NOAEL Studies
Cosmetic Ingredient
Basic Orange 31 NOAEL Studies
INCI: BASIC ORANGE 31
CAS: 97404-02-9
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 229 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; RCC Project 699647. (1999). Subchronic 13-week oral toxicity (feeding) study in therat |
| COSMOS_DB | NOAEL | 66 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; RCC Project 699647. (1999). Subchronic 13-week oral toxicity (feeding) study in therat |
SCCNFP_vision_codex 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"st substance- related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in do","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in double distilled water. One male and female served as control","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | - | dermal | - | repeated dose toxicity | {"citation":"Ref : 3 2","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose-related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref : 3 2.3.6. Repeated dose inhalation toxicity No data","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4 hours GLP : In compliance After clipping t","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"purity dye with less salt content. A high salt content may increase dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"se dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"e. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"st substance- related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in do","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in double distilled water. One male and female served as control","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | - | dermal | - | repeated dose toxicity | {"citation":"Ref : 3 2","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose-related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref : 3 2.3.6. Repeated dose inhalation toxicity No data","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4 hours GLP : In compliance After clipping t","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"purity dye with less salt content. A high salt content may increase dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"se dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"e. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"st substance- related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in do","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in double distilled water. One male and female served as control","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | - | dermal | - | repeated dose toxicity | {"citation":"Ref : 3 2","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose-related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref : 3 2.3.6. Repeated dose inhalation toxicity No data","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4 hours GLP : In compliance After clipping t","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"purity dye with less salt content. A high salt content may increase dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"se dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"e. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"st substance- related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in do","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw | rat | dermal | 14 days | repeated dose toxicity | {"citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","effect":"organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in double distilled water. One male and female served as control","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | - | dermal | - | repeated dose toxicity | {"citation":"Ref : 3 2","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose-related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref : 3 2.3.6. Repeated dose inhalation toxicity No data","page":7,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4 hours GLP : In compliance After clipping t","page":9,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =53 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"purity dye with less salt content. A high salt content may increase dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =18 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"se dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | {"dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","effect":"e. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","page":21,"pdf":"out236_en.pdf","row_type":"noael_study","study_id":"out236_en_noael_009"} |
SCCS_vision_codex 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =94.1 | % | rabbit | dermal | - | irritation | {"citation":"Ref.: 3 3","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose- related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref.: 3 3.3.2.2. Mucous membrane irritation Taken from SCCS/1334/10 Study 1 Guideline: OECD 405 (1981) Species/strain: albino rabbits, New Zealand Group size: 3 females Test substance: MIP 3100 Batch: 013673A1 Purity: 94.1% (as chloride salt) Dose: 0.045 g (neat substance) GLP: In compliance The test material was placed into the averted lower lid of the right eye of each animal. The left eye served as the untreated control. The eyes of the 3 animal","page":11,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"est substance related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theo","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_002"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"ights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theoretical dose levels of 20, 70 and 250 mg/kg bw/day","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_003"} |
| SCCS_vision_codex | NOAEL | =18 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"nces from control. Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 S","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_004"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 Salmonella strains: 10.0, 33.3, 100,","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0013 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_007"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...","effect":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_010"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","effect":"ssion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_012"} |
