NOAEL Studies
Cosmetic Ingredient
Basic Red 51 NOAEL Studies
INCI: BASIC RED 51
CAS: 77061-58-6
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 | 91 day | Subchronic | SCCS; RCC Project 681322. (1998). Subchronic 13-week oral toxicity (feeding) study in therat |
SCCNFP_vision_codex 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"ation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"cable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"ation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"cable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"ation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"cable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"ation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"cable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.","effect":"higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 Species/strain : Albino Guinea pig, Ibm: GOHI, SPF Group Size : 4 males and 4 females Test material : MIP 2985 Batch no : CGF-F016740/0018 Purity : 98% Dose : 1.0, 0.5, 0.1%w/w Observ. period : 14 days GLP : in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentrations of 1.0, 0.5 and","page":8,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref. : 10 2","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"eated with 50, 25, 15 and 10% test material. The data indicated that MIP 2985 does not exhibit photoallergic potential. Ref. : 10 2.11. Safety evaluation Not applicable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.","effect":"higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 Species/strain : Albino Guinea pig, Ibm: GOHI, SPF Group Size : 4 males and 4 females Test material : MIP 2985 Batch no : CGF-F016740/0018 Purity : 98% Dose : 1.0, 0.5, 0.1%w/w Observ. period : 14 days GLP : in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentrations of 1.0, 0.5 and","page":8,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref. : 10 2","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"eated with 50, 25, 15 and 10% test material. The data indicated that MIP 2985 does not exhibit photoallergic potential. Ref. : 10 2.11. Safety evaluation Not applicable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.","effect":"higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 Species/strain : Albino Guinea pig, Ibm: GOHI, SPF Group Size : 4 males and 4 females Test material : MIP 2985 Batch no : CGF-F016740/0018 Purity : 98% Dose : 1.0, 0.5, 0.1%w/w Observ. period : 14 days GLP : in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentrations of 1.0, 0.5 and","page":8,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref. : 10 2","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"eated with 50, 25, 15 and 10% test material. The data indicated that MIP 2985 does not exhibit photoallergic potential. Ref. : 10 2.11. Safety evaluation Not applicable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 4 weeks | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.","effect":"higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 Species/strain : Albino Guinea pig, Ibm: GOHI, SPF Group Size : 4 males and 4 females Test material : MIP 2985 Batch no : CGF-F016740/0018 Purity : 98% Dose : 1.0, 0.5, 0.1%w/w Observ. period : 14 days GLP : in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentrations of 1.0, 0.5 and","page":8,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =12.25 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref. : 10 2","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","effect":"eated with 50, 25, 15 and 10% test material. The data indicated that MIP 2985 does not exhibit photoallergic potential. Ref. : 10 2.11. Safety evaluation Not applicable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","page":20,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) R","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) R","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) R","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) R","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"lasia considered as a non- neoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"lasia considered as a non- neoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"lasia considered as a non- neoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"lasia considered as a non- neoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":10,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) Replicate cells : 12 Analyt method : HPLC (detection at 523 nm). Detection li","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) Replicate cells : 12 Analyt method : HPLC (detection at 523 nm). Detection li","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) Replicate cells : 12 Analyt method : HPLC (detection at 523 nm). Detection li","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =180 | mg/kg bw/day | human | - | - | developmental toxicity | {"citation":"Ref. : 11 2","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) Replicate cells : 12 Analyt method : HPLC (detection at 523 nm). Detection li","page":13,"pdf":"out237_en.pdf","row_type":"noael_study","study_id":"out237_en_noael_006"} |
SCCS_vision_codex 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.005 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) =...","effect":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxici","page":29,"pdf":"sccs_o_067.pdf","row_type":"noael_study","study_id":"sccs_o_067_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.005 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) =...","effect":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxici","page":29,"pdf":"sccs_o_067.pdf","row_type":"noael_study","study_id":"sccs_o_067_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.005 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) =...","effect":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxici","page":29,"pdf":"sccs_o_067.pdf","row_type":"noael_study","study_id":"sccs_o_067_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.005 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) =...","effect":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxici","page":29,"pdf":"sccs_o_067.pdf","row_type":"noael_study","study_id":"sccs_o_067_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"________________________________________________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability