NOAEL Studies Cosmetic Ingredient

5-Amino-6-Chloro-o-Cresol NOAEL Studies

INCI: 5-AMINO-6-CHLORO-O-CRESOL

CAS: 84540-50-1

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 100 mg/kg bw/day rat oral 90 day Subchronic SCCS; van Otterdijk, F.M. Repeated dose 90-day oral toxicity study with A 094 by daily gavage in the rat followed by a 28-day recovery period. NOTOX B.V., Hertogenbosch, The Netherlands,HenkelKGaA, Düsseldorf Report No. R 0500279
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =100 mg/kg/day - - - NOAEL study {"dose":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose).","effect":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose). Based on these findings (under exclusion of the one incidence at the low dose) the authors concluded “Hepatocytic hypertrophy […] occurred in the absence of any other supportive functional or morphological changes. Centrilobular hypertrophy of hepatocytes is frequently an adaptive change in response to xenobiotics and at low incidence and severity considered not to be adverse.”). The authors of the study establish a NOAEL of 100 mg/kg/day. Other microscopic findings were only related to the high dose group (and confined to the males), like cortical tubular basophilia in the kidneys (8/12 males), limiting ridge hyperplasia of the forestomach (12/12 males) with squamous hyperplasia of the main stomach (2/12 males). At the high dose (600) histopathological findings were accompanied by increased relative and absolute liver weights (persisting through the recovery period) and effects on a number of clinical biochemistry parameters (li","page":16,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the judgement of the authors these two cases were not related to treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_002"}
SCCS_vision_codex NOAEL =24 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"trols and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_004"}
SCCS_vision_codex NOAEL =270 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat - 90-day irritation {"dose":"Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested).","effect":"are the targets of systemic toxicity of 5-amino-6- chloro-o-cresol. Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested). This LOAEL is supported by the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_006"}
SCCS_vision_codex NOAEL =33 mg/kg bw/day rabbit dermal 90-day dermal absorption {"dose":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose.","effect":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between the two experiments using a 50% concentration of 5-Amino-6- chloro-o-cresol is unexplained. However, the overall evidence suggests that 5-amino-6- chloro-o-cresol may be considered a non-sensitiser. Dermal absorption Under the condition of the experiments in which hair dye formu","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_007"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - - NOAEL study {"dose":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose).","effect":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose). Based on these findings (under exclusion of the one incidence at the low dose) the authors concluded “Hepatocytic hypertrophy […] occurred in the absence of any other supportive functional or morphological changes. Centrilobular hypertrophy of hepatocytes is frequently an adaptive change in response to xenobiotics and at low incidence and severity considered not to be adverse.”). The authors of the study establish a NOAEL of 100 mg/kg/day. Other microscopic findings were only related to the high dose group (and confined to the males), like cortical tubular basophilia in the kidneys (8/12 males), limiting ridge hyperplasia of the forestomach (12/12 males) with squamous hyperplasia of the main stomach (2/12 males). At the high dose (600) histopathological findings were accompanied by increased relative and absolute liver weights (persisting through the recovery period) and effects on a number of clinical biochemistry parameters (li","page":16,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the judgement of the authors these two cases were not related to treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_002"}
SCCS_vision_codex NOAEL =24 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"trols and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_004"}
SCCS_vision_codex NOAEL =270 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat - 90-day irritation {"dose":"Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested).","effect":"are the targets of systemic toxicity of 5-amino-6- chloro-o-cresol. Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested). This LOAEL is supported by the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_006"}
SCCS_vision_codex NOAEL =33 mg/kg bw/day rabbit dermal 90-day dermal absorption {"dose":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose.","effect":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between the two experiments using a 50% concentration of 5-Amino-6- chloro-o-cresol is unexplained. However, the overall evidence suggests that 5-amino-6- chloro-o-cresol may be considered a non-sensitiser. Dermal absorption Under the condition of the experiments in which hair dye formu","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_007"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - - NOAEL study {"dose":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose).","effect":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose). Based on these findings (under exclusion of the one incidence at the low dose) the authors concluded “Hepatocytic hypertrophy […] occurred in the absence of any other supportive functional or morphological changes. Centrilobular hypertrophy of hepatocytes is frequently an adaptive change in response to xenobiotics and at low incidence and severity considered not to be adverse.”). The authors of the study establish a NOAEL of 100 mg/kg/day. Other microscopic findings were only related to the high dose group (and confined to the males), like cortical tubular basophilia in the kidneys (8/12 males), limiting ridge hyperplasia of the forestomach (12/12 males) with squamous hyperplasia of the main stomach (2/12 males). At the high dose (600) histopathological findings were accompanied by increased relative and absolute liver weights (persisting through the recovery period) and effects on a number of clinical biochemistry parameters (li","page":16,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the judgement of the authors these two cases were not related to treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_002"}
