NOAEL Studies
Cosmetic Ingredient
2-Nitro-5-Glyceryl Methylaniline NOAEL Studies
INCI: 2-NITRO-5-GLYCERYL METHYLANILINE
CAS: 80062-31-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 50 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; C. Fabreguettes. Imexine FT: 13-Week Toxicity Study by Oral Route in Rats. CITStudy No. 11389 TCR (CIES1 94022), 1995 |
SCCNFP_vision_codex 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | - | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data","page":6,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rabbit | oral | 30 d | repeated dose toxicity | {"dose":"Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw.","effect":"ive data on solubility and stability of 2- nitro-5-glyceryl methylamine have been provided. Solubility of the compound in the receptor fluid used for percutaneous absorption study has not been reported. 2-nitro-5-glyceryl methylamine is a secondary alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw. The test substance was considered as non-irritant to the intact rabbit skin and eye at a 1% suspension in 1,2-propanediol. The macroscopic and histological results indicated that the test substance did not produce any cutaneous sensitisation reaction in guinea pigs. However, the study does not conform with OECD guidelines. Teratogenicity studies lead to the result that 300 mg/kg bw showed no evidence of maternal toxicity, embryotoxicity or teratogenic","page":16,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | - | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data","page":6,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rabbit | oral | 30 d | repeated dose toxicity | {"dose":"Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw.","effect":"ive data on solubility and stability of 2- nitro-5-glyceryl methylamine have been provided. Solubility of the compound in the receptor fluid used for percutaneous absorption study has not been reported. 2-nitro-5-glyceryl methylamine is a secondary alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw. The test substance was considered as non-irritant to the intact rabbit skin and eye at a 1% suspension in 1,2-propanediol. The macroscopic and histological results indicated that the test substance did not produce any cutaneous sensitisation reaction in guinea pigs. However, the study does not conform with OECD guidelines. Teratogenicity studies lead to the result that 300 mg/kg bw showed no evidence of maternal toxicity, embryotoxicity or teratogenic","page":16,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | - | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data","page":6,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rabbit | oral | 30 d | repeated dose toxicity | {"dose":"Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw.","effect":"ive data on solubility and stability of 2- nitro-5-glyceryl methylamine have been provided. Solubility of the compound in the receptor fluid used for percutaneous absorption study has not been reported. 2-nitro-5-glyceryl methylamine is a secondary alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw. The test substance was considered as non-irritant to the intact rabbit skin and eye at a 1% suspension in 1,2-propanediol. The macroscopic and histological results indicated that the test substance did not produce any cutaneous sensitisation reaction in guinea pigs. However, the study does not conform with OECD guidelines. Teratogenicity studies lead to the result that 300 mg/kg bw showed no evidence of maternal toxicity, embryotoxicity or teratogenic","page":16,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | - | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data","page":6,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rabbit | oral | 30 d | repeated dose toxicity | {"dose":"Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw.","effect":"ive data on solubility and stability of 2- nitro-5-glyceryl methylamine have been provided. Solubility of the compound in the receptor fluid used for percutaneous absorption study has not been reported. 2-nitro-5-glyceryl methylamine is a secondary alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw. The test substance was considered as non-irritant to the intact rabbit skin and eye at a 1% suspension in 1,2-propanediol. The macroscopic and histological results indicated that the test substance did not produce any cutaneous sensitisation reaction in guinea pigs. However, the study does not conform with OECD guidelines. Teratogenicity studies lead to the result that 300 mg/kg bw showed no evidence of maternal toxicity, embryotoxicity or teratogenic","page":16,"pdf":"out212_en.pdf","row_type":"noael_study","study_id":"out212_en_noael_002"} |
SCCS_vision_codex 44 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.","page":14,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_001"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg/day | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Geno","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_003"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 dissolved in DMSO Batch: Batch op26 Purity: / Concentrations: 9 concentrations – direct plate incorporation assay With and without metabolic activation","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_004"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":"day 16. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.","page":26,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 13-week | irritation | {"dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","effect":"y amine, and thus, prone to nitrosation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-n","page":28,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_007"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 Comment","dose":"Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically.","effect":"g/kg bw/day correlated with cortical cell vacuolation. Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically. Blackish/brownish/reddish discolouration of the glandular stomach mucosa correlated with erosions observed microscopically in some animals. Histopathological changes reported consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg bw/day. Conclusion The NOAEL for this study was 200 mg/kg bw/day. Ref.: 5 Comment","page":16,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_002"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate, with and without metab","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":". No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.","page":28,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.04 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS =...","effect":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.011 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS...","effect":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a second","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_008"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.","page":14,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_001"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg/day | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Geno","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_003"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 dissolved in DMSO Batch: Batch op26 Purity: / Concentrations: 9 concentrations – direct plate incorporation assay With and without metabolic activation","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_004"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":"day 16. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.","page":26,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 13-week | irritation | {"dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","effect":"y amine, and thus, prone to nitrosation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-n","page":28,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_007"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.","page":14,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_001"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg/day | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Geno","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_003"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 dissolved in DMSO Batch: Batch op26 Purity: / Concentrations: 9 concentrations – direct plate incorporation assay With and without metabolic activation","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_004"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":"day 16. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.","page":26,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 13-week | irritation | {"dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","effect":"y amine, and thus, prone to nitrosation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-n","page":28,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_007"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 Comment","dose":"Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically.","effect":"g/kg bw/day correlated with cortical cell vacuolation. Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically. Blackish/brownish/reddish discolouration of the glandular stomach mucosa correlated with erosions observed microscopically in some animals. Histopathological changes reported consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg bw/day. Conclusion The NOAEL for this study was 200 mg/kg bw/day. Ref.: 5 Comment","page":16,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_002"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate, with and without metab","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":". No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.","page":28,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.04 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS =...","effect":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.011 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS...","effect":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a second","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_008"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 Comment","dose":"Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically.","effect":"g/kg bw/day correlated with cortical cell vacuolation. Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically. Blackish/brownish/reddish discolouration of the glandular stomach mucosa correlated with erosions observed microscopically in some animals. Histopathological changes reported consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg bw/day. Conclusion The NOAEL for this study was 200 mg/kg bw/day. Ref.: 5 Comment","page":16,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_002"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate, with and without metab","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":". No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.","page":28,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.04 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS =...","effect":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.011 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS...","effect":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a second","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_008"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.","page":14,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_001"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg/day | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Geno","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_003"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","effect":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 dissolved in DMSO Batch: Batch op26 Purity: / Concentrations: 9 concentrations – direct plate incorporation assay With and without metabolic activation","page":16,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_004"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":"day 16. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.","page":26,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 13-week | irritation | {"dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","effect":"y amine, and thus, prone to nitrosation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-n","page":28,"pdf":"sccp_o_163.pdf","row_type":"noael_study","study_id":"sccp_o_163_noael_007"} |
| SCCS_vision_codex | NOAEL | =800 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: 5 Comment","dose":"Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically.","effect":"g/kg bw/day correlated with cortical cell vacuolation. Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically. Blackish/brownish/reddish discolouration of the glandular stomach mucosa correlated with erosions observed microscopically in some animals. Histopathological changes reported consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg bw/day. Conclusion The NOAEL for this study was 200 mg/kg bw/day. Ref.: 5 Comment","page":16,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_002"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | - | 28 days | genotoxicity | {"dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate, with and without metab","page":17,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.","effect":". No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.","page":28,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.04 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS =...","effect":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.011 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | {"dose":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS...","effect":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a second","page":30,"pdf":"sccs_o_108.pdf","row_type":"noael_study","study_id":"sccs_o_108_noael_008"} |
