NOAEL Studies Cosmetic Ingredient

CI 61570 NOAEL Studies

CAS: 4403-90-1

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

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 100 mg/kg bw/day rat oral 91 day Subchronic SCCP; Hamann, H.-J. et al. (2000): D&C Green 5 (CI 61750): 13-week oral toxicity (gavage)study in rats. Project n° 740687, RCC Ltd, Switzerland
NTP_ICE_acute_oral 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >3160 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_6512; row=4137; data_type=In Vivo; mixture=Chemical; chemical_name=D&C Green 5; preferred_name=Benzenesulfonic acid, 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)diimino]bis[5-methyl-, sodium salt (1:2); dtxsid=DTXSID2024903; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024903; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2024903; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >10000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_6513; row=4138; data_type=In Vivo; mixture=Chemical; chemical_name=D&C Green 5; preferred_name=Benzenesulfonic acid, 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)diimino]bis[5-methyl-, sodium salt (1:2); dtxsid=DTXSID2024903; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024903; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2024903; source_file=acute_oral.xlsx
SCCS_vision_codex 32 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 4 3","dose":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship.","effect":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship. Some changes in haematology parameters were found at the highest dose level. Urinalysis revealed a significant increase in urine volume in males of the high dose group. No abnormalities were noted in the histological investigation or with regard to markers of kidney physiology. Comment Due to the effects on absolute and relative kidney weight at 300 mg/kg bw/day and above, a no observed effect level (NOEL) of 100 mg/kg bw/day was deduced. Ref.: 4 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7 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 with and without metabolic activation Test substance : Acid Green 25 (C 178); D&C Green 5 (C.I. 61570) in deionised water Batch No. : 33 (purity: 95%) Lot No. : AJ 6720 Concen","page":13,"pdf":"sccp_o_009.pdf","row_type":"noael_study","study_id":"sccp_o_009_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - - NOAEL study {"citation":"Ref.: 4 (subm I","dose":"males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related.","effect":"SCCS-rejected applicant NOAEL: males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","page":17,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_001"}
SCCS_vision_codex NOAEL =95 % - - Chronic genotoxicity {"dose":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males.","effect":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males. The SCCS also noted that this NOAEL is also the NOAEL for changes in haematological parameters. 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 gene mutation assay Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537; E. coli, WP2uvrA Replicates: Two independent tests with and without metabolic activation Test substance: D&C Green n° 5 (C.I. 61570) Batch: 33 Purity: 95% Vehicle: deionised water Concentrations: 33,","page":18,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"ment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_007"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 D...","effect":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic pr","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_008"}
SCCS_vision_codex NOAEL =95 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_009"}
SCCS_vision_codex NOAEL =48 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products according to Annex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 4 3","dose":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship.","effect":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship. Some changes in haematology parameters were found at the highest dose level. Urinalysis revealed a significant increase in urine volume in males of the high dose group. No abnormalities were noted in the histological investigation or with regard to markers of kidney physiology. Comment Due to the effects on absolute and relative kidney weight at 300 mg/kg bw/day and above, a no observed effect level (NOEL) of 100 mg/kg bw/day was deduced. Ref.: 4 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7 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 with and without metabolic activation Test substance : Acid Green 25 (C 178); D&C Green 5 (C.I. 61570) in deionised water Batch No. : 33 (purity: 95%) Lot No. : AJ 6720 Concen","page":13,"pdf":"sccp_o_009.pdf","row_type":"noael_study","study_id":"sccp_o_009_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 4 3","dose":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship.","effect":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship. Some changes in haematology parameters were found at the highest dose level. Urinalysis revealed a significant increase in urine volume in males of the high dose group. No abnormalities were noted in the histological investigation or with regard to markers of kidney physiology. Comment Due to the effects on absolute and relative kidney weight at 300 mg/kg bw/day and above, a no observed effect level (NOEL) of 100 mg/kg bw/day was deduced. Ref.: 4 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7 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 with and without metabolic activation Test substance : Acid Green 25 (C 178); D&C Green 5 (C.I. 61570) in deionised water Batch No. : 33 (purity: 95%) Lot No. : AJ 6720 Concen","page":13,"pdf":"sccp_o_009.pdf","row_type":"noael_study","study_id":"sccp_o_009_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - - NOAEL study {"citation":"Ref.: 4 (subm I","dose":"males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related.","effect":"SCCS-rejected applicant NOAEL: males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","page":17,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_001"}
