NOAEL Studies Cosmetic Ingredient

HC Green No. 1 NOAEL Studies

CAS: 52136-25-1

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

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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":"Other findings were similar for control and treated animals.","effect":"d/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substance : IMEXINE IK at 0.5% in water/propyleneglycol, 50/50 Batch no : op.3 (purity not stated in study report) Dose : 0.5 ml GLP : not in compl","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_002"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"d/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substance : IMEXINE IK at 0.5% in water/propyleneglycol, 50/50 Batch no : op.3 (purity not stated in study report) Dose : 0.5 ml GLP : not in compl","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_002"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"d/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substance : IMEXINE IK at 0.5% in water/propyleneglycol, 50/50 Batch no : op.3 (purity not stated in study report) Dose : 0.5 ml GLP : not in compl","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_002"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"d/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substance : IMEXINE IK at 0.5% in water/propyleneglycol, 50/50 Batch no : op.3 (purity not stated in study report) Dose : 0.5 ml GLP : not in compl","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_002"}
SCCNFP_vision_codex NOAEL =100.7 % human dermal - dermal absorption {"dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","effect":"n on : HC Green n° 1 _____________________________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (","page":15,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_004"}
SCCNFP_vision_codex NOAEL =100.7 % human dermal - dermal absorption {"dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","effect":"n on : HC Green n° 1 _____________________________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (","page":15,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_004"}
SCCNFP_vision_codex NOAEL =100.7 % human dermal - dermal absorption {"dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","effect":"n on : HC Green n° 1 _____________________________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (","page":15,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_004"}
SCCNFP_vision_codex NOAEL =100.7 % human dermal - dermal absorption {"dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","effect":"n on : HC Green n° 1 _____________________________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (","page":15,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_004"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"ation and opinion on : HC Green n° 1 _____________________________________________________________________________________________ 7 oedema and/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substa","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_001"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"ation and opinion on : HC Green n° 1 _____________________________________________________________________________________________ 7 oedema and/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substa","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_001"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"ation and opinion on : HC Green n° 1 _____________________________________________________________________________________________ 7 oedema and/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substa","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_001"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","effect":"ation and opinion on : HC Green n° 1 _____________________________________________________________________________________________ 7 oedema and/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substa","page":7,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_001"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw/day rat - - dermal absorption {"citation":"Ref. : 11 2","dose":"There were no dose-related increases in foetal abnormalities or malformations.","effect":"nce occurrence. There were no dose-related increases in foetal abnormalities or malformations. Some individual significant differences were observed for abnormalities of a very low incidence, which were considered to be spontaneous. In the high dose group, the only abnormal observation was of 2/166 foetuses with fused ribs. In absence of other abnormalities, and because the two foetuses were from the same litter, this was not considered to have toxicological significance. The highest dose, 1000 mg/kg bw/day, was a NOAEL for the pregnant female rat and for the foetus. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Guideline : / Tissue : Human mammary epidermis, heat-separated","page":9,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_003"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw/day rat - - dermal absorption {"citation":"Ref. : 11 2","dose":"There were no dose-related increases in foetal abnormalities or malformations.","effect":"nce occurrence. There were no dose-related increases in foetal abnormalities or malformations. Some individual significant differences were observed for abnormalities of a very low incidence, which were considered to be spontaneous. In the high dose group, the only abnormal observation was of 2/166 foetuses with fused ribs. In absence of other abnormalities, and because the two foetuses were from the same litter, this was not considered to have toxicological significance. The highest dose, 1000 mg/kg bw/day, was a NOAEL for the pregnant female rat and for the foetus. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Guideline : / Tissue : Human mammary epidermis, heat-separated","page":9,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_003"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw/day rat - - dermal absorption {"citation":"Ref. : 11 2","dose":"There were no dose-related increases in foetal abnormalities or malformations.","effect":"nce occurrence. There were no dose-related increases in foetal abnormalities or malformations. Some individual significant differences were observed for abnormalities of a very low incidence, which were considered to be spontaneous. In the high dose group, the only abnormal observation was of 2/166 foetuses with fused ribs. In absence of other abnormalities, and because the two foetuses were from the same litter, this was not considered to have toxicological significance. The highest dose, 1000 mg/kg bw/day, was a NOAEL for the pregnant female rat and for the foetus. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Guideline : / Tissue : Human mammary epidermis, heat-separated","page":9,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_003"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw/day rat - - dermal absorption {"citation":"Ref. : 11 2","dose":"There were no dose-related increases in foetal abnormalities or malformations.","effect":"nce occurrence. There were no dose-related increases in foetal abnormalities or malformations. Some individual significant differences were observed for abnormalities of a very low incidence, which were considered to be spontaneous. In the high dose group, the only abnormal observation was of 2/166 foetuses with fused ribs. In absence of other abnormalities, and because the two foetuses were from the same litter, this was not considered to have toxicological significance. The highest dose, 1000 mg/kg bw/day, was a NOAEL for the pregnant female rat and for the foetus. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Guideline : / Tissue : Human mammary epidermis, heat-separated","page":9,"pdf":"out_196.pdf","row_type":"noael_study","study_id":"out_196_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 100.7 % human dermal - dermal absorption SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=100.7; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...; EFFECT=n on : HC Green n° 1 _____________________________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52136-25-1","citation":"","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","duration":"","effect":"n on : HC Green n° 1 _____________________________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (","endpoint":"dermal absorption","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"%","noael_value":"100.7","page":15,"route":"dermal","species":"human","study_id":"out_196_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 100.7 % human dermal - dermal absorption SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=100.7; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...; EFFECT=_________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (reagents and i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52136-25-1","citation":"","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","duration":"","effect":"_________________________________________________________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (reagents and i","endpoint":"dermal absorption","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"%","noael_value":"100.7","page":15,"route":"dermal","species":"human","study_id":"out_196_noael_005"}
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 100.7 % human dermal - dermal absorption SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=100.7; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...; EFFECT=_________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (reagents and intermediates), of which impurities C and E (cf.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52136-25-1","citation":"","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemi...","duration":"","effect":"_________________________ 15 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY HC Green n° 1 (Semi-permanent) Based on a usage volume of 35 ml, containing at maximum … % Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Three batches of C129, i.e op.3, op.5 and op.7 have been used for various studies. The purity reported for op.7 is 100.7 % and 97.9%; op.5 has been reported to be 94.9% and 98.3% pure, while no purity for op.3 has been reported. The purity description reflects quality control problems in the analytical laboratory. The purity of C129 has been determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (reagents and intermediates), of which impurities C and E (cf.","endpoint":"dermal absorption","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"%","noael_value":"100.7","page":15,"route":"dermal","species":"human","study_id":"out_196_noael_006"}
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 1000 mg/kg bw/day rat - - dermal absorption SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=1000; DOSE=There were no dose-related increases in foetal abnormalities or malformations.; EFFECT=nce occurrence. There were no dose-related increases in foetal abnormalities or malformations. Some individual significant differences were observed for abnormalities of a very low incidence, which were considered to be spontaneous. In the high dose group, the only abnormal observation was of 2/166 foetuses with fused ribs. In absence of other abnormalities, and because the two foetuses were from the same litter, this was not considered to have toxicological significance. The highest dose, 1000 mg/kg bw/day, was a NOAEL for the pregnant female rat and for the foetus. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Guideline : / Tissue : Human mammary epidermis, heat-separated; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"52136-25-1","citation":"Ref. : 11 2","dose":"There were no dose-related increases in foetal abnormalities or malformations.","duration":"","effect":"nce occurrence. There were no dose-related increases in foetal abnormalities or malformations. Some individual significant differences were observed for abnormalities of a very low incidence, which were considered to be spontaneous. In the high dose group, the only abnormal observation was of 2/166 foetuses with fused ribs. In absence of other abnormalities, and because the two foetuses were from the same litter, this was not considered to have toxicological significance. The highest dose, 1000 mg/kg bw/day, was a NOAEL for the pregnant female rat and for the foetus. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Guideline : / Tissue : Human mammary epidermis, heat-separated","endpoint":"dermal absorption","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":9,"route":"","species":"rat","study_id":"out_196_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies irritation 100 mg/kg bw/day rat oral 13-week irritation SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=100; DOSE=The structure of these compounds should be established, they should be quantified, and the major toxic properties of these compounds should be elucidated A 13-week oral study in rats provided evidence of toxicity in both sexes at 1000 mg/kg bw/day, and minimal signs in females only at 300 mg/kg bw/day.; EFFECT=determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (reagents and intermediates), of which impurities C and E (cf. 2.1.9) appear to be in the range 1-2% and 10-20% respectively. The structure of these compounds should be established, they should be quantified, and the major toxic properties of these compounds should be elucidated A 13-week oral study in rats provided evidence of toxicity in both sexes at 1000 mg/kg bw/day, and minimal signs in females only at 300 mg/kg bw/day. The NOEL was 100 mg/kg bw/day. It was not irritant to the rabbit skin or eye but should be regarded as a potential sensitiser. Percutaneous penetration of 0.045% is indicated from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. C 129 has been tested in procaryotic cells for gene mutation in two experiments that gave positive results. The in vitro test for mammalian gene mutation assay is accepted as being positive.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52136-25-1","citation":"","dose":"The structure of these compounds should be established, they should be quantified, and the major toxic properties of these compounds should be elucidated A 13-week oral study in rats provided evidence of toxicity in both sexes at 1000 mg/kg bw/day, and minimal signs in females only at 300 mg/kg bw/day.","duration":"13-week","effect":"determined by alkalinity. HPLC analysis of C129 revealed the presence of 5 impurities (reagents and intermediates), of which impurities C and E (cf. 2.1.9) appear to be in the range 1-2% and 10-20% respectively. The structure of these compounds should be established, they should be quantified, and the major toxic properties of these compounds should be elucidated A 13-week oral study in rats provided evidence of toxicity in both sexes at 1000 mg/kg bw/day, and minimal signs in females only at 300 mg/kg bw/day. The NOEL was 100 mg/kg bw/day. It was not irritant to the rabbit skin or eye but should be regarded as a potential sensitiser. Percutaneous penetration of 0.045% is indicated from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. C 129 has been tested in procaryotic cells for gene mutation in two experiments that gave positive results. The in vitro test for mammalian gene mutation assay is accepted as being positive.","endpoint":"irritation","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":15,"route":"oral","species":"rat","study_id":"out_196_noael_007"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 100 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=100; DOSE=Other findings were similar for control and treated animals.; EFFECT=d/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substance : IMEXINE IK at 0.5% in water/propyleneglycol, 50/50 Batch no : op.3 (purity not stated in study report) Dose : 0.5 ml GLP : not in compl; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"52136-25-1","citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","duration":"Sub-chronic","effect":"d/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substance : IMEXINE IK at 0.5% in water/propyleneglycol, 50/50 Batch no : op.3 (purity not stated in study report) Dose : 0.5 ml GLP : not in compl","endpoint":"repeated dose toxicity","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":7,"route":"dermal","species":"rat","study_id":"out_196_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 300 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out_196; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC GREEN Nº 1 COLIPA n° C129; OPINION_NUMBER=SCCNFP/0665/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=300; DOSE=Other findings were similar for control and treated animals.; EFFECT=ation and opinion on : HC Green n° 1 _____________________________________________________________________________________________ 7 oedema and/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substa; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"52136-25-1","citation":"Ref. : 5 2","dose":"Other findings were similar for control and treated animals.","duration":"Sub-chronic","effect":"ation and opinion on : HC Green n° 1 _____________________________________________________________________________________________ 7 oedema and/or inflammatory cell aggregation. The study authors considered these observations to be consistent with spontaneous occurrence and not of toxicological importance. Other findings were similar for control and treated animals. Based upon the decreased food consumption and weight gain in females, hypokalemia in both sexes, and oliguria in males, the authors concluded that the NOAEL was 300 mg/kg bw/day. The dose-related hypokalemia was statistically significant in female rats treated at 300 and 1000 mg/kg bw/day. A NOEL of 100 mg/kg bw/day should therefore be assumed. 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 : Journal Officiel de la République Française of 21/2/82 Species/strain : New Zealand albino rabbit Group size : 6 males Test substa","endpoint":"repeated dose toxicity","ingredient":"2-(\u0001-Hydroxyethylamino)-5-(4’-bis(\u0001-hydroxyethyl)amino)-anilino-1,4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":7,"route":"dermal","species":"rat","study_id":"out_196_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 578544UDFJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C18H23N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"578544UDFJ"}
openFDA substances FDA UNII substance identifier 578544UDFJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C18H23N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"578544UDFJ"}
openFDA substances FDA UNII substance identifier 578544UDFJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C18H23N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"578544UDFJ"}
openFDA substances FDA UNII substance identifier 578544UDFJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C18H23N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"578544UDFJ"}