NOAEL Studies
Cosmetic Ingredient
HC Red No. 14 NOAEL Studies
INCI: HC RED NO. 14
CAS: 99788-75-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 50 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; C. Fabreguettes. IMEXINE BJ : 13-Week Toxicity Study by Oral Route in Rats, followed by a 4-week Recovery Period. CIT Study N° 13425 TCR, |
SCCNFP_vision_codex 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg/day | - | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg/day was defined as the NOAEL. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data","page":7,"pdf":"out240_en.pdf","row_type":"noael_study","study_id":"out240_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg/day | - | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg/day was defined as the NOAEL. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data","page":7,"pdf":"out240_en.pdf","row_type":"noael_study","study_id":"out240_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg/day | - | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg/day was defined as the NOAEL. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data","page":7,"pdf":"out240_en.pdf","row_type":"noael_study","study_id":"out240_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg/day | - | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg/day was defined as the NOAEL. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data","page":7,"pdf":"out240_en.pdf","row_type":"noael_study","study_id":"out240_en_noael_001"} |
SCCS_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | - | 4 weeks | genotoxicity | {"citation":"Ref.: 8 3","dose":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg bw/day was defined as the NOAEL. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1994) Species/strain: S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 3 independent tests Test substance: Imexine BJ Solvent: DMSO Batch: Pil 1 Purity: 94.6% (HPLC) Concentrations: 0, 312.5, 625, 1250, 2500, 5000 µg/plate, without and with S9-mix Treatment: direct pla","page":17,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"togenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities descri","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described ar","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_004"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"nvestigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric ti","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | 13-week | dermal absorption | {"dose":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed...","effect":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric titration of amine function. Thus, the reported purities also include amounts of impurities C,","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_006"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | - | 4 weeks | genotoxicity | {"citation":"Ref.: 8 3","dose":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg bw/day was defined as the NOAEL. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1994) Species/strain: S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 3 independent tests Test substance: Imexine BJ Solvent: DMSO Batch: Pil 1 Purity: 94.6% (HPLC) Concentrations: 0, 312.5, 625, 1250, 2500, 5000 µg/plate, without and with S9-mix Treatment: direct pla","page":17,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"togenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities descri","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described ar","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_004"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"nvestigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric ti","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | 13-week | dermal absorption | {"dose":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed...","effect":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric titration of amine function. Thus, the reported purities also include amounts of impurities C,","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_006"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | - | 4 weeks | genotoxicity | {"citation":"Ref.: 8 3","dose":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg bw/day was defined as the NOAEL. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1994) Species/strain: S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 3 independent tests Test substance: Imexine BJ Solvent: DMSO Batch: Pil 1 Purity: 94.6% (HPLC) Concentrations: 0, 312.5, 625, 1250, 2500, 5000 µg/plate, without and with S9-mix Treatment: direct pla","page":17,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"togenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities descri","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described ar","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_004"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"nvestigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric ti","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | 13-week | dermal absorption | {"dose":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed...","effect":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric titration of amine function. Thus, the reported purities also include amounts of impurities C,","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_006"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | - | 4 weeks | genotoxicity | {"citation":"Ref.: 8 3","dose":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","effect":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg bw/day was defined as the NOAEL. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1994) Species/strain: S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 3 independent tests Test substance: Imexine BJ Solvent: DMSO Batch: Pil 1 Purity: 94.6% (HPLC) Concentrations: 0, 312.5, 625, 1250, 2500, 5000 µg/plate, without and with S9-mix Treatment: direct pla","page":17,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"togenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities descri","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described ar","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_004"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"nvestigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric ti","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | 13-week | dermal absorption | {"dose":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed...","effect":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric titration of amine function. Thus, the reported purities also include amounts of impurities C,","page":25,"pdf":"sccs_o_062.pdf","row_type":"noael_study","study_id":"sccs_o_062_noael_006"} |
