NOAEL Studies Cosmetic Ingredient

2-Hydroxyethylamino-5-Nitroanisole NOAEL Studies

INCI: 2-HYDROXYETHYLAMINO-5-NITROANISOLE

CAS: 66095-81-6

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

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 25 mg/kg bw/day rat oral 90 day Subchronic SCCS; S-A. Brownlie. Imexine FM: 13 Week Oral (Gavage) Toxicity Study in the Rat. Quintiles Study No. LRL/81/95, 1997
SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral 28 day dermal absorption {"dose":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males.","effect":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males. The substance can be classified as slightly irritating to the eyes and not irritating to the skin. Percutaneous absorption of a formulation was 0.64 % in absence and 0.29 % in presence of hair. In a 28 day study in rats, 100 mg/kg/day was the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 250 mg/kg. The substance was found to be not mutagenic.” The substance is currently regulated in the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 29 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submi","page":5,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral 13 weeks NOAEL study {"dose":"10 animals per sex and dose group Test substance:","effect":"Sprague-Dawley Crl:CD(SD)BR strain (VAF plus) Group size: 10 animals per sex and dose group Test substance: Imexine FM suspended in 0.5 % carboxymethylcellulose Batch: OpT 39 Purity: 99.9% Dose: 0, 25, 100 and 500 mg/kg bw/day Route: oral, gavage Exposure: 13 weeks GLP: in compliance The test substance was given orally by gavage at dose levels 25, 100 or 500 mg/kg bw/day while the controls received the vehicle 0.5% carboxymethylcellulose alone. The dose levels were selected based on a 4-week range finding study (NOAEL 100 mg/kg bw/day). Animals were observed daily for mortality and clinical signs. Body weights and feed consumption were recorded weekly. Ophthalmoscopy was performed with all animals before the start of treatment and on control and high dose animals during week 13. Haematology, blood chemistry and urinalysis were investigated during week 12/13. At study end necroscopy was performed and several tissues of control and high dose animals were examined microscopically. Results No substance-related deaths and no clinic","page":13,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_002"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral 28 day dermal absorption {"dose":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males.","effect":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males. The substance can be classified as slightly irritating to the eyes and not irritating to the skin. Percutaneous absorption of a formulation was 0.64 % in absence and 0.29 % in presence of hair. In a 28 day study in rats, 100 mg/kg/day was the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 250 mg/kg. The substance was found to be not mutagenic.” The substance is currently regulated in the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 29 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submi","page":5,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral 13 weeks NOAEL study {"dose":"10 animals per sex and dose group Test substance:","effect":"Sprague-Dawley Crl:CD(SD)BR strain (VAF plus) Group size: 10 animals per sex and dose group Test substance: Imexine FM suspended in 0.5 % carboxymethylcellulose Batch: OpT 39 Purity: 99.9% Dose: 0, 25, 100 and 500 mg/kg bw/day Route: oral, gavage Exposure: 13 weeks GLP: in compliance The test substance was given orally by gavage at dose levels 25, 100 or 500 mg/kg bw/day while the controls received the vehicle 0.5% carboxymethylcellulose alone. The dose levels were selected based on a 4-week range finding study (NOAEL 100 mg/kg bw/day). Animals were observed daily for mortality and clinical signs. Body weights and feed consumption were recorded weekly. Ophthalmoscopy was performed with all animals before the start of treatment and on control and high dose animals during week 13. Haematology, blood chemistry and urinalysis were investigated during week 12/13. At study end necroscopy was performed and several tissues of control and high dose animals were examined microscopically. Results No substance-related deaths and no clinic","page":13,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_002"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral 28 day dermal absorption {"dose":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males.","effect":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males. The substance can be classified as slightly irritating to the eyes and not irritating to the skin. Percutaneous absorption of a formulation was 0.64 % in absence and 0.29 % in presence of hair. In a 28 day study in rats, 100 mg/kg/day was the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 250 mg/kg. The substance was found to be not mutagenic.” The substance is currently regulated in the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 29 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submi","page":5,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral 13 weeks NOAEL study {"dose":"10 animals per sex and dose group Test substance:","effect":"Sprague-Dawley Crl:CD(SD)BR strain (VAF plus) Group size: 10 animals per sex and dose group Test substance: Imexine FM suspended in 0.5 % carboxymethylcellulose Batch: OpT 39 Purity: 99.9% Dose: 0, 25, 100 and 500 mg/kg bw/day Route: oral, gavage Exposure: 13 weeks GLP: in compliance The test substance was given orally by gavage at dose levels 25, 100 or 500 mg/kg bw/day while the controls received the vehicle 0.5% carboxymethylcellulose alone. The dose levels were selected based on a 4-week range finding study (NOAEL 100 mg/kg bw/day). Animals were observed daily for mortality and clinical signs. Body weights and feed consumption were recorded weekly. Ophthalmoscopy was performed with all animals before the start of treatment and on control and high dose animals during week 13. Haematology, blood chemistry and urinalysis were investigated during week 12/13. At study end necroscopy was performed and several tissues of control and high dose animals were examined microscopically. Results No substance-related deaths and no clinic","page":13,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_002"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral 28 day dermal absorption {"dose":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males.","effect":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males. The substance can be classified as slightly irritating to the eyes and not irritating to the skin. Percutaneous absorption of a formulation was 0.64 % in absence and 0.29 % in presence of hair. In a 28 day study in rats, 100 mg/kg/day was the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 250 mg/kg. The substance was found to be not mutagenic.” The substance is currently regulated in the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 29 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submi","page":5,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral 13 weeks NOAEL study {"dose":"10 animals per sex and dose group Test substance:","effect":"Sprague-Dawley Crl:CD(SD)BR strain (VAF plus) Group size: 10 animals per sex and dose group Test substance: Imexine FM suspended in 0.5 % carboxymethylcellulose Batch: OpT 39 Purity: 99.9% Dose: 0, 25, 100 and 500 mg/kg bw/day Route: oral, gavage Exposure: 13 weeks GLP: in compliance The test substance was given orally by gavage at dose levels 25, 100 or 500 mg/kg bw/day while the controls received the vehicle 0.5% carboxymethylcellulose alone. The dose levels were selected based on a 4-week range finding study (NOAEL 100 mg/kg bw/day). Animals were observed daily for mortality and clinical signs. Body weights and feed consumption were recorded weekly. Ophthalmoscopy was performed with all animals before the start of treatment and on control and high dose animals during week 13. Haematology, blood chemistry and urinalysis were investigated during week 12/13. At study end necroscopy was performed and several tissues of control and high dose animals were examined microscopically. Results No substance-related deaths and no clinic","page":13,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day human oral - NOAEL study {"citation":"Ref.: 10 3","dose":"at 750 mg/kg bw/d accompanied by reduced feed consumption.","effect":"at 750 mg/kg bw/d accompanied by reduced feed consumption. The number of resorptions was not changed. Mean foetal weight was significantly reduced in the highest dose group. One external abnormality (acaudia) was found at 750 mg/kg bw/d which was considered an isolated finding. Visceral examination did not reveal further abnormalities. Parallel to the reduction in foetal weight in the high dose group incomplete ossification of os supraoccipitale, thoracic and sternal ossification centers occurred. Conclusion The NOAEL of maternal and embryo/foetal toxicity is 250 mg/kg bw/day. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 18","page":18,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day human oral - NOAEL study {"citation":"Ref.: 10 3","dose":"at 750 mg/kg bw/d accompanied by reduced feed consumption.","effect":"at 750 mg/kg bw/d accompanied by reduced feed consumption. The number of resorptions was not changed. Mean foetal weight was significantly reduced in the highest dose group. One external abnormality (acaudia) was found at 750 mg/kg bw/d which was considered an isolated finding. Visceral examination did not reveal further abnormalities. Parallel to the reduction in foetal weight in the high dose group incomplete ossification of os supraoccipitale, thoracic and sternal ossification centers occurred. Conclusion The NOAEL of maternal and embryo/foetal toxicity is 250 mg/kg bw/day. