NOAEL Studies
Cosmetic Ingredient
Disperse Red 17 NOAEL Studies
INCI: DISPERSE RED 17
CAS: 3179-89-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 10 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCP; Fabreguettes, C.; 13-week toxicity study by oral administration (gavage) in rats;CENTRE INTERNATIONAL DE TOXICOLOGIE |
SCCNFP Opinion 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"r minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25cm2 area of intact skin of 3 male rabbits. Semi-occlusive patches were applied and left in place for a 4-hour period. Remaining test substance","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"r minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25cm2 area of intact skin of 3 male rabbits. Semi-occlusive patches were applied and left in place for a 4-hour period. Remaining test substance","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"r minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25cm2 area of intact skin of 3 male rabbits. Semi-occlusive patches were applied and left in place for a 4-hour period. Remaining test substance","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"r minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25cm2 area of intact skin of 3 male rabbits. Semi-occlusive patches were applied and left in place for a 4-hour period. Remaining test substance","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"e levels. As these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25c","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_002"} |
| SCCNFP Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"e levels. As these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25c","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_002"} |
| SCCNFP Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"e levels. As these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25c","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_002"} |
| SCCNFP Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | - | irritation | {"dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"e levels. As these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25c","page":9,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_002"} |
| SCCNFP Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"dose":"n high dose males and ovary weights were increased in mid and high dose females.","effect":"n high dose males and ovary weights were increased in mid and high dose females. Histopathology revealed dose-related incidence and severity of haemosiderin deposits in the spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. A NOAEL could not be established from this study. The significance of the increased incidence of hairloss in the top dose group is unclear. Ref. : 5.1 Low dose study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley rat, Crl:CD (SD) BR Group Size : 10 males + 10 females Test material : Disperse Red 17 formulated in purified water Batch no : 928017/02 (dye content : 41.2%) Dose : 0, 10 and 30 mg/kg bw/day Exposure period : 13 weeks GLP : in compliance Groups of 10 male and 10 female rats were dosed with the test","page":8,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"dose":"n high dose males and ovary weights were increased in mid and high dose females.","effect":"n high dose males and ovary weights were increased in mid and high dose females. Histopathology revealed dose-related incidence and severity of haemosiderin deposits in the spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. A NOAEL could not be established from this study. The significance of the increased incidence of hairloss in the top dose group is unclear. Ref. : 5.1 Low dose study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley rat, Crl:CD (SD) BR Group Size : 10 males + 10 females Test material : Disperse Red 17 formulated in purified water Batch no : 928017/02 (dye content : 41.2%) Dose : 0, 10 and 30 mg/kg bw/day Exposure period : 13 weeks GLP : in compliance Groups of 10 male and 10 female rats were dosed with the test","page":8,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"dose":"n high dose males and ovary weights were increased in mid and high dose females.","effect":"n high dose males and ovary weights were increased in mid and high dose females. Histopathology revealed dose-related incidence and severity of haemosiderin deposits in the spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. A NOAEL could not be established from this study. The significance of the increased incidence of hairloss in the top dose group is unclear. Ref. : 5.1 Low dose study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley rat, Crl:CD (SD) BR Group Size : 10 males + 10 females Test material : Disperse Red 17 formulated in purified water Batch no : 928017/02 (dye content : 41.2%) Dose : 0, 10 and 30 mg/kg bw/day Exposure period : 13 weeks GLP : in compliance Groups of 10 male and 10 female rats were dosed with the test","page":8,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"dose":"n high dose males and ovary weights were increased in mid and high dose females.","effect":"n high dose males and ovary weights were increased in mid and high dose females. Histopathology revealed dose-related incidence and severity of haemosiderin deposits in the spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. A NOAEL could not be established from this study. The significance of the increased incidence of hairloss in the top dose group is unclear. Ref. : 5.1 Low dose study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley rat, Crl:CD (SD) BR Group Size : 10 males + 10 females Test material : Disperse Red 17 formulated in purified water Batch no : 928017/02 (dye content : 41.2%) Dose : 0, 10 and 30 mg/kg bw/day Exposure period : 13 weeks GLP : in compliance Groups of 10 male and 10 female rats were dosed with the test","page":8,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"fat and mammary tissue were observed. No other treatment-related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed, which were within the normal range and treated groups did not differ significantly from control. The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human female breast skin Method : Franz diffusion cell Test material : Disperse Red 17, 0.2 % in formulation Batch No : 928017/02 (dye content : 41.2 %) Dose Levels : circa 40 mg formulation in the","page":12,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_004"} |
| SCCNFP Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"fat and mammary tissue were observed. No other treatment-related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed, which were within the normal range and treated groups did not differ significantly from control. The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human female breast skin Method : Franz diffusion cell Test material : Disperse Red 17, 0.2 % in formulation Batch No : 928017/02 (dye content : 41.2 %) Dose Levels : circa 40 mg formulation in the","page":12,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_004"} |