i","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"________________________________________________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability i","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"________________________________________________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability i","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"________________________________________________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability i","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_007"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_______________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an o","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_______________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an o","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_______________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an o","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_______________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an o","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref: 4 3","dose":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration.","effect":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr","page":16,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref: 4 3","dose":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration.","effect":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr","page":16,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref: 4 3","dose":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration.","effect":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr","page":16,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =12.25 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref: 4 3","dose":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration.","effect":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr","page":16,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administra","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administra","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administra","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administra","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","effect":"d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c","page":18,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_002"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administration: oral, single gavage GLP: in compliance Study period: 1 – 14 September","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_006"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administration: oral, single gavage GLP: in compliance Study period: 1 – 14 September","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_006"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administration: oral, single gavage GLP: in compliance Study period: 1 – 14 September","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_006"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 11 3","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administration: oral, single gavage GLP: in compliance Study period: 1 – 14 September","page":24,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_006"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | - | oral | sub-chronic | repeated dose toxicity | {"dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","effect":"concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | - | oral | sub-chronic | repeated dose toxicity | {"dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","effect":"concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | - | oral | sub-chronic | repeated dose toxicity | {"dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","effect":"concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | - | oral | sub-chronic | repeated dose toxicity | {"dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","effect":"concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost","page":28,"pdf":"sccs_o_059.pdf","row_type":"noael_study","study_id":"sccs_o_059_noael_009"} |
ToxValDB_ECHA_IUCLID 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOEL | =20 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1cfe4b0a7c65d2303c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23102/7/9/3?documentUUID=b65d9bd1-9885-419b-b112-cd6d2ae0cdc2; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: mortality|maternal: pre and post implantation loss; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|mortality/survival|reproduction; STUDY_GROUP=ECHA IUCLID:15822261:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ef1a90d88e9e3dca57ca90c10aefd919 |
| ToxValDB_ECHA_IUCLID | NOEL | =180 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1cfe4b0a7c65d2303c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23102/7/9/3?documentUUID=b65d9bd1-9885-419b-b112-cd6d2ae0cdc2; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=fetus: changes in sex ratio|fetus: fetal/pup body weight changes|fetus: skeletal malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15820918:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a9d87503c7bb4089862f29569b6f597a |
UnifiedCodex:SCCNFP:beta.noael_studies 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | human | - | - | developmental toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=20; DOSE=Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.; EFFECT=io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) R; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref. : 11 2","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","duration":"","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) R","endpoint":"developmental toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":13,"route":"","species":"human","study_id":"out237_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 180 | mg/kg bw/day | human | - | - | developmental toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=180; DOSE=during foetal examination: externally, one cleft palate was observed in the low dose group.; EFFECT=during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) Replicate cells : 12 Analyt method : HPLC (detection at 523 nm). Detection li; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref. : 11 2","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","duration":"","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) In vitro study of percutaneous absorption