SCCS_vision_codex NOAEL =95 % - - Chronic genotoxicity {"dose":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males.","effect":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males. The SCCS also noted that this NOAEL is also the NOAEL for changes in haematological parameters. 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 gene mutation assay Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537; E. coli, WP2uvrA Replicates: Two independent tests with and without metabolic activation Test substance: D&C Green n° 5 (C.I. 61570) Batch: 33 Purity: 95% Vehicle: deionised water Concentrations: 33,","page":18,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"ment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_007"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 D...","effect":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic pr","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_008"}
SCCS_vision_codex NOAEL =95 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_009"}
SCCS_vision_codex NOAEL =48 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products according to Annex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - - NOAEL study {"citation":"Ref.: 4 (subm I","dose":"males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related.","effect":"SCCS-rejected applicant NOAEL: males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","page":17,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_001"}
SCCS_vision_codex NOAEL =95 % - - Chronic genotoxicity {"dose":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males.","effect":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males. The SCCS also noted that this NOAEL is also the NOAEL for changes in haematological parameters. 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 gene mutation assay Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537; E. coli, WP2uvrA Replicates: Two independent tests with and without metabolic activation Test substance: D&C Green n° 5 (C.I. 61570) Batch: 33 Purity: 95% Vehicle: deionised water Concentrations: 33,","page":18,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"ment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_007"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 D...","effect":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic pr","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_008"}
SCCS_vision_codex NOAEL =95 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_009"}
SCCS_vision_codex NOAEL =48 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products according to Annex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 4 3","dose":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship.","effect":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship. Some changes in haematology parameters were found at the highest dose level. Urinalysis revealed a significant increase in urine volume in males of the high dose group. No abnormalities were noted in the histological investigation or with regard to markers of kidney physiology. Comment Due to the effects on absolute and relative kidney weight at 300 mg/kg bw/day and above, a no observed effect level (NOEL) of 100 mg/kg bw/day was deduced. Ref.: 4 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7 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 with and without metabolic activation Test substance : Acid Green 25 (C 178); D&C Green 5 (C.I. 61570) in deionised water Batch No. : 33 (purity: 95%) Lot No. : AJ 6720 Concen","page":13,"pdf":"sccp_o_009.pdf","row_type":"noael_study","study_id":"sccp_o_009_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - - NOAEL study {"citation":"Ref.: 4 (subm I","dose":"males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related.","effect":"SCCS-rejected applicant NOAEL: males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","page":17,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_001"}
SCCS_vision_codex NOAEL =95 % - - Chronic genotoxicity {"dose":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males.","effect":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males. The SCCS also noted that this NOAEL is also the NOAEL for changes in haematological parameters. 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 gene mutation assay Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537; E. coli, WP2uvrA Replicates: Two independent tests with and without metabolic activation Test substance: D&C Green n° 5 (C.I. 61570) Batch: 33 Purity: 95% Vehicle: deionised water Concentrations: 33,","page":18,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - developmental developmental toxicity {"citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","effect":"ment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","page":22,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_007"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 D...","effect":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic pr","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_008"}
SCCS_vision_codex NOAEL =95 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_009"}
SCCS_vision_codex NOAEL =48 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products according to Annex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye","page":23,"pdf":"sccs_o_126.pdf","row_type":"noael_study","study_id":"sccs_o_126_noael_010"}
ToxValDB_ECHA_IUCLID 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Rat oral - reproduction developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab68e4b0a7c65d1ba28f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17364/7/9/2?documentUUID=953196e5-a1b2-436d-adf1-42193f710c0c; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15861680:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_f51bc7cee563577c1d42280a57d146bc
