NOAEL Studies Cosmetic Ingredient

2-Amino-5-Ethylphenol HCl NOAEL Studies

INCI: 2-AMINO-5-ETHYLPHENOL HCL

CAS: 149861-22-3

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

Back to parent ingredient page
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =16 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 27 3","dose":"At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration).","effect":"yaline droplets and increased lymphoid cell infiltration and tubular basophilia were observed in male rats. Corneal opacities were also noted in four males and seven females. At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration). Conclusion As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL. Ref.: 27 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 Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicate cultures in two independent experiments Test substance: ethyl-oxygelb-phosphat Batch: GST079-03/33-08 Purity: 99.6 area% (HPLC) Vehicle: deionised water Concentration: experiment 1: 33, 100, 333, 1000, 250","page":17,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_001"}
SCCS_vision_codex NOAEL =74 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"artery or in skeletal malformations such as delayed in ossification of bones were reported. There were increased incidences of malformed bones and splits in the cartilage of the sternebrae. Enlarged thyroids and malpositioned origin of the common carotid artery occurred in this group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_002"}
SCCS_vision_codex NOAEL =369 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"his group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_003"}
SCCS_vision_codex NOAEL =7 - - oral 90 days NOAEL study {"citation":"Ref.: 36 3","dose":"Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine.","effect":"ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","page":25,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_004"}
SCCS_vision_codex NOAEL =0.026 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"icity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_005"}
SCCS_vision_codex NOAEL =16 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"ata submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation was pr","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_006"}
SCCS_vision_codex NOAEL =16 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 27 3","dose":"At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration).","effect":"yaline droplets and increased lymphoid cell infiltration and tubular basophilia were observed in male rats. Corneal opacities were also noted in four males and seven females. At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration). Conclusion As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL. Ref.: 27 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 Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicate cultures in two independent experiments Test substance: ethyl-oxygelb-phosphat Batch: GST079-03/33-08 Purity: 99.6 area% (HPLC) Vehicle: deionised water Concentration: experiment 1: 33, 100, 333, 1000, 250","page":17,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_001"}
SCCS_vision_codex NOAEL =74 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"artery or in skeletal malformations such as delayed in ossification of bones were reported. There were increased incidences of malformed bones and splits in the cartilage of the sternebrae. Enlarged thyroids and malpositioned origin of the common carotid artery occurred in this group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_002"}
SCCS_vision_codex NOAEL =369 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"his group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_003"}
SCCS_vision_codex NOAEL =7 - - oral 90 days NOAEL study {"citation":"Ref.: 36 3","dose":"Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine.","effect":"ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","page":25,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_004"}
SCCS_vision_codex NOAEL =0.026 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"icity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_005"}
SCCS_vision_codex NOAEL =16 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"ata submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation was pr","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_006"}
SCCS_vision_codex NOAEL =16 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 27 3","dose":"At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration).","effect":"yaline droplets and increased lymphoid cell infiltration and tubular basophilia were observed in male rats. Corneal opacities were also noted in four males and seven females. At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration). Conclusion As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL. Ref.: 27 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 Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicate cultures in two independent experiments Test substance: ethyl-oxygelb-phosphat Batch: GST079-03/33-08 Purity: 99.6 area% (HPLC) Vehicle: deionised water Concentration: experiment 1: 33, 100, 333, 1000, 250","page":17,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_001"}
SCCS_vision_codex NOAEL =74 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"artery or in skeletal malformations such as delayed in ossification of bones were reported. There were increased incidences of malformed bones and splits in the cartilage of the sternebrae. Enlarged thyroids and malpositioned origin of the common carotid artery occurred in this group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_002"}
SCCS_vision_codex NOAEL =369 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"his group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_003"}
SCCS_vision_codex NOAEL =7 - - oral 90 days NOAEL study {"citation":"Ref.: 36 3","dose":"Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine.","effect":"ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","page":25,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_004"}
SCCS_vision_codex NOAEL =0.026 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"icity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_005"}
SCCS_vision_codex NOAEL =16 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"ata submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation was pr","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_006"}
SCCS_vision_codex NOAEL =16 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 27 3","dose":"At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration).","effect":"yaline droplets and increased lymphoid cell infiltration and tubular basophilia were observed in male rats. Corneal opacities were also noted in four males and seven females. At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration). Conclusion As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL. Ref.: 27 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 Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicate cultures in two independent experiments Test substance: ethyl-oxygelb-phosphat Batch: GST079-03/33-08 Purity: 99.6 area% (HPLC) Vehicle: deionised water Concentration: experiment 1: 33, 100, 333, 1000, 250","page":17,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_001"}