| SCCNFP Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"fat and mammary tissue were observed. No other treatment-related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed, which were within the normal range and treated groups did not differ significantly from control. The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human female breast skin Method : Franz diffusion cell Test material : Disperse Red 17, 0.2 % in formulation Batch No : 928017/02 (dye content : 41.2 %) Dose Levels : circa 40 mg formulation in the","page":12,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_004"} |
| SCCNFP Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"fat and mammary tissue were observed. No other treatment-related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed, which were within the normal range and treated groups did not differ significantly from control. The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human female breast skin Method : Franz diffusion cell Test material : Disperse Red 17, 0.2 % in formulation Batch No : 928017/02 (dye content : 41.2 %) Dose Levels : circa 40 mg formulation in the","page":12,"pdf":"out210_en.pdf","row_type":"noael_study","study_id":"out210_en_noael_004"} |
SCCS Opinion 60 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =41.2 | % | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear","dose":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997 Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 10 and 30 mg/kg bw/day, 7 days a w","page":17,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_001"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: hese differences in thyroid weights were not associated with relevant histopathological findings, they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 153","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: gan weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 1537, Replicates: triplicates in one experiment Test substance: Disperse Red 17 (WR 18044) Solvent: Deionised water Batch: 40T60N4520 (dye content: 31.0% by NMR) Purit","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_003"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"ary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range, and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics (ADME) No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data","page":25,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_006"} |
| SCCS Opinion | NOAEL | =0.0075 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"____________________________________________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorp","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_007"} |
| SCCS Opinion | NOAEL | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_009"} |
| SCCS Opinion | NOAEL | =31 | % | rat | dermal | - | dermal absorption | {"dose":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect...","effect":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse ef","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_010"} |
| SCCS Opinion | NOAEL | =0.0055 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","effect":"Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_011"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"ne content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alter","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_016"} |
| SCCS Opinion | NOAEL | =3.1 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen.","effect":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligman study: excessive staining due to the test substance made assessment “difficult” in 6/10 an","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_018"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear","dose":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997 Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 10 and 30 mg/kg bw/day, 7 days a w","page":17,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_001"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: hese differences in thyroid weights were not associated with relevant histopathological findings, they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 153","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: gan weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 1537, Replicates: triplicates in one experiment Test substance: Disperse Red 17 (WR 18044) Solvent: Deionised water Batch: 40T60N4520 (dye content: 31.0% by NMR) Purit","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_003"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"ary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range, and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics (ADME) No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data","page":25,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_006"} |
| SCCS Opinion | NOAEL | =0.0075 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"____________________________________________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorp","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_007"} |
| SCCS Opinion | NOAEL | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_009"} |
| SCCS Opinion | NOAEL | =31 | % | rat | dermal | - | dermal absorption | {"dose":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect...","effect":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse ef","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_010"} |
| SCCS Opinion | NOAEL | =0.0055 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","effect":"Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_011"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"ne content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alter","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_016"} |
| SCCS Opinion | NOAEL | =3.1 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen.","effect":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligman study: excessive staining due to the test substance made assessment “difficult” in 6/10 an","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_018"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear","dose":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997 Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 10 and 30 mg/kg bw/day, 7 days a w","page":17,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_001"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: hese differences in thyroid weights were not associated with relevant histopathological findings, they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 153","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: gan weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 1537, Replicates: triplicates in one experiment Test substance: Disperse Red 17 (WR 18044) Solvent: Deionised water Batch: 40T60N4520 (dye content: 31.0% by NMR) Purit","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_003"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"ary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range, and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics (ADME) No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data","page":25,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_006"} |
