NOAEL Studies Cosmetic Ingredient

2-Chloro-6-Ethylamino-4-Nitrophenol NOAEL Studies

INCI: 2-CHLORO-6-ETHYLAMINO-4-NITROPHENOL

CAS: 131657-78-8

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 10 mg/kg bw/day rat oral 90 day Subchronic SCCP; Korn, W.-D.; 3-month oral toxicity studywith "ROT CO" (Cos. 552) in rats (followedby a 4-week recovery period); IBR ;1989
SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =10 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 5 1. BACKGROUND Submission I for 2-chloro-6-ethylamino-4-nitrophenol was submitted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/7","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"itted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 55 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-","page":28,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_005"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 5 1. BACKGROUND Submission I for 2-chloro-6-ethylamino-4-nitrophenol was submitted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/7","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"itted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 55 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-","page":28,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_005"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 5 1. BACKGROUND Submission I for 2-chloro-6-ethylamino-4-nitrophenol was submitted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/7","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"itted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 55 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-","page":28,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_005"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 5 1. BACKGROUND Submission I for 2-chloro-6-ethylamino-4-nitrophenol was submitted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/7","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw rat - 90-day dermal absorption {"dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","effect":"itted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 55 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions","page":5,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-","page":28,"pdf":"sccp_o_118.pdf","row_type":"noael_study","study_id":"sccp_o_118_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 10 mg/kg bw rat - 4-week - SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=10; DOSE=The histomorphological examination of the organs of high dose group did not reveal morphological changes related to the treatment.; EFFECT=did not reach statistical significance. All the findings were reversible during the 4-week recovery period. The histomorphological examination of the organs of high dose group did not reveal morphological changes related to the treatment. The alterations observed in different organs were considered to be similar in treated and control animals with regard to type, incidence and severity. Conclusion Due to significantly increased liver weight of male rats seen at 30 and 90 mg/kg bw after the 90 days of exposure, a NOEL of 10 mg/kg bw was deduced. Ref.: 23 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 23 3; CITATION_NUMBERS=[23,3]; REFERENCE=Ref.: 23 3; DETAILS_JSON={"cas_number":"131657-78-8","citation":"Ref.: 23 3","dose":"The histomorphological examination of the organs of high dose group did not reveal morphological changes related to the treatment.","duration":"4-week","effect":"did not reach statistical significance. All the findings were reversible during the 4-week recovery period. The histomorphological examination of the organs of high dose group did not reveal morphological changes related to the treatment. The alterations observed in different organs were considered to be similar in treated and control animals with regard to type, incidence and severity. Conclusion Due to significantly increased liver weight of male rats seen at 30 and 90 mg/kg bw after the 90 days of exposure, a NOEL of 10 mg/kg bw was deduced. Ref.: 23 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":16,"route":"","species":"rat","study_id":"sccp_o_118_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 10 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=10; DOSE=In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.; EFFECT=SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 5 1. BACKGROUND Submission I for 2-chloro-6-ethylamino-4-nitrophenol was submitted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131657-78-8","citation":"","dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","duration":"90-day","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 5 1. BACKGROUND Submission I for 2-chloro-6-ethylamino-4-nitrophenol was submitted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/7","endpoint":"dermal absorption","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":5,"route":"","species":"rat","study_id":"sccp_o_118_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 