Guideline : / Tissue : Human epidermal skin membrane (exposure area: 1 cm²) Method : Franz diffusion cells Test material : Basic Red 51, 0.214% in a hair dye formulation Batch No : CGF-F016740/0018 (Purity: 98.6%) Dose level : 103 mg/cm² of the formulation Receptor fluid : 25% (w/v) ethanol in PBS (pH 7.4) Replicate cells : 12 Analyt method : HPLC (detection at 523 nm). Detection li","endpoint":"developmental toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":13,"route":"","species":"human","study_id":"out237_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=ation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data; CITATION=Ref : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref : 5 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Sub-chronic","effect":"ation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":10,"route":"dermal","species":"","study_id":"out237_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=fuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=fuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data; CITATION=Ref : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref : 5 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref : 5 2","dose":"fuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Sub-chronic","effect":"fuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":10,"route":"dermal","species":"","study_id":"out237_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.; EFFECT=cable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"cable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":20,"route":"oral","species":"","study_id":"out237_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 12.25 | mg/kg | rat | dermal | 4 weeks | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=12.25; DOSE=Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.; EFFECT=higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 Species/strain : Albino Guinea pig, Ibm: GOHI, SPF Group Size : 4 males and 4 females Test material : MIP 2985 Batch no : CGF-F016740/0018 Purity : 98% Dose : 1.0, 0.5, 0.1%w/w Observ. period : 14 days GLP : in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentrations of 1.0, 0.5 and; CITATION=Ref : 4 2; CITATION_NUMBERS=[4,2]; REFERENCE=Ref : 4 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref : 4 2","dose":"Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.","duration":"4 weeks","effect":"higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 Species/strain : Albino Guinea pig, Ibm: GOHI, SPF Group Size : 4 males and 4 females Test material : MIP 2985 Batch no : CGF-F016740/0018 Purity : 98% Dose : 1.0, 0.5, 0.1%w/w Observ. period : 14 days GLP : in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentrations of 1.0, 0.5 and","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg","noael_value":"12.25","page":8,"route":"dermal","species":"rat","study_id":"out237_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 12.25 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=12.25; DOSE=The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.; EFFECT=eated with 50, 25, 15 and 10% test material. The data indicated that MIP 2985 does not exhibit photoallergic potential. Ref. : 10 2.11. Safety evaluation Not applicable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.; CITATION=Ref. : 10 2; CITATION_NUMBERS=[10,2]; REFERENCE=Ref. : 10 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref. : 10 2","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"eated with 50, 25, 15 and 10% test material. The data indicated that MIP 2985 does not exhibit photoallergic potential. Ref. : 10 2.11. Safety evaluation Not applicable 2.12. Conclusions Chemical identification of an impurity in the test material, content up to 0.4%, has not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12.25","page":20,"route":"oral","species":"","study_id":"out237_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=20; DOSE=The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.; EFFECT=not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"not been performed. No experimental data is provided on stability of the test material. The acute oral LD5O was set at 250 - 500 mg/kg bw in females and at 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was set at 12.25 mg/kg bw/day (repeated dose oral toxicity study). In light of the effects on the thyroid and pituitary (sub-chronic oral toxicity study), the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was not toxic to embryo or foetus and was not teratogenic. The NOEL for the maternal effects was set at 20 mg/kg bw/day and at 180 mg/kg bw/day for foetal effects. Basic Red 51was not irritating to the skin and moderately irritating to the eyes. It is not considered to be a sensitiser.","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":20,"route":"oral","species":"","study_id":"out237_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 50 | mg/kg | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out237_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51; OPINION_NUMBER=SCCNFP/0735/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=50; DOSE=An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=lasia considered as a non- neoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data; CITATION=Ref : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref : 5 2; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref : 5 2","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Sub-chronic","effect":"lasia considered as a non- neoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. The study authors estimated the NOAEL to be 50 mg/kg body weight/day, and the NOEL, 10 mg/kg/day, the lowest dose used. The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day in light of the effects on the thyroid and pituitary. Ref : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","endpoint":"repeated dose toxicity","ingredient":"2-[((4-Dimethylamino)phenyl)azo]-1,3-dimethyl-1H-imidazolium","loael_value":"","noael_unit":"mg/kg","noael_value":"50","page":10,"route":"dermal","species":"","study_id":"out237_en_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | mouse | oral | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=20; DOSE=Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.; EFFECT=io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administra; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 11 