| SCCS_vision_codex | NOAEL | =94.1 | % | rabbit | dermal | - | irritation | {"citation":"Ref.: 3 3","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose- related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref.: 3 3.3.2.2. Mucous membrane irritation Taken from SCCS/1334/10 Study 1 Guideline: OECD 405 (1981) Species/strain: albino rabbits, New Zealand Group size: 3 females Test substance: MIP 3100 Batch: 013673A1 Purity: 94.1% (as chloride salt) Dose: 0.045 g (neat substance) GLP: In compliance The test material was placed into the averted lower lid of the right eye of each animal. The left eye served as the untreated control. The eyes of the 3 animal","page":11,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"est substance related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theo","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_002"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"ights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theoretical dose levels of 20, 70 and 250 mg/kg bw/day","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_003"} |
| SCCS_vision_codex | NOAEL | =18 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"nces from control. Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 S","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_004"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 Salmonella strains: 10.0, 33.3, 100,","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0013 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_007"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...","effect":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_010"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","effect":"ssion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_012"} |
| SCCS_vision_codex | NOAEL | =94.1 | % | rabbit | dermal | - | irritation | {"citation":"Ref.: 3 3","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose- related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref.: 3 3.3.2.2. Mucous membrane irritation Taken from SCCS/1334/10 Study 1 Guideline: OECD 405 (1981) Species/strain: albino rabbits, New Zealand Group size: 3 females Test substance: MIP 3100 Batch: 013673A1 Purity: 94.1% (as chloride salt) Dose: 0.045 g (neat substance) GLP: In compliance The test material was placed into the averted lower lid of the right eye of each animal. The left eye served as the untreated control. The eyes of the 3 animal","page":11,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"est substance related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theo","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_002"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"ights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theoretical dose levels of 20, 70 and 250 mg/kg bw/day","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_003"} |
| SCCS_vision_codex | NOAEL | =18 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"nces from control. Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 S","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_004"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 Salmonella strains: 10.0, 33.3, 100,","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0013 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_007"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...","effect":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_010"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","effect":"ssion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_012"} |
| SCCS_vision_codex | NOAEL | =94.1 | % | rabbit | dermal | - | irritation | {"citation":"Ref.: 3 3","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose.","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose- related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref.: 3 3.3.2.2. Mucous membrane irritation Taken from SCCS/1334/10 Study 1 Guideline: OECD 405 (1981) Species/strain: albino rabbits, New Zealand Group size: 3 females Test substance: MIP 3100 Batch: 013673A1 Purity: 94.1% (as chloride salt) Dose: 0.045 g (neat substance) GLP: In compliance The test material was placed into the averted lower lid of the right eye of each animal. The left eye served as the untreated control. The eyes of the 3 animal","page":11,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_001"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"est substance related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theo","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_002"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","effect":"ights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theoretical dose levels of 20, 70 and 250 mg/kg bw/day","page":18,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_003"} |
| SCCS_vision_codex | NOAEL | =18 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"nces from control. Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 S","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_004"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref: 5 3","dose":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","effect":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 Salmonella strains: 10.0, 33.3, 100,","page":19,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0013 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_007"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","page":28,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...","effect":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_010"} |
| SCCS_vision_codex | NOAEL | =53 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","effect":"ssion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were","page":29,"pdf":"sccs_o_082.pdf","row_type":"noael_study","study_id":"sccs_o_082_noael_012"} |