SCCS_vision_codex NOAEL =74 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"artery or in skeletal malformations such as delayed in ossification of bones were reported. There were increased incidences of malformed bones and splits in the cartilage of the sternebrae. Enlarged thyroids and malpositioned origin of the common carotid artery occurred in this group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_002"}
SCCS_vision_codex NOAEL =369 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","effect":"his group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","page":23,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_003"}
SCCS_vision_codex NOAEL =7 - - oral 90 days NOAEL study {"citation":"Ref.: 36 3","dose":"Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine.","effect":"ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","page":25,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_004"}
SCCS_vision_codex NOAEL =0.026 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"icity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_005"}
SCCS_vision_codex NOAEL =16 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","effect":"ata submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation was pr","page":26,"pdf":"sccs_o_085.pdf","row_type":"noael_study","study_id":"sccs_o_085_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 7 - - oral 90 days - SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=unclear:ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted; DOSE=Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine.; EFFECT=ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted; CITATION=Ref.: 36 3; CITATION_NUMBERS=[36,3]; REFERENCE=Ref.: 36 3; DETAILS_JSON={"cas_number":"149861-22-3","citation":"Ref.: 36 3","dose":"Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine.","duration":"90 days","effect":"ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","endpoint":"","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"","noael_value":"unclear:ified and 7 metabolites were detected in urine. Sulfation, glucuronidation and acetylation were the major metabolic pathways whereas cysteine and glucose conjugation, carboxylation and hydroxylation were of minor importance. Conclusion Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. Ref.: 36 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted","page":25,"route":"oral","species":"","study_id":"sccs_o_085_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.026 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT== 0.026; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...; EFFECT=icity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149861-22-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","duration":"90 day","effect":"icity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation","endpoint":"dermal absorption","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.026","page":26,"route":"oral","species":"rat","study_id":"sccs_o_085_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =16 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT== 16; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...; EFFECT=ata submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation was pr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149861-22-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/6...","duration":"90 day","effect":"ata submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY INCI Name Oxidative / Non oxidative conditions Absorption through the skin A = 2.70 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.56 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.026 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 16 mg/kg bw/d (90 day study, oral route, rat) MOS = 614 3.3.14. Discussion Physico-chemical properties 2-Amino-5-ethylphenol hydrochloride is used as an oxidative hair colouring agent pre- cursor. The intended maximum on-head concentration is 1.0% in oxidative hair dye formulations. 2-Amino-5-ethylphenol hydrochloride is used in hair colouring formulations, but it has no EC number. A study report on the chemical characterisation of a batch of 2-amino-5-ethanol HCl was submitted. But no documentation was pr","endpoint":"dermal absorption","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 16","page":26,"route":"oral","species":"rat","study_id":"sccs_o_085_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 74 mg/kg bw/day - oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=74; DOSE=At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.; EFFECT=artery or in skeletal malformations such as delayed in ossification of bones were reported. There were increased incidences of malformed bones and splits in the cartilage of the sternebrae. Enlarged thyroids and malpositioned origin of the common carotid artery occurred in this group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.; CITATION=Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec; CITATION_NUMBERS=[35,369]; REFERENCE=Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec; DETAILS_JSON={"cas_number":"149861-22-3","citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","duration":"developmental","effect":"artery or in skeletal malformations such as delayed in ossification of bones were reported. There were increased incidences of malformed bones and splits in the cartilage of the sternebrae. Enlarged thyroids and malpositioned origin of the common carotid artery occurred in this group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","endpoint":"developmental toxicity","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"74","page":23,"route":"oral","species":"","study_id":"sccs_o_085_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 369 mg/kg bw/day - oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=369; DOSE=At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.; EFFECT=his group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.; CITATION=Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec; CITATION_NUMBERS=[35,369]; REFERENCE=Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec; DETAILS_JSON={"cas_number":"149861-22-3","citation":"Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effec","dose":"At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported.","duration":"developmental","effect":"his group. At 22 and 74 mg/kg bw/day, no maternal clinical signs, feed consumption and body weight gain change of sign of toxicity were reported. No variations in pregnancy and litter data were reported in these 2 dose groups. Conclusion The NOEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Ref.: 35 Comments Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses to be 74 mg/kg bw/day.","endpoint":"developmental toxicity","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"369","page":23,"route":"oral","species":"","study_id":"sccs_o_085_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 16 mg/kg bw/day rat - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=16; DOSE=At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration).; EFFECT=yaline