90 mg/kg bw rat - 90-day dermal absorption SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=90; DOSE=In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.; EFFECT=itted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 55 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131657-78-8","citation":"","dose":"In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL.","duration":"90-day","effect":"itted in July 1992 by COLIPA1,2. The Scientific Committee on Cosmetology (SCC) adopted at its 62nd plenary meeting on 18 February 1996 an opinion (SPC/1394/93) with the final conclusion that: “The substance can be classified as non irritating to mucous membranes and as non sensitizer. In the 90-day studies with rats, 10 mg/kg bw is considered to be the NOAEL. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 90 mg/kg bw in rats. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month. Percutaneous absorption of a formulation was 0.14% without and 0.10% with H2O2. In general the test substance did not show any mutagenic potential.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 55 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions","endpoint":"dermal absorption","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":5,"route":"","species":"rat","study_id":"sccp_o_118_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =10 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 10; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...; EFFECT=SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131657-78-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...","duration":"90-day","effect":"SCCP/1090/07 Opinion on 2-chloro-6-ethylamino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-","endpoint":"dermal absorption","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 10","page":28,"route":"oral","species":"rat","study_id":"sccp_o_118_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =10 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 10; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...; EFFECT=ino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-6-ethylamino-4-nitrophenol is a secondary amine, and t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131657-78-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic e...","duration":"90-day","effect":"ino-4-nitrophenol 28 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-chloro-6-ethylamino-4-nitrophenol) (non-oxidative) Maximum absorption through the skin A (µg/cm2) = 3.77 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg No observed effect level (mg/kg) NOEL = 10 mg/kg (90-day, oral, rat) Margin of Safety NOEL / SED = 250 3.3.14. Discussion Physico-chemical properties 2-Chloro-6-ethylamino-4-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.5 %. It is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on head concentration of 3 %. No documentation is provided for the characterisation and composition of various batches of 2-Chloro-6-ethylamino-4-nitrophenol. 2-Chloro-6-ethylamino-4-nitrophenol is a secondary amine, and t","endpoint":"dermal absorption","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 10","page":28,"route":"oral","species":"rat","study_id":"sccp_o_118_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 90 mg/kg bw rat - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=90; DOSE=Neither a statistically significant difference nor a dose-dependent increase in any malformation was noted.; EFFECT=he foetuses revealed no treatment related findings. Neither a statistically significant difference nor a dose-dependent increase in any malformation was noted. The observed variations represented common findings for the rat strain used and were within the spontaneous variation range and/or revealed no dose-response relation. Conclusion 2-Chloro-6-ethylamino-4-nitrophenol revealed neither maternal toxic effects nor did it induce embryotoxicity or teratogenicity in female rats. Based on the results of the study the NOAEL for both maternal and developmental toxicity was a dose of 90 mg/kg bw administered during organogenesis. Ref.: 31 Comment For hazard identification, the highest dose applied in teratogenicity studies should lead to maternal and/or developmental toxicity 3.3.9. Toxicokinetics Guideline: / Species/strain: Rat, strain Sprague Dawley Him:OFA ( SPF) Group size: 3 per sex and dose Test substance: 14C-2-chloro-6-ethylamino-4-nitrophenol (ring-labelled) Batch: 109F9206 Purity: > 98% (Radiochemical, HPLC), specific act; CITATION=Ref.: 31 Comment For hazard identification, the highest dose applied in teratogenicity studies should lead to maternal and/or developmental toxicity 3; CITATION_NUMBERS=[31,3]; REFERENCE=Ref.: 31 Comment For hazard identification, the highest dose applied in teratogenicity studies should lead to maternal and/or developmental toxicity 3; DETAILS_JSON={"cas_number":"131657-78-8","citation":"Ref.: 31 Comment For hazard identification, the highest dose applied in teratogenicity studies should lead to