NOAEL Studies
Cosmetic Ingredient
4-Nitrophenyl Aminoethylurea NOAEL Studies
INCI: 4-NITROPHENYL AMINOETHYLUREA
CAS: 27080-42-8
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 | 1 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCS; Ravel, G.; 4-Nitrophenyl Aminoethylurea (WR23348) - 13 week oral (gavage) toxicitystudy in the rat; MDS PHARMA SERVICES; 2005 |
SCCS_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =125 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoe","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoethylurea","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref: 29","dose":"Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.","effect":"mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref: 29","page":22,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"Ref.: 25","dose":"A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"nsidered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25","page":17,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.01 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"itrophenyl aminoethylurea ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of","page":26,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_004"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoe","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoethylurea","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref: 29","dose":"Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.","effect":"mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref: 29","page":22,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoe","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoethylurea","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref: 29","dose":"Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.","effect":"mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref: 29","page":22,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"Ref.: 25","dose":"A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"nsidered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25","page":17,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.01 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"itrophenyl aminoethylurea ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of","page":26,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_004"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"Ref.: 25","dose":"A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"nsidered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25","page":17,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.01 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"itrophenyl aminoethylurea ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of","page":26,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_004"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoe","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoethylurea","page":18,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref: 29","dose":"Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.","effect":"mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref: 29","page":22,"pdf":"sccp_o_103.pdf","row_type":"noael_study","study_id":"sccp_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | - | - | - | NOAEL study | {"citation":"Ref.: 25","dose":"A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","effect":"nsidered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25","page":17,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.01 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"itrophenyl aminoethylurea ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of","page":26,"pdf":"sccs_o_036.pdf","row_type":"noael_study","study_id":"sccs_o_036_noael_004"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccp_o_103; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCP/1037/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=50; DOSE=Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.; EFFECT=mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref: 29; CITATION=Ref: 29; CITATION_NUMBERS=[29]; REFERENCE=Ref: 29; DETAILS_JSON={"cas_number":"27080-42-8","citation":"Ref: 29","dose":"Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.","duration":"","effect":"mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref: 29","endpoint":"","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":22,"route":"","species":"","study_id":"sccp_o_103_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 125 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT=125; DOSE=A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.; EFFECT=opoiesis and haemosiderosis were considered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25; CITATION=Ref.: 25; CITATION_NUMBERS=[25]; REFERENCE=Ref.: 25; DETAILS_JSON={"cas_number":"27080-42-8","citation":"Ref.: 25","dose":"A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","duration":"","effect":"opoiesis and haemosiderosis were considered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25","endpoint":"","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":17,"route":"","species":"","study_id":"sccs_o_036_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | mg/kg bw/d | - | - | - | - | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT=5; DOSE=A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.; EFFECT=nsidered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25; CITATION=Ref.: 25; CITATION_NUMBERS=[25]; REFERENCE=Ref.: 25; DETAILS_JSON={"cas_number":"27080-42-8","citation":"Ref.: 25","dose":"A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","duration":"","effect":"nsidered to represent a response to a haemolytic anaemia. A slight decrease in the amount of fatty tissue seen in the femoral bone marrow of a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw/d. Ref.: 25","endpoint":"","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":17,"route":"","species":"","study_id":"sccs_o_036_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT=50; DOSE=Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.; EFFECT=0 mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10%) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref.: 29 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted; CITATION=Ref.: 29 3; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 3; DETAILS_JSON={"cas_number":"27080-42-8","citation":"Ref.: 29 3","dose":"Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival.","duration":"","effect":"0 mg/kg bw). Conclusion Treatment of females with 4-nitrophenylaminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity, i.e. reduction in the foetal weight and reduction of foetal ossification, but with no influence on embryo-foetal survival. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10%) and in ossification were noted. The low dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Ref.: 29 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","endpoint":"","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":24,"route":"","species":"","study_id":"sccs_o_036_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.01 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT== 0.01; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...; EFFECT=itrophenyl aminoethylurea ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","duration":"90-day","effect":"itrophenyl aminoethylurea ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of","endpoint":"dermal absorption","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.01","page":26,"route":"oral","species":"rat","study_id":"sccs_o_036_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =5 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT== 5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...; EFFECT=____________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of 0.5%,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","duration":"90-day","effect":"____________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of 0.5%,","endpoint":"dermal absorption","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 5","page":26,"route":"oral","species":"rat","study_id":"sccs_o_036_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =5 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT== 5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...; EFFECT=________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of 0.5%, and as a hair colouring agent (direct dye) in oxidative hai; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose S...","duration":"90-day","effect":"________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-nitrophenyl aminoethylurea (Oxidative conditions) Absorption through the skin (in vivo) A = 1.097 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.64 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.01 mg/kg bw/d No observed adverse effect level NOAEL = 5 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 500 The value obtained for dermal absorption under non-oxidative conditions (0.938 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given. 3.3.14. Discussion Physico-chemical specifications 4-Nitrophenyl aminoethylurea is used as direct dye in semi-permanent hair formulations at a maximum on-head concentration of 0.5%, and as a hair colouring agent (direct dye) in oxidative hai","endpoint":"dermal absorption","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 5","page":26,"route":"oral","species":"rat","study_id":"sccs_o_036_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 50 | mg/kg bw | rat | dermal | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_103; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCP/1037/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=50; DOSE=d in the bone marrow at dose levels of 25 or 125 mg/kg bw.; EFFECT=d in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Irritation / sensitisation Nitrogelb applied ‘as is’ was not irritant to rabbit skin but was irritant to rabbit eyes. 4-Nitrophenyl aminoethylurea induced no immune response in local lymph nodes after dermal application to the mouse ear using DMSO as vehicle. Consequently, no EC3 value was calculated and 4-nitrophenyl aminoethylurea was evaluated as not being a skin sensitiser. Dermal penetration In the absence of valid in vitro studies, the values of 1.097 µg/cm2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"d in the bone marrow at dose levels of 25 or 125 mg/kg bw.","duration":"","effect":"d in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Irritation / sensitisation Nitrogelb applied ‘as is’ was not irritant to rabbit skin but was irritant to rabbit eyes. 4-Nitrophenyl aminoethylurea induced no immune response in local lymph nodes after dermal application to the mouse ear using DMSO as vehicle. Consequently, no EC3 value was calculated and 4-nitrophenyl aminoethylurea was evaluated as not being a skin sensitiser. Dermal penetration In the absence of valid in vitro studies, the values of 1.097 µg/cm2","endpoint":"developmental toxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":24,"route":"dermal","species":"rat","study_id":"sccp_o_103_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 50 | mg/kg bw | rat | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT=50; DOSE=in the bone marrow at dose levels of 25 or 125 mg/kg bw.; EFFECT=in the bone marrow at dose levels of 25 or 125 mg/kg bw. The no observed adverse effect level (NOAEL) was 5 mg/kg bw/day. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"in the bone marrow at dose levels of 25 or 125 mg/kg bw.","duration":"","effect":"in the bone marrow at dose levels of 25 or 125 mg/kg bw. The no observed adverse effect level (NOAEL) was 5 mg/kg bw/day. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity.","endpoint":"developmental toxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":26,"route":"","species":"rat","study_id":"sccs_o_036_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 125 | mg/kg bw | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_103; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCP/1037/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=125; DOSE=SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.; EFFECT=SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoe; CITATION=Ref.: 25 3; CITATION_NUMBERS=[25,3]; REFERENCE=Ref.: 25 3; DETAILS_JSON={"cas_number":"27080-42-8","citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","duration":"Chronic","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoe","endpoint":"genotoxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":18,"route":"","species":"rat","study_id":"sccp_o_103_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 5 | mg/kg bw | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_103; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCP/1037/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=5; DOSE=SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.; EFFECT=SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoethylurea; CITATION=Ref.: 25 3; CITATION_NUMBERS=[25,3]; REFERENCE=Ref.: 25 3; DETAILS_JSON={"cas_number":"27080-42-8","citation":"Ref.: 25 