SCCS_vision_codex NOAEL =24 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"trols and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_004"}
SCCS_vision_codex NOAEL =270 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat - 90-day irritation {"dose":"Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested).","effect":"are the targets of systemic toxicity of 5-amino-6- chloro-o-cresol. Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested). This LOAEL is supported by the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_006"}
SCCS_vision_codex NOAEL =33 mg/kg bw/day rabbit dermal 90-day dermal absorption {"dose":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose.","effect":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between the two experiments using a 50% concentration of 5-Amino-6- chloro-o-cresol is unexplained. However, the overall evidence suggests that 5-amino-6- chloro-o-cresol may be considered a non-sensitiser. Dermal absorption Under the condition of the experiments in which hair dye formu","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_007"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - - NOAEL study {"dose":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose).","effect":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose). Based on these findings (under exclusion of the one incidence at the low dose) the authors concluded “Hepatocytic hypertrophy […] occurred in the absence of any other supportive functional or morphological changes. Centrilobular hypertrophy of hepatocytes is frequently an adaptive change in response to xenobiotics and at low incidence and severity considered not to be adverse.”). The authors of the study establish a NOAEL of 100 mg/kg/day. Other microscopic findings were only related to the high dose group (and confined to the males), like cortical tubular basophilia in the kidneys (8/12 males), limiting ridge hyperplasia of the forestomach (12/12 males) with squamous hyperplasia of the main stomach (2/12 males). At the high dose (600) histopathological findings were accompanied by increased relative and absolute liver weights (persisting through the recovery period) and effects on a number of clinical biochemistry parameters (li","page":16,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the judgement of the authors these two cases were not related to treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_002"}
SCCS_vision_codex NOAEL =24 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"trols and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_004"}
SCCS_vision_codex NOAEL =270 mg/kg bw/d rat - developmental developmental toxicity {"citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","effect":"n the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","page":21,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat - 90-day irritation {"dose":"Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested).","effect":"are the targets of systemic toxicity of 5-amino-6- chloro-o-cresol. Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested). This LOAEL is supported by the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_006"}
SCCS_vision_codex NOAEL =33 mg/kg bw/day rabbit dermal 90-day dermal absorption {"dose":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose.","effect":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between the two experiments using a 50% concentration of 5-Amino-6- chloro-o-cresol is unexplained. However, the overall evidence suggests that 5-amino-6- chloro-o-cresol may be considered a non-sensitiser. Dermal absorption Under the condition of the experiments in which hair dye formu","page":24,"pdf":"sccs_o_005.pdf","row_type":"noael_study","study_id":"sccs_o_005_noael_007"}
ToxValDB_ECHA_IUCLID 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =100 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf23e4b0a7c65d1ccad5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21096/7/6/2?documentUUID=c9875bba-b31c-4c06-8236-d32092717d74; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=clinical biochemistry|clinical signs|haematology|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|clinical signs|hematology|organ weight; STUDY_GROUP=ECHA IUCLID:15837141:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a5dedc3e6d7d082b320c2a62e3709202
ToxValDB_ECHA_IUCLID NOAEL <750 mg/kg bw/day Rat oral short-term; 28 days short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf23e4b0a7c65d1ccad8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21096/7/6/2?documentUUID=c9875bba-b31c-4c06-8236-d32092717d74; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=liver: body weight and weight gain|clinical signs|food consumption and compound intake|gross pathology|histopathology: neoplastic|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=cancer|clinical signs|food and/or water consumption|gross pathology|organ weight; STUDY_GROUP=ECHA IUCLID:15843416:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fce139d26ce9d1afed3e153a838a4247