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 18","page":18,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day human oral - NOAEL study {"citation":"Ref.: 10 3","dose":"at 750 mg/kg bw/d accompanied by reduced feed consumption.","effect":"at 750 mg/kg bw/d accompanied by reduced feed consumption. The number of resorptions was not changed. Mean foetal weight was significantly reduced in the highest dose group. One external abnormality (acaudia) was found at 750 mg/kg bw/d which was considered an isolated finding. Visceral examination did not reveal further abnormalities. Parallel to the reduction in foetal weight in the high dose group incomplete ossification of os supraoccipitale, thoracic and sternal ossification centers occurred. Conclusion The NOAEL of maternal and embryo/foetal toxicity is 250 mg/kg bw/day. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 18","page":18,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day human oral - NOAEL study {"citation":"Ref.: 10 3","dose":"at 750 mg/kg bw/d accompanied by reduced feed consumption.","effect":"at 750 mg/kg bw/d accompanied by reduced feed consumption. The number of resorptions was not changed. Mean foetal weight was significantly reduced in the highest dose group. One external abnormality (acaudia) was found at 750 mg/kg bw/d which was considered an isolated finding. Visceral examination did not reveal further abnormalities. Parallel to the reduction in foetal weight in the high dose group incomplete ossification of os supraoccipitale, thoracic and sternal ossification centers occurred. Conclusion The NOAEL of maternal and embryo/foetal toxicity is 250 mg/kg bw/day. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 18","page":18,"pdf":"sccp_o_109.pdf","row_type":"noael_study","study_id":"sccp_o_109_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day - oral 13 weeks - SOURCE_SUBDIR=sccp_o_109; REPORT_TITLE=OPINION ON 2-Hydroxyethylamino-5-nitroanisole COLIPA n° B52; OPINION_NUMBER=SCCP/1099/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=10 animals per sex and dose group Test substance:; EFFECT=Sprague-Dawley Crl:CD(SD)BR strain (VAF plus) Group size: 10 animals per sex and dose group Test substance: Imexine FM suspended in 0.5 % carboxymethylcellulose Batch: OpT 39 Purity: 99.9% Dose: 0, 25, 100 and 500 mg/kg bw/day Route: oral, gavage Exposure: 13 weeks GLP: in compliance The test substance was given orally by gavage at dose levels 25, 100 or 500 mg/kg bw/day while the controls received the vehicle 0.5% carboxymethylcellulose alone. The dose levels were selected based on a 4-week range finding study (NOAEL 100 mg/kg bw/day). Animals were observed daily for mortality and clinical signs. Body weights and feed consumption were recorded weekly. Ophthalmoscopy was performed with all animals before the start of treatment and on control and high dose animals during week 13. Haematology, blood chemistry and urinalysis were investigated during week 12/13. At study end necroscopy was performed and several tissues of control and high dose animals were examined microscopically. Results No substance-related deaths and no clinic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66095-81-6","citation":"","dose":"10 animals per sex and dose group Test substance:","duration":"13 weeks","effect":"Sprague-Dawley Crl:CD(SD)BR strain (VAF plus) Group size: 10 animals per sex and dose group Test substance: Imexine FM suspended in 0.5 % carboxymethylcellulose Batch: OpT 39 Purity: 99.9% Dose: 0, 25, 100 and 500 mg/kg bw/day Route: oral, gavage Exposure: 13 weeks GLP: in compliance The test substance was given orally by gavage at dose levels 25, 100 or 500 mg/kg bw/day while the controls received the vehicle 0.5% carboxymethylcellulose alone. The dose levels were selected based on a 4-week range finding study (NOAEL 100 mg/kg bw/day). Animals were observed daily for mortality and clinical signs. Body weights and feed consumption were recorded weekly. Ophthalmoscopy was performed with all animals before the start of treatment and on control and high dose animals during week 13. Haematology, blood chemistry and urinalysis were investigated during week 12/13. At study end necroscopy was performed and several tissues of control and high dose animals were examined microscopically. Results No substance-related deaths and no clinic","endpoint":"","ingredient":"2-Hydroxyethylamino-5-nitroanisole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":13,"route":"oral","species":"","study_id":"sccp_o_109_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw/day human oral - - SOURCE_SUBDIR=sccp_o_109; REPORT_TITLE=OPINION ON 2-Hydroxyethylamino-5-nitroanisole COLIPA n° B52; OPINION_NUMBER=SCCP/1099/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=250; DOSE=at 750 mg/kg bw/d accompanied by reduced feed consumption.; EFFECT=at 750 mg/kg bw/d accompanied by reduced feed consumption. The number of resorptions was not changed. Mean foetal weight was significantly reduced in the highest dose group. One external abnormality (acaudia) was found at 750 mg/kg bw/d which was considered an isolated finding. Visceral examination did not reveal further abnormalities. Parallel to the reduction in foetal weight in the high dose group incomplete ossification of os supraoccipitale, thoracic and sternal ossification centers occurred. Conclusion The NOAEL of maternal and embryo/foetal toxicity is 250 mg/kg bw/day. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 18; CITATION=Ref.: 10 3; CITATION_NUMBERS=[10,3]; REFERENCE=Ref.: 10 3; DETAILS_JSON={"cas_number":"66095-81-6","citation":"Ref.: 10 3","dose":"at 750 mg/kg bw/d accompanied by reduced feed consumption.","duration":"","effect":"at 750 mg/kg bw/d accompanied by reduced feed consumption. The number of resorptions was not changed. Mean foetal weight was significantly reduced in the highest dose group. One external abnormality (acaudia) was found at 750 mg/kg bw/d which was considered an isolated finding. Visceral examination did not reveal further abnormalities. Parallel to the reduction in foetal weight in the high dose group incomplete ossification of os supraoccipitale, thoracic and sternal ossification centers occurred. Conclusion The NOAEL of maternal and embryo/foetal toxicity is 250 mg/kg bw/day. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 18","endpoint":"","ingredient":"2-Hydroxyethylamino-5-nitroanisole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":18,"route":"oral","species":"human","study_id":"sccp_o_109_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 100 mg/kg/day rat oral 28 day dermal absorption SOURCE_SUBDIR=sccp_o_109; REPORT_TITLE=OPINION ON 2-Hydroxyethylamino-5-nitroanisole COLIPA n° B52; OPINION_NUMBER=SCCP/1099/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males.; EFFECT=nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males. The substance can be classified as slightly irritating to the eyes and not irritating to the skin. Percutaneous absorption of a formulation was 0.64 % in absence and 0.29 % in presence of hair. In a 28 day study in rats, 100 mg/kg/day was the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 250 mg/kg. The substance was found to be not mutagenic.” The substance is currently regulated in the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 29 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66095-81-6","citation":"","dose":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males.","duration":"28 day","effect":"nary meeting on 20 May 1998 its opinion (XXIV/1289/97) with the final conclusion that: “The acute oral toxicity of 1-methoxy-2-(ß-hydroxyethyl)-amino-5-nitrobenzene in the rat is estimated to be >2000 mg/kg bw for the females and in the region of 2000 mg/kg bw for the males. The substance can be classified as slightly irritating to the eyes and not irritating to the skin. Percutaneous absorption of a formulation was 0.64 % in absence and 0.29 % in presence of hair. In a 28 day study in rats, 100 mg/kg/day was the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 250 mg/kg. The substance was found to be not mutagenic.” The substance is currently regulated in the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 29 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submi","endpoint":"dermal absorption","ingredient":"2-Hydroxyethylamino-5-nitroanisole","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":5,"route":"oral","species":"rat","study_id":"sccp_o_109_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 100 mg/kg bw/day rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_109; REPORT_TITLE=OPINION ON 2-Hydroxyethylamino-5-nitroanisole COLIPA n° B52; OPINION_NUMBER=SCCP/1099/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats.; EFFECT=rone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No documentation was submitted on the stability of the test substance in marketed products. General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats. The NOAEL of Imexine FM in a 90-day oral toxicity study in rats was 100 mg/kg bw/day. The NOAEL for maternal and embryo/foetal toxicity was 250 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, a 10% dilution of 2-hydroxyethylamino-5-nitroanisole showed transient, slight irritant potential to rabbit skin. 1% 2-hydroxyethylamino-5-nitroanisole was non-irritating to rabbit eyes. On the basis of the results of the murine LLNA, 2-hydroxyethylamino-5-nitroanisole at a maximal dilution of 10% was considered to have no skin sensitising potential. Dermal absorption As only a total of 7 ch; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66095-81-6","citation":"","dose":"General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats.","duration":"90-day","effect":"rone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No documentation was submitted on the stability of the test substance in marketed products. General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats. The NOAEL of Imexine FM in a 90-day oral toxicity study in rats was 100 mg/kg bw/day. The NOAEL for maternal and embryo/foetal toxicity was 250 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, a 10% dilution of 2-hydroxyethylamino-5-nitroanisole showed transient, slight irritant potential to rabbit skin. 1% 2-hydroxyethylamino-5-nitroanisole was non-irritating to rabbit eyes. On the basis of the results of the murine LLNA, 2-hydroxyethylamino-5-nitroanisole at a maximal dilution of 10% was considered to have no skin sensitising potential. Dermal absorption As only a total of 7 ch","endpoint":"dermal absorption","ingredient":"2-Hydroxyethylamino-5-nitroanisole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":19,"route":"oral","species":"rat","study_id":"sccp_o_109_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw/day rat oral 90-day irritation SOURCE_SUBDIR=sccp_o_109; REPORT_TITLE=OPINION ON 2-Hydroxyethylamino-5-nitroanisole COLIPA n° B52; OPINION_NUMBER=SCCP/1099/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats.; EFFECT=tration of 0.2%. 