3","dose":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow.","duration":"Chronic","effect":"SCCP/1037/06 Opinion on 4-nitrophenyl aminoethylurea 18 a few animals at 125 mg/kg bw also suggested a regenerative response of the bone marrow. Conclusion In conclusion, the haemopoietic system was identified as a target organ for 4- nitrophenylaminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9-mix. Test substance: LGH 110583/2 (4-nitrophenylaminoethylurea","endpoint":"genotoxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"5","page":18,"route":"","species":"rat","study_id":"sccp_o_103_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 125 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_103; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCP/1037/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=125; DOSE=Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.; EFFECT=re seen in HPLC. N-(2-aminoethyl)-4 nitroanilinine was present at more than 1% in batch LEH/52. This substance is a secondary amine. No further information was given. Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Irritation / sensitisation Nitrogelb appli; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.","duration":"Sub-chronic","effect":"re seen in HPLC. N-(2-aminoethyl)-4 nitroanilinine was present at more than 1% in batch LEH/52. This substance is a secondary amine. No further information was given. Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Irritation / sensitisation Nitrogelb appli","endpoint":"repeated dose toxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":24,"route":"oral","species":"rat","study_id":"sccp_o_103_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 5 | mg/kg bw | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_103; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCP/1037/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=5; DOSE=Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.; EFFECT=nitroanilinine was present at more than 1% in batch LEH/52. This substance is a secondary amine. No further information was given. Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Irritation / sensitisation Nitrogelb applied ‘as i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.","duration":"Sub-chronic","effect":"nitroanilinine was present at more than 1% in batch LEH/52. This substance is a secondary amine. No further information was given. Supportive analytical data for only some batches was provided General toxicity In the rat Sub-chronic (90 days) oral study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The “No observed adverse effect level” (NOAEL) was 5 mg/kg bw. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity. Irritation / sensitisation Nitrogelb applied ‘as i","endpoint":"repeated dose toxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"5","page":24,"route":"oral","species":"rat","study_id":"sccp_o_103_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 125 | mg/kg bw | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT=125; DOSE=General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.; EFFECT=was present at more than 1% in batch LEH5/2. This substance is a secondary amine. (The applicant stated that LEH 5/2 is an old batch from 1983) The content of N-(2-aminoethyl)-4 nitroaniline in other batches was <0.22%. General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The no observed adverse effect level (NOAEL) was 5 mg/kg bw/day. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.","duration":"sub-chronic","effect":"was present at more than 1% in batch LEH5/2. This substance is a secondary amine. (The applicant stated that LEH 5/2 is an old batch from 1983) The content of N-(2-aminoethyl)-4 nitroaniline in other batches was <0.22%. General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The no observed adverse effect level (NOAEL) was 5 mg/kg bw/day. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity.","endpoint":"repeated dose toxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw","noael_value":"125","page":26,"route":"oral","species":"rat","study_id":"sccs_o_036_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 5 | mg/kg bw/day | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_036; REPORT_TITLE=OPINION ON 4-Nitrophenyl aminoethylurea COLIPA n° B70; OPINION_NUMBER=SCCS/1369/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 19 June 2007; VALUE_TEXT=5; DOSE=General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.; EFFECT=tch LEH5/2. This substance is a secondary amine. (The applicant stated that LEH 5/2 is an old batch from 1983) The content of N-(2-aminoethyl)-4 nitroaniline in other batches was <0.22%. General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The no observed adverse effect level (NOAEL) was 5 mg/kg bw/day. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27080-42-8","citation":"","dose":"General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw.","duration":"sub-chronic","effect":"tch LEH5/2. This substance is a secondary amine. (The applicant stated that LEH 5/2 is an old batch from 1983) The content of N-(2-aminoethyl)-4 nitroaniline in other batches was <0.22%. General toxicity In the rat sub-chronic (90 days) oral toxicity study the haemopoietic system was identified as a target organ for 4-nitrophenyl aminoethylurea based on the occurrence of anaemia and adaptive responses in the spleen and in the bone marrow at dose levels of 25 or 125 mg/kg bw. The no observed adverse effect level (NOAEL) was 5 mg/kg bw/day. In the rat teratogenic study, treatment of females with 4-nitrophenyl aminoethylurea at 600 mg/kg bw resulted in severe maternal toxicity including deaths and in corresponding embryo-foetal toxicity. At 250 mg/kg bw, less severe maternal toxicity and only slight reductions in foetal weight (-10 %) and in ossification were noted. A dose level of 50 mg/kg bw of 4-nitrophenylaminoethylurea was the NOAEL for both maternal and embryo-foetal toxicity.","endpoint":"repeated dose toxicity","ingredient":"4-Nitrophenyl aminoethylurea","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":26,"route":"oral","species":"rat","study_id":"sccs_o_036_noael_008"} |
openFDA substances 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 1G48T8PRLV | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H12N4O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1G48T8PRLV"} |
| openFDA substances | FDA UNII substance identifier | 1G48T8PRLV | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H12N4O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1G48T8PRLV"} |