maternal mortality. Study investigators did not determine NOEL values for this study. It should be noted that, due to the design of the study (e.g., lack of evaluation of parameters typically assessed in reproductive toxicity studies), it was not possible to reach any clear conclusion of the impact of these data. Piekacz, 1978 (78) Predates GLP and OECD 1 Statistically and biologically significant findings have been outlined. Non-GLP Studies in the Mouse In addition to the GLP studies in mice, limited reproductive toxicity data were found in a published, non-GLP mouse “spot; DOSE=in the high-dose group.; EFFECT=in the high-dose group. The significant decrease in number of live foetuses in the low dose group is not considered to be treatment-related due to the lack of a dose relationship. Also, there was no increase in number of resorptions, suggesting that there might have been a decrease in ovulation or implantation rate (could not be confirmed due to lack of corpora lutea data). The decrease in number of live foetuses in the high- dose group was accompanied by maternal mortality. Study investigators did not determine NOEL values for this study. It should be noted that, due to the design of the study (e.g., lack of evaluation of parameters typically assessed in reproductive toxicity studies), it was not possible to reach any clear conclusion of the impact of these data. Piekacz, 1978 (78) Predates GLP and OECD 1 Statistically and biologically significant findings have been outlined. Non-GLP Studies in the Mouse In addition to the GLP studies in mice, limited reproductive toxicity data were found in a published, non-GLP mouse “spot; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"in the high-dose group.","duration":"","effect":"in the high-dose group. The significant decrease in number of live foetuses in the low dose group is not considered to be treatment-related due to the lack of a dose relationship. Also, there was no increase in number of resorptions, suggesting that there might have been a decrease in ovulation or implantation rate (could not be confirmed due to lack of corpora lutea data). The decrease in number of live foetuses in the high- dose group was accompanied by maternal mortality. Study investigators did not determine NOEL values for this study. It should be noted that, due to the design of the study (e.g., lack of evaluation of parameters typically assessed in reproductive toxicity studies), it was not possible to reach any clear conclusion of the impact of these data. Piekacz, 1978 (78) Predates GLP and OECD 1 Statistically and biologically significant findings have been outlined. Non-GLP Studies in the Mouse In addition to the GLP studies in mice, limited reproductive toxicity data were found in a published, non-GLP mouse “spot","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:in the high-dose group. The significant decrease in number of live foetuses in the low dose group is not considered to be treatment-related due to the lack of a dose relationship. Also, there was no increase in number of resorptions, suggesting that there might have been a decrease in ovulation or implantation rate (could not be confirmed due to lack of corpora lutea data). The decrease in number of live foetuses in the high- dose group was accompanied by maternal mortality. Study investigators did not determine NOEL values for this study. It should be noted that, due to the design of the study (e.g., lack of evaluation of parameters typically assessed in reproductive toxicity studies), it was not possible to reach any clear conclusion of the impact of these data. Piekacz, 1978 (78) Predates GLP and OECD 1 Statistically and biologically significant findings have been outlined. Non-GLP Studies in the Mouse In addition to the GLP studies in mice, limited reproductive toxicity data were found in a published, non-GLP mouse “spot","page":66,"route":"","species":"mouse","study_id":"sccp_o_166_noael_097"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
200 |