2-Hydroxyethylamino-5-nitroanisole is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No documentation was submitted on the stability of the test substance in marketed products. General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats. The NOAEL of Imexine FM in a 90-day oral toxicity study in rats was 100 mg/kg bw/day. The NOAEL for maternal and embryo/foetal toxicity was 250 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, a 10% dilution of 2-hydroxyethylamino-5-nitroanisole showed transient, slight irritant potential to rabbit skin. 1% 2-hydroxyethylamino-5-nitroanisole was non-irritating to rabbit eyes. On the basis of the results of the murine LLNA, 2-hydroxyethylamino-5-nitroanisole at a maximal dilution of 10% was conside; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"66095-81-6","citation":"","dose":"General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats.","duration":"90-day","effect":"tration of 0.2%. 2-Hydroxyethylamino-5-nitroanisole is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No documentation was submitted on the stability of the test substance in marketed products. General toxicity The maximal non-lethal dose of the test substance was 500 mg/kg bw and the minimal lethal dose is 1000 mg/kg bw under the experimental conditions of the acute oral toxicity study in rats. The NOAEL of Imexine FM in a 90-day oral toxicity study in rats was 100 mg/kg bw/day. The NOAEL for maternal and embryo/foetal toxicity was 250 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, a 10% dilution of 2-hydroxyethylamino-5-nitroanisole showed transient, slight irritant potential to rabbit skin. 1% 2-hydroxyethylamino-5-nitroanisole was non-irritating to rabbit eyes. On the basis of the results of the murine LLNA, 2-hydroxyethylamino-5-nitroanisole at a maximal dilution of 10% was conside","endpoint":"irritation","ingredient":"2-Hydroxyethylamino-5-nitroanisole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":19,"route":"oral","species":"rat","study_id":"sccp_o_109_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 100 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_109; REPORT_TITLE=OPINION ON 2-Hydroxyethylamino-5-nitroanisole COLIPA n° B52; OPINION_NUMBER=SCCP/1099/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=Relative spleen and liver weights of high dose females were significantly increased.; EFFECT=. Relative spleen and liver weights of high dose females were significantly increased. In haematology elevated prothrombin times (males and females) and fibrinogen levels (males) were observed in the high dose. Also in the high dose changes in the mean blood urea nitrogen (females) and mean alanine aminotransferase levels (males) were recorded as well an increase in urinary volume (males and females). Macroscopic and microscopic examinations of tissues revealed no pathological evidence of toxicity. Conclusion The NOAEL of Imexine FM in this subchronic oral toxicity study in rats is 100 mg/kg bw/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 13; CITATION=Ref.: 5 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref.: 5 3; DETAILS_JSON={"cas_number":"66095-81-6","citation":"Ref.: 5 3","dose":"Relative spleen and liver weights of high dose females were significantly increased.","duration":"subchronic","effect":". Relative spleen and liver weights of high dose females were significantly increased. In haematology elevated prothrombin times (males and females) and fibrinogen levels (males) were observed in the high dose. Also in the high dose changes in the mean blood urea nitrogen (females) and mean alanine aminotransferase levels (males) were recorded as well an increase in urinary volume (males and females). Macroscopic and microscopic examinations of tissues revealed no pathological evidence of toxicity. Conclusion The NOAEL of Imexine FM in this subchronic oral toxicity study in rats is 100 mg/kg bw/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 13","endpoint":"repeated dose toxicity","ingredient":"2-Hydroxyethylamino-5-nitroanisole","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":13,"route":"oral","species":"rat","study_id":"sccp_o_109_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 249S4E2270 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"249S4E2270"}
openFDA substances FDA UNII substance identifier 249S4E2270 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"249S4E2270"}
openFDA substances FDA UNII substance identifier 249S4E2270 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"249S4E2270"}
openFDA substances FDA UNII substance identifier 249S4E2270 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"249S4E2270"}