NOAEL Studies
Cosmetic Ingredient
6-Hydroxyindole NOAEL Studies
INCI: 6-HYDROXYINDOLE
CAS: 2380-86-1 (per CIR/SCCP records)
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =100 | - | rat | oral gavage | 13 weeks | NOAEL study | {"citation":"25","page":4,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"1"} |
| CIR_vision_codex | NOAEL | =150 | - | rat | oral gavage | gestation days 6-15 | NOAEL study | {"citation":"26","page":4,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"2"} |
| CIR_vision_codex | NOAEL | =240 | - | rat | oral gavage | gestation days 6-19 | NOAEL study | {"citation":"27","page":5,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"3"} |
| CIR_vision_codex | NOAEL | =25 | - | rat | oral gavage | 105 weeks | NOAEL study | {"citation":"36","page":6,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"4"} |
| CIR_vision_codex | NOAEL | =100 | - | rat | oral gavage | 13 weeks | NOAEL study | {"citation":"25","page":4,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"1"} |
| CIR_vision_codex | NOAEL | =150 | - | rat | oral gavage | gestation days 6-15 | NOAEL study | {"citation":"26","page":4,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"2"} |
| CIR_vision_codex | NOAEL | =240 | - | rat | oral gavage | gestation days 6-19 | NOAEL study | {"citation":"27","page":5,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"3"} |
| CIR_vision_codex | NOAEL | =25 | - | rat | oral gavage | 105 weeks | NOAEL study | {"citation":"36","page":6,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"4"} |
| CIR_vision_codex | NOAEL | =100 | - | rat | oral gavage | 13 weeks | NOAEL study | {"citation":"25","page":4,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"1"} |
| CIR_vision_codex | NOAEL | =150 | - | rat | oral gavage | gestation days 6-15 | NOAEL study | {"citation":"26","page":4,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"2"} |
| CIR_vision_codex | NOAEL | =240 | - | rat | oral gavage | gestation days 6-19 | NOAEL study | {"citation":"27","page":5,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"3"} |
| CIR_vision_codex | NOAEL | =25 | - | rat | oral gavage | 105 weeks | NOAEL study | {"citation":"36","page":6,"pdf":"PRS635.pdf","row_type":"noael_study","study_id":"4"} |
SCCNFP_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"d to be treatment-related. No treatment-related macroscopic changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Bat","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"c changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Batch no : pil.10 (purity not stated) Dose : 0.5 g GLP :","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 14 2","dose":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses...","effect":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses of 150 and 300 mg/kg bw. The NOAEL was reported to be 50 mg/kg bw/day. Ref. : 14 2.7. Toxicokinetics (incl. Percutaneous absorption) 2.7.1 Percutaneous absorption in vitro In vitro study without coupler Guideline : / Tissue : Human abdominal epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 6-hydroxyindole, 1% in formulation/H2O2 mix Batch no : DG2 (purity not stated in study report) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 7/8 GLP : not in compliance The skin","page":11,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | rat | oral | 13-week | carcinogenicity | {"dose":"A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.","effect":"o but these properties have not been observed in in vivo assays with different endpoints and species/or strains. 2.9. Carcinogenicity No data 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Not Applicable 2.12. Conclusion The overall package of tests is adequate and most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours,","page":19,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"d to be treatment-related. No treatment-related macroscopic changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Bat","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"c changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Batch no : pil.10 (purity not stated) Dose : 0.5 g GLP :","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 14 2","dose":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses...","effect":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses of 150 and 300 mg/kg bw. The NOAEL was reported to be 50 mg/kg bw/day. Ref. : 14 2.7. Toxicokinetics (incl. Percutaneous absorption) 2.7.1 Percutaneous absorption in vitro In vitro study without coupler Guideline : / Tissue : Human abdominal epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 6-hydroxyindole, 1% in formulation/H2O2 mix Batch no : DG2 (purity not stated in study report) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 7/8 GLP : not in compliance The skin","page":11,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | rat | oral | 13-week | carcinogenicity | {"dose":"A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.","effect":"o but these properties have not been observed in in vivo assays with different endpoints and species/or strains. 