ToxValDB_ECHA_IUCLID NOEL =270 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac7be4b0a7c65d1bf559; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21096/7/9/3?documentUUID=c9875bba-b31c-4c06-8236-d32092717d74; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=fetus: fetal/pup body weight changes|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821333:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_47516db9723e9a264e0295fdf793f908
ToxValDB_ECHA_IUCLID NOEL =90 mg/kg bw/day Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac7be4b0a7c65d1bf559; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21096/7/9/3?documentUUID=c9875bba-b31c-4c06-8236-d32092717d74; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: food consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ECHA IUCLID:15822650:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e0f23d4da19af806c00541672a44728d
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg/day - - - - SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=100; DOSE=) at the end of recovery (although at slight severity; no recovery groups for medium and low dose).; EFFECT=) at the end of recovery (although at slight severity; no recovery groups for medium and low dose). Based on these findings (under exclusion of the one incidence at the low dose) the authors concluded “Hepatocytic hypertrophy […] occurred in the absence of any other supportive functional or morphological changes. Centrilobular hypertrophy of hepatocytes is frequently an adaptive change in response to xenobiotics and at low incidence and severity considered not to be adverse.”). The authors of the study establish a NOAEL of 100 mg/kg/day. Other microscopic findings were only related to the high dose group (and confined to the males), like cortical tubular basophilia in the kidneys (8/12 males), limiting ridge hyperplasia of the forestomach (12/12 males) with squamous hyperplasia of the main stomach (2/12 males). At the high dose (600) histopathological findings were accompanied by increased relative and absolute liver weights (persisting through the recovery period) and effects on a number of clinical biochemistry parameters (li; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-50-1","citation":"","dose":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose).","duration":"","effect":") at the end of recovery (although at slight severity; no recovery groups for medium and low dose). Based on these findings (under exclusion of the one incidence at the low dose) the authors concluded “Hepatocytic hypertrophy […] occurred in the absence of any other supportive functional or morphological changes. Centrilobular hypertrophy of hepatocytes is frequently an adaptive change in response to xenobiotics and at low incidence and severity considered not to be adverse.”). The authors of the study establish a NOAEL of 100 mg/kg/day. Other microscopic findings were only related to the high dose group (and confined to the males), like cortical tubular basophilia in the kidneys (8/12 males), limiting ridge hyperplasia of the forestomach (12/12 males) with squamous hyperplasia of the main stomach (2/12 males). At the high dose (600) histopathological findings were accompanied by increased relative and absolute liver weights (persisting through the recovery period) and effects on a number of clinical biochemistry parameters (li","endpoint":"","ingredient":". Before any further consideration, the following","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":16,"route":"","species":"","study_id":"sccs_o_005_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 33 mg/kg bw/day rabbit dermal 90-day dermal absorption SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=33; DOSE=the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose.; LOAEL_VALUE=33 mg/kg bw/day; EFFECT=the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between the two experiments using a 50% concentration of 5-Amino-6- chloro-o-cresol is unexplained. However, the overall evidence suggests that 5-amino-6- chloro-o-cresol may be considered a non-sensitiser. Dermal absorption Under the condition of the experiments in which hair dye formu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-50-1","citation":"","dose":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose.","duration":"90-day","effect":"the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between the two experiments using a 50% concentration of 5-Amino-6- chloro-o-cresol is unexplained. However, the overall evidence suggests that 5-amino-6- chloro-o-cresol may be considered a non-sensitiser. Dermal absorption Under the condition of the experiments in which hair dye formu","endpoint":"dermal absorption","ingredient":". Before any further consideration, the following","loael_value":"33 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"33","page":24,"route":"dermal","species":"rabbit","study_id":"sccs_o_005_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 90 mg/kg/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=90; DOSE=There was no further statistical evidence for differences between the treated groups and the control group.; EFFECT=n the judgement of the authors these two cases were not related to treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of; CITATION=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; CITATION_NUMBERS=[14,30,24]; REFERENCE=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; DETAILS_JSON={"cas_number":"84540-50-1","citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","duration":"developmental","effect":"n the judgement of the authors these two cases were not related to treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following","loael_value":"","noael_unit":"mg/kg/d","noael_value":"90","page":21,"route":"","species":"rat","study_id":"sccs_o_005_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 90 mg/kg/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=90; DOSE=There was