UnifiedCodex:SCCNFP:beta.noael_studies 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | human | - | - | developmental toxicity | SOURCE_SUBDIR=out240_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC BLUE N° 14 COLIPA n° C172; OPINION_NUMBER=SCCNFP/0734/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=1000; DOSE=post-implantation loss and mean number of foetuses per dam were similar between treated and control dams.; EFFECT=post-implantation loss and mean number of foetuses per dam were similar between treated and control dams. The mean foetal body weights were similar in all groups to the controls. The sex ratio for foetuses was similar in all groups. Any abnormal findings noted were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, Imexine BJ was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg/day. Ref. : 10 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Test substance : IMEXINE BJ 1,4-bis-(2,3-dihydroxy-propylamino)-anthraquinone Batch no : Pil 1 Purity : 94.6% (HPLC) Tissue : human skin (absorption across isolated epidermis) Skin integrity : visual evaluation using a microscope before the test. At the end of the test, application of Chinese ink to verify the absence of leakage Method : in vitro static diffusion cell 2 cm² Receptor fluid : phos; CITATION=Ref. : 10 2; CITATION_NUMBERS=[10,2]; REFERENCE=Ref. : 10 2; DETAILS_JSON={"cas_number":"99788-75-7","citation":"Ref. : 10 2","dose":"post-implantation loss and mean number of foetuses per dam were similar between treated and control dams.","duration":"","effect":"post-implantation loss and mean number of foetuses per dam were similar between treated and control dams. The mean foetal body weights were similar in all groups to the controls. The sex ratio for foetuses was similar in all groups. Any abnormal findings noted were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, Imexine BJ was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg/day. Ref. : 10 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Test substance : IMEXINE BJ 1,4-bis-(2,3-dihydroxy-propylamino)-anthraquinone Batch no : Pil 1 Purity : 94.6% (HPLC) Tissue : human skin (absorption across isolated epidermis) Skin integrity : visual evaluation using a microscope before the test. At the end of the test, application of Chinese ink to verify the absence of leakage Method : in vitro static diffusion cell 2 cm² Receptor fluid : phos","endpoint":"developmental toxicity","ingredient":"1,4-bis[(2,3-dihydroxypropyl)amino]-9,10-anthracenedione","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":10,"route":"","species":"human","study_id":"out240_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | oral | 13-week | developmental toxicity | SOURCE_SUBDIR=out240_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC BLUE N° 14 COLIPA n° C172; OPINION_NUMBER=SCCNFP/0734/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=1000; DOSE=The LD50 of the test substance was higher than 2000 mg/kg in rats.; EFFECT=e to nitrosation. No information is provided on the nitrosamine content of the test material. Some impurities have been characterised and quantified but there are also unidentified impurities. The information on solubility and stability of the test material is insufficient. The LD50 of the test substance was higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg/day. HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. The percutaneous absorption study was considered inadequate. HC Blue n° 14 has been tested in prokaryotic and mammalian cells for gene mutation, and in mammalian cells for chromosomal aberration in vitro. Two in vivo tests have been perform; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"The LD50 of the test substance was higher than 2000 mg/kg in rats.","duration":"13-week","effect":"e to nitrosation. No information is provided on the nitrosamine content of the test material. Some impurities have been characterised and quantified but there are also unidentified impurities. The information on solubility and stability of the test material is insufficient. The LD50 of the test substance was higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg/day. HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. The percutaneous absorption study was considered inadequate. HC Blue n° 14 has been tested in prokaryotic and mammalian cells for gene mutation, and in mammalian cells for chromosomal aberration in vitro. Two in vivo tests have been perform","endpoint":"developmental toxicity","ingredient":"1,4-bis[(2,3-dihydroxypropyl)amino]-9,10-anthracenedione","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":16,"route":"oral","species":"rat","study_id":"out240_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | oral | 13-week | developmental toxicity | SOURCE_SUBDIR=out240_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC BLUE N° 14 COLIPA n° C172; OPINION_NUMBER=SCCNFP/0734/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=1000; DOSE=The LD50 of the test substance was higher than 2000 mg/kg in rats.; EFFECT=rised and quantified but there are also unidentified impurities. The information on solubility and stability of the test material is insufficient. The LD50 of the test substance was higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg/day. HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. The percutaneous absorption study was considered inadequate. HC Blue n° 14 has been tested in prokaryotic and mammalian cells for gene mutation, and in mammalian cells for chromosomal aberration in vitro. Two in vivo tests have been performed (bone marrow micronucleus and UDS tests). The in vitro test for gene mutation in prokaryotes has been found positive in the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"The LD50 of the test substance was higher than 2000 mg/kg in rats.","duration":"13-week","effect":"rised and quantified but there are also unidentified impurities. The information on solubility and stability of the test material is insufficient. The LD50 of the test substance was higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg/day. HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. The percutaneous absorption study was considered inadequate. HC Blue n° 14 has been tested in prokaryotic and mammalian cells for gene mutation, and in mammalian cells for chromosomal aberration in vitro. Two in vivo tests have been performed (bone marrow micronucleus and UDS tests). The in vitro test for gene mutation in prokaryotes has been found positive in the","endpoint":"developmental toxicity","ingredient":"1,4-bis[(2,3-dihydroxypropyl)amino]-9,10-anthracenedione","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":16,"route":"oral","species":"rat","study_id":"out240_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 1000 | mg/kg/day | - | dermal | 4 weeks | repeated dose toxicity | SOURCE_SUBDIR=out240_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC BLUE N° 14 COLIPA n° C172; OPINION_NUMBER=SCCNFP/0734/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=1000; DOSE=e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).; EFFECT=e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg/day was defined as the NOAEL. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"99788-75-7","citation":"Ref. : 5 2","dose":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","duration":"4 weeks","effect":"e tail in females of each treated group and in males given 1000 mg/kg/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg/day was defined as the NOAEL. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data","endpoint":"repeated dose toxicity","ingredient":"1,4-bis[(2,3-dihydroxypropyl)amino]-9,10-anthracenedione","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":7,"route":"dermal","species":"","study_id":"out240_en_noael_001"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0008 | mg/kg bw | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT== 0.0008; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=togenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities descri; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"13-week","effect":"togenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities descri","endpoint":"dermal absorption","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0008","page":25,"route":"oral","species":"rat","study_id":"sccs_o_062_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =1000 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT== 1000; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described ar; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"13-week","effect":"3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described ar","endpoint":"dermal absorption","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 1000","page":25,"route":"oral","species":"rat","study_id":"sccs_o_062_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =500 | mg/kg bw/d | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT== 500; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=nvestigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric ti; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"13-week","effect":"nvestigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric ti","endpoint":"dermal absorption","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 500","page":25,"route":"oral","species":"rat","study_id":"sccs_o_062_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 50 | % | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=50; DOSE=) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed...; EFFECT=) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric titration of amine function. Thus, the reported purities also include amounts of impurities C,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed...","duration":"13-week","effect":") CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 14 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 0.083 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0008 mg/kg bw No Observed Adverse Effect Level NOAEL = 1000 mg/kg bw/d (13-week, oral, rat) Adjusted NOAEL = 500 mg/kg bw/d MOS = 625 000 Since no data on oral bioavailability were given, the NOAEL was adjusted assuming 50% bio-availability according to the SCCS Notes for Guidance. 3.3.14. Discussion Physico-chemical specification HC Blue n° 14 is used as semi-permanent hair dye in hair dye formulation at 0.3%. 35 ml hair dye formulation is used per application. Absolute concentration of HC Blue n° 14 in various batches is not reported. The purities described are based on measurements performed by potentiometric titration of amine function. Thus, the reported purities also include amounts of impurities C,","endpoint":"dermal absorption","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"%","noael_value":"50","page":25,"route":"oral","species":"rat","study_id":"sccs_o_062_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | - | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=1000; DOSE=post-implantation loss and mean number of foetuses per dam were similar between treated and control dams.; EFFECT=post-implantation loss and mean number of foetuses per dam were similar between treated and control dams. The mean foetal body weights were similar in all groups to the controls. The sex ratio for foetuses was similar in all groups. Any abnormal findings noted were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, Imexine BJ was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOAEL was defined as 1000 mg/kg bw/day. Ref.: 15; CITATION=Ref.: 15; CITATION_NUMBERS=[15]; REFERENCE=Ref.: 15; DETAILS_JSON={"cas_number":"99788-75-7","citation":"Ref.: 15","dose":"post-implantation loss and mean number of foetuses per dam were similar between treated and control dams.","duration":"","effect":"post-implantation loss and mean number of foetuses per dam were similar between treated and control dams. The mean foetal body weights were similar in all groups to the controls. The sex ratio for foetuses was similar in all groups. Any abnormal findings noted were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, Imexine BJ was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOAEL was defined as 1000 mg/kg bw/day. Ref.: 15","endpoint":"developmental toxicity","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":24,"route":"","species":"","study_id":"sccs_o_062_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | rat | oral | 13-week | developmental toxicity | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=1000; DOSE=General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats.; EFFECT=__________ 26 HC Blue n° 14 is a secondary alkanolamine and thus it is prone to nitrosation. No information is provided