| SCCS Opinion | NOAEL | =0.0075 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"____________________________________________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorp","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_007"} |
| SCCS Opinion | NOAEL | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_009"} |
| SCCS Opinion | NOAEL | =31 | % | rat | dermal | - | dermal absorption | {"dose":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect...","effect":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse ef","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_010"} |
| SCCS Opinion | NOAEL | =0.0055 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","effect":"Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_011"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"ne content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alter","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_016"} |
| SCCS Opinion | NOAEL | =3.1 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen.","effect":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligman study: excessive staining due to the test substance made assessment “difficult” in 6/10 an","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_018"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear","dose":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997 Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 10 and 30 mg/kg bw/day, 7 days a w","page":17,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_001"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: hese differences in thyroid weights were not associated with relevant histopathological findings, they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 153","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: gan weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 1537, Replicates: triplicates in one experiment Test substance: Disperse Red 17 (WR 18044) Solvent: Deionised water Batch: 40T60N4520 (dye content: 31.0% by NMR) Purit","page":18,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_003"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"ary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range, and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics (ADME) No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data","page":25,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_006"} |
| SCCS Opinion | NOAEL | =0.0075 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"____________________________________________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorp","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_007"} |
| SCCS Opinion | NOAEL | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | {"dose":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_009"} |
| SCCS Opinion | NOAEL | =31 | % | rat | dermal | - | dermal absorption | {"dose":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect...","effect":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse ef","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_010"} |
| SCCS Opinion | NOAEL | =0.0055 | mg/kg | rat | dermal | - | dermal absorption | {"dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","effect":"Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a","page":26,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_011"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"ne content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alter","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_016"} |
| SCCS Opinion | NOAEL | =3.1 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen.","effect":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligman study: excessive staining due to the test substance made assessment “difficult” in 6/10 an","page":27,"pdf":"sccs_o_143.pdf","row_type":"noael_study","study_id":"sccs_o_143_noael_018"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"t reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure t","page":24,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_008"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"t reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure t","page":24,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_008"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"t reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure t","page":24,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_008"} |
| SCCS Opinion | NOAEL | =4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | {"dose":"General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","effect":"t reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure t","page":24,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_008"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_003"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_003"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_003"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_003"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_002"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_002"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_002"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | - | Chronic | NOAEL study | {"citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","effect":"SCCS-rejected applicant NOAEL: these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":17,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_002"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"citation":"Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear","dose":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997","page":16,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_001"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"citation":"Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear","dose":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997","page":16,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_001"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"citation":"Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear","dose":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997","page":16,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_001"} |
| SCCS Opinion | NOAEL | =41.2 | % | rat | - | 13 weeks | NOAEL study | {"citation":"Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear","dose":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","effect":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997","page":16,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_001"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"mary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":23,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_006"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"mary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":23,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_006"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"mary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":23,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_006"} |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","effect":"mary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":23,"pdf":"sccp_o_156.pdf","row_type":"noael_study","study_id":"sccp_o_156_noael_006"} |