no further statistical evidence for differences between the treated groups and the control group.; EFFECT=treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of; CITATION=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; CITATION_NUMBERS=[14,30,24]; REFERENCE=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; DETAILS_JSON={"cas_number":"84540-50-1","citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","duration":"developmental","effect":"treatment. Skeletal examinations showed dumbbell formed thoracic vertebral bodies in 1, 3, 2, 4 foetuses of groups 1 to 4. The difference between controls and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following","loael_value":"","noael_unit":"mg/kg/d","noael_value":"90","page":21,"route":"","species":"rat","study_id":"sccs_o_005_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 24 mg/kg bw/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=24; DOSE=There was no further statistical evidence for differences between the treated groups and the control group.; EFFECT=trols and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of; CITATION=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; CITATION_NUMBERS=[14,30,24]; REFERENCE=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; DETAILS_JSON={"cas_number":"84540-50-1","citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","duration":"developmental","effect":"trols and dosed groups were significant. According to the authors these cases are within the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"24","page":21,"route":"","species":"rat","study_id":"sccs_o_005_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 270 mg/kg bw/d rat - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=270; DOSE=There was no further statistical evidence for differences between the treated groups and the control group.; EFFECT=n the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of; CITATION=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; CITATION_NUMBERS=[14,30,24]; REFERENCE=Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain; DETAILS_JSON={"cas_number":"84540-50-1","citation":"Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain","dose":"There was no further statistical evidence for differences between the treated groups and the control group.","duration":"developmental","effect":"n the normal range of abnormal findings in this strain of rats. There was no further statistical evidence for differences between the treated groups and the control group. Conclusion The study authors considered the NOAEL for this study was 90 mg/kg/d for maternal toxicity and the NOEL for developmental toxicity was 270 mg/kg/day. Ref.: 14 Comments The SCCS considers 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) as the NOAEL of maternal toxicity in this study due to reduced maternal body weight gain. The NOAEL of embryo-foetal toxicity was 270 mg/kg bw/d (219 mg/kg bw/d calculated as free base), the highest dose tested. There are significant, but not dose-related differences in the number of","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"270","page":21,"route":"","species":"rat","study_id":"sccs_o_005_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 30 mg/kg bw/d rat - 90-day irritation SOURCE_SUBDIR=sccs_o_005; REPORT_TITLE=OPINION ON 5-Amino-6-chloro-o-cresol COLIPA n° A94; OPINION_NUMBER=SCCS/1225/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=07 January 2011; VALUE_TEXT=30; DOSE=Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested).; LOAEL_VALUE=100 mg/kg/day; EFFECT=are the targets of systemic toxicity of 5-amino-6- chloro-o-cresol. Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested). This LOAEL is supported by the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-50-1","citation":"","dose":"Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested).","duration":"90-day","effect":"are the targets of systemic toxicity of 5-amino-6- chloro-o-cresol. Based on the haematological changes, in particular the reduced mean corpuscular Hb concentration in all dose groups of female rats, the LOAEL is 100 mg/kg/day (the lowest dose tested). This LOAEL is supported by the obvious dose-dependency of centrilobular hypertrophy of the liver which in males was observed down to the low dose. In the high dose recovery group, this effect persisted until termination of the study. In a teratogenicity study, the NOAEL of maternal toxicity was 30 mg/kg bw/d (24 mg/kg bw/d calculated as free base) due to reduced maternal body weight gain. For the margin of safety calculation, the LOAEL of the 90-day study was adjusted with a factor of 3, resulting in 33 mg/kg bw/day. This is similar to the NOAEL of the teratogenicity study. Irritation / sensitisation 5-Amino-6-chloro-o-cresol was not irritant to rabbit skin. Under the conditions of the study, the undiluted test material was irritating to the rabbit eye. The discrepancy between","endpoint":"irritation","ingredient":". Before any further consideration, the following","loael_value":"100 mg/kg/day","noael_unit":"mg/kg bw/d","noael_value":"30","page":24,"route":"","species":"rat","study_id":"sccs_o_005_noael_006"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 8077WHL3XK UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8ClNO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8077WHL3XK"}
openFDA substances FDA UNII substance identifier 8077WHL3XK UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8ClNO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8077WHL3XK"}
openFDA substances FDA UNII substance identifier 8077WHL3XK UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8ClNO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8077WHL3XK"}
openFDA substances FDA UNII substance identifier 8077WHL3XK UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8ClNO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8077WHL3XK"}