on the nitrosamine content of the test material. The stability of HC Blue n° 14 in typical hair dye formulations is not reported. General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg bw/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg bw/day. Irritation, sensitisation HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. In the LLNA, the highest concentration tested (10%) did not elicit a SI >3. However, this concentration was too low for hazard identification and therefore, a sensitising potential cannot be excluded. Dermal ab; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats.","duration":"13-week","effect":"__________ 26 HC Blue n° 14 is a secondary alkanolamine and thus it is prone to nitrosation. No information is provided on the nitrosamine content of the test material. The stability of HC Blue n° 14 in typical hair dye formulations is not reported. General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg bw/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg bw/day. Irritation, sensitisation HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. In the LLNA, the highest concentration tested (10%) did not elicit a SI >3. However, this concentration was too low for hazard identification and therefore, a sensitising potential cannot be excluded. Dermal ab","endpoint":"developmental toxicity","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":26,"route":"oral","species":"rat","study_id":"sccs_o_062_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | rat | oral | 13-week | developmental toxicity | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=1000; DOSE=General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats.; EFFECT=nitrosamine content of the test material. The stability of HC Blue n° 14 in typical hair dye formulations is not reported. General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg bw/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg bw/day. Irritation, sensitisation HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. In the LLNA, the highest concentration tested (10%) did not elicit a SI >3. However, this concentration was too low for hazard identification and therefore, a sensitising potential cannot be excluded. Dermal absorption There is a high variability in the absorption of HC Blue n° 14, ranging from 0.011 to 0.076 µg/cm² with a CV of 68%, p; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99788-75-7","citation":"","dose":"General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats.","duration":"13-week","effect":"nitrosamine content of the test material. The stability of HC Blue n° 14 in typical hair dye formulations is not reported. General toxicity The LD50 of the test substance was higher than 2000 mg/kg bw in rats. No signs of toxicity were observed at this dose. Only minor biochemical changes were noted in a 13-week oral toxicity study. The dose level of 1000 mg/kg bw/day was defined as the NOAEL. HC Blue n° 14 was not toxic to embryo or foetus and was not teratogenic. There was no evidence of maternal toxicity. The NOEL was defined as 1000 mg/kg bw/day. Irritation, sensitisation HC Blue n° 14 is not irritant to the skin and a minor irritant to the eyes. It was considered not to be a sensitiser. In the LLNA, the highest concentration tested (10%) did not elicit a SI >3. However, this concentration was too low for hazard identification and therefore, a sensitising potential cannot be excluded. Dermal absorption There is a high variability in the absorption of HC Blue n° 14, ranging from 0.011 to 0.076 µg/cm² with a CV of 68%, p","endpoint":"developmental toxicity","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":26,"route":"oral","species":"rat","study_id":"sccs_o_062_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 1000 | mg/kg bw/day | - | - | 4 weeks | genotoxicity | SOURCE_SUBDIR=sccs_o_062; REPORT_TITLE=OPINION ON HC Blue n° 14 COLIPA n° C172; OPINION_NUMBER=SCCS/1383/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=1000; DOSE=females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).; EFFECT=females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg bw/day was defined as the NOAEL. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1994) Species/strain: S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 3 independent tests Test substance: Imexine BJ Solvent: DMSO Batch: Pil 1 Purity: 94.6% (HPLC) Concentrations: 0, 312.5, 625, 1250, 2500, 5000 µg/plate, without and with S9-mix Treatment: direct pla; CITATION=Ref.: 8 3; CITATION_NUMBERS=[8,3]; REFERENCE=Ref.: 8 3; DETAILS_JSON={"cas_number":"99788-75-7","citation":"Ref.: 8 3","dose":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group).","duration":"4 weeks","effect":"females of each treated group and in males given 1000 mg/kg bw/day (not reversible after 4 weeks recovery); blue coloration of the extremities and hair in animals given 300 and 1000 mg/kg bw/day; bluish or greenish discoloration of the gastrointestinal mucosa and contents in some animals of each treated group). No treatment-related microscopic changes were noted. Conclusion Since only minor biochemical changes were noted, under these experimental conditions, the dose level of 1000 mg/kg bw/day was defined as the NOAEL. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1994) Species/strain: S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 3 independent tests Test substance: Imexine BJ Solvent: DMSO Batch: Pil 1 Purity: 94.6% (HPLC) Concentrations: 0, 312.5, 625, 1250, 2500, 5000 µg/plate, without and with S9-mix Treatment: direct pla","endpoint":"genotoxicity","ingredient":"HC Blue No. 14","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":17,"route":"","species":"","study_id":"sccs_o_062_noael_001"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | UVQ553995F | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H22N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UVQ553995F"} |
| openFDA substances | FDA UNII substance identifier | UVQ553995F | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H22N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UVQ553995F"} |
| openFDA substances | FDA UNII substance identifier | UVQ553995F | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H22N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UVQ553995F"} |
| openFDA substances | FDA UNII substance identifier | UVQ553995F | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C20H22N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UVQ553995F"} |