UnifiedCodex:SCCNFP:beta.noael_studies 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 60 | mg/kg | human | - | - | developmental toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=60; DOSE=Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group).; EFFECT=were unaffected. Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group). Delayed ossification commonly occurs secondary to maternal toxicity. Thus the skeletal findings were considered unrelated to the tested product. Based on these results, the study authors considered the NOAEL to be 60 mg/kg body weight/day for maternal and foetal effects. MIP Orange 3100 did not reveal any teratogenic effects. Ref. : 12 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 Orange 31, 0.200 % dye in a hair dye formulation Batch No : CGF-F020088/0010, purity: 98.0 % Dose level : 101 mg/cm² of the formulation; 202 µg/cm² of; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref. : 12 2","dose":"Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group).","duration":"","effect":"were unaffected. Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group). Delayed ossification commonly occurs secondary to maternal toxicity. Thus the skeletal findings were considered unrelated to the tested product. Based on these results, the study authors considered the NOAEL to be 60 mg/kg body weight/day for maternal and foetal effects. MIP Orange 3100 did not reveal any teratogenic effects. Ref. : 12 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 Orange 31, 0.200 % dye in a hair dye formulation Batch No : CGF-F020088/0010, purity: 98.0 % Dose level : 101 mg/cm² of the formulation; 202 µg/cm² of","endpoint":"developmental toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"60","page":13,"route":"","species":"human","study_id":"out236_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 15 | mg/kg | rat | dermal | 14 days | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=15; DOSE=These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.; EFFECT=st substance- related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in do; CITATION=Ref : 4 2; CITATION_NUMBERS=[4,2]; REFERENCE=Ref : 4 2; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","duration":"14 days","effect":"st substance- related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in do","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"15","page":7,"route":"dermal","species":"rat","study_id":"out236_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 53 | mg/kg bw | rat | dermal | 14 days | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=53; DOSE=These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.; EFFECT=organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in double distilled water. One male and female served as control; CITATION=Ref : 4 2; CITATION_NUMBERS=[4,2]; REFERENCE=Ref : 4 2; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref : 4 2","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw.","duration":"14 days","effect":"organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg body weight/day and a NOAEL of 53 mg/kg bw. Ref : 4 2.3.5. Repeated dose dermal toxicity Guideline : OECD Guideline 402 (1987) Species/strain : Albino Guinea pig Group Size : 4 males and 4 females Test material : MIP ORANGE 3100 Batch no : CGF-F020088/0010 Purity : 98% Dose : 5.0, 3.0, 1.0 or 0.5 w/w Observ. period : 14 days GLP : in compliance To assess the cumulative irritation potential, MIP ORANGE 3100 was applied daily at concentrations of 5.0, 3.0, 1.0 or 0.5 % w/w in double distilled water. One male and female served as control","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg bw","noael_value":"53","page":7,"route":"dermal","species":"rat","study_id":"out236_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 1 | % | - | dermal | - | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=1; DOSE=Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose.; EFFECT=ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose-related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref : 3 2.3.6. Repeated dose inhalation toxicity No data; CITATION=Ref : 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref : 3 2; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref : 3 2","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose.","duration":"","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1 % dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose-related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref : 3 2.3.6. Repeated dose inhalation toxicity No data","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"%","noael_value":"1","page":7,"route":"dermal","species":"","study_id":"out236_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 18 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=18; DOSE=Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.; EFFECT=SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4; CITATION=Ref : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref : 5 2; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","duration":"Sub-chronic","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"18","page":9,"route":"dermal","species":"rat","study_id":"out236_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 60 | mg/kg | rat | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=60; DOSE=Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.; EFFECT=SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4 hours GLP : In compliance After clipping t; CITATION=Ref : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref : 5 2; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref : 5 2","dose":"Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment.","duration":"Sub-chronic","effect":"SCCNFP/0736/03 Evaluation and opinion on : Basic Orange 31 _____________________________________________________________________________________________ 9 findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg body weight/day and the NOAEL, 60 mg/kg. bw/day. 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 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : albino rabbits, New Zealand Group size : 2 males, 1 female Test substance : MIP Orange 3100 Batch number : 013673A1 Purity : 94.1% (expressed as the chloride) Dose : 0.5g applied to 6.25 cm2 of intact skin for 4 hours GLP : In compliance After clipping t","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"60","page":9,"route":"dermal","species":"rat","study_id":"out236_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 53 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=53; DOSE=The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.; EFFECT=purity dye with less salt content. A high salt content may increase dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","duration":"sub-chronic","effect":"purity dye with less salt content. A high salt content may increase dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"53","page":21,"route":"oral","species":"","study_id":"out236_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 18 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=18; DOSE=The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.; EFFECT=se dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","duration":"sub-chronic","effect":"se dermal penetration of the dye. