NOAEL Studies Cosmetic Ingredient

Hydroxyanthraquinoneaminopropyl Methyl Morpholinium Methosulfate NOAEL Studies

INCI: HYDROXYANTHRAQUINONEAMINOPROPYL METHYL MORPHOLINIUM METHOSULFATE

CAS: 38866-20-5

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 200 mg/kg bw/day rat oral 90 day Subchronic SCCP; C. Fabreguettes. 13-Week Toxicity Studyby Oral Route in Rats. CIT Study No. 12417TCR (95/2/002), November 6, 1995
COSMOS_DB NOAEL 50 mg/kg bw/day rat oral 90 day Subchronic SCCP; C. Fabreguettes. 13-Week Toxicity Studyby Oral Route in Rats. CIT Study No. 12417TCR (95/2/002), November 6, 1995
SCCS_vision_codex 32 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 3","dose":"The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d.","effect":"onsidered treatment-related. The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related decrease in the number of monocytes of females was found at 800 mg/kg bw/d while biochemistry and urinalysis values were not changed. The microscopic pathology findings revealed no substance-related effects. The NOAEL is 200 mg/kg bw/d. Ref.: 9 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline : OECD 472 Species/strain : S. typhimurium, TA98, TA100, TA1535, TA1537 ; E. coli, WP2uvrA Replicates : Two independent tests Test substance : IMEXINE BD in distilled water Batch No. : op. T54 (purity: 87.5%) Concentrations : 312.5 - 5000 µg/plate without metabolic activation 62.5 - 2000 µg/plate with metabolic activatio","page":14,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 3","dose":"Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed.","effect":"examination. Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain were noted. The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio was similar to controls. No external foetal anomalies were observed. No substance-related soft tissue anomalies were found. No treatment-related changes in the frequency of variations and abnormalities were registered. The NOEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 mg/kg bw/d. Ref.: 16 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data /","page":18,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"05 Opinion on Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_003"}
SCCS_vision_codex NOAEL =87.5 % rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"olinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"treatment-related. The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 T","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 Test substance: IMEXINE BD 46 Batch: op. T54 47 Purity: 87.5% 48 Solvent: distilled water 49 Con","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_002"}
SCCS_vision_codex NOAEL =26 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 28 29 3","dose":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed.","effect":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain 20 were noted. 21 The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio 22 was similar to controls. No external foetal anomalies were observed. No substance-related 23 soft tissue anomalies were found. No treatment-related changes in the frequency of 24 variations and abnormalities were registered. 25 The NOAEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 26 mg/kg bw/d. 27 Ref.: 16 28 29 3.3.9. Toxicokinetics 30 31 No data submitted 32 33 3.3.10. Photo-induced toxicity 34 35 3.3.10.1. Phototoxicity / photoirritation and photosensitisation 36 37 No data submitted 38 39 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 40 41 No data submitted 42 43 3.3.11. Human data 44 45 No data submitted 46 47 3.3.12. Special investigations 48 49 No data submitted 50 51","page":27,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_003"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw/d rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...","effect":"_________________________________________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyan","page":28,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 3","dose":"The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d.","effect":"onsidered treatment-related. The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related decrease in the number of monocytes of females was found at 800 mg/kg bw/d while biochemistry and urinalysis values were not changed. The microscopic pathology findings revealed no substance-related effects. The NOAEL is 200 mg/kg bw/d. Ref.: 9 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline : OECD 472 Species/strain : S. typhimurium, TA98, TA100, TA1535, TA1537 ; E. coli, WP2uvrA Replicates : Two independent tests Test substance : IMEXINE BD in distilled water Batch No. : op. T54 (purity: 87.5%) Concentrations : 312.5 - 5000 µg/plate without metabolic activation 62.5 - 2000 µg/plate with metabolic activatio","page":14,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 3","dose":"Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed.","effect":"examination. Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain were noted. The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio was similar to controls. No external foetal anomalies were observed. No substance-related soft tissue anomalies were found. No treatment-related changes in the frequency of variations and abnormalities were registered. The NOEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 mg/kg bw/d. Ref.: 16 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data /","page":18,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"05 Opinion on Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_003"}
