NOAEL Studies
Cosmetic Ingredient
5-Amino-4-Chloro-o-Cresol HCl NOAEL Studies
INCI: 5-AMINO-4-CHLORO-O-CRESOL HCL
CAS: 110102-85-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | NOAEL | 180 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCP; Potokar, M., Bartnik, F., Pittermann, W. (1987) 5-Amino-4-chlor-2-methylphenolhydrochlorid 90-Tage-Test mit wiederholter oraler Verabreichung anRatten Institut fur Toxikologie, Henkel KGaA Dusseldorf, Germany, Report No. 870036 |
SCCNFP_vision_codex 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"Bodyweight gain and food and water consumption were similar for all dose groups.","effect":"ed. Bodyweight gain and food and water consumption were similar for all dose groups. Haematological and biochemical parameters showed some individual minor statistical differences, but these were not dose related and were not considered to be of toxicological consequence. Similarly, occasional minor abnormalities were reported at autopsy and histopathological examination for some animals of each dose group, but these were not treatment-related. No treatment related effects were reported in the recovery groups. The NOAEL was 180 mg/kg bw/day. The rationale for selection of the dose groups is not clear. The study failed to identify a critical effect. Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Single application study with substance at 10% Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit (Chbb:HM)","page":6,"pdf":"out_191.pdf","row_type":"noael_study","study_id":"out_191_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"Bodyweight gain and food and water consumption were similar for all dose groups.","effect":"ed. Bodyweight gain and food and water consumption were similar for all dose groups. Haematological and biochemical parameters showed some individual minor statistical differences, but these were not dose related and were not considered to be of toxicological consequence. Similarly, occasional minor abnormalities were reported at autopsy and histopathological examination for some animals of each dose group, but these were not treatment-related. No treatment related effects were reported in the recovery groups. The NOAEL was 180 mg/kg bw/day. The rationale for selection of the dose groups is not clear. The study failed to identify a critical effect. Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Single application study with substance at 10% Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit (Chbb:HM)","page":6,"pdf":"out_191.pdf","row_type":"noael_study","study_id":"out_191_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"Bodyweight gain and food and water consumption were similar for all dose groups.","effect":"ed. Bodyweight gain and food and water consumption were similar for all dose groups. Haematological and biochemical parameters showed some individual minor statistical differences, but these were not dose related and were not considered to be of toxicological consequence. Similarly, occasional minor abnormalities were reported at autopsy and histopathological examination for some animals of each dose group, but these were not treatment-related. No treatment related effects were reported in the recovery groups. The NOAEL was 180 mg/kg bw/day. The rationale for selection of the dose groups is not clear. The study failed to identify a critical effect. Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Single application study with substance at 10% Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit (Chbb:HM)","page":6,"pdf":"out_191.pdf","row_type":"noael_study","study_id":"out_191_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"Bodyweight gain and food and water consumption were similar for all dose groups.","effect":"ed. Bodyweight gain and food and water consumption were similar for all dose groups. Haematological and biochemical parameters showed some individual minor statistical differences, but these were not dose related and were not considered to be of toxicological consequence. Similarly, occasional minor abnormalities were reported at autopsy and histopathological examination for some animals of each dose group, but these were not treatment-related. No treatment related effects were reported in the recovery groups. The NOAEL was 180 mg/kg bw/day. The rationale for selection of the dose groups is not clear. The study failed to identify a critical effect. Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Single application study with substance at 10% Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit (Chbb:HM)","page":6,"pdf":"out_191.pdf","row_type":"noael_study","study_id":"out_191_noael_001"} |
SCCS_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low","dose":"No change in body weight gain was found in the treated animals.","effect":"lly relevant effects. No change in body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activa","page":14,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | human | oral | - | developmental toxicity | {"citation":"Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low","dose":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested.","effect":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested. Also up to the highest dose tested, the test chemical was neither embryo-lethal, embryotoxic nor teratogenic. Therefore the No-Observed-Adverse Effect-Level (NOAEL) for both maternal and foetal toxicity was 500 mg/kg bw/day. Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigatio","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.19 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"a No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_005"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low","dose":"No change in body weight gain was found in the treated animals.","effect":"lly relevant effects. No change in body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activa","page":14,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | human | oral | - | developmental toxicity | {"citation":"Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low","dose":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested.","effect":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested. Also up to the highest dose tested, the test chemical was neither embryo-lethal, embryotoxic nor teratogenic. Therefore the No-Observed-Adverse Effect-Level (NOAEL) for both maternal and foetal toxicity was 500 mg/kg bw/day. Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigatio","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.19 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"a No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_005"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low","dose":"No change in body weight gain was found in the treated animals.","effect":"lly relevant effects. No change in body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activa","page":14,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | human | oral | - | developmental toxicity | {"citation":"Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low","dose":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested.","effect":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested. Also up to the highest dose tested, the test chemical was neither embryo-lethal, embryotoxic nor teratogenic. Therefore the No-Observed-Adverse Effect-Level (NOAEL) for both maternal and foetal toxicity was 500 mg/kg bw/day. Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigatio","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.19 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"a No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_005"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low","dose":"No change in body weight gain was found in the treated animals.","effect":"lly relevant effects. No change in body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activa","page":14,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | human | oral | - | developmental toxicity | {"citation":"Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low","dose":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested.","effect":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested. Also up to the highest dose tested, the test chemical was neither embryo-lethal, embryotoxic nor teratogenic. Therefore the No-Observed-Adverse Effect-Level (NOAEL) for both maternal and foetal toxicity was 500 mg/kg bw/day. Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigatio","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.19 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","effect":"a No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","page":19,"pdf":"sccp_o_115.pdf","row_type":"noael_study","study_id":"sccp_o_115_noael_005"} |
UnifiedCodex:SCCNFP:beta.noael_studies 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 180 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out_191; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 5-AMINO-4-CHLORO-O-CRESOL HCL COLIPA n° A117; OPINION_NUMBER=SCCNFP/00659/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=180; DOSE=Bodyweight gain and food and water consumption were similar for all dose groups.; EFFECT=ed. Bodyweight gain and food and water consumption were similar for all dose groups. Haematological and biochemical parameters showed some individual minor statistical differences, but these were not dose related and were not considered to be of toxicological consequence. Similarly, occasional minor abnormalities were reported at autopsy and histopathological examination for some animals of each dose group, but these were not treatment-related. No treatment related effects were reported in the recovery groups. The NOAEL was 180 mg/kg bw/day. The rationale for selection of the dose groups is not clear. The study failed to identify a critical effect. Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Single application study with substance at 10% Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit (Chbb:HM); CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"110102-85-7","citation":"Ref. : 11 2","dose":"Bodyweight gain and food and water consumption were similar for all dose groups.","duration":"Sub-chronic","effect":"ed. Bodyweight gain and food and water consumption were similar for all dose groups. Haematological and biochemical parameters showed some individual minor statistical differences, but these were not dose related and were not considered to be of toxicological consequence. Similarly, occasional minor abnormalities were reported at autopsy and histopathological examination for some animals of each dose group, but these were not treatment-related. No treatment related effects were reported in the recovery groups. The NOAEL was 180 mg/kg bw/day. The rationale for selection of the dose groups is not clear. The study failed to identify a critical effect. Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Single application study with substance at 10% Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit (Chbb:HM)","endpoint":"repeated dose toxicity","ingredient":"5-Amino-4-chloro-2-methylphenol hydrochloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":6,"route":"dermal","species":"rabbit","study_id":"out_191_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 180 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=out_191; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 5-AMINO-4-CHLORO-O-CRESOL HCL COLIPA n° A117; OPINION_NUMBER=SCCNFP/00659/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=180; DOSE=The subchronic study in rats used low dose levels in comparison to the acute toxicity and failed to identify any adverse effects.; EFFECT=/ SED = 2.12. Conclusions Insufficient information is provided on physico-chemical properties : solubility, potential impurities, stability. The database on toxicological properties is inadequate. Acute toxicity, irritation, sensitisation and embryotoxicity have been adequately investigated. The substance has shown sensitisation potential. The subchronic study in rats used low dose levels in comparison to the acute toxicity and failed to identify any adverse effects. However it complied with OECD guidelines and a NOAEL of 180 mg/kg bw/day can be assumed. Skin penetration has been investigated in the rat in vivo. Sufficient information on tissue distribution and recovery is provided to assume that the results are acceptable. The major deficiency is in mutagenicity testing. The test for bacterial gene mutation was not in compliance with OECD guidelines, and gave a positive result in the presence of metabolic activation. Negative results were obtained for mammalian cell mutation in vitro. The in vivo micronucleus test in CFW1 mice; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"The subchronic study in rats used low dose levels in comparison to the acute toxicity and failed to identify any adverse effects.","duration":"subchronic","effect":"/ SED = 2.12. Conclusions Insufficient information is provided on physico-chemical properties : solubility, potential impurities, stability. The database on toxicological properties is inadequate. Acute toxicity, irritation, sensitisation and embryotoxicity have been adequately investigated. The substance has shown sensitisation potential. The subchronic study in rats used low dose levels in comparison to the acute toxicity and failed to identify any adverse effects. However it complied with OECD guidelines and a NOAEL of 180 mg/kg bw/day can be assumed. Skin penetration has been investigated in the rat in vivo. Sufficient information on tissue distribution and recovery is provided to assume that the results are acceptable. The major deficiency is in mutagenicity testing. The test for bacterial gene mutation was not in compliance with OECD guidelines, and gave a positive result in the presence of metabolic activation. Negative results were obtained for mammalian cell mutation in vitro. The in vivo micronucleus test in CFW1 mice","endpoint":"repeated dose toxicity","ingredient":"5-Amino-4-chloro-2-methylphenol hydrochloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":18,"route":"","species":"rat","study_id":"out_191_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.19 | mg/kg | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 0.19; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...; EFFECT=data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","duration":"90-day","effect":"data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","endpoint":"dermal absorption","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.19","page":19,"route":"oral","species":"rat","study_id":"sccp_o_115_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =180 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 180; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...; EFFECT=a No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","duration":"90-day","effect":"a No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","endpoint":"dermal absorption","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 180","page":19,"route":"oral","species":"rat","study_id":"sccp_o_115_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =180 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 180; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...; EFFECT=ta submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg System...","duration":"90-day","effect":"ta submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (5-Amino-4-chloro-o-cresol HCl) (oxidative / permanent) Maximum absorption through the skin A (µg/cm2) = 16.47 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 11.53 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.19 mg/kg No observed adverse effect level NOAEL = 180 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 947","endpoint":"dermal absorption","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 180","page":19,"route":"oral","species":"rat","study_id":"sccp_o_115_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 500 | mg/kg bw/day | human | oral | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=500; DOSE=SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested.; EFFECT=SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested. Also up to the highest dose tested, the test chemical was neither embryo-lethal, embryotoxic nor teratogenic. Therefore the No-Observed-Adverse Effect-Level (NOAEL) for both maternal and foetal toxicity was 500 mg/kg bw/day. Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigatio; CITATION=Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low; CITATION_NUMBERS=[5,15,16]; REFERENCE=Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low; DETAILS_JSON={"cas_number":"110102-85-7","citation":"Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low","dose":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested.","duration":"","effect":"SCCP/1120/07 Opinion on 5-amino-4-chloro-o-cresol HCl 19 Daily oral administration of Ro 934 during organogenesis (day 6-15 of gestation) did not cause any adverse effects in dams up to the highest dose tested. Also up to the highest dose tested, the test chemical was neither embryo-lethal, embryotoxic nor teratogenic. Therefore the No-Observed-Adverse Effect-Level (NOAEL) for both maternal and foetal toxicity was 500 mg/kg bw/day. Ref.: 5, 15, 16 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigatio","endpoint":"developmental toxicity","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":19,"route":"oral","species":"human","study_id":"sccp_o_115_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 180 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=180; DOSE=No change in body weight gain was found in the treated animals.; EFFECT=lly relevant effects. No change in body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activa; CITATION=Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low; CITATION_NUMBERS=[4,14]; REFERENCE=Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low; DETAILS_JSON={"cas_number":"110102-85-7","citation":"Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low","dose":"No change in body weight gain was found in the treated animals.","duration":"Chronic","effect":"lly relevant effects. No change in body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activa","endpoint":"genotoxicity","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":14,"route":"","species":"rat","study_id":"sccp_o_115_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 180 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=180; DOSE=body weight gain was found in the treated animals.; EFFECT=body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activation. T; CITATION=Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low; CITATION_NUMBERS=[4,14]; REFERENCE=Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low; DETAILS_JSON={"cas_number":"110102-85-7","citation":"Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low","dose":"body weight gain was found in the treated animals.","duration":"Chronic","effect":"body weight gain was found in the treated animals. Minor deviations of a few biochemical and haematological parameters were recorded but these findings were not dose-related and were not correlated with organ toxicity and therefore are not regarded as indication of systemic toxicity. Macroscopy did not reveal any effect. Histopathology was only performed on the control and the high dose group, and did also not reveal any effect. Conclusions On the basis of the these results, the No-Observed-Adverse Effect-Level (NOAEL) in rats is 180 mg/kg bw/day Ref.: 4, 14 Comment For hazard identification, the test concentration used was too low. However, the study is useful for evaluation. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicates both in the presence and absence of metabolic activation. T","endpoint":"genotoxicity","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":14,"route":"","species":"rat","study_id":"sccp_o_115_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 180 | mg/kg bw/day | rat | - | 90-day | irritation | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=180; DOSE=an impurity in the test material varied up to 640 ppm.; EFFECT=an impurity in the test material varied up to 640 ppm. Water solubility of the test material is not determined by an EU method. A calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification. The stability of 5-Amino-4-chloro-o-cresol HCl in the marketed products is not reported. General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw. The LD50 value for females was > 2000 mg/kg bw. On the basis of the results of a 90-day study in rats, the No-Observed-Adverse Effect-Level (NOAEL) was set at 180 mg/kg bw/day. In a teratogenicity study in rats, the NOAEL for both maternal and foetal toxicity was set at 500 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the undiluted test substance caused some reversible irritation when applied to the intact rabbit skin under semi-occlusive conditions. The undiluted test substance was extremely irritating to the rabbit eye. Based on the criteria of the test system, A117 / SAT 050780 was found to be a non- sensitizer when; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"an impurity in the test material varied up to 640 ppm.","duration":"90-day","effect":"an impurity in the test material varied up to 640 ppm. Water solubility of the test material is not determined by an EU method. A calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification. The stability of 5-Amino-4-chloro-o-cresol HCl in the marketed products is not reported. General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw. The LD50 value for females was > 2000 mg/kg bw. On the basis of the results of a 90-day study in rats, the No-Observed-Adverse Effect-Level (NOAEL) was set at 180 mg/kg bw/day. In a teratogenicity study in rats, the NOAEL for both maternal and foetal toxicity was set at 500 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the undiluted test substance caused some reversible irritation when applied to the intact rabbit skin under semi-occlusive conditions. The undiluted test substance was extremely irritating to the rabbit eye. Based on the criteria of the test system, A117 / SAT 050780 was found to be a non- sensitizer when","endpoint":"irritation","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":20,"route":"","species":"rat","study_id":"sccp_o_115_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 180 | mg/kg bw/day | rat | - | 90-day | irritation | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=180; DOSE=varied up to 640 ppm.; EFFECT=varied up to 640 ppm. Water solubility of the test material is not determined by an EU method. A calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification. The stability of 5-Amino-4-chloro-o-cresol HCl in the marketed products is not reported. General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw. The LD50 value for females was > 2000 mg/kg bw. On the basis of the results of a 90-day study in rats, the No-Observed-Adverse Effect-Level (NOAEL) was set at 180 mg/kg bw/day. In a teratogenicity study in rats, the NOAEL for both maternal and foetal toxicity was set at 500 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the undiluted test substance caused some reversible irritation when applied to the intact rabbit skin under semi-occlusive conditions. The undiluted test substance was extremely irritating to the rabbit eye. Based on the criteria of the test system, A117 / SAT 050780 was found to be a non- sensitizer when tested; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"varied up to 640 ppm.","duration":"90-day","effect":"varied up to 640 ppm. Water solubility of the test material is not determined by an EU method. A calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification. The stability of 5-Amino-4-chloro-o-cresol HCl in the marketed products is not reported. General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw. The LD50 value for females was > 2000 mg/kg bw. On the basis of the results of a 90-day study in rats, the No-Observed-Adverse Effect-Level (NOAEL) was set at 180 mg/kg bw/day. In a teratogenicity study in rats, the NOAEL for both maternal and foetal toxicity was set at 500 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the undiluted test substance caused some reversible irritation when applied to the intact rabbit skin under semi-occlusive conditions. The undiluted test substance was extremely irritating to the rabbit eye. Based on the criteria of the test system, A117 / SAT 050780 was found to be a non- sensitizer when tested","endpoint":"irritation","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":20,"route":"","species":"rat","study_id":"sccp_o_115_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 180 | mg/kg bw/day | rat | - | 90-day | irritation | SOURCE_SUBDIR=sccp_o_115; REPORT_TITLE=OPINION ON 5-Amino-4-chloro-o-cresol HCl COLIPA n° A117; OPINION_NUMBER=SCCP/1120/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=180; DOSE=General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw.; EFFECT=ed by an EU method. A calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification. The stability of 5-Amino-4-chloro-o-cresol HCl in the marketed products is not reported. General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw. The LD50 value for females was > 2000 mg/kg bw. On the basis of the results of a 90-day study in rats, the No-Observed-Adverse Effect-Level (NOAEL) was set at 180 mg/kg bw/day. In a teratogenicity study in rats, the NOAEL for both maternal and foetal toxicity was set at 500 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the undiluted test substance caused some reversible irritation when applied to the intact rabbit skin under semi-occlusive conditions. The undiluted test substance was extremely irritating to the rabbit eye. Based on the criteria of the test system, A117 / SAT 050780 was found to be a non- sensitizer when tested up to the highest technically achievable concentration of 20% (w/v) in mic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"110102-85-7","citation":"","dose":"General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw.","duration":"90-day","effect":"ed by an EU method. A calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification. The stability of 5-Amino-4-chloro-o-cresol HCl in the marketed products is not reported. General toxicity For male rats the LD50 was between 1539 and 2000 mg/kg bw. The LD50 value for females was > 2000 mg/kg bw. On the basis of the results of a 90-day study in rats, the No-Observed-Adverse Effect-Level (NOAEL) was set at 180 mg/kg bw/day. In a teratogenicity study in rats, the NOAEL for both maternal and foetal toxicity was set at 500 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the undiluted test substance caused some reversible irritation when applied to the intact rabbit skin under semi-occlusive conditions. The undiluted test substance was extremely irritating to the rabbit eye. Based on the criteria of the test system, A117 / SAT 050780 was found to be a non- sensitizer when tested up to the highest technically achievable concentration of 20% (w/v) in mic","endpoint":"irritation","ingredient":"5-Amino-4-chloro-o-cresol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":20,"route":"","species":"rat","study_id":"sccp_o_115_noael_009"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 31J4UQW59L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H8ClNO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"31J4UQW59L"} |
| openFDA substances | FDA UNII substance identifier | 31J4UQW59L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H8ClNO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"31J4UQW59L"} |
| openFDA substances | FDA UNII substance identifier | 31J4UQW59L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H8ClNO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"31J4UQW59L"} |
| openFDA substances | FDA UNII substance identifier | 31J4UQW59L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H8ClNO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"31J4UQW59L"} |