3","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","duration":"","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administra","endpoint":"developmental toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":24,"route":"oral","species":"mouse","study_id":"sccs_o_059_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg bw/day | - | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=20; DOSE=Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.; EFFECT=io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 11 3","dose":"Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group.","duration":"","effect":"io for foetuses was similar in all groups. Some abnormal findings were noted during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics","endpoint":"developmental toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":24,"route":"","species":"","study_id":"sccs_o_067_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 180 | mg/kg bw/day | mouse | oral | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=180; DOSE=during foetal examination: externally, one cleft palate was observed in the low dose group.; EFFECT=during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administration: oral, single gavage GLP: in compliance Study period: 1 – 14 September; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 11 3","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","duration":"","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Vibracolor® Red (MIP 2985) Batch: 21187FC3 3501-069 (radio-labelled) (2072 MBq/mmol; 56 mCi/mmol) Purity: 95.9% (containing about 4% inorganic salts) 98.15% (radio-labelled) Vehicle: water (MilliQ) Dose: 33 mg/kg bw Administration: oral, single gavage GLP: in compliance Study period: 1 – 14 September","endpoint":"developmental toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":24,"route":"oral","species":"mouse","study_id":"sccs_o_059_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 180 | mg/kg bw/day | - | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=180; DOSE=during foetal examination: externally, one cleft palate was observed in the low dose group.; EFFECT=during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 11 3","dose":"during foetal examination: externally, one cleft palate was observed in the low dose group.","duration":"","effect":"during foetal examination: externally, one cleft palate was observed in the low dose group. Skeletal changes included a small number of foetuses in each group with abnormally shaped sternebrae. These were not considered related to the test substance, as they were within the range for historical controls. Under the experimental conditions, MIP 2985 was not toxic to embryo or foetus and was not teratogenic. The study authors considered the NOEL for the maternal effects is 20 mg/kg bw/day and for foetal effects the NOEL is 180 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics","endpoint":"developmental toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180","page":24,"route":"","species":"","study_id":"sccs_o_067_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat; CITATION=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; CITATION_NUMBERS=[5,50,10]; REFERENCE=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Chronic","effect":"of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat","endpoint":"genotoxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"","species":"","study_id":"sccs_o_059_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells.; EFFECT=Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP 2985 Batch: 029753A8AA Purity: 98.8% by HPLC Concentrations: S. typhimurium Without metabolic activation Test #1: 3.; CITATION=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; CITATION_NUMBERS=[5,50,10]; REFERENCE=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells.","duration":"Chronic","effect":"Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP 2985 Batch: 029753A8AA Purity: 98.8% by HPLC Concentrations: S. typhimurium Without metabolic activation Test #1: 3.","endpoint":"genotoxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"","species":"","study_id":"sccs_o_059_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=10; DOSE=An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, the SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat; CITATION=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; CITATION_NUMBERS=[5,50,10]; REFERENCE=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Chronic","effect":"of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, the SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicat","endpoint":"genotoxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"","species":"","study_id":"sccs_o_067_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=10; DOSE=Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells.; EFFECT=Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, the SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP 2985 Batch: 029753A8AA Purity: 98.8% by HPLC; CITATION=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; CITATION_NUMBERS=[5,50,10]; REFERENCE=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells.","duration":"Chronic","effect":"Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, the SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP 2985 Batch: 029753A8AA Purity: 98.8% by HPLC","endpoint":"genotoxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"","species":"","study_id":"sccs_o_067_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 50 | mg/kg bw/d | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=50; DOSE=An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c; CITATION=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; CITATION_NUMBERS=[5,50,10]; REFERENCE=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Chronic","effect":"d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, The SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c","endpoint":"genotoxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":18,"route":"","species":"","study_id":"sccs_o_059_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 50 | mg/kg bw/d | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=50; DOSE=An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.; EFFECT=d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, the SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c; CITATION=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; CITATION_NUMBERS=[5,50,10]; REFERENCE=Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used","dose":"An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group.","duration":"Chronic","effect":"d as a nonneoplastic proliferation of cellular components of the interstitial gland. An increased diffuse fatty change was observed in the adrenal cortices of males and females of the high dose group. Thyroid of mid- and high-dose males and females showed an increased incidence of follicular cell hypertrophy, pigmented colloid, and pigmented follicular cells. The pituitary gland of males of these two groups showed an increased incidence of TSH/ACTH cell hypertrophy. Ref.: 5 Comment The study authors estimated the NOAEL to be 50 mg/kg bw/d, and the NOEL, 10 mg/kg bw/day, the lowest dose used. However, in light of the effects on the thyroid and pituitary at 50 mg/kg bw/d and higher, the SCCNFP concluded that the NOAEL should be 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0735/03 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium TA98, TA100, TA1535 and TA1537; E. c","endpoint":"genotoxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":18,"route":"","species":"","study_id":"sccs_o_067_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.005 | mg/kg | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 0.005; DOSE=m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) =...; EFFECT=m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxici; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) =...","duration":"subchronic","effect":"m2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxici","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.005","page":29,"route":"oral","species":"rat","study_id":"sccs_o_067_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.006 | mg/kg | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 0.006; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=________________________________________________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"subchronic","effect":"________________________________________________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability i","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.006","page":28,"route":"oral","species":"rat","study_id":"sccs_o_059_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.006 | mg/kg | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 0.006; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=SCCS/1436/11 Opinion on Basic Red 51 __________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"subchronic","effect":"SCCS/1436/11 Opinion on Basic Red 51 __________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.006","page":29,"route":"oral","species":"rat","study_id":"sccs_o_067_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 10; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=_______________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"subchronic","effect":"_______________________________________________ 28 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 0.2% and in oxidative hair dyes at a final concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an o","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 10","page":28,"route":"oral","species":"rat","study_id":"sccs_o_059_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10; DOSE=General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.; EFFECT=ere used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low. Irritation, sensitisation Basic Red 51 is considered as a non skin irritant in a skin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"ere used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low. Irritation, sensitisation Basic Red 51 is considered as a non skin irritant in a skin","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":28,"route":"oral","species":"","study_id":"sccs_o_059_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 10; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=n Basic Red 51 __________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formul; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"subchronic","effect":"n Basic Red 51 __________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Red 51 (non-oxidative) Absorption through the skin A (mean + 1SD) = 0.66 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formul","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 10","page":29,"route":"oral","species":"rat","study_id":"sccs_o_067_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =10 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 10; DOSE=t SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per tr...; EFFECT=t SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxicity The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"t SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per tr...","duration":"subchronic","effect":"t SAS x A x 0.001 = 0.383 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.006 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 1567 (oxidative) Absorption through the skin A (mean + 1SD) = 0.54 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.313 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.005 mg/kg No Observed Adverse Effect Level NOAEL = 10 mg/kg bw (subchronic, oral, rat) MOS = 2000 3.3.14. Discussion Physico-chemical specification Basic Red 51 is intended for use in direct hair dye formulations at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxicity The","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 10","page":29,"route":"oral","species":"rat","study_id":"sccs_o_067_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=10; DOSE=General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.; EFFECT=lations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"lations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low.","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":29,"route":"oral","species":"","study_id":"sccs_o_067_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 12.25 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=12.25; DOSE=SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration.; EFFECT=SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr; CITATION=Ref: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref: 4 3; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref: 4 3","dose":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration.","duration":"14 