SCCS_vision_codex NOAEL =87.5 % rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"olinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 3","dose":"The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d.","effect":"onsidered treatment-related. The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related decrease in the number of monocytes of females was found at 800 mg/kg bw/d while biochemistry and urinalysis values were not changed. The microscopic pathology findings revealed no substance-related effects. The NOAEL is 200 mg/kg bw/d. Ref.: 9 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline : OECD 472 Species/strain : S. typhimurium, TA98, TA100, TA1535, TA1537 ; E. coli, WP2uvrA Replicates : Two independent tests Test substance : IMEXINE BD in distilled water Batch No. : op. T54 (purity: 87.5%) Concentrations : 312.5 - 5000 µg/plate without metabolic activation 62.5 - 2000 µg/plate with metabolic activatio","page":14,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 3","dose":"Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed.","effect":"examination. Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain were noted. The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio was similar to controls. No external foetal anomalies were observed. No substance-related soft tissue anomalies were found. No treatment-related changes in the frequency of variations and abnormalities were registered. The NOEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 mg/kg bw/d. Ref.: 16 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data /","page":18,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"05 Opinion on Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_003"}
SCCS_vision_codex NOAEL =87.5 % rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"olinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"treatment-related. The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 T","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 Test substance: IMEXINE BD 46 Batch: op. T54 47 Purity: 87.5% 48 Solvent: distilled water 49 Con","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_002"}
SCCS_vision_codex NOAEL =26 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 28 29 3","dose":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed.","effect":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain 20 were noted. 21 The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio 22 was similar to controls. No external foetal anomalies were observed. No substance-related 23 soft tissue anomalies were found. No treatment-related changes in the frequency of 24 variations and abnormalities were registered. 25 The NOAEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 26 mg/kg bw/d. 27 Ref.: 16 28 29 3.3.9. Toxicokinetics 30 31 No data submitted 32 33 3.3.10. Photo-induced toxicity 34 35 3.3.10.1. Phototoxicity / photoirritation and photosensitisation 36 37 No data submitted 38 39 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 40 41 No data submitted 42 43 3.3.11. Human data 44 45 No data submitted 46 47 3.3.12. Special investigations 48 49 No data submitted 50 51","page":27,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_003"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw/d rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...","effect":"_________________________________________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyan","page":28,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"treatment-related. The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 T","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 Test substance: IMEXINE BD 46 Batch: op. T54 47 Purity: 87.5% 48 Solvent: distilled water 49 Con","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_002"}
SCCS_vision_codex NOAEL =26 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 28 29 3","dose":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed.","effect":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain 20 were noted. 21 The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio 22 was similar to controls. No external foetal anomalies were observed. No substance-related 23 soft tissue anomalies were found. No treatment-related changes in the frequency of 24 variations and abnormalities were registered. 