droplets and increased lymphoid cell infiltration and tubular basophilia were observed in male rats. Corneal opacities were also noted in four males and seven females. At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration). Conclusion As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL. Ref.: 27 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 Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicate cultures in two independent experiments Test substance: ethyl-oxygelb-phosphat Batch: GST079-03/33-08 Purity: 99.6 area% (HPLC) Vehicle: deionised water Concentration: experiment 1: 33, 100, 333, 1000, 250; CITATION=Ref.: 27 3; CITATION_NUMBERS=[27,3]; REFERENCE=Ref.: 27 3; DETAILS_JSON={"cas_number":"149861-22-3","citation":"Ref.: 27 3","dose":"At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration).","duration":"Chronic","effect":"yaline droplets and increased lymphoid cell infiltration and tubular basophilia were observed in male rats. Corneal opacities were also noted in four males and seven females. At the dose of 55 mg/kg bw/day, signs of slight anaemia were observed in male and female rats (significant elevation in the reticulocyte counts, increased mean cell volume and reduced mean cell haemoglobin concentration). Conclusion As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL. Ref.: 27 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 Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicate cultures in two independent experiments Test substance: ethyl-oxygelb-phosphat Batch: GST079-03/33-08 Purity: 99.6 area% (HPLC) Vehicle: deionised water Concentration: experiment 1: 33, 100, 333, 1000, 250","endpoint":"genotoxicity","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"16","page":17,"route":"","species":"rat","study_id":"sccs_o_085_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 16 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=16; DOSE=The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt.; EFFECT=hydrochloride is considered as biologically available. General toxicity The acute toxicity of 2-amino-5-ethylphenol phosphate is low after single oral administration to female rats. The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt. In a subchronic toxicity study in rats signs of slight anemia were observed at 55 mg/kg bw/day. As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL (2-amino-5-ethylphenol HCl). Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149861-22-3","citation":"","dose":"The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt.","duration":"subchronic","effect":"hydrochloride is considered as biologically available. General toxicity The acute toxicity of 2-amino-5-ethylphenol phosphate is low after single oral administration to female rats. The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt. In a subchronic toxicity study in rats signs of slight anemia were observed at 55 mg/kg bw/day. As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL (2-amino-5-ethylphenol HCl). Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and d","endpoint":"repeated dose toxicity","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"16","page":27,"route":"oral","species":"rat","study_id":"sccs_o_085_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 369 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=369; DOSE=The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt.; EFFECT=rats. The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt. In a subchronic toxicity study in rats signs of slight anemia were observed at 55 mg/kg bw/day. As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL (2-amino-5-ethylphenol HCl). Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. No further reproducti; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149861-22-3","citation":"","dose":"The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt.","duration":"subchronic","effect":"rats. The LD50 of 2-amino-5-ethylphenol phosphate is greater than 2000 mg/kg bw, corresponding to 1476 mg/kg bw as hydrochloride salt. In a subchronic toxicity study in rats signs of slight anemia were observed at 55 mg/kg bw/day. As no test item-related effects were observed at the dose of 16 mg/kg bw/day, this dose was considered as the NOAEL (2-amino-5-ethylphenol HCl). Based on the clinical effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. No further reproducti","endpoint":"repeated dose toxicity","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"369","page":27,"route":"oral","species":"rat","study_id":"sccs_o_085_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 74 mg/kg bw/day mouse oral developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_085; REPORT_TITLE=OPINION ON 2-Amino-5-ethylphenol HCl COLIPA n° A158; OPINION_NUMBER=SCCS/1442/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2012; VALUE_TEXT=74; DOSE=l effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day.; EFFECT=l effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. No further reproductive toxicity studies were provided. Mutagenicity Overall, the genotoxicity of 2-amino-5-ethylphenol phosphate is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. 2-amino-5-ethylphenol phosphate did not induce gene mutations in a gene mutation test in bacteria nor in a mouse lymphoma assay in mamma; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149861-22-3","citation":"","dose":"l effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day.","duration":"developmental","effect":"l effects on dams and the resorption and malformations on foetuses at the dose of 369 mg/kg bw/day, the SCCS considered the NOAEL for maternal effects and for developmental effects on foetuses were both considered to be 74 mg/kg bw/day. Amino-5-Ethylphenol hydrochloride administered orally was extensively absorbed, largely distributed and extensively metabolized and excreted in urine. No major qualitative differences in the metabolite profile between the oral and dermal routes of administration were observed. The NOAEL derived from the 90 days oral toxicity study can be used to calculate the MoS without any adjustment. No further reproductive toxicity studies were provided. Mutagenicity Overall, the genotoxicity of 2-amino-5-ethylphenol phosphate is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. 2-amino-5-ethylphenol phosphate did not induce gene mutations in a gene mutation test in bacteria nor in a mouse lymphoma assay in mamma","endpoint":"reproductive toxicity","ingredient":"2-Amino-5-ethylphenol HCl","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"74","page":27,"route":"oral","species":"mouse","study_id":"sccs_o_085_noael_009"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier B5IWK1V8FX UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B5IWK1V8FX"}
openFDA substances FDA UNII substance identifier B5IWK1V8FX UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B5IWK1V8FX"}
openFDA substances FDA UNII substance identifier B5IWK1V8FX UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B5IWK1V8FX"}
openFDA substances FDA UNII substance identifier B5IWK1V8FX UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B5IWK1V8FX"}