UnifiedCodex:SCCNFP:beta.noael_studies 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/day | - | dermal | - | repeated dose toxicity | SOURCE_SUBDIR=out212_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2-NITRO-5-GLYCERYL METHYLANILINE COLIPA n° B60; OPINION_NUMBER=SCCNFP/0688/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=100; DOSE=at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.; EFFECT=at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"80062-31-3","citation":"Ref. : 5 2","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","duration":"","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":6,"route":"dermal","species":"","study_id":"out212_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw | rabbit | oral | 30 d | repeated dose toxicity | SOURCE_SUBDIR=out212_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2-NITRO-5-GLYCERYL METHYLANILINE COLIPA n° B60; OPINION_NUMBER=SCCNFP/0688/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=100; DOSE=Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw.; EFFECT=ive data on solubility and stability of 2- nitro-5-glyceryl methylamine have been provided. Solubility of the compound in the receptor fluid used for percutaneous absorption study has not been reported. 2-nitro-5-glyceryl methylamine is a secondary alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw. The test substance was considered as non-irritant to the intact rabbit skin and eye at a 1% suspension in 1,2-propanediol. The macroscopic and histological results indicated that the test substance did not produce any cutaneous sensitisation reaction in guinea pigs. However, the study does not conform with OECD guidelines. Teratogenicity studies lead to the result that 300 mg/kg bw showed no evidence of maternal toxicity, embryotoxicity or teratogenic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw.","duration":"30 d","effect":"ive data on solubility and stability of 2- nitro-5-glyceryl methylamine have been provided. Solubility of the compound in the receptor fluid used for percutaneous absorption study has not been reported. 2-nitro-5-glyceryl methylamine is a secondary alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. Acute toxicity was in a range between 1000 and 2000 mg/kg bw whereas the NOAEL in a repeated dose oral toxicity study (30 d) was 100 mg/kg bw. The test substance was considered as non-irritant to the intact rabbit skin and eye at a 1% suspension in 1,2-propanediol. The macroscopic and histological results indicated that the test substance did not produce any cutaneous sensitisation reaction in guinea pigs. However, the study does not conform with OECD guidelines. Teratogenicity studies lead to the result that 300 mg/kg bw showed no evidence of maternal toxicity, embryotoxicity or teratogenic","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":16,"route":"oral","species":"rabbit","study_id":"out212_en_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 21 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.; EFFECT=at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.; CITATION=Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day; CITATION_NUMBERS=[5,100]; REFERENCE=Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day; DETAILS_JSON={"cas_number":"80062-31-3","citation":"Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day","dose":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings.","duration":"","effect":"at the top dose of 1000 mg/kg bw/day, but there were no related histopathological findings. All other macroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":14,"route":"","species":"","study_id":"sccp_o_163_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=100; DOSE=They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”.; EFFECT=acroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.; CITATION=Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day; CITATION_NUMBERS=[5,100]; REFERENCE=Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day; DETAILS_JSON={"cas_number":"80062-31-3","citation":"Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day","dose":"They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”.","duration":"","effect":"acroscopic and microscopic observations revealed no abnormalities related to the treatment. The authors considered that the discoloration of the eye was due to the staining properties of the dye and was not of toxicological significance. They therefore concluded that 300 mg/kg bw/day was the “No Toxic Effect Level”. On the basis of ophthalmoscopic examination 100 mg/kg bw/day should therefore be considered as the NOAEL. Ref.: 5 (subm I) Comment Because of the coloration of the fundus oculi, the SCCP considers the NOEL to be 100 mg/kg bw per day.","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":14,"route":"","species":"","study_id":"sccp_o_163_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.; EFFECT=day 16. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.","duration":"","effect":"day 16. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":26,"route":"","species":"","study_id":"sccp_o_163_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.; EFFECT=consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant.","duration":"","effect":"consumption at 1000 mg/kg/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg/day.","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":26,"route":"","species":"","study_id":"sccp_o_163_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 800 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=800; DOSE=Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically.; EFFECT=g/kg bw/day correlated with cortical cell vacuolation. Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically. Blackish/brownish/reddish discolouration of the glandular stomach mucosa correlated with erosions observed microscopically in some animals. Histopathological changes reported consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg bw/day. Conclusion The NOAEL for this study was 200 mg/kg bw/day. Ref.: 5 Comment; CITATION=Ref.: 5 Comment; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 Comment; DETAILS_JSON={"cas_number":"80062-31-3","citation":"Ref.: 5 Comment","dose":"Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically.","duration":"","effect":"g/kg bw/day correlated with cortical cell vacuolation. Small thymuses and spleens at 800 mg/kg bw/day correlated with lower organ weights and lymphoid depletion observed microscopically. Blackish/brownish/reddish discolouration of the glandular stomach mucosa correlated with erosions observed microscopically in some animals. Histopathological changes reported consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg bw/day. Conclusion The NOAEL for this study was 200 mg/kg bw/day. Ref.: 5 Comment","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"800","page":16,"route":"","species":"","study_id":"sccs_o_108_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=300; DOSE=Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.; EFFECT=. No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.","duration":"","effect":". No abortions were observed. Maternal body weight gain and food consumption at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":28,"route":"","species":"","study_id":"sccs_o_108_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=300; DOSE=on at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.; EFFECT=on at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"on at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant.","duration":"","effect":"on at 1000 mg/kg bw/day were slightly lower than control group values; however, these changes were not statistically significant. No other compound-related findings were