25 The NOAEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 26 mg/kg bw/d. 27 Ref.: 16 28 29 3.3.9. Toxicokinetics 30 31 No data submitted 32 33 3.3.10. Photo-induced toxicity 34 35 3.3.10.1. Phototoxicity / photoirritation and photosensitisation 36 37 No data submitted 38 39 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 40 41 No data submitted 42 43 3.3.11. Human data 44 45 No data submitted 46 47 3.3.12. Special investigations 48 49 No data submitted 50 51","page":27,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_003"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw/d rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...","effect":"_________________________________________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyan","page":28,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 3","dose":"The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d.","effect":"onsidered treatment-related. The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related decrease in the number of monocytes of females was found at 800 mg/kg bw/d while biochemistry and urinalysis values were not changed. The microscopic pathology findings revealed no substance-related effects. The NOAEL is 200 mg/kg bw/d. Ref.: 9 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline : OECD 472 Species/strain : S. typhimurium, TA98, TA100, TA1535, TA1537 ; E. coli, WP2uvrA Replicates : Two independent tests Test substance : IMEXINE BD in distilled water Batch No. : op. T54 (purity: 87.5%) Concentrations : 312.5 - 5000 µg/plate without metabolic activation 62.5 - 2000 µg/plate with metabolic activatio","page":14,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 3","dose":"Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed.","effect":"examination. Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain were noted. The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio was similar to controls. No external foetal anomalies were observed. No substance-related soft tissue anomalies were found. No treatment-related changes in the frequency of variations and abnormalities were registered. The NOEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 mg/kg bw/d. Ref.: 16 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data /","page":18,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"05 Opinion on Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_003"}
SCCS_vision_codex NOAEL =87.5 % rat oral 13 week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","effect":"olinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175","page":19,"pdf":"sccp_o_008.pdf","row_type":"noael_study","study_id":"sccp_o_008_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"treatment-related. The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 T","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - Chronic genotoxicity {"citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","effect":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 Test substance: IMEXINE BD 46 Batch: op. T54 47 Purity: 87.5% 48 Solvent: distilled water 49 Con","page":17,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_002"}
SCCS_vision_codex NOAEL =26 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 16 28 29 3","dose":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed.","effect":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain 20 were noted. 21 The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio 22 was similar to controls. No external foetal anomalies were observed. No substance-related 23 soft tissue anomalies were found. No treatment-related changes in the frequency of 24 variations and abnormalities were registered. 25 The NOAEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 26 mg/kg bw/d. 27 Ref.: 16 28 29 3.3.9. Toxicokinetics 30 31 No data submitted 32 33 3.3.10. Photo-induced toxicity 34 35 3.3.10.1. Phototoxicity / photoirritation and photosensitisation 36 37 No data submitted 38 39 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 40 41 No data submitted 42 43 3.3.11. Human data 44 45 No data submitted 46 47 3.3.12. Special investigations 48 49 No data submitted 50 51","page":27,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_003"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw/d rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...","effect":"_________________________________________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyan","page":28,"pdf":"sccs_o_135.pdf","row_type":"noael_study","study_id":"sccs_o_135_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 800 mg/kg bw/d human - - - SOURCE_SUBDIR=sccp_o_008; REPORT_TITLE=Opinion on Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate COLIPA n° C117; OPINION_NUMBER=SCCP/0875/05; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=800; DOSE=Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed.; EFFECT=examination. Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain were noted. The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio was similar to controls. No external foetal anomalies were observed. No substance-related soft tissue anomalies were found. No treatment-related changes in the frequency of variations and abnormalities were registered. The NOEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 mg/kg bw/d. Ref.: 16 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data /; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"38866-20-5","citation":"Ref.: 16 3","dose":"Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed.","duration":"","effect":"examination. Results No mortality and no clinical signs with the exception of ptyalism and some discolouration at 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain were noted. The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio was similar to controls. No external foetal anomalies were observed. No substance-related soft tissue anomalies were found. No treatment-related changes in the frequency of variations and abnormalities were registered. The NOEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 mg/kg bw/d. Ref.: 16 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data /","endpoint":"","ingredient":"Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"800","page":18,"route":"","species":"human","study_id":"sccp_o_008_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 26 mg/kg bw/d human - - - SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=26; DOSE=No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed.; EFFECT=No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain 20 were noted. 