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=100; DOSE=males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related.; EFFECT=SCCS-rejected applicant NOAEL: males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with; CITATION=Ref.: 4 (subm I; CITATION_NUMBERS=[4]; REFERENCE=Ref.: 4 (subm I; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 4 (subm I","dose":"males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related.","duration":"","effect":"SCCS-rejected applicant NOAEL: males of the high dose group; due to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","endpoint":"","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":17,"route":"","species":"rat","study_id":"sccs_o_126_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=100; DOSE=The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured.; EFFECT=SCCS-rejected applicant NOAEL: to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with; CITATION=Ref.: 4 (subm I; CITATION_NUMBERS=[4]; REFERENCE=Ref.: 4 (subm I; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 4 (subm I","dose":"The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured.","duration":"","effect":"SCCS-rejected applicant NOAEL: to the increased kidney weights, this finding was considered to be test article related. The macroscopical findings included bluish discolouration in the gastrointestinal tract and the testes in the low-dose group; in the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","endpoint":"","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":17,"route":"","species":"rat","study_id":"sccs_o_126_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day rat - - - SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=100; DOSE=the mid- and high-dose groups the whole body was bluish discoloured.; EFFECT=SCCS-rejected applicant NOAEL: the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with; CITATION=Ref.: 4 (subm I; CITATION_NUMBERS=[4]; REFERENCE=Ref.: 4 (subm I; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 4 (subm I","dose":"the mid- and high-dose groups the whole body was bluish discoloured.","duration":"","effect":"SCCS-rejected applicant NOAEL: the mid- and high-dose groups the whole body was bluish discoloured. The microscopical findings were within the range of the spontaneous background lesions recorded in rats of this strain and age and therefore, not considered to be treatment-related. Conclusion The No Observed Adverse Effect Level (NOAEL) was 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on the results in this study, especially the increased organ weight ratios of the kidneys. Ref.: 4 (subm I; 14, subm II) Comment The SCCS agrees with the NOAEL as concluded by the study authors although it is noted that no abnormalities were noted in the histological investigation of the kidneys or with","endpoint":"","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":17,"route":"","species":"rat","study_id":"sccs_o_126_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.0004 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 0.0004; DOSE=CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 D...; EFFECT=CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic pr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 D...","duration":"90-day","effect":"CS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic pr","endpoint":"dermal absorption","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.0004","page":23,"route":"oral","species":"rat","study_id":"sccs_o_126_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =95 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 95; DOSE=25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...; EFFECT=25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","duration":"90-day","effect":"25 ___________________________________________________________________________________________ 23 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products","endpoint":"dermal absorption","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 95","page":23,"route":"oral","species":"rat","study_id":"sccs_o_126_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =48 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 48; DOSE=3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...; EFFECT=3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products according to Annex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","duration":"90-day","effect":"3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Green 25) (non-oxidative conditions) Absorption through the skin A = 0.04 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.023 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg bw/d No observed adverse effect level NOAEL = 95 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 48 mg/kg bw/d Margin of Safety NOAEL / SED = 120000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-Chemical Properties Acid Green 25 is proposed for use in semi-permanent hair dye formulations as a direct dye at a maximum concentration of 0.3% in the finished cosmetic product. Acid Green 25 is permitted for the use in other cosmetic products according to Annex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye","endpoint":"dermal absorption","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 48","page":23,"route":"oral","species":"rat","study_id":"sccs_o_126_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=300; DOSE=At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.; EFFECT=considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data; CITATION=Ref.: 17 (subm I, updated) 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 (subm I, updated) 3; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","duration":"developmental","effect":"considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data","endpoint":"developmental toxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":22,"route":"","species":"human","study_id":"sccs_o_126_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=300; DOSE=At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.; EFFECT=the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitt; CITATION=Ref.: 17 (subm I, updated) 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 (subm I, updated) 3; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","duration":"developmental","effect":"the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitt","endpoint":"developmental toxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":22,"route":"","species":"human","study_id":"sccs_o_126_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/day human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.; EFFECT=ment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted; CITATION=Ref.: 17 (subm I, updated) 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 (subm I, updated) 3; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 