observed in dams at any dose level. One dead foetus and an increase in the number of foetuses with unossified 4th metacarpals were observed at 1000 mg/kg bw/day. No other compound-related anomalies or malformations of toxicological significance were observed. Conclusion The NOAEL for materno-toxicity for this study was 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was 1000 mg/kg bw/day.","endpoint":"","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":28,"route":"","species":"","study_id":"sccs_o_108_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 300 | mg/kg/day | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.; EFFECT=ents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-nitro-5-glyceryl methylaniline can be drawn. Dermal absorption Too few chambers were used. The me; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","duration":"13-week","effect":"ents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-nitro-5-glyceryl methylaniline can be drawn. Dermal absorption Too few chambers were used. The me","endpoint":"dermal absorption","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":28,"route":"oral","species":"rat","study_id":"sccp_o_163_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.04 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT== 0.04; DOSE=2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS =...; EFFECT=2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS =...","duration":"13 weeks","effect":"2 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090","endpoint":"dermal absorption","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.04","page":30,"route":"oral","species":"rat","study_id":"sccs_o_108_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =200 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT== 200; DOSE=methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per t...; EFFECT=methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * sta; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per t...","duration":"13 weeks","effect":"methylaniline ___________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-Nitro-5-glyceryl methylaniline Oxidative Absorption through the skin A = 4.11 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * sta","endpoint":"dermal absorption","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 200","page":30,"route":"oral","species":"rat","study_id":"sccs_o_108_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.011 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT== 0.011; DOSE=.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS...; EFFECT=.001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a second; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS...","duration":"13 weeks","effect":".001 = 2.38 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a second","endpoint":"dermal absorption","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.011","page":30,"route":"oral","species":"rat","study_id":"sccs_o_108_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =200 | mg/kg bw/d | rat | oral | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT== 200; DOSE=t of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per t...; EFFECT=t of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a secondary am; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"t of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per t...","duration":"13 weeks","effect":"t of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 2500 Non oxidative conditions Absorption through the skin A = 1.12 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.65 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.011 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (13 weeks, oral, rats) Corrected for bio-availability (50 %)* 100 mg/kg bw/d MOS = 9090 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14 Discussion Physico-chemical properties 2-Nitro-5-glyceryl methylaniline is used in semi permanent hair colouring products at a maximum concentration of 1%. The formulation is applied as such without any further dilution. 2-Nitro-5-glyceryl methylaniline is a secondary am","endpoint":"dermal absorption","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 200","page":30,"route":"oral","species":"rat","study_id":"sccs_o_108_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 300 | mg/kg bw/day | rabbit | dermal | 90 days | dermal absorption | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=300; DOSE=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days.; EFFECT=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. The NOAEL for materno-toxicity was set at 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was set at 1000 mg/kg bw/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-nitro-5-glyceryl methylaniline can be drawn. Dermal absorption In oxidative conditions, the mea; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days.","duration":"90 days","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. The NOAEL for materno-toxicity was set at 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was set at 1000 mg/kg bw/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-nitro-5-glyceryl methylaniline can be drawn. Dermal absorption In oxidative conditions, the mea","endpoint":"dermal absorption","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":31,"route":"dermal","species":"rabbit","study_id":"sccs_o_108_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 800 | mg/kg/day | - | - | 28 days | genotoxicity | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=800; DOSE=SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.; EFFECT=SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Geno; CITATION=Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days; CITATION_NUMBERS=[5,1000,28,7,10,4,300]; REFERENCE=Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days; DETAILS_JSON={"cas_number":"80062-31-3","citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","duration":"28 days","effect":"SCCP/1162/08 Opinion on 2-nitro-5-glyceryl methylaniline 16 consisted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Geno","endpoint":"genotoxicity","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg/day","noael_value":"800","page":16,"route":"","species":"","study_id":"sccp_o_163_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 50 | mg/kg bw | - | - | 28 days | genotoxicity | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.; EFFECT=isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 dissolved in DMSO Batch: Batch op26 Purity: / Concentrations: 9 concentrations – direct plate incorporation assay With and without metabolic activation; CITATION=Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days; CITATION_NUMBERS=[5,1000,28,7,10,4,300]; REFERENCE=Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days; DETAILS_JSON={"cas_number":"80062-31-3","citation":"Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days","dose":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day.","duration":"28 days","effect":"isted of vacuolated Langerhans islet cells in the pancreas and renal tubular epithelial cells, and tubular nephrosis at 800 mg/kg/day. Conclusion The NOAEL for this study was 200 mg/kg/day. Ref.: 5 