21 The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio 22 was similar to controls. No external foetal anomalies were observed. No substance-related 23 soft tissue anomalies were found. No treatment-related changes in the frequency of 24 variations and abnormalities were registered. 25 The NOAEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 26 mg/kg bw/d. 27 Ref.: 16 28 29 3.3.9. Toxicokinetics 30 31 No data submitted 32 33 3.3.10. Photo-induced toxicity 34 35 3.3.10.1. Phototoxicity / photoirritation and photosensitisation 36 37 No data submitted 38 39 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 40 41 No data submitted 42 43 3.3.11. Human data 44 45 No data submitted 46 47 3.3.12. Special investigations 48 49 No data submitted 50 51; CITATION=Ref.: 16 28 29 3; CITATION_NUMBERS=[16,28,29,3]; REFERENCE=Ref.: 16 28 29 3; DETAILS_JSON={"cas_number":"38866-20-5","citation":"Ref.: 16 28 29 3","dose":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed.","duration":"","effect":"No mortality and no clinical signs with the exception of ptyalism and some discolouration at 19 800 mg/kg bw/d were observed. No changes in food consumption and body weight gain 20 were noted. 21 The resorption rate, mean number of foetuses, mean foetal body weight and the sex ratio 22 was similar to controls. No external foetal anomalies were observed. No substance-related 23 soft tissue anomalies were found. No treatment-related changes in the frequency of 24 variations and abnormalities were registered. 25 The NOAEL for maternal and foetotoxicity as well as teratogenicity was found to be 800 26 mg/kg bw/d. 27 Ref.: 16 28 29 3.3.9. Toxicokinetics 30 31 No data submitted 32 33 3.3.10. Photo-induced toxicity 34 35 3.3.10.1. Phototoxicity / photoirritation and photosensitisation 36 37 No data submitted 38 39 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 40 41 No data submitted 42 43 3.3.11. Human data 44 45 No data submitted 46 47 3.3.12. Special investigations 48 49 No data submitted 50 51","endpoint":"","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"26","page":27,"route":"","species":"human","study_id":"sccs_o_135_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =200 mg/kg rat oral 13 week dermal absorption SOURCE_SUBDIR=sccp_o_008; REPORT_TITLE=Opinion on Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate COLIPA n° C117; OPINION_NUMBER=SCCP/0875/05; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT== 200; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...; EFFECT=05 Opinion on Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","duration":"13 week","effect":"05 Opinion on Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes","endpoint":"dermal absorption","ingredient":"Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 200","page":19,"route":"oral","species":"rat","study_id":"sccp_o_008_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 87.5 % rat oral 13 week dermal absorption SOURCE_SUBDIR=sccp_o_008; REPORT_TITLE=Opinion on Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate COLIPA n° C117; OPINION_NUMBER=SCCP/0875/05; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=87.5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...; EFFECT=olinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg N...","duration":"13 week","effect":"olinium methosulfate 19 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.89 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.623 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.010 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, 13 week, oral) Margin of Safety NOAEL / SED = 20000 3.3.14. Discussion Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175","endpoint":"dermal absorption","ingredient":"Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate (INCI name)","loael_value":"","noael_unit":"%","noael_value":"87.5","page":19,"route":"oral","species":"rat","study_id":"sccp_o_008_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.015 mg/kg bw/d rat oral 13-week dermal absorption SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 0.015; DOSE=Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...; EFFECT=_________________________________________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyan; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...","duration":"13-week","effect":"_________________________________________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyan","endpoint":"dermal absorption","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.015","page":28,"route":"oral","species":"rat","study_id":"sccs_o_135_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw/d rat oral 13-week dermal absorption SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...; EFFECT=________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyanthraqu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human =...","duration":"13-week","effect":"________________________________________________ 28 3.3.13. Safety evaluation (including calculation of the MoS) 1 2 CALCULATION OF THE MARGIN OF SAFETY 3 4 hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate 5 6 7 8 Absorption through the skin A = 1.51 µg/cm² 9 Skin Area surface SAS = 580 cm2 10 Dermal absorption per treatment SAS x A x 0.001 = 0.0.876 mg 11 Typical body weight of human = 60 kg 12 Systemic exposure dose SAS x A x 0.001/60 = 0.015 mg/kg bw/d 13 No Observed Adverse Effect Level NOAEL = 50 mg/kg bw/d 14 (13-week, oral route, rat) 15 Bioavailability 50% = 100 16 17 MOS = 1667 18 19 3.3.14. Discussion 20 21 Physico-Chemical Properties 22 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is used in direct hair 23 dye formulations at a maximum concentration of 0.5%. 24 Purity: 87.5%. Impurities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- 25 anthracene-9,10 dione, three other impurities with proposed tentative structures water and 26 residual solvents.Hydroxyanthraqu","endpoint":"dermal absorption","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":28,"route":"oral","species":"rat","study_id":"sccs_o_135_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 200 mg/kg bw/d - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_008; REPORT_TITLE=Opinion on Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate COLIPA n° C117; OPINION_NUMBER=SCCP/0875/05; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=200; DOSE=The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d.; EFFECT=onsidered treatment-related. The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related decrease in the number of monocytes of females was found at 800 mg/kg bw/d while biochemistry and urinalysis values were not changed. The microscopic pathology findings revealed no substance-related effects. The NOAEL is 200 mg/kg bw/d. Ref.: 9 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline : OECD 472 Species/strain : S. typhimurium, TA98, TA100, TA1535, TA1537 ; E. coli, WP2uvrA Replicates : Two independent tests Test substance : IMEXINE BD in distilled water Batch No. : op. T54 (purity: 87.5%) Concentrations : 312.5 - 5000 µg/plate without metabolic activation 62.5 - 2000 µg/plate with metabolic activatio; CITATION=Ref.: 9 3; CITATION_NUMBERS=[9,3]; REFERENCE=Ref.: 9 3; DETAILS_JSON={"cas_number":"38866-20-5","citation":"Ref.: 9 3","dose":"The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d.","duration":"Chronic","effect":"onsidered treatment-related. The body weight of the males in the 200 and 800 mg/kg bw/d groups was slightly decreased (weight change compared with controls -15 %) as well as the thymus weight of females (absolute and relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related decrease in the number of monocytes of females was found at 800 mg/kg bw/d while biochemistry and urinalysis values were not changed. The microscopic pathology findings revealed no substance-related effects. The NOAEL is 200 mg/kg bw/d. Ref.: 9 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline : OECD 472 Species/strain : S. typhimurium, TA98, TA100, TA1535, TA1537 ; E. coli, WP2uvrA Replicates : Two independent tests Test substance : IMEXINE BD in distilled water Batch No. : op. T54 (purity: 87.5%) Concentrations : 312.5 - 5000 µg/plate without metabolic activation 62.5 - 2000 µg/plate with metabolic activatio","endpoint":"genotoxicity","ingredient":"Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":14,"route":"","species":"","study_id":"sccp_o_008_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 200 mg/kg bw/d - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=200; DOSE=The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.; EFFECT=treatment-related. The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 T; CITATION=Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose; CITATION_NUMBERS=[9,28,29,50]; REFERENCE=Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose; DETAILS_JSON={"cas_number":"38866-20-5","citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","duration":"Chronic","effect":"treatment-related. The body weight 20 of the males in the 200 and 800 mg/kg bw/d groups was decreased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 T","endpoint":"genotoxicity","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":17,"route":"","species":"","study_id":"sccs_o_135_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 50 mg/kg bw/d - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=50; DOSE=reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.; EFFECT=reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 Test substance: IMEXINE BD 46 Batch: op. T54 47 Purity: 87.5% 48 Solvent: distilled water 49 Con; CITATION=Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose; CITATION_NUMBERS=[9,28,29,50]; REFERENCE=Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose; DETAILS_JSON={"cas_number":"38866-20-5","citation":"Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose","dose":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d.","duration":"Chronic","effect":"reased (weight change 21 compared with controls -15 %) as well as the thymus weight of females (absolute and 22 relative) and males (absolute) at 800 mg/kg bw/d. A statistically significant dose-related 23 decrease in the number of monocytes of males was found at 800 mg/kg bw/d while 24 biochemistry and urinalysis values were not changed. The microscopic pathology findings 25 revealed no substance-related effects. 