Regulatory source 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 10 | mg/kg bw/day | rat | oral | 13 week | - | SOURCE_SUBDIR=out210_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE RED 17 COLIPA n° B5; OPINION_NUMBER=SCCNFP/0677/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=10; DOSE=When administered during organogenesis, the substance adversely affected maternal food consumption and bodyweight gain at doses of 125, 250 and 500mg/kg bw/day.; EFFECT=e not been addressed.. Disperse Red 17 was minimally toxic in an acute rat oral toxicity test. When administered during organogenesis, the substance adversely affected maternal food consumption and bodyweight gain at doses of 125, 250 and 500mg/kg bw/day. There was no evidence of foetotoxicity or teratogenicity. Two 13 week oral rat studies have been conducted. The first showed evidence of dose-related effects on the liver spleen and thyroid at doses of 100, 200 and 400 mg/kg bw/day. The second study established a NOAEL of 10 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. It was slightly irritating when applied neat to the rabbit eye but not to rabbit skin. It has been tested for sensitising potential using a Magnusson and Kligman protocol. Discoloration due to the staining properties of the dye precluded accurate evaluation of the skin and therefore the study should be considered equivocal. Percutaneous penetration has been inves; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"When administered during organogenesis, the substance adversely affected maternal food consumption and bodyweight gain at doses of 125, 250 and 500mg/kg bw/day.","duration":"13 week","effect":"e not been addressed.. Disperse Red 17 was minimally toxic in an acute rat oral toxicity test. When administered during organogenesis, the substance adversely affected maternal food consumption and bodyweight gain at doses of 125, 250 and 500mg/kg bw/day. There was no evidence of foetotoxicity or teratogenicity. Two 13 week oral rat studies have been conducted. The first showed evidence of dose-related effects on the liver spleen and thyroid at doses of 100, 200 and 400 mg/kg bw/day. The second study established a NOAEL of 10 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. It was slightly irritating when applied neat to the rabbit eye but not to rabbit skin. It has been tested for sensitising potential using a Magnusson and Kligman protocol. Discoloration due to the staining properties of the dye precluded accurate evaluation of the skin and therefore the study should be considered equivocal. Percutaneous penetration has been inves","endpoint":"","ingredient":"1-(4’-Nitrophenylazo)-2-methyl-4-bis-(beta-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":17,"route":"oral","species":"rat","study_id":"out210_en_noael_005"} |
| Regulatory source | - | 41.2 | % | rat | - | 13 weeks | - | SOURCE_SUBDIR=out210_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE RED 17 COLIPA n° B5; OPINION_NUMBER=SCCNFP/0677/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=41.2; DOSE=n high dose males and ovary weights were increased in mid and high dose females.; EFFECT=n high dose males and ovary weights were increased in mid and high dose females. Histopathology revealed dose-related incidence and severity of haemosiderin deposits in the spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. A NOAEL could not be established from this study. The significance of the increased incidence of hairloss in the top dose group is unclear. Ref. : 5.1 Low dose study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley rat, Crl:CD (SD) BR Group Size : 10 males + 10 females Test material : Disperse Red 17 formulated in purified water Batch no : 928017/02 (dye content : 41.2%) Dose : 0, 10 and 30 mg/kg bw/day Exposure period : 13 weeks GLP : in compliance Groups of 10 male and 10 female rats were dosed with the test; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"n high dose males and ovary weights were increased in mid and high dose females.","duration":"13 weeks","effect":"n high dose males and ovary weights were increased in mid and high dose females. Histopathology revealed dose-related incidence and severity of haemosiderin deposits in the spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. A NOAEL could not be established from this study. The significance of the increased incidence of hairloss in the top dose group is unclear. Ref. : 5.1 Low dose study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley rat, Crl:CD (SD) BR Group Size : 10 males + 10 females Test material : Disperse Red 17 formulated in purified water Batch no : 928017/02 (dye content : 41.2%) Dose : 0, 10 and 30 mg/kg bw/day Exposure period : 13 weeks GLP : in compliance Groups of 10 male and 10 female rats were dosed with the test","endpoint":"","ingredient":"1-(4’-Nitrophenylazo)-2-methyl-4-bis-(beta-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"%","noael_value":"41.2","page":8,"route":"","species":"rat","study_id":"out210_en_noael_001"} |
| Regulatory source | developmental toxicity | 125 | mg/kg bw/day | human | - | - | developmental toxicity | SOURCE_SUBDIR=out210_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE RED 17 COLIPA n° B5; OPINION_NUMBER=SCCNFP/0677/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=125; DOSE=The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.; EFFECT=fat and mammary tissue were observed. No other treatment-related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed, which were within the normal range and treated groups did not differ significantly from control. The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human female breast skin Method : Franz diffusion cell Test material : Disperse Red 17, 0.2 % in formulation Batch No : 928017/02 (dye content : 41.2 %) Dose Levels : circa 40 mg formulation in the; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref. : 11 2","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","duration":"","effect":"fat and mammary tissue were observed. No other treatment-related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed, which were within the normal range and treated groups did not differ significantly from control. The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref. : 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human female breast skin Method : Franz diffusion cell Test material : Disperse Red 17, 0.2 % in formulation Batch No : 928017/02 (dye content : 41.2 %) Dose Levels : circa 40 mg formulation in the","endpoint":"developmental toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl-4-bis-(beta-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"125","page":12,"route":"","species":"human","study_id":"out210_en_noael_004"} |