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":21,"route":"oral","species":"","study_id":"out236_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 60 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=60; DOSE=The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.; EFFECT=e. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","duration":"sub-chronic","effect":"e. The chemical identification of 1.3% Basic Orange 31 in one of the test batches is not provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":21,"route":"oral","species":"","study_id":"out236_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 60 | mg/kg bw/day | - | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out236_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC ORANGE 31; OPINION_NUMBER=SCCNFP/0736/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=60; DOSE=The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.; EFFECT=ot provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg.","duration":"sub-chronic","effect":"ot provided. Data provided on stability of the test material is insufficient. Acute oral toxicity : none of the animals showed signs of toxicity or adverse effects. The study indicated a LD50 greater than l000 mg/kg but less than 2000 mg/kg. The acute dermal LD5O is greater than 2000 mg/kg bw. A repeated dose oral toxicity suggests a NOAEL of 53 mg/kg bw/day. The sub-chronic oral toxicity yielded a NOEL of 18 mg/kg bw/day and an NOAEL of 60 mg/kg bw/day. Basic Orange 31 did not reveal any teratogenic effects. The NOAEL was set at 60 mg/kg bw/day for maternal and foetal effects. The test material was considered to be slightly irritating to the skin. A 1% solution was slightly irritating to the eye. It was considered not to be a sensitiser. It induces delayed contact hypersensitivity in the murine Local Lymph Node Assay.","endpoint":"repeated dose toxicity","ingredient":"2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-Imidazolium chloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":21,"route":"oral","species":"","study_id":"out236_en_noael_010"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0013 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 0.0013; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"90-day","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","endpoint":"dermal absorption","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0013","page":28,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"90-day","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","endpoint":"dermal absorption","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":28,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=stigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"90-day","effect":"stigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Orange 31 non-oxidative conditions Absorption through the skin A (mean + 1SD) = 0.136 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.08 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0013 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 46 000","endpoint":"dermal absorption","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":28,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 0.0011; DOSE=SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...; EFFECT=SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...","duration":"90-day","effect":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic","endpoint":"dermal absorption","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0011","page":29,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =60 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT== 60; DOSE=SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...; EFFECT=SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg...","duration":"90-day","effect":"SCCS/1447/11 0pinion on Basic Orange 31 ___________________________________________________________________________________________ 29 oxidative conditions Absorption through the skin A (mean + 1SD) = 0.112 µg/cm² Skin Area surface SAS (cm2) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.065 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No Observed Adverse Effect Level NOAEL = 60 mg/kg bw (90-day, oral, rat) MOS (rounded) NOAEL/ SED = 55 000 3.3.14. Discussion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange","endpoint":"dermal absorption","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":29,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 60 | mg/kg bw/day | mouse | oral | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=60; DOSE=Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group).; EFFECT=were unaffected. Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group). Delayed ossification commonly occurs secondary to maternal toxicity. Thus the skeletal findings were considered unrelated to the tested product. Based on these results, the study authors considered the NOAEL to be 60 mg/kg bw/day for maternal and foetal effects. MIP Orange 3100 did not reveal any teratogenic effects. Ref.: 12 3.3.9. Toxicokinetics Taken from SCCS/1334/10 Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Orange (MIP 3100) Batch: 028407A2 3496175 (radio-labelled, 1295 MBq/mmol; 35 mCi/mmol) Purity: 94.6% > 97% (radio-labelled) Vehicle: purified water Dose: 100 mg/kg bw Administration: oral; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref.: 12 3","dose":"Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group).","duration":"","effect":"were unaffected. Some abnormal findings were noted on external features (one abdominal hernia in the low-dose group; low weight, cleft palate and tail defects in the high-dose group) and skeletal parameters (small number