26 The NOAEL is 200 mg/kg bw/d. 27 Ref.: 9 28 SCCS comment 29 The SCCS considers 50 mg/kg bw/d as the NOAEL due to bw reduction in the middle dose. 30 31 3.3.5.3. Chronic (> 12 months) toxicity 32 33 No data submitted 34 35 3.3.6. Mutagenicity / Genotoxicity 36 37 3.3.6.1 Mutagenicity / Genotoxicity in vitro 38 39 Bacterial gene mutation assay 40 41 Guideline: OECD 471 (1994) 42 Species/strain: S. typhimurium, TA98, TA100, TA102, TA1535, TA1537; E. coli, 43 WP2uvrA 44 Replicates: Triplicates in two independent tests 45 Test substance: IMEXINE BD 46 Batch: op. T54 47 Purity: 87.5% 48 Solvent: distilled water 49 Con","endpoint":"genotoxicity","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":17,"route":"","species":"","study_id":"sccs_o_135_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/d rat oral 13 week repeated dose toxicity SOURCE_SUBDIR=sccp_o_008; REPORT_TITLE=Opinion on Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate COLIPA n° C117; OPINION_NUMBER=SCCP/0875/05; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=200; DOSE=The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye;; EFFECT=purities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye; 95% confidence limit). The NOAEL was 200 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOEL for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. Because of staining of the skin, evaluation of irritant potential has not been possible. However, it was not irritant to the rabbit eye. Several studies have shown it to be a contact allergen. Percutaneous absorption of Imexidine BD, present in a hair dye formulation, has been determined to be 0.89 ± 0.31 µg/cm² in human dermatomed abdominal skin. IMEXIN; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye;","duration":"13 week","effect":"purities include 1.2% 1-Hydroxy-4-(3-morpholin-4-yl-propylamino)- anthracene-9,10 dione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye; 95% confidence limit). The NOAEL was 200 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOEL for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. Because of staining of the skin, evaluation of irritant potential has not been possible. However, it was not irritant to the rabbit eye. Several studies have shown it to be a contact allergen. Percutaneous absorption of Imexidine BD, present in a hair dye formulation, has been determined to be 0.89 ± 0.31 µg/cm² in human dermatomed abdominal skin. IMEXIN","endpoint":"repeated dose toxicity","ingredient":"Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":19,"route":"oral","species":"rat","study_id":"sccp_o_008_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/d rat oral 13 week repeated dose toxicity SOURCE_SUBDIR=sccp_o_008; REPORT_TITLE=Opinion on Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate COLIPA n° C117; OPINION_NUMBER=SCCP/0875/05; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=200; DOSE=The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye;; EFFECT=ione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye; 95% confidence limit). The NOAEL was 200 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOEL for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. Because of staining of the skin, evaluation of irritant potential has not been possible. However, it was not irritant to the rabbit eye. Several studies have shown it to be a contact allergen. Percutaneous absorption of Imexidine BD, present in a hair dye formulation, has been determined to be 0.89 ± 0.31 µg/cm² in human dermatomed abdominal skin. IMEXINE BD is mutagenic in vitro. It induced gene mutation in bacteria and in cultured m; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye;","duration":"13 week","effect":"ione, two other hydroxylated impurities at 7% and 2.6%, water and residual solvents. Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The acute oral LD50 for Imexine BD (87.5% pure) in both sexes of rats was estimated to be between 200 and 2000 mg/kg (175 and 1750 mg/kg active dye; 95% confidence limit). The NOAEL was 200 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOEL for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. Because of staining of the skin, evaluation of irritant potential has not been possible. However, it was not irritant to the rabbit eye. Several studies have shown it to be a contact allergen. Percutaneous absorption of Imexidine BD, present in a hair dye formulation, has been determined to be 0.89 ± 0.31 µg/cm² in human dermatomed abdominal skin. IMEXINE BD is mutagenic in vitro. It induced gene mutation in bacteria and in cultured m","endpoint":"repeated dose toxicity","ingredient":"Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":19,"route":"oral","species":"rat","study_id":"sccp_o_008_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral 13 week repeated dose toxicity SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=50; DOSE=39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg.; EFFECT=f Log Pow, usually without any reference to the respective pH, cannot be correlated 36 to physiological conditions and to the pH conditions of the percutaneous absorption studies. 