17 (subm I, updated) 3","dose":"At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams.","duration":"developmental","effect":"ment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Conclusion The No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Ref.: 17 (subm I, updated) 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","endpoint":"developmental toxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":22,"route":"","species":"human","study_id":"sccs_o_126_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw/day rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=100; DOSE=General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels.; EFFECT=nex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye formulations was not demonstrated. Irritation / sensitisation Acid Green 25 is evaluated not to be an irritant to the skin and eyes. It did not induce sensitisation in one Guinea pig experiment. Dermal absorption The total dermal absorption of Acid Green 25 at 72 hours was 0.02 ± 0.02 μg equiv./cm². The mean + SD: 0.04 μg equiv./cm² was used to calculate MoS. General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels. In the teratogenicity study, the NOAEL for maternal toxicity was 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity was 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Mutagenicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels.","duration":"13 week","effect":"nex IV of the Cosmetics Directive Stability of Acid Green 25 in in typical hair dye formulations was not demonstrated. Irritation / sensitisation Acid Green 25 is evaluated not to be an irritant to the skin and eyes. It did not induce sensitisation in one Guinea pig experiment. Dermal absorption The total dermal absorption of Acid Green 25 at 72 hours was 0.02 ± 0.02 μg equiv./cm². The mean + SD: 0.04 μg equiv./cm² was used to calculate MoS. General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels. In the teratogenicity study, the NOAEL for maternal toxicity was 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity was 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Mutagenicity","endpoint":"developmental toxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":23,"route":"oral","species":"rat","study_id":"sccs_o_126_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=300; DOSE=General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels.; EFFECT=nt to the skin and eyes. It did not induce sensitisation in one Guinea pig experiment. Dermal absorption The total dermal absorption of Acid Green 25 at 72 hours was 0.02 ± 0.02 μg equiv./cm². The mean + SD: 0.04 μg equiv./cm² was used to calculate MoS. General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels. In the teratogenicity study, the NOAEL for maternal toxicity was 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity was 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Mutagenicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels.","duration":"13 week","effect":"nt to the skin and eyes. It did not induce sensitisation in one Guinea pig experiment. Dermal absorption The total dermal absorption of Acid Green 25 at 72 hours was 0.02 ± 0.02 μg equiv./cm². The mean + SD: 0.04 μg equiv./cm² was used to calculate MoS. General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels. In the teratogenicity study, the NOAEL for maternal toxicity was 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity was 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Mutagenicity","endpoint":"developmental toxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":23,"route":"oral","species":"rat","study_id":"sccs_o_126_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/day rat oral 13 week developmental toxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels.; EFFECT=Dermal absorption The total dermal absorption of Acid Green 25 at 72 hours was 0.02 ± 0.02 μg equiv./cm². The mean + SD: 0.04 μg equiv./cm² was used to calculate MoS. General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels. In the teratogenicity study, the NOAEL for maternal toxicity was 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity was 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Mutagenicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels.","duration":"13 week","effect":"Dermal absorption The total dermal absorption of Acid Green 25 at 72 hours was 0.02 ± 0.02 μg equiv./cm². The mean + SD: 0.04 μg equiv./cm² was used to calculate MoS. General toxicity The 13 week oral toxicity study in rats revealed a NOAEL of 100 mg/kg bw/day (95 mg active dye/kg bw/day) based on increased kidney weights and changes in haematological parameters at the two higher dose levels. In the teratogenicity study, the NOAEL for maternal toxicity was 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for developmental toxicity was 1000 mg/kg bw/day (861 mg active dye/kg bw/day). Mutagenicity","endpoint":"developmental toxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":23,"route":"oral","species":"rat","study_id":"sccs_o_126_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 100 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_009; REPORT_TITLE=Opinion on Acid Green 25 COLIPA N° C 178; OPINION_NUMBER=SCCP/0879/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT=100; DOSE=ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship.; EFFECT=ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship. Some changes in haematology parameters were found at the highest dose level. Urinalysis revealed a significant increase in urine volume in males of the high dose group. No abnormalities were noted in the histological investigation or with regard to markers of kidney physiology. Comment Due to the effects on absolute and relative kidney weight at 300 mg/kg bw/day and above, a no observed effect level (NOEL) of 100 mg/kg bw/day was deduced. Ref.: 4 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7 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 with and without metabolic activation Test substance : Acid Green 25 (C 178); D&C Green 5 (C.I. 61570) in deionised water Batch No. : 33 (purity: 95%) Lot No. : AJ 6720 Concen; CITATION=Ref.: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref.: 4 3; DETAILS_JSON={"cas_number":"4403-90-1","citation":"Ref.: 