Comment Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCP considers the NOEL to be 50 mg/kg bw per day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 dissolved in DMSO Batch: Batch op26 Purity: / Concentrations: 9 concentrations – direct plate incorporation assay With and without metabolic activation","endpoint":"genotoxicity","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":16,"route":"","species":"","study_id":"sccp_o_163_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 50 | mg/kg bw | - | - | 28 days | genotoxicity | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=50; DOSE=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.; EFFECT=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","duration":"28 days","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500","endpoint":"genotoxicity","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":17,"route":"","species":"","study_id":"sccs_o_108_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 200 | mg/kg bw/d | - | - | 28 days | genotoxicity | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=200; DOSE=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.; EFFECT=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate, with and without metab; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days.","duration":"28 days","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 17 Bilateral coloration was reported in the fundus oculi in all animals at 1000 mg/kg bw/ 28 days and 7/10 males and 4/10 at 300 mg/kg bw 28 days. Bilateral opacity of the lens was seen at 800 mg/kg bw/90 days. Discoloration of the fundus oculi was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Submission III, 2005 Bacterial reverse mutation test, study 1 Guideline: / Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Triplicate plates, only 1 test performed Test substance: B 60 Solvent: DMSO Batch: Batch op26 Purity: / Concentrations: 10, 20, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate, with and without metab","endpoint":"genotoxicity","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":17,"route":"","species":"","study_id":"sccs_o_108_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 50 | mg/kg/day | rat | oral | 13-week | irritation | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.; EFFECT=y amine, and thus, prone to nitrosation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-n; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","duration":"13-week","effect":"y amine, and thus, prone to nitrosation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-n","endpoint":"irritation","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg/day","noael_value":"50","page":28,"route":"oral","species":"rat","study_id":"sccp_o_163_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 50 | mg/kg/day | rat | oral | 13-week | irritation | SOURCE_SUBDIR=sccp_o_163; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCP/1162/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=50; DOSE=General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.; EFFECT=ation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-nitro-5-glyceryl methylaniline can b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats.","duration":"13-week","effect":"ation. It should not be used in combination with nitrosating agents. The nitrosamine content should be < 50 ppb. The nitrosamine content in the test materials was not reported. The stability of 2-Nitro-5-glyceryl methylaniline in the marketed products was not reported. General toxicity The maximal non-lethal dose of 2-nitro-5-glyceryl methylaniline was higher than 1000 mg/kg but lower than 2000 mg/kg after a single oral administration in fasted rats. In a 13-week oral study, the NOEL was set at 50 mg/kg/day. The NOAEL for materno-toxicity was set at 300 mg/kg/day, while the NOAEL for embryo- toxicity/teratogenicity was set at 1000 mg/kg/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2-nitro-5-glyceryl methylaniline can b","endpoint":"irritation","ingredient":"2-Nitro-5-glyceryl methylaniline","loael_value":"","noael_unit":"mg/kg/day","noael_value":"50","page":28,"route":"oral","species":"rat","study_id":"sccp_o_163_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 50 | mg/kg bw | rabbit | - | 90 days | irritation | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=50; DOSE=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days.; EFFECT=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. The NOAEL for materno-toxicity was set at 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was set at 1000 mg/kg bw/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days.","duration":"90 days","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. The NOAEL for materno-toxicity was set at 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was set at 1000 mg/kg bw/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion","endpoint":"irritation","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":31,"route":"","species":"rabbit","study_id":"sccs_o_108_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 200 | mg/kg bw/d | rabbit | - | 90 days | irritation | SOURCE_SUBDIR=sccs_o_108; REPORT_TITLE=OPINION ON 2-Nitro-5-glyceryl methylaniline COLIPA n° B60; OPINION_NUMBER=SCCS/1477/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=200; DOSE=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days.; EFFECT=SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. The NOAEL for materno-toxicity was set at 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was set at 1000 mg/kg bw/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"80062-31-3","citation":"","dose":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days.","duration":"90 days","effect":"SCCS/1477/12 Opinion on 2-nitro-5-glyceryl methylaniline ___________________________________________________________________________________________ 31 was seen at 200 and 800 mg/kg bw/90 days. Therefore, the SCCS considers the NOEL to be 50 mg/kg bw per day, and the NOAEL to be 200 mg/kg bw/d. The NOAEL for materno-toxicity was set at 300 mg/kg bw/day, while the NOAEL for embryo-toxicity/teratogenicity was set at 1000 mg/kg bw/day. Irritation / sensitisation The test substance was considered as non-irritant to rabbit skin when applied as a 1% suspension in 1,2-propanediol. The 1% suspension caused some slight and transient irritation of the rabbit eye. The highest concentration tested (10%) in the LLNA was considered too low. No conclusion regarding the sensitising potential of 2","endpoint":"irritation","ingredient":"2-Nitro-5-glyceryl methylaniline (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":31,"route":"","species":"rabbit","study_id":"sccs_o_108_noael_011"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | Y6YE3133F5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Y6YE3133F5"} |
| openFDA substances | FDA UNII substance identifier | Y6YE3133F5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Y6YE3133F5"} |
| openFDA substances | FDA UNII substance identifier | Y6YE3133F5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Y6YE3133F5"} |
| openFDA substances | FDA UNII substance identifier | Y6YE3133F5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Y6YE3133F5"} |