mg/kg |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=200; DOSE=reported at the high dose of 400 mg/kg body weight/day (7.05 vs.; EFFECT=reported at the high dose of 400 mg/kg body weight/day (7.05 vs. 1.59% mortality in controls, with the accompanying finding of increased numbers of resorptions at the high dose)1. These effects could not conclusively be attributed to the direct action of triclosan, as this dose also caused maternal toxicity (diarrhoea, incontinence, piloerection, decreased food consumption). There was no evidence of teratogenic effects caused by triclosan at any of the doses tested. Although study investigators did not determine a NOEL for this study, a NOEL value of 200 mg/kg body weight/day may be considered appropriate based on the absence of any significant maternal or foetal effects at this dose. The early study by Piekacz [1978 (78)] included data from experiments conducted using both rats and hamsters. This study was not consistent with current guidelines for the conduct of reproductive toxicity studies, especially with regard to the parameters evaluated, the species used (i.e., hamsters are not conventionally used as they are considered; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"reported at the high dose of 400 mg/kg body weight/day (7.05 vs.","duration":"","effect":"reported at the high dose of 400 mg/kg body weight/day (7.05 vs. 1.59% mortality in controls, with the accompanying finding of increased numbers of resorptions at the high dose)1. These effects could not conclusively be attributed to the direct action of triclosan, as this dose also caused maternal toxicity (diarrhoea, incontinence, piloerection, decreased food consumption). There was no evidence of teratogenic effects caused by triclosan at any of the doses tested. Although study investigators did not determine a NOEL for this study, a NOEL value of 200 mg/kg body weight/day may be considered appropriate based on the absence of any significant maternal or foetal effects at this dose. The early study by Piekacz [1978 (78)] included data from experiments conducted using both rats and hamsters. This study was not consistent with current guidelines for the conduct of reproductive toxicity studies, especially with regard to the parameters evaluated, the species used (i.e., hamsters are not conventionally used as they are considered","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"200","page":67,"route":"","species":"rat","study_id":"sccp_o_166_noael_098"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
200 |
mg/kg |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=200; DOSE=se of 400 mg/kg body weight/day (7.05 vs.; EFFECT=se of 400 mg/kg body weight/day (7.05 vs. 1.59% mortality in controls, with the accompanying finding of increased numbers of resorptions at the high dose)1. These effects could not conclusively be attributed to the direct action of triclosan, as this dose also caused maternal toxicity (diarrhoea, incontinence, piloerection, decreased food consumption). There was no evidence of teratogenic effects caused by triclosan at any of the doses tested. Although study investigators did not determine a NOEL for this study, a NOEL value of 200 mg/kg body weight/day may be considered appropriate based on the absence of any significant maternal or foetal effects at this dose. The early study by Piekacz [1978 (78)] included data from experiments conducted using both rats and hamsters. This study was not consistent with current guidelines for the conduct of reproductive toxicity studies, especially with regard to the parameters evaluated, the species used (i.e., hamsters are not conventionally used as they are considered to be a highly sensitiv; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"se of 400 mg/kg body weight/day (7.05 vs.","duration":"","effect":"se of 400 mg/kg body weight/day (7.05 vs. 1.59% mortality in controls, with the accompanying finding of increased numbers of resorptions at the high dose)1. These effects could not conclusively be attributed to the direct action of triclosan, as this dose also caused maternal toxicity (diarrhoea, incontinence, piloerection, decreased food consumption). There was no evidence of teratogenic effects caused by triclosan at any of the doses tested. Although study investigators did not determine a NOEL for this study, a NOEL value of 200 mg/kg body weight/day may be considered appropriate based on the absence of any significant maternal or foetal effects at this dose. The early study by Piekacz [1978 (78)] included data from experiments conducted using both rats and hamsters. This study was not consistent with current guidelines for the conduct of reproductive toxicity studies, especially with regard to the parameters evaluated, the species used (i.e., hamsters are not conventionally used as they are considered to be a highly sensitiv","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"200","page":67,"route":"","species":"rat","study_id":"sccp_o_166_noael_099"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1987 |
- |
rat |
- |
Developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:/day were accompanied by maternal toxicity effects consisting of deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration; EFFECT=/day were accompanied by maternal toxicity effects consisting of deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Developmental","effect":"/day were accompanied by maternal toxicity effects consisting of deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:/day were accompanied by maternal toxicity effects consisting of deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration","page":67,"route":"","species":"rat","study_id":"sccp_o_166_noael_100"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1987 |
- |
rat |
oral |
Developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:f deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration (i.e., oral) were used in the studies. Although toxicokinetic pa; EFFECT=f deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration (i.e., oral) were used in the studies. Although toxicokinetic pa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"Developmental","effect":"f deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration (i.e., oral) were used in the studies. Although toxicokinetic pa","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:f deaths, and thus were not clearly a direct effect of triclosan. Overall, regardless of the contention that the study may have been inadequately conducted compared to current standards, the study provides little to no evidence of any treatment-related effect of triclosan on the development of rats or hamsters. As with the study by Kawashima et al. [1987 (77)], there were reported to be no teratogenic effects of triclosan at any of the doses tested. No NOEL level was determined for this study. 3.3.8.3 Summary and NOAEL Values from Reproductive and Developmental Toxicology Studies Both GLP and non-GLP reproductive and developmental toxicology studies have investigated the effects of triclosan on fertility, development, parturition and lactation. The pivotal studies were conducted pursuant to GLP regulations and generally followed the relevant ICH and OECD guidelines. Appropriate test species (i.e., rats and rabbits) and a clinically relevant route of administration (i.e., oral) were used in the studies. Although toxicokinetic pa","page":67,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_101"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1192 |
- |
rat |
oral |
Developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=unclear:SCCP/1192/08 Opinion on triclosan 69 Table 21: Summary of NOAEL1 Values from GLP Reproductive and Developmental Toxicity Studies for Triclosan Species Route of Administration Maternal NOAEL (NOEL)1 (mg/kg bw/d) Foetal NOAEL (NOEL)1 (mg/kg bw/d) Comment Fertility and Reproduction Effects Rat Diet 2032 No adverse effects on fertility and reproduction, based on lack of remarkable findings in F0 and F1 pups. Foetal Effects Mouse Diet 25 25 Maternal liver effects noted in 2 higher dose groups. Foetal effects limited to decreased foetal body weights and delayed ossification at doses that caused maternal toxicity. Rat Oral (gavage; carboxymethyl- cellulose) 50 50 Decreases in food consumption in high- dose; DOSE=Summary of NOAEL1 Values from GLP Reproductive and Developmental Toxicity Studies for Triclosan Species Route of Administration Maternal NOAEL (NOEL)1 (mg/kg bw/d) Foetal NOAEL (NOEL)1 (mg/kg bw/d) Comment Fertility and Reproduction Effects Rat Diet 2032 No adverse effects on fertility and reproduction, based on lack of remarkable findings in F0...; EFFECT=SCCP/1192/08 Opinion on triclosan 69 Table 21: Summary of NOAEL1 Values from GLP Reproductive and Developmental Toxicity Studies for Triclosan Species Route of Administration Maternal NOAEL (NOEL)1 (mg/kg bw/d) Foetal NOAEL (NOEL)1 (mg/kg bw/d) Comment Fertility and Reproduction Effects Rat Diet 2032 No adverse effects on fertility and reproduction, based on lack of remarkable findings in F0 and F1 pups. Foetal Effects Mouse Diet 25 25 Maternal liver effects noted in 2 higher dose groups. Foetal effects limited to decreased foetal body weights and delayed ossification at doses that caused maternal toxicity. Rat Oral (gavage; carboxymethyl- cellulose) 50 50 Decreases in food consumption in high- dose; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Summary of NOAEL1 Values from GLP Reproductive and Developmental Toxicity Studies for Triclosan Species Route of Administration Maternal NOAEL (NOEL)1 (mg/kg bw/d) Foetal NOAEL (NOEL)1 (mg/kg bw/d) Comment Fertility and Reproduction Effects Rat Diet 2032 No adverse effects on fertility and reproduction, based on lack of remarkable findings in F0...","duration":"Developmental","effect":"SCCP/1192/08 Opinion on triclosan 69 Table 21: Summary of NOAEL1 Values from GLP Reproductive and Developmental Toxicity Studies for Triclosan Species Route of Administration Maternal NOAEL (NOEL)1 (mg/kg bw/d) Foetal NOAEL (NOEL)1 (mg/kg bw/d) Comment