| Regulatory source | irritation | 10 | mg/kg bw/day | rat | - | - | irritation | SOURCE_SUBDIR=out210_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE RED 17 COLIPA n° B5; OPINION_NUMBER=SCCNFP/0677/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=10; DOSE=All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.; EFFECT=r minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25cm2 area of intact skin of 3 male rabbits. Semi-occlusive patches were applied and left in place for a 4-hour period. Remaining test substance; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","duration":"","effect":"r minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25cm2 area of intact skin of 3 male rabbits. Semi-occlusive patches were applied and left in place for a 4-hour period. Remaining test substance","endpoint":"irritation","ingredient":"1-(4’-Nitrophenylazo)-2-methyl-4-bis-(beta-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":9,"route":"","species":"rat","study_id":"out210_en_noael_003"} |
| Regulatory source | irritation | 30 | mg/kg bw/day | rat | - | - | irritation | SOURCE_SUBDIR=out210_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE RED 17 COLIPA n° B5; OPINION_NUMBER=SCCNFP/0677/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=30; DOSE=All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.; EFFECT=e levels. As these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","duration":"","effect":"e levels. As these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. The authors concluded that the dose of 30mg/kg bw/day was a No Observed Adverse Effect Level. Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day is concluded by the SCCNFP. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1992), 92/69/EEC. Annex V Species/strain : New Zealand albino rabbits Group size : 3 females Test material : Disperse Red 17 Batch No : 928017/02 Dose : 0.5g GLP : in compliance The substance (0.5 g moistened with water) was applied to a 6.25c","endpoint":"irritation","ingredient":"1-(4’-Nitrophenylazo)-2-methyl-4-bis-(beta-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":9,"route":"","species":"rat","study_id":"out210_en_noael_002"} |
| Regulatory source | - | 41.2 | % | rat | oral | 13 weeks | - | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=41.2; DOSE=spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.; EFFECT=spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997 Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 10 and 30 mg/kg bw/day, 7 days a w; CITATION=Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear; CITATION_NUMBERS=[25]; REFERENCE=Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear","dose":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","duration":"13 weeks","effect":"spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 SCCS comment The significance of the increased incidence of hair loss in all dose groups is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997 Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 10 and 30 mg/kg bw/day, 7 days a w","endpoint":"","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"%","noael_value":"41.2","page":17,"route":"oral","species":"rat","study_id":"sccs_o_143_noael_001"} |
| Regulatory source | - | 10 | mg/kg bw/day | rat | - | Chronic | - | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=10; DOSE=All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.; EFFECT=SCCS-rejected applicant NOAEL: in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg; CITATION_NUMBERS=[26,30,10,4]; REFERENCE=Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","duration":"Chronic","effect":"SCCS-rejected applicant NOAEL: in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":17,"route":"","species":"rat","study_id":"sccp_o_156_noael_003"} |
| Regulatory source | - | 30 | mg/kg bw/day | rat | - | Chronic | - | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=30; DOSE=All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.; EFFECT=SCCS-rejected applicant NOAEL: these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg; CITATION_NUMBERS=[26,30,10,4]; REFERENCE=Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","duration":"Chronic","effect":"SCCS-rejected applicant NOAEL: these differences in thyroid weights were not associated with relevant histopathological findings they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 Comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":17,"route":"","species":"rat","study_id":"sccp_o_156_noael_002"} |
| Regulatory source | - | 41.2 | % | rat | - | 13 weeks | - | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=41.2; DOSE=he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.; EFFECT=he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997; CITATION=Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear; CITATION_NUMBERS=[25]; REFERENCE=Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear","dose":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters.","duration":"13 weeks","effect":"he spleens of all female dose groups and mid and high male groups, corresponding to the changes in spleen weight and haematological parameters. Centrilobular hepatocyte hypertrophy was apparent in the livers of mid and high dose animals, with a greater incidence in the high dose and consistent with the liver weights and increases in ALT and AST. Ref.: 25 Comment The significance of the increased incidence of hairloss in the top dose group is unclear. Since compound related effects were noted in all dose groups, a NOAEL could not be established from this study. Low dose study Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD (SD) BR Group Size: 10 males + 10 females Test material: Disperse Red 17 formulated in purified water Batch: 928017/02 (dye content: 41.2%) Dose: 0, 10 and 30 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study period: 14 May 1997 – 14 august 1997","endpoint":"","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"%","noael_value":"41.2","page":16,"route":"","species":"rat","study_id":"sccp_o_156_noael_001"} |
| Regulatory source | dermal absorption | =0.0075 | mg/kg | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 0.0075; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...; EFFECT=____________________________________________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorp; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...","duration":"","effect":"____________________________________________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorp","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0075","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_007"} |
| Regulatory source | dermal absorption | =0.0075 | mg/kg | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 0.0075; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...; EFFECT=___________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption p; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dos...","duration":"","effect":"___________ 26 No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption p","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0075","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_008"} |