2.9. Carcinogenicity No data 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Not Applicable 2.12. Conclusion The overall package of tests is adequate and most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours,","page":19,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"d to be treatment-related. No treatment-related macroscopic changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Bat","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"c changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Batch no : pil.10 (purity not stated) Dose : 0.5 g GLP :","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 14 2","dose":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses...","effect":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses of 150 and 300 mg/kg bw. The NOAEL was reported to be 50 mg/kg bw/day. Ref. : 14 2.7. Toxicokinetics (incl. Percutaneous absorption) 2.7.1 Percutaneous absorption in vitro In vitro study without coupler Guideline : / Tissue : Human abdominal epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 6-hydroxyindole, 1% in formulation/H2O2 mix Batch no : DG2 (purity not stated in study report) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 7/8 GLP : not in compliance The skin","page":11,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | rat | oral | 13-week | carcinogenicity | {"dose":"A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.","effect":"o but these properties have not been observed in in vivo assays with different endpoints and species/or strains. 2.9. Carcinogenicity No data 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Not Applicable 2.12. Conclusion The overall package of tests is adequate and most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours,","page":19,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"d to be treatment-related. No treatment-related macroscopic changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Bat","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","effect":"c changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Batch no : pil.10 (purity not stated) Dose : 0.5 g GLP :","page":7,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 14 2","dose":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses...","effect":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses of 150 and 300 mg/kg bw. The NOAEL was reported to be 50 mg/kg bw/day. Ref. : 14 2.7. Toxicokinetics (incl. Percutaneous absorption) 2.7.1 Percutaneous absorption in vitro In vitro study without coupler Guideline : / Tissue : Human abdominal epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 6-hydroxyindole, 1% in formulation/H2O2 mix Batch no : DG2 (purity not stated in study report) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 7/8 GLP : not in compliance The skin","page":11,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | rat | oral | 13-week | carcinogenicity | {"dose":"A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.","effect":"o but these properties have not been observed in in vivo assays with different endpoints and species/or strains. 2.9. Carcinogenicity No data 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Not Applicable 2.12. Conclusion The overall package of tests is adequate and most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours,","page":19,"pdf":"out244_en.pdf","row_type":"noael_study","study_id":"out244_en_noael_004"} |
ToxValDB_ECHA_IUCLID 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | ~600 | mg/kg bw/day | Rat | oral | - | acute | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID:15811557: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_4b8e26b0a29f0f1a2d8a1a15a6e39754 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~100 | mg/kg bw/day | Rat | oral | - | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bcb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817912_15817913: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_aca6205bac2e427f48cac0e61eccd5ca |
| ToxValDB_ECHA_IUCLID | NOAEL | ~25 | mg/kg bw/day | Rat | oral | - | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bcb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=body weight and weight gain|haematology; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|hematology; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817912_15817913: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_73dc21991983eaa5c9a1a161da7446de |
| ToxValDB_ECHA_IUCLID | NOAEL | ~150 | mg/kg bw/day | Rat | oral | - | reproduction developmental | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcece; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=maternal: food consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption; STUDY_GROUP=ECHA IUCLID:15823114: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_5c59440df51e78770a1c760528b77362 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~30 | mg/kg bw/day | Rat | oral | - | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cae7e4b0a7c65d2240a2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15845381: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_212973cfca135b57d41b7c649cb0ff18 |
| ToxValDB_ECHA_IUCLID | NOEL | ~50 | mg/kg bw/day | Rat | oral | - | developmental | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcece; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9971?documentUUID=0bdbe7f4-5863-44ce-8008-ceaf1943eebc; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=fetus: skeletal malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821834:-:-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_effa3d2dec69e2fc73b87990d75524f5 |
