NOAEL Studies Cosmetic Ingredient

4-Chlororesorcinol NOAEL Studies

INCI: 4-CHLORORESORCINOL

CAS: 95-88-5

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 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 100 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCS; Marburger, A., Flade D. (2005). Prenatal Developmental Toxicity Study in the HanWistar Rat. RCC Ltd, Itingen, Switzerland, internal study code: 854669. Archive codeat Henkel KGaA, Düsseldorf, Report No. R 0500030
COSMOS_DB NOAEL 50 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCS; Marburger, A., Flade D. (2005). Prenatal Developmental Toxicity Study in the HanWistar Rat. RCC Ltd, Itingen, Switzerland, internal study code: 854669. Archive codeat Henkel KGaA, Düsseldorf, Report No. R 0500030
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =369 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_11776; row=14565; data_type=In Vivo; mixture=Chemical; chemical_name=4-Chlororesorcinol; preferred_name=4-Chlororesorcinol; dtxsid=DTXSID8052643; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8052643; source_file=acute_oral.xlsx
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =210 mg/kg bw/d rat oral Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental.","effect":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two indepen","page":16,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"a (compensatory) enlarged left kidney was noted for one female. Mean foetal body weights and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"s and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"revision of 12.07.10 Opinion on 4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical prope","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_005"}
SCCS_vision_codex NOAEL =50 mg/kg/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_006"}
SCCS_vision_codex NOAEL =0.106 mg/kg rat oral - dermal absorption {"dose":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2)...","effect":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_008"}
SCCS_vision_codex NOAEL =210 mg/kg bw/d rat oral Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental.","effect":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two indepen","page":16,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"a (compensatory) enlarged left kidney was noted for one female. Mean foetal body weights and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"s and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"revision of 12.07.10 Opinion on 4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical prope","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_005"}
SCCS_vision_codex NOAEL =50 mg/kg/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_006"}
SCCS_vision_codex NOAEL =0.106 mg/kg rat oral - dermal absorption {"dose":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2)...","effect":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_008"}
SCCS_vision_codex NOAEL =210 mg/kg bw/d rat oral Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental.","effect":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two indepen","page":16,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"a (compensatory) enlarged left kidney was noted for one female. Mean foetal body weights and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"s and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"revision of 12.07.10 Opinion on 4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical prope","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_005"}
SCCS_vision_codex NOAEL =50 mg/kg/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_006"}
SCCS_vision_codex NOAEL =0.106 mg/kg rat oral - dermal absorption {"dose":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2)...","effect":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_008"}
SCCS_vision_codex NOAEL =210 mg/kg bw/d rat oral Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental.","effect":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two indepen","page":16,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"a (compensatory) enlarged left kidney was noted for one female. Mean foetal body weights and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","effect":"s and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"revision of 12.07.10 Opinion on 4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical prope","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_005"}
SCCS_vision_codex NOAEL =50 mg/kg/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_006"}
SCCS_vision_codex NOAEL =0.106 mg/kg rat oral - dermal absorption {"dose":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2)...","effect":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute","page":23,"pdf":"sccs_o_016.pdf","row_type":"noael_study","study_id":"sccs_o_016_noael_008"}
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =4.996 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15630696:-:--; 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_a0dd2ae7e83d12b71ed0bdf9235e3fcd
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 14 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/d human - - - SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=50; DOSE=Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.; EFFECT=a (compensatory) enlarged left kidney was noted for one female. Mean foetal body weights and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"95-88-5","citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","duration":"","effect":"a (compensatory) enlarged left kidney was noted for one female. Mean foetal body weights and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":22,"route":"","species":"human","study_id":"sccs_o_016_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/d human - - - SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=200; DOSE=Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.; EFFECT=s and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"95-88-5","citation":"Ref.: 14 3","dose":"Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity.","duration":"","effect":"s and foetal sex ratios were similar in all groups and gave no indication of a test item related effect. No abnormalities were noted during external examination of foetuses. During visceral examination of fixed foetuses no test item related abnormal findings were noted. Skeletal examination gave no indication for test item-related effects. Conclusion With respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. Ref.: 14 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":22,"route":"","species":"human","study_id":"sccs_o_016_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.08 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 0.080; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=revision of 12.07.10 Opinion on 4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical prope; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"","effect":"revision of 12.07.10 Opinion on 4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical prope","endpoint":"dermal absorption","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.080","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"","effect":"4-chlororesorcinol __________________________________________________________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties","endpoint":"dermal absorption","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 50","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=_________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formul; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"","effect":"_________________________________ 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-Chlororesorcinol (with H2O2) Absorption through the skin A (μg/cm2) = 8.