| Regulatory source | dermal absorption | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 1.55; DOSE=ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...; EFFECT=ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","duration":"","effect":"ation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1.55","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_009"} |
| Regulatory source | dermal absorption | 31 | % | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=31; DOSE=HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect...; EFFECT=HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse ef; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect...","duration":"","effect":"HE MARGIN OF SAFETY (Disperse Red 17) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.78 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.452 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0075 mg/kg No observed adverse effect level NOAEL = 3.1(mg/kg (one generation study, maternal toxicity, rat) bw/day)* Bioavailability 50%** adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse ef","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"%","noael_value":"31","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_010"} |
| Regulatory source | dermal absorption | =0.0055 | mg/kg | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 0.0055; DOSE=(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...; EFFECT=Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","duration":"","effect":"Safety adjusted NOAEL / SED = 205 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0055","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_011"} |
| Regulatory source | dermal absorption | =0.0055 | mg/kg | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 0.0055; DOSE=(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...; EFFECT=5 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a maximu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","duration":"","effect":"5 * corrected for dye content (31% dye) ** standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a maximu","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0055","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_012"} |
| Regulatory source | dermal absorption | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 1.55; DOSE=(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...; EFFECT=for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a maximum on-head concentration of 0.2 %, inclusive of dispersant.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","duration":"","effect":"for the testing of cosmetic ingredients and their safety evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a maximum on-head concentration of 0.2 %, inclusive of dispersant.","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1.55","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_013"} |
| Regulatory source | dermal absorption | =1.55 | mg/kg bw/day | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 1.55; DOSE=(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...; EFFECT=evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a maximum on-head concentration of 0.2 %, inclusive of dispersant.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"(Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAE...","duration":"","effect":"evaluation. (Disperse Red 17) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.57 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.3306 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0055 mg/kg No observed adverse effect level NOAEL = 3.1 (mg/kg (one generation study, maternal toxicity, rat) bw/day) Bioavailability 50% adjusted NOAEL = 1.55 mg/kg bw/day) Margin of Safety adjusted NOAEL / SED = 281 3.3.14. Discussion Physico-chemical properties Disperse Red 17 is used as a non-reactive hair colouring agent (direct dye) in oxidative hair dye formulations at a maximum on-head concentration of 2 % inclusive of dispersant; and it is used as a non-reactive hair colouring agent (direct dye) in semi-permanent hair dye formulations at a maximum on-head concentration of 0.2 %, inclusive of dispersant.","endpoint":"dermal absorption","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1.55","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_143_noael_014"} |
| Regulatory source | developmental toxicity | 30 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=30; DOSE=dex, weaning index, and survival rate in any treated group as compared to the controls.; EFFECT=dex, weaning index, and survival rate in any treated group as compared to the controls. Mean pup body weight at birth appeared to be slightly decreased at 200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%); CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 32 3","dose":"dex, weaning index, and survival rate in any treated group as compared to the controls.","duration":"developmental","effect":"dex, weaning index, and survival rate in any treated group as compared to the controls. Mean pup body weight at birth appeared to be slightly decreased at 200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%)","endpoint":"developmental toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":24,"route":"","species":"rat","study_id":"sccs_o_143_noael_004"} |
| Regulatory source | developmental toxicity | 30 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=30; DOSE=at 200 mg/kg bw/day as compared to the control, in particular in males.; EFFECT=at 200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%); CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 32 3","dose":"at 200 mg/kg bw/day as compared to the control, in particular in males.","duration":"developmental","effect":"at 200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%)","endpoint":"developmental toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":24,"route":"","species":"rat","study_id":"sccs_o_143_noael_005"} |
| Regulatory source | developmental toxicity | 125 | mg/kg bw/day | human | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=125; DOSE=The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.; EFFECT=ary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range, and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics (ADME) No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data; CITATION=Ref.: 33 3; CITATION_NUMBERS=[33,3]; REFERENCE=Ref.: 33 3; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","duration":"","effect":"ary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range, and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics (ADME) No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data","endpoint":"developmental toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"125","page":25,"route":"","species":"human","study_id":"sccs_o_143_noael_006"} |