UnifiedCodex:CIR:beta.noael_studies 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | - | 100 | - | rat | oral gavage | 13 weeks | - | SOURCE_SUBDIR=PRS635; REPORT_TITLE=Safety Assessment of 6-Hydroxyindole as Used in Cosmetics; OPINION_NUMBER=PRS635; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; VALUE_TEXT=100 mg/kg body weight/d; CITATION=25; CITATION_NUMBERS=[25]; REFERENCE=25; DETAILS_JSON={"cas_number":"","citation":"25","dose":"","duration":"13 weeks","effect":"","endpoint":"","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"","noael_value":"100 mg/kg body weight/d","page":4,"route":"oral gavage","species":"rat","study_id":"1"} |
| UnifiedCodex:CIR:beta.noael_studies | - | 150 | - | rat | oral gavage | gestation days 6-15 | - | SOURCE_SUBDIR=PRS635; REPORT_TITLE=Safety Assessment of 6-Hydroxyindole as Used in Cosmetics; OPINION_NUMBER=PRS635; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; VALUE_TEXT=maternal 150 mg/kg bw; fetal 50 mg/kg bw; CITATION=26; CITATION_NUMBERS=[26]; REFERENCE=26; DETAILS_JSON={"cas_number":"","citation":"26","dose":"","duration":"gestation days 6-15","effect":"","endpoint":"","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"","noael_value":"maternal 150 mg/kg bw; fetal 50 mg/kg bw","page":4,"route":"oral gavage","species":"rat","study_id":"2"} |
| UnifiedCodex:CIR:beta.noael_studies | - | 240 | - | rat | oral gavage | gestation days 6-19 | - | SOURCE_SUBDIR=PRS635; REPORT_TITLE=Safety Assessment of 6-Hydroxyindole as Used in Cosmetics; OPINION_NUMBER=PRS635; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; VALUE_TEXT=maternal NOEL 240 mg/kg bw/d; fetal NOEL 60 mg/kg bw/d; CITATION=27; CITATION_NUMBERS=[27]; REFERENCE=27; DETAILS_JSON={"cas_number":"","citation":"27","dose":"","duration":"gestation days 6-19","effect":"","endpoint":"","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"","noael_value":"maternal NOEL 240 mg/kg bw/d; fetal NOEL 60 mg/kg bw/d","page":5,"route":"oral gavage","species":"rat","study_id":"3"} |
| UnifiedCodex:CIR:beta.noael_studies | - | 25 | - | rat | oral gavage | 105 weeks | - | SOURCE_SUBDIR=PRS635; REPORT_TITLE=Safety Assessment of 6-Hydroxyindole as Used in Cosmetics; OPINION_NUMBER=PRS635; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; VALUE_TEXT=general toxicity 25 mg/kg bw/d; NOEL for carcinogenicity 100 mg/kg bw/d; CITATION=36; CITATION_NUMBERS=[36]; REFERENCE=36; DETAILS_JSON={"cas_number":"","citation":"36","dose":"","duration":"105 weeks","effect":"","endpoint":"","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"","noael_value":"general toxicity 25 mg/kg bw/d; NOEL for carcinogenicity 100 mg/kg bw/d","page":6,"route":"oral gavage","species":"rat","study_id":"4"} |
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | carcinogenicity | 0 | mg/kg bw/day | rat | oral | 13-week | carcinogenicity | SOURCE_SUBDIR=out244_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 6-HYDROXYINDOLE COLIPA n° A128; OPINION_NUMBER=SCCNFP/0667/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=0; DOSE=A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.; EFFECT=o but these properties have not been observed in in vivo assays with different endpoints and species/or strains. 2.9. Carcinogenicity No data 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Not Applicable 2.12. Conclusion The overall package of tests is adequate and most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2380-86-1","citation":"","dose":"A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.","duration":"13-week","effect":"o but these properties have not been observed in in vivo assays with different endpoints and species/or strains. 2.9. Carcinogenicity No data 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Not Applicable 2.12. Conclusion The overall package of tests is adequate and most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours,","endpoint":"carcinogenicity","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"0","page":19,"route":"oral","species":"rat","study_id":"out244_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 50 | mg/kg bw/day | human | - | - | dermal absorption | SOURCE_SUBDIR=out244_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 6-HYDROXYINDOLE COLIPA n° A128; OPINION_NUMBER=SCCNFP/0667/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=50; DOSE=SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses...; EFFECT=SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses of 150 and 300 mg/kg bw. The NOAEL was reported to be 50 mg/kg bw/day. Ref. : 14 2.7. Toxicokinetics (incl. Percutaneous absorption) 2.7.1 Percutaneous absorption in vitro In vitro study without coupler Guideline : / Tissue : Human abdominal epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 6-hydroxyindole, 1% in formulation/H2O2 mix Batch no : DG2 (purity not stated in study report) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 7/8 GLP : not in compliance The skin; CITATION=Ref. : 14 2; CITATION_NUMBERS=[14,2]; REFERENCE=Ref. : 14 2; DETAILS_JSON={"cas_number":"2380-86-1","citation":"Ref. : 14 2","dose":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses...","duration":"","effect":"SCCNFP/0667/03 Evaluation and opinion on 6-Hydroxyindole _____________________________________________________________________________________________ 11 The test substance gave no convincing