Fertility and Reproduction Effects Rat Diet 2032 No adverse effects on fertility and reproduction, based on lack of remarkable findings in F0 and F1 pups. Foetal Effects Mouse Diet 25 25 Maternal liver effects noted in 2 higher dose groups. Foetal effects limited to decreased foetal body weights and delayed ossification at doses that caused maternal toxicity. Rat Oral (gavage; carboxymethyl- cellulose) 50 50 Decreases in food consumption in high- dose","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"unclear:SCCP/1192/08 Opinion on triclosan 69 Table 21: Summary of NOAEL1 Values from GLP Reproductive and Developmental Toxicity Studies for Triclosan Species Route of Administration Maternal NOAEL (NOEL)1 (mg/kg bw/d) Foetal NOAEL (NOEL)1 (mg/kg bw/d) Comment Fertility and Reproduction Effects Rat Diet 2032 No adverse effects on fertility and reproduction, based on lack of remarkable findings in F0 and F1 pups. Foetal Effects Mouse Diet 25 25 Maternal liver effects noted in 2 higher dose groups. Foetal effects limited to decreased foetal body weights and delayed ossification at doses that caused maternal toxicity. Rat Oral (gavage; carboxymethyl- cellulose) 50 50 Decreases in food consumption in high- dose","page":69,"route":"oral","species":"rat","study_id":"sccp_o_166_noael_108"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
350 |
mg/kg |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=350; DOSE=Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.; EFFECT=ts. Hamsters showed increased liver toxicity relative to the rat, but no tumours. According to the EU classification system, triclosan is not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mice liver. Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.","duration":"developmental","effect":"ts. Hamsters showed increased liver toxicity relative to the rat, but no tumours. According to the EU classification system, triclosan is not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mice liver. Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"350","page":121,"route":"","species":"rat","study_id":"sccp_o_166_noael_117"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
350 |
mg/kg |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=350; DOSE=Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.; EFFECT=sters showed increased liver toxicity relative to the rat, but no tumours. According to the EU classification system, triclosan is not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mice liver. Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also observ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day.","duration":"developmental","effect":"sters showed increased liver toxicity relative to the rat, but no tumours. According to the EU classification system, triclosan is not considered classifiable as a carcinogen. It should be noted that triclosan is a peroxisome proliferator in mice liver. Reproductive/developmental Toxicity Triclosan was not teratogenic nor a reproductive toxicant in a full complement of reproductive and developmental toxicity studies conducted in mice, rats, and rabbits conducted at doses of up to 350 mg/kg body weight/day. NOAEL (NOEL) values from the definitive GLP studies were summarized in Table 21. It is important to note the determination of the foetal NOAEL value for each study was based on foetal variation effects that were most likely secondary to general maternal toxicity, and not direct effects of triclosan per se. It is also worth noting that the low NOAEL value for foetal effects in the mouse study (25 mg/kg body weight/day) is likely attributable to the sensitivity of the maternal mice to the liver effects of triclosan, also observ","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"mg/kg","noael_value":"350","page":121,"route":"","species":"rat","study_id":"sccp_o_166_noael_118"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2 |
- |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_166; REPORT_TITLE=OPINION ON Triclosan COLIPA n° P32; OPINION_NUMBER=SCCP/1192/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=delines (ICH, 2; EFFECT=Table 17: Summ: study in the rat. | Based | on international | gui | delines (ICH, 2 | 005), effects on | fertility and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3380-34-5","citation":"","dose":"","duration":"","effect":"Table 17: Summ: study in the rat. | Based | on international | gui | delines (ICH, 2 | 005), effects on | fertility and","endpoint":"reproductive toxicity","ingredient":"5-chloro-2-(2,4-dichlorophenoxy)phenol","loael_value":"","noael_unit":"","noael_value":"delines (ICH, 2","page":59,"route":"","species":"rat","study_id":"sccp_o_166_noael_158"} |