| Regulatory source | developmental toxicity | 3.1 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=3.1; DOSE=xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen.; EFFECT=xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligman study: excessive staining due to the test substance made assessment “difficult” in 6/10 an; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen.","duration":"developmental","effect":"xposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligman study: excessive staining due to the test substance made assessment “difficult” in 6/10 an","endpoint":"developmental toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3.1","page":27,"route":"","species":"rabbit","study_id":"sccs_o_143_noael_018"} |
| Regulatory source | developmental toxicity | 30 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=30; DOSE=, weaning index, and survival rate in any treated group as compared to the controls.; EFFECT=, weaning index, and survival rate in any treated group as compared to the controls. Mean pup body weight at birth appeared to be slightly decreased at 200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike to their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%) Dose Levels: 0, 125, 250; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 32 3","dose":", weaning index, and survival rate in any treated group as compared to the controls.","duration":"developmental","effect":", weaning index, and survival rate in any treated group as compared to the controls. Mean pup body weight at birth appeared to be slightly decreased at 200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike to their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%) Dose Levels: 0, 125, 250","endpoint":"developmental toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":22,"route":"","species":"rat","study_id":"sccp_o_156_noael_004"} |
| Regulatory source | developmental toxicity | 30 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=30; DOSE=200 mg/kg bw/day as compared to the control, in particular in males.; EFFECT=200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike to their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%) Dose Levels: 0, 125, 250 and 500 mg/kg bw/day Treatment Period: Days 6-15 of pregnancy, inclusive GLP: in compliance Study period: 8 January – 1 February 1996 Groups of 24 fema; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 32 3","dose":"200 mg/kg bw/day as compared to the control, in particular in males.","duration":"developmental","effect":"200 mg/kg bw/day as compared to the control, in particular in males. Slightly lower body weight was also noted on lactation days 14 and 21. No behavioural or other physical abnormalities were observed in any dose group. Unlike to their high dose parents, the suckling pups were not discoloured at necropsy, nor were there any macroscopic observations. Conclusion The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Ref.: 32 3.3.8.2. Teratogenicity Taken from SCCNFP/0677/06 Guideline: OECD 414 (1981) Species/strain: Sprague-Dawley rat, Crl : CD (SD) BR Group size: 24 females (mated) Test material: Disperse Red 17 dispersed in water Batch: 928017/02 (dye content: 41.2%) Dose Levels: 0, 125, 250 and 500 mg/kg bw/day Treatment Period: Days 6-15 of pregnancy, inclusive GLP: in compliance Study period: 8 January – 1 February 1996 Groups of 24 fema","endpoint":"developmental toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":22,"route":"","species":"rat","study_id":"sccp_o_156_noael_005"} |
| Regulatory source | developmental toxicity | 125 | mg/kg bw/day | human | - | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=125; DOSE=The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.; EFFECT=mary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable; CITATION=Ref.: 33 3; CITATION_NUMBERS=[33,3]; REFERENCE=Ref.: 33 3; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 33 3","dose":"The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups.","duration":"","effect":"mary tissue were observed. No other treatment- related abnormalities were seen. The mean numbers of corpora lutea, implantation sites, post-implantation loss, live foetuses and foetal body weights were similar for control and treated groups. A small number of foetal malformations were observed which were within the normal range and treated groups did not differ significantly from control. Conclusion The test substance elicited maternal toxicity at the dose levels tested but was not embryotoxic or teratogenic. The NOAEL for maternal toxicity was less than 125 mg/kg bw/day. The observation of accumulation of the test substance in mammary tissue raises concern with respect to potential effects on the offspring during lactation. Ref.: 33 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","endpoint":"developmental toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"125","page":23,"route":"","species":"human","study_id":"sccp_o_156_noael_006"} |
| Regulatory source | genotoxicity | 30 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=30; DOSE=All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.; EFFECT=SCCS-rejected applicant NOAEL: hese differences in thyroid weights were not associated with relevant histopathological findings, they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 153; CITATION=Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4; CITATION_NUMBERS=[26,30,10,4]; REFERENCE=Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","duration":"Chronic","effect":"SCCS-rejected applicant NOAEL: hese differences in thyroid weights were not associated with relevant histopathological findings, they were considered not to be related to treatment. Other minor differences were noted in organ weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 153","endpoint":"genotoxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":18,"route":"","species":"rat","study_id":"sccs_o_143_noael_002"} |
| Regulatory source | genotoxicity | 10 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=10; DOSE=All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.; EFFECT=SCCS-rejected applicant NOAEL: gan weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 1537, Replicates: triplicates in one experiment Test substance: Disperse Red 17 (WR 18044) Solvent: Deionised water Batch: 40T60N4520 (dye content: 31.0% by NMR) Purit; CITATION=Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4; CITATION_NUMBERS=[26,30,10,4]; REFERENCE=Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4; DETAILS_JSON={"cas_number":"3179-89-3","citation":"Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4","dose":"All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance.","duration":"Chronic","effect":"SCCS-rejected applicant NOAEL: gan weights but were not considered to be treatment-related. All microscopic findings were considered to be within the normal range for the strain and age of rat and were similar in control and treated animals and therefore of no toxicological importance. Conclusion The authors concluded that the dose of 30 mg/kg bw/day was a No Observed Adverse Effect Level. Ref.: 26 SCCS comment Because of the changes in spleen weights observed at 30 mg/kg bw/day, which were consistent with the effects at higher dose levels, a NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw/day pure dye) was concluded by the SCCP. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA 1535 and TA 1537, Replicates: triplicates in one experiment Test substance: Disperse Red 17 (WR 18044) Solvent: Deionised water Batch: 40T60N4520 (dye content: 31.0% by NMR) Purit","endpoint":"genotoxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"","species":"rat","study_id":"sccs_o_143_noael_003"} |