4 3","dose":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship.","duration":"Chronic","effect":"ly decreased compared to control controls for all treated groups, without revealing a dose-response relationship. Some changes in haematology parameters were found at the highest dose level. Urinalysis revealed a significant increase in urine volume in males of the high dose group. No abnormalities were noted in the histological investigation or with regard to markers of kidney physiology. Comment Due to the effects on absolute and relative kidney weight at 300 mg/kg bw/day and above, a no observed effect level (NOEL) of 100 mg/kg bw/day was deduced. Ref.: 4 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7 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 with and without metabolic activation Test substance : Acid Green 25 (C 178); D&C Green 5 (C.I. 61570) in deionised water Batch No. : 33 (purity: 95%) Lot No. : AJ 6720 Concen","endpoint":"genotoxicity","ingredient":"Acid Green 25 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":13,"route":"","species":"","study_id":"sccp_o_009_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 100 mg/kg bw/day rat oral 13 week genotoxicity SOURCE_SUBDIR=sccp_o_009; REPORT_TITLE=Opinion on Acid Green 25 COLIPA N° C 178; OPINION_NUMBER=SCCP/0879/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT=100; DOSE=The 13 week oral toxicity study in rats revealed a NOEL of 100 mg/kg bw/day.; EFFECT=OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The submitted data on physico-chemical properties of Acid Green 25 is incomplete. No data is provided for the chemical identification of an impurity that is present in >10% in Acid Green 25. Acid Green 25 is evaluated not to be an irritant to the skin and eyes. It did not induce sensitisation in one Guinea pig experiment. The submitted in vitro dermal absorption study of Acid Green 25 is inadequate. The 13 week oral toxicity study in rats revealed a NOEL of 100 mg/kg bw/day. No data on reproduction toxicity were submitted. Acid Green 25 (C178) has been tested for mutagenicity in two appropriately performed in vitro tests. It did neither induce gene mutations in bacteria nor in cultured mammalian cells. Since the mouse lymphoma assay (MLA) also detects clastogenic activity of a test compound, the negative result suggests that Acid Green 25 does not induce structural chromosome aberrations. However, an additional in vitro test specifically detecting chromosomal abe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"The 13 week oral toxicity study in rats revealed a NOEL of 100 mg/kg bw/day.","duration":"13 week","effect":"OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The submitted data on physico-chemical properties of Acid Green 25 is incomplete. No data is provided for the chemical identification of an impurity that is present in >10% in Acid Green 25. Acid Green 25 is evaluated not to be an irritant to the skin and eyes. It did not induce sensitisation in one Guinea pig experiment. The submitted in vitro dermal absorption study of Acid Green 25 is inadequate. The 13 week oral toxicity study in rats revealed a NOEL of 100 mg/kg bw/day. No data on reproduction toxicity were submitted. Acid Green 25 (C178) has been tested for mutagenicity in two appropriately performed in vitro tests. It did neither induce gene mutations in bacteria nor in cultured mammalian cells. Since the mouse lymphoma assay (MLA) also detects clastogenic activity of a test compound, the negative result suggests that Acid Green 25 does not induce structural chromosome aberrations. However, an additional in vitro test specifically detecting chromosomal abe","endpoint":"genotoxicity","ingredient":"Acid Green 25 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":16,"route":"oral","species":"rat","study_id":"sccp_o_009_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 95 % - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_126; REPORT_TITLE=OPINION ON Acid Green 25 COLIPA n° C178; OPINION_NUMBER=SCCS/1498/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=95; DOSE=SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males.; EFFECT=SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males. The SCCS also noted that this NOAEL is also the NOAEL for changes in haematological parameters. 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 gene mutation assay Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537; E. coli, WP2uvrA Replicates: Two independent tests with and without metabolic activation Test substance: D&C Green n° 5 (C.I. 61570) Batch: 33 Purity: 95% Vehicle: deionised water Concentrations: 33,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4403-90-1","citation":"","dose":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males.","duration":"Chronic","effect":"SCCS/1498/12 Opinion on Acid Green 25 ___________________________________________________________________________________________ 18 regard to markers of kidney physiology except for the increase in urine volume in high-dose males. The SCCS also noted that this NOAEL is also the NOAEL for changes in haematological parameters. 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 gene mutation assay Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537; E. coli, WP2uvrA Replicates: Two independent tests with and without metabolic activation Test substance: D&C Green n° 5 (C.I. 61570) Batch: 33 Purity: 95% Vehicle: deionised water Concentrations: 33,","endpoint":"genotoxicity","ingredient":"1,4-Di-((2-sulpho-4","loael_value":"","noael_unit":"%","noael_value":"95","page":18,"route":"","species":"","study_id":"sccs_o_126_noael_004"}
openFDA substances 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 8J6RDU8L9X UNII - - - chemical {"approval_status":null,"molecular_formula":"C28H20N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8J6RDU8L9X"}
openFDA substances FDA UNII substance identifier 8J6RDU8L9X UNII - - - chemical {"approval_status":null,"molecular_formula":"C28H20N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8J6RDU8L9X"}
openFDA substances FDA UNII substance identifier 8J6RDU8L9X UNII - - - chemical {"approval_status":null,"molecular_formula":"C28H20N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8J6RDU8L9X"}