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formul","endpoint":"dermal absorption","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 50","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.106 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 0.106; DOSE=atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2)...; EFFECT=atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2)...","duration":"","effect":"atment SAS x A x 0.001 = 4.82 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute","endpoint":"dermal absorption","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.106","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 50; DOSE=Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per t...; EFFECT=Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute media; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per t...","duration":"","effect":"Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute media","endpoint":"dermal absorption","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 50","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 50; DOSE=AS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 6...; EFFECT=AS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"AS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 6...","duration":"","effect":"AS x A x 0.001/60 = 0.080 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 625 (without H2O2) Absorption through the skin A (μg/cm2) = 10.99 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 6.37 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.106 mg/kg No observed adverse effect level NOAEL = 50 mg/kg/d (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 472 3.3.14. Discussion Physico-chemical properties 4-Chlororesorcinol is used as a coupler in oxidative hair dye formulations. It reacts with primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4","endpoint":"dermal absorption","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg/d","noael_value":"= 50","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 210 mg/kg bw/d rat oral Chronic genotoxicity SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=210; DOSE=-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental.; EFFECT=-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two indepen; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"95-88-5","citation":"Ref.: 12 3","dose":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental.","duration":"Chronic","effect":"-body weight and thymus- to-body weight in males at 210 mg/kg bw/d were associated with a minimally depressed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two indepen","endpoint":"genotoxicity","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"210","page":16,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 210 mg/kg bw/d rat oral Chronic genotoxicity SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=210; DOSE=Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day.; EFFECT=sed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two independent experiments, both in absence and presence of S9-mix Test substance: A12 / SAT 030386 Batch: 4 CRB 921; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"95-88-5","citation":"Ref.: 12 3","dose":"Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day.","duration":"Chronic","effect":"sed body weight and the findings were considered incidental. Macroscopic and microscopic examination of the deaths did not reveal an underlying cause. The histopathological investigations revealed no changes to the organ or tissue morphology, which could be related to the treatment with the test item. Conclusion Because of changes in the electrolyte parameters Na+, K+, Cl- (both sexes, all doses) and PO4 -, a NOEL could not be established. Due to mortality, clinical signs and haematotoxicity at 210 mg/kg bw/d the NOAEL in rats after daily oral treatment in rats is determined to be 70 mg/kg bw/day. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 Replicates: triplicate in two independent experiments, both in absence and presence of S9-mix Test substance: A12 / SAT 030386 Batch: 4 CRB 921","endpoint":"genotoxicity","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"210","page":16,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 210 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=210; DOSE=Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.; EFFECT=primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.","duration":"subchronic","effect":"primary intermediates to form the final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation","endpoint":"repeated dose toxicity","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"210","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 210 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=210; DOSE=Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.; EFFECT=final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.","duration":"subchronic","effect":"final dye-stuff. It is used at a maximum on head concentration of 2.5%. The solubility of 4-chlororesorcinol was not determined by the EC method A6. The stability of 4-chlororesorcinol in a typical hair dye formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation","endpoint":"repeated dose toxicity","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"210","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=50; DOSE=Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.; EFFECT=e formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.","duration":"subchronic","effect":"e formulation was not reported. Toxicity The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation","endpoint":"repeated dose toxicity","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_016; REPORT_TITLE=OPINION ON 4-Chlororesorcinol COLIPA n° A12; OPINION_NUMBER=SCCS/1224/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=200; DOSE=its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.; EFFECT=its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-88-5","citation":"","dose":"its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg.","duration":"subchronic","effect":"its 95% confidence limits to rats of 4- chlororesorcinol were calculated to 369 (314-433) mg/kg. In a subchronic toxicity study, due to clinical signs and haematotoxicity at 210 mg/kg bw/d, the No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment was determined to be 70 mg/kg bw/day. In the prenatal developmental toxicity study, with respect to the clinical signs noticed in the mid and high dose group, the NOAEL was considered to be 50 mg/kg bw/d for maternal toxicity. For foetotoxicity, the NOAEL was set at 200 mg/kg bw/d. No two generation study was submitted. Skin/eye irritation and sensitisation","endpoint":"repeated dose toxicity","ingredient":"to class B and asked for more data on","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":23,"route":"oral","species":"rat","study_id":"sccs_o_016_noael_014"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 87045U29QJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5ClO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"87045U29QJ"}
openFDA substances FDA UNII substance identifier 87045U29QJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5ClO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"87045U29QJ"}
openFDA substances FDA UNII substance identifier 87045U29QJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5ClO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"87045U29QJ"}
openFDA substances FDA UNII substance identifier 87045U29QJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5ClO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"87045U29QJ"}