| Regulatory source | repeated dose toxicity | 10 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=10; DOSE=General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.; EFFECT=ld not be used in combination with nitrosating agents. The nitrosamine content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slig; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","duration":"subchronic","effect":"ld not be used in combination with nitrosating agents. The nitrosamine content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slig","endpoint":"repeated dose toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":27,"route":"","species":"rat","study_id":"sccs_o_143_noael_015"} |
| Regulatory source | repeated dose toxicity | 4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=4; DOSE=General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.; EFFECT=ne content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alter; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","duration":"subchronic","effect":"ne content should be < 50ppb. The stability of Disperse Red 17 in the marketed products is not reported. General toxicity Disperse Red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alter","endpoint":"repeated dose toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw","noael_value":"4","page":27,"route":"","species":"rat","study_id":"sccs_o_143_noael_016"} |
| Regulatory source | repeated dose toxicity | 30 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_143; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCS/1522/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=30; DOSE=a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.; EFFECT=a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligma; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","duration":"subchronic","effect":"a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings, i.e. dose-related incidence and severity of haemosiderin deposits in the spleen. A NOAEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). This NOAEL will be used for MoS calculation. Irritation / sensitisation No signs of irritation were noted on the skin. Red/orange staining was reported at all-time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritating to the rabbit eye. Magnusson & Kligma","endpoint":"repeated dose toxicity","ingredient":"Disperse Red 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":27,"route":"","species":"rat","study_id":"sccs_o_143_noael_017"} |
| Regulatory source | repeated dose toxicity | 4 | mg/kg bw | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=4; DOSE=General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.; EFFECT=t reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","duration":"subchronic","effect":"t reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure t","endpoint":"repeated dose toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"4","page":24,"route":"","species":"rat","study_id":"sccp_o_156_noael_008"} |
| Regulatory source | repeated dose toxicity | 10 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=10; DOSE=General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.; EFFECT=ed. The stability of Disperse Red 17 in the marketed products is not reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","duration":"subchronic","effect":"ed. The stability of Disperse Red 17 in the marketed products is not reported. The stability of Disperse Red 17 in oxidative hair dye formulations has not been demonstrated. General toxicity Disperse red 17 demonstrated a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye.","endpoint":"repeated dose toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":24,"route":"","species":"rat","study_id":"sccp_o_156_noael_007"} |
| Regulatory source | repeated dose toxicity | 30 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_156; REPORT_TITLE=OPINION ON Disperse Red 17 COLIPA n° B5; OPINION_NUMBER=SCCP/1161/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=30; DOSE=ed a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.; EFFECT=ed a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritant to the rabbit eye. Sensitisation Magnusson & Kligman study: excessive staining due to the test su; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3179-89-3","citation":"","dose":"ed a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats.","duration":"subchronic","effect":"ed a low acute toxicity potential with LD50 values above 2000 mg/kg bw in rats. On subchronic exposure, changes in spleen weights were observed at 30 mg/kg bw/day, which were consistent with the histopathology findings i.e. dose-related incidence and severity of haemosiderin deposits in the spleen a NOEL of 10 mg/kg bw/day (or 4 mg/kg bw pure dye) is concluded. The NOAEL for developmental toxicity was set at 30 mg/kg bw/day. Because of the pigmentation of the splenic red pulp in the females at 30 mg/kg bw/day, the NOAEL for maternal toxicity was set at 10 mg/kg bw/day (or 3.1 mg/kg bw/day pure dye). Irritation No signs of irritation were noted on the skin. Red/orange staining was reported at all time points. A 3% test concentration caused only very slight short lasting conjunctival irritation of the rabbit eye. No alteration of the cornea was observed macroscopically. The pure test substance was considered to be slightly irritant to the rabbit eye. Sensitisation Magnusson & Kligman study: excessive staining due to the test su","endpoint":"repeated dose toxicity","ingredient":"1-(4’-Nitrophenylazo)-2-methyl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":24,"route":"","species":"rat","study_id":"sccp_o_156_noael_009"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | HHG9JOS5G7 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20N4O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HHG9JOS5G7"} |
| openFDA substances | FDA UNII substance identifier | HHG9JOS5G7 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20N4O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HHG9JOS5G7"} |
| openFDA substances | FDA UNII substance identifier | HHG9JOS5G7 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20N4O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HHG9JOS5G7"} |
| openFDA substances | FDA UNII substance identifier | HHG9JOS5G7 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20N4O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HHG9JOS5G7"} |