37 Stability of Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate in typical 38 hair dye formulations has not been reported. 39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg. The 43 NOAEL was 50 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOAEL 44 for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. 45 46 Irritation/Sensitisation 47 Because of staining of the skin, evaluation of irritant potential has not been possible. 48 However, it was not an irritant to the rabbit eye. 49 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is a strong contact 50 allergen. 51 52 Percutaneous absorption 53 Percutaneous absorption of Hydroxyanthraqui; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg.","duration":"13 week","effect":"f Log Pow, usually without any reference to the respective pH, cannot be correlated 36 to physiological conditions and to the pH conditions of the percutaneous absorption studies. 37 Stability of Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate in typical 38 hair dye formulations has not been reported. 39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg. The 43 NOAEL was 50 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOAEL 44 for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. 45 46 Irritation/Sensitisation 47 Because of staining of the skin, evaluation of irritant potential has not been possible. 48 However, it was not an irritant to the rabbit eye. 49 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is a strong contact 50 allergen. 51 52 Percutaneous absorption 53 Percutaneous absorption of Hydroxyanthraqui","endpoint":"repeated dose toxicity","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":28,"route":"oral","species":"rat","study_id":"sccs_o_135_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral 13 week repeated dose toxicity SOURCE_SUBDIR=sccs_o_135; REPORT_TITLE=OPINION ON Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate COLIPA n° C117; OPINION_NUMBER=SCCS/1505/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=50; DOSE=39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg.; EFFECT=d 36 to physiological conditions and to the pH conditions of the percutaneous absorption studies. 37 Stability of Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate in typical 38 hair dye formulations has not been reported. 39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg. The 43 NOAEL was 50 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOAEL 44 for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. 45 46 Irritation/Sensitisation 47 Because of staining of the skin, evaluation of irritant potential has not been possible. 48 However, it was not an irritant to the rabbit eye. 49 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is a strong contact 50 allergen. 51 52 Percutaneous absorption 53 Percutaneous absorption of Hydroxyanthraquinone aminopropyl methyl morpholinium 54 methosulfate, present in a hair dye formul; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"38866-20-5","citation":"","dose":"39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg.","duration":"13 week","effect":"d 36 to physiological conditions and to the pH conditions of the percutaneous absorption studies. 37 Stability of Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate in typical 38 hair dye formulations has not been reported. 39 40 General Toxicity 41 The acute oral toxicity of Hydroxyanthraquinone aminopropyl methyl morpholinium 42 methosulfate (87.5% pure) in both sexes of rats was estimated to be < 2000 mg/kg. The 43 NOAEL was 50 mg/kg bw/d in a 13 week sub-chronic oral toxicity study in rats. The NOAEL 44 for maternal, foetal toxicity and teratogenicity in rats was 800 mg/kg bw/d. 45 46 Irritation/Sensitisation 47 Because of staining of the skin, evaluation of irritant potential has not been possible. 48 However, it was not an irritant to the rabbit eye. 49 Hydroxyanthraquinone aminopropyl methyl morpholinium methosulfate is a strong contact 50 allergen. 51 52 Percutaneous absorption 53 Percutaneous absorption of Hydroxyanthraquinone aminopropyl methyl morpholinium 54 methosulfate, present in a hair dye formul","endpoint":"repeated dose toxicity","ingredient":"Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":28,"route":"oral","species":"rat","study_id":"sccs_o_135_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier RNJ1LHE5O7 UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H25N2O4.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"RNJ1LHE5O7"}
openFDA substances FDA UNII substance identifier RNJ1LHE5O7 UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H25N2O4.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"RNJ1LHE5O7"}
openFDA substances FDA UNII substance identifier RNJ1LHE5O7 UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H25N2O4.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"RNJ1LHE5O7"}
openFDA substances FDA UNII substance identifier RNJ1LHE5O7 UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H25N2O4.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"RNJ1LHE5O7"}