days","effect":"SCCS/1332/10 Opinion on Basic Red 51 __________________________________________________________________________________ 16 all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg","noael_value":"12.25","page":16,"route":"dermal","species":"rat","study_id":"sccs_o_059_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 12.25 | mg/kg | rat | dermal | 4 weeks | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=12.25; DOSE=Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.; EFFECT=higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr; CITATION=Ref: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref: 4 3; DETAILS_JSON={"cas_number":"77061-58-6","citation":"Ref: 4 3","dose":"Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female.","duration":"4 weeks","effect":"higher terminal body weights of the rats. Macroscopically, there was a reddish brown discoloration of the thyroid gland observed at 4 weeks in 80% of the males and in all the females of the high-dose group, 40% of the males in mid-dose group and one control female. At 6 weeks, all the high dose recovery group animals showed thyroid discoloration. All other lesions recorded were considered to be within the normal range of background findings commonly seen in rats of this strain and age. Based on these results, the NOAEL of MIP 2985 was estimated as 12.25 mg/kg body weight/day. Ref: 4 3.3.5.2. Repeated Dose (14 days) dermal toxicity Taken from SCCNFP/0735/03 Guideline: OECD Guideline 402 Species/strain: Albino Guinea pig, Ibm: GOHI, SPF Group Size: 4 males and 4 females Test material: MIP 2985 Batch: CGF-F016740/0018 Purity: 98% Dose: 1.0, 0.5, 0.1%w/w Observ. period: 14 days GLP: in compliance A 14-day repeated dose dermal toxicity study to assess the cumulative irritation potential with MIP 2985 was applied daily at concentr","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg","noael_value":"12.25","page":16,"route":"dermal","species":"rat","study_id":"sccs_o_067_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=20; DOSE=General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.; EFFECT=been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low. Irritation, sensitisation Basic Red 51 is considered as a non skin irritant in a skin irritation study; however, the acute dermal toxicity study shows that the substance is mildly irritating. Basic Red 51 is moderate; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low. Irritation, sensitisation Basic Red 51 is considered as a non skin irritant in a skin irritation study; however, the acute dermal toxicity study shows that the substance is mildly irritating. Basic Red 51 is moderate","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":28,"route":"oral","species":"","study_id":"sccs_o_059_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=20; DOSE=General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.; EFFECT=and its impurities. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"and its impurities. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost completely metabolized and eliminated with urine and faeces. Dermal absorption was very low.","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":29,"route":"oral","species":"","study_id":"sccs_o_067_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 2000 | mg/kg bw | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_059; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1332/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=2000; DOSE=General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.; EFFECT=concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"concentration of 0.1%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 1 and its impurities. The stability in an oxidative environment has not been demonstrated. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":28,"route":"oral","species":"","study_id":"sccs_o_059_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 2000 | mg/kg bw | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_067; REPORT_TITLE=OPINION ON Basic Red 51 COLIPA n° B116; OPINION_NUMBER=SCCS/1436/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=2000; DOSE=General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.; EFFECT=ns at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"77061-58-6","citation":"","dose":"General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males.","duration":"sub-chronic","effect":"ns at concentrations up to 1% and in oxidative hair dyes at a final concentration of 0.5%, after mixing with the oxidative agent. Stability of Basic Red 51 in typical hair dye formulations has been studied only for 24 hours. No reference materials were used for identification and quantification of Basic Red 51 and its impurities. General toxicity The acute oral LD5O is considered to be between 250 - 500 mg/kg bw in females and 500 - 1000 mg/kg bw in males. The acute dermal LD5O is greater than 2000 mg/kg bw. The NOAEL was considered to be 12.25 mg/kg bw/day in the repeated dose oral toxicity study. In the sub-chronic oral toxicity study, due to the effects on the thyroid and pituitary, the NOAEL was set at 10 mg/kg bw/day. Basic Red 51 was neither embryotoxic nor foetotoxic nor teratogenic in the performed assays. The NOEL for the maternal effects was considered to be 20 mg/kg bw/day and 180 mg/kg bw/day for foetal effects. Basic Red 51 was rapidly absorbed after oral dosing. The systemically absorbed test substance was almost","endpoint":"repeated dose toxicity","ingredient":"2-[(4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":29,"route":"oral","species":"","study_id":"sccs_o_067_noael_011"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | A7A946JJ6I | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H18N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A7A946JJ6I"} |
| openFDA substances | FDA UNII substance identifier | A7A946JJ6I | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H18N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A7A946JJ6I"} |
| openFDA substances | FDA UNII substance identifier | A7A946JJ6I | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H18N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A7A946JJ6I"} |
| openFDA substances | FDA UNII substance identifier | A7A946JJ6I | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H18N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A7A946JJ6I"} |