of shaped sternebrae or wavy ribs in all groups, delayed ossification in the high dose group). Delayed ossification commonly occurs secondary to maternal toxicity. Thus the skeletal findings were considered unrelated to the tested product. Based on these results, the study authors considered the NOAEL to be 60 mg/kg bw/day for maternal and foetal effects. MIP Orange 3100 did not reveal any teratogenic effects. Ref.: 12 3.3.9. Toxicokinetics Taken from SCCS/1334/10 Bioavailability after oral administration, mice Guideline: OECD 417 (1984) Species/strain: Hybrid mice, NMRI, SPF-quality Group Size: 15 females Test material: Orange (MIP 3100) Batch: 028407A2 3496175 (radio-labelled, 1295 MBq/mmol; 35 mCi/mmol) Purity: 94.6% > 97% (radio-labelled) Vehicle: purified water Dose: 100 mg/kg bw Administration: oral","endpoint":"developmental toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":25,"route":"oral","species":"mouse","study_id":"sccs_o_082_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 18 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=18; DOSE=Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.; EFFECT=nces from control. Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 S; CITATION=Ref: 5 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref: 5 3; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref: 5 3","dose":"Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","duration":"Chronic","effect":"nces from control. Compared with the control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 S","endpoint":"genotoxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"18","page":19,"route":"","species":"rat","study_id":"sccs_o_082_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 60 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=60; DOSE=he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.; EFFECT=he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 Salmonella strains: 10.0, 33.3, 100,; CITATION=Ref: 5 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref: 5 3; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref: 5 3","dose":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw.","duration":"Chronic","effect":"he control group, a slight increase in relative kidney weight and a decrease in relative heart weight were observed and attributed to the test article at the high dose of 250 mg/kg bw. All macroscopic findings observed were similar in treated and control animals. Some microscopic findings, classified as either minimal or slight, differed from treated and controls rats: hepatocellular hypertrophy considered as a metabolic response to the treatment. The study authors estimated the NOEL to be 18 mg/kg bw/day and the NOAEL, 60 mg/kg bw/day. Ref: 5 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 SCCS/1334/10 Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA Replicates: Triplicate plates, 2 independent tests Test substance: MIP Orange 3100 Solvent: water Batch: 013673A1 Purity: 94.1% Concentrations: Experiment 1 Salmonella strains: 10.0, 33.3, 100,","endpoint":"genotoxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":19,"route":"","species":"rat","study_id":"sccs_o_082_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 94.1 | % | rabbit | dermal | - | irritation | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=94.1; DOSE=Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose.; EFFECT=ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose- related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref.: 3 3.3.2.2. Mucous membrane irritation Taken from SCCS/1334/10 Study 1 Guideline: OECD 405 (1981) Species/strain: albino rabbits, New Zealand Group size: 3 females Test substance: MIP 3100 Batch: 013673A1 Purity: 94.1% (as chloride salt) Dose: 0.045 g (neat substance) GLP: In compliance The test material was placed into the averted lower lid of the right eye of each animal. The left eye served as the untreated control. The eyes of the 3 animal; CITATION=Ref.: 3 3; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 3; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref.: 3 3","dose":"Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose.","duration":"","effect":"ained coloured. Macroscopic isolated reddish foci in the subcutis were noted in one animal at 1% dose. The skin, at vehicle alone sites, showed no histopathological changes. The MIP Orange 3100 application sites showed minimal to moderate epidermal hyperplasia and in some cases with minimal to slight dermal inflammatory cell infiltrate. These observations were not dose- related. No deaths occurred during the study. MIP Orange 3100 is considered to be non-irritant when tested under these experimental conditions. A NOEL could not be established under these experimental conditions. Ref.: 3 3.3.2.2. Mucous membrane irritation Taken from SCCS/1334/10 Study 1 Guideline: OECD 405 (1981) Species/strain: albino rabbits, New Zealand Group size: 3 females Test substance: MIP 3100 Batch: 013673A1 Purity: 94.1% (as chloride salt) Dose: 0.045 g (neat substance) GLP: In compliance The test material was placed into the averted lower lid of the right eye of each animal. The left eye served as the untreated control. The eyes of the 3 animal","endpoint":"irritation","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"%","noael_value":"94.1","page":11,"route":"dermal","species":"rabbit","study_id":"sccs_o_082_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=15; DOSE=These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.; EFFECT=est substance related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theo; CITATION=Ref.: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref.: 4 3; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","duration":"Sub-chronic","effect":"est substance related differences in any organ weights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theo","endpoint":"repeated dose toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":18,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 53 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=53; DOSE=These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.; EFFECT=ights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theoretical dose levels of 20, 70 and 250 mg/kg bw/day; CITATION=Ref.: 4 3; CITATION_NUMBERS=[4,3]; REFERENCE=Ref.: 4 3; DETAILS_JSON={"cas_number":"97404-02-9","citation":"Ref.: 4 3","dose":"These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw.","duration":"Sub-chronic","effect":"ights or organ weight ratios compared with the controls were evident either at the end of the treatment or recovery. All macroscopic and microscopic findings observed (renal pelvic dilatation, bilateral dilatation of the uterine horns, incomplete deflation of the lung, one renal nephroblastoma) were considered to be within the normal range of background findings commonly seen in rats of this strain and age and not related to MIP Orange 3100. These results suggest a NOEL of MIP Orange 3100 at 15 mg/kg bw/day and a NOAEL of 53 mg/kg bw. Ref.: 4 3.3.5.3. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCS/1334/10 Guideline: OECD 408 (1981) and Directive 96/54/EEC Species/strain: Wistar rat, Hannover (SPF) Group Size: 10 males + 10 females per dose Test material: MIP ORANGE 3100 Batch: CGF-F020088//0010 Purity: 98% Dose: 0, 20, 70 and 250 mg/kg bw/day Exposure period: 13 weeks GLP: in compliance Study date 1999 MIP Orange 3100 was administered in feed at theoretical dose levels of 20, 70 and 250 mg/kg bw/day","endpoint":"repeated dose toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw","noael_value":"53","page":18,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 53 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=53; DOSE=General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.; EFFECT=ssion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","duration":"28-day","effect":"ssion Physico-chemical specification Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were","endpoint":"reproductive toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"53","page":29,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 53 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=53; DOSE=General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.; EFFECT=ion Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were decrea; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","duration":"28-day","effect":"ion Basic Orange 31 is incorporated in non-oxidative hair dye formulations at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were decrea","endpoint":"reproductive toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"53","page":29,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 60 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=60; DOSE=General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.; EFFECT=s at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were decreased maternal weight and foetal body weights. This lead to delayed foetal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw.","duration":"28-day","effect":"s at a maximum concentration of 1.0%, and in oxidative hair dye formulations at a maximum final concentration of 0.5%, after mixing with the oxidative agent. The stability of Basic Orange 31 in typical hair dye formulations is not reported. General toxicity In an acute oral toxicity study, the calculated LD50 of Basic Orange 31 was between l000 and 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were decreased maternal weight and foetal body weights. This lead to delayed foetal","endpoint":"reproductive toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":29,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 60 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_082; REPORT_TITLE=OPINION ON Basic Orange 31 COLIPA n° B118; OPINION_NUMBER=SCCS/1447/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=60; DOSE=In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day.; EFFECT=nd 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were decreased maternal weight and foetal body weights. This lead to delayed foetal ossification that commonly occurs secondary to maternal toxicity. Irritation, sensitisation Basic Orange 31 is slightly irritating to rabbit skin, and is severely irritating to the eye undiluted and slight irritant in a 1% dilution. Basic Orange 31 is a moderate sensitiser. Dermal absorption In an in vitro dermal absorption assay using human sk; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"97404-02-9","citation":"","dose":"In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day.","duration":"28-day","effect":"nd 2000 mg/kg bw. In an oral 28-day feeding study in rats, the No Observed Adverse Effect Level (NOAEL) was 53 mg/kg bw/day. In an oral 90-day feeding study in rats, the NOAEL was 60 mg/kg bw/day. Adverse effects observed in this study were statistically significant alterations in some haematological and biochemical parameters with hepatocellular hypertrophy, a metabolic response to the test substance. No data on two-generation reproductive toxicity was submitted. In a teratogenicity study, the maternal and foetal NOAEL was 60 mg/kg bw/day. The only effects considered adverse observed at 60 mg/kg bw/day were decreased maternal weight and foetal body weights. This lead to delayed foetal ossification that commonly occurs secondary to maternal toxicity. Irritation, sensitisation Basic Orange 31 is slightly irritating to rabbit skin, and is severely irritating to the eye undiluted and slight irritant in a 1% dilution. Basic Orange 31 is a moderate sensitiser. Dermal absorption In an in vitro dermal absorption assay using human sk","endpoint":"reproductive toxicity","ingredient":"Basic Orange 31","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":29,"route":"oral","species":"rat","study_id":"sccs_o_082_noael_015"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | O1JIQ710E2 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H14N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O1JIQ710E2"} |
| openFDA substances | FDA UNII substance identifier | O1JIQ710E2 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H14N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O1JIQ710E2"} |
| openFDA substances | FDA UNII substance identifier | O1JIQ710E2 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H14N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O1JIQ710E2"} |
| openFDA substances | FDA UNII substance identifier | O1JIQ710E2 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H14N5.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O1JIQ710E2"} |