evidence of maternal toxicity, and no evidence of embryolethality or teratogenicity, but there was a definite retardation of embryonic development at doses of 150 and 300 mg/kg bw. The NOAEL was reported to be 50 mg/kg bw/day. Ref. : 14 2.7. Toxicokinetics (incl. Percutaneous absorption) 2.7.1 Percutaneous absorption in vitro In vitro study without coupler Guideline : / Tissue : Human abdominal epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 6-hydroxyindole, 1% in formulation/H2O2 mix Batch no : DG2 (purity not stated in study report) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 7/8 GLP : not in compliance The skin","endpoint":"dermal absorption","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":11,"route":"","species":"human","study_id":"out244_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | genotoxicity | 50 | mg/kg bw/day | rat | oral | 13-week | genotoxicity | SOURCE_SUBDIR=out244_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 6-HYDROXYINDOLE COLIPA n° A128; OPINION_NUMBER=SCCNFP/0667/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=50; DOSE=A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.; EFFECT=d most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours, and after contact of 30 minutes, represents 2.23 % (5.40 µg/cm²) of the applied dose. The substance induced gene mutations in bacteria and chromosomal aberrations in human cells in vitro. In vivo genotoxicity studies using complementary species and endpoints indicated that the in vitro mutagenic potential was not express; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2380-86-1","citation":"","dose":"A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day.","duration":"13-week","effect":"d most have been conducted to GLP and appropriate guidelines. The substance was moderately toxic by ingestion. A 13-week oral repeat dose study in rats showed liver changes in female rats and the NOEL was 30 mg/kg bw/day. It was non-irritating to rabbit skin when applied neat and non-irritating to the rabbit eye at a concentration of 5%, which provides an adequate margin of safety compared with the 0.5% intended for use. It is a sensitiser. The substance was embryotoxic, resulting in delayed ossification, with a NOEL of 50 mg/kg bw/day. It gave no evidence of teratogenicity. Percutaneous penetration has been investigated using human skin in vitro. When formulated with H2O2, the absorbed amount after 24 hours, and after contact of 30 minutes, represents 2.23 % (5.40 µg/cm²) of the applied dose. The substance induced gene mutations in bacteria and chromosomal aberrations in human cells in vitro. In vivo genotoxicity studies using complementary species and endpoints indicated that the in vitro mutagenic potential was not express","endpoint":"genotoxicity","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":19,"route":"oral","species":"rat","study_id":"out244_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out244_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 6-HYDROXYINDOLE COLIPA n° A128; OPINION_NUMBER=SCCNFP/0667/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=100; DOSE=Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.; EFFECT=d to be treatment-related. No treatment-related macroscopic changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Bat; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"2380-86-1","citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","duration":"Sub-chronic","effect":"d to be treatment-related. No treatment-related macroscopic changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Bat","endpoint":"repeated dose toxicity","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":7,"route":"dermal","species":"rat","study_id":"out244_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 30 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out244_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 6-HYDROXYINDOLE COLIPA n° A128; OPINION_NUMBER=SCCNFP/0667/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=30; DOSE=Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.; EFFECT=c changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Batch no : pil.10 (purity not stated) Dose : 0.5 g GLP :; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"2380-86-1","citation":"Ref. : 5 2","dose":"Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day.","duration":"Sub-chronic","effect":"c changes were noted at autopsy. Hepatocyte hypertrophy was reported in 4 of 10 females dosed at 300 mg/kg bw/day. Other occasional minor abnormalities observed in the histopathological examination were within the normal range of background alterations and were not treatment-related. The authors concluded that the effects seen in liver, and associated elevation of transaminases, in female rats treated at 300 mg/kg bw/day were treatment-related and that the NOAEL was 100 mg/kg bw/day. The SCCNFP concluded that the NOEL was 30 mg/kg bw/day, based upon the observation of dose-related elevation in blood cholesterol and inorganic phosphate. Ref. : 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : Imexine OBA, moistened with water Batch no : pil.10 (purity not stated) Dose : 0.5 g GLP :","endpoint":"repeated dose toxicity","ingredient":"6-Hydroxyindole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":7,"route":"dermal","species":"rat","study_id":"out244_en_noael_002"} |