maternal and/or developmental toxicity 3","dose":"Neither a statistically significant difference nor a dose-dependent increase in any malformation was noted.","duration":"developmental","effect":"he foetuses revealed no treatment related findings. Neither a statistically significant difference nor a dose-dependent increase in any malformation was noted. The observed variations represented common findings for the rat strain used and were within the spontaneous variation range and/or revealed no dose-response relation. Conclusion 2-Chloro-6-ethylamino-4-nitrophenol revealed neither maternal toxic effects nor did it induce embryotoxicity or teratogenicity in female rats. Based on the results of the study the NOAEL for both maternal and developmental toxicity was a dose of 90 mg/kg bw administered during organogenesis. Ref.: 31 Comment For hazard identification, the highest dose applied in teratogenicity studies should lead to maternal and/or developmental toxicity 3.3.9. Toxicokinetics Guideline: / Species/strain: Rat, strain Sprague Dawley Him:OFA ( SPF) Group size: 3 per sex and dose Test substance: 14C-2-chloro-6-ethylamino-4-nitrophenol (ring-labelled) Batch: 109F9206 Purity: > 98% (Radiochemical, HPLC), specific act","endpoint":"developmental toxicity","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":25,"route":"","species":"rat","study_id":"sccp_o_118_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 10 mg/kg bw rat oral 90 days developmental toxicity SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=10; DOSE=General toxicity The acute median lethal oral doses (LD50) of 2-chloro-6-ethylamino-4-nitrophenol in rats were 1461 mg/kg bw for females, 2026 mg/kg bw for males and 1728 mg/kg bw for both sexes.; EFFECT=6-ethylamino-4-nitrophenol in marketed products is not provided. General toxicity The acute median lethal oral doses (LD50) of 2-chloro-6-ethylamino-4-nitrophenol in rats were 1461 mg/kg bw for females, 2026 mg/kg bw for males and 1728 mg/kg bw for both sexes. The acute median lethal dermal dose (LD50) of 2-chloro-6-ethylamino-4- nitrophenol was > 2000 mg/kg bw in both sexes of rats. Due to statistically significantly increased liver weight in male rats observed at 30 and 90 mg/kg bw after the 90 days exposure a NOAEL of 10 mg/kg bw was deduced. 2-Chloro-6-ethylamino-4-nitrophenol revealed neither maternal toxic effects nor did it induce embryotoxicity or teratogenicity in female rats on the highest exposure level used (90 mg/kg bw). Based on this the NOAEL for both maternal and developmental toxicity was a dose of 90 mg/kg bw administered during organogenesis. Toxico-kinetics 2-Chloro-6-ethylamino-4-nitrophenol given orally to rats is quickly absorbed and practically completely excreted within 72 h, with the majority eliminat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131657-78-8","citation":"","dose":"General toxicity The acute median lethal oral doses (LD50) of 2-chloro-6-ethylamino-4-nitrophenol in rats were 1461 mg/kg bw for females, 2026 mg/kg bw for males and 1728 mg/kg bw for both sexes.","duration":"90 days","effect":"6-ethylamino-4-nitrophenol in marketed products is not provided. General toxicity The acute median lethal oral doses (LD50) of 2-chloro-6-ethylamino-4-nitrophenol in rats were 1461 mg/kg bw for females, 2026 mg/kg bw for males and 1728 mg/kg bw for both sexes. The acute median lethal dermal dose (LD50) of 2-chloro-6-ethylamino-4- nitrophenol was > 2000 mg/kg bw in both sexes of rats. Due to statistically significantly increased liver weight in male rats observed at 30 and 90 mg/kg bw after the 90 days exposure a NOAEL of 10 mg/kg bw was deduced. 2-Chloro-6-ethylamino-4-nitrophenol revealed neither maternal toxic effects nor did it induce embryotoxicity or teratogenicity in female rats on the highest exposure level used (90 mg/kg bw). Based on this the NOAEL for both maternal and developmental toxicity was a dose of 90 mg/kg bw administered during organogenesis. Toxico-kinetics 2-Chloro-6-ethylamino-4-nitrophenol given orally to rats is quickly absorbed and practically completely excreted within 72 h, with the majority eliminat","endpoint":"developmental toxicity","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":28,"route":"oral","species":"rat","study_id":"sccp_o_118_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 90 mg/kg bw rat dermal 90 days developmental toxicity SOURCE_SUBDIR=sccp_o_118; REPORT_TITLE=OPINION ON 2-Chloro-6-ethylamino-4-nitrophenol COLIPA n° B89; OPINION_NUMBER=SCCP/1090/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=90; DOSE=The acute median lethal dermal dose (LD50) of 2-chloro-6-ethylamino-4- nitrophenol was > 2000 mg/kg bw in both sexes of rats.; EFFECT=bw for both sexes. The acute median lethal dermal dose (LD50) of 2-chloro-6-ethylamino-4- nitrophenol was > 2000 mg/kg bw in both sexes of rats. Due to statistically significantly increased liver weight in male rats observed at 30 and 90 mg/kg bw after the 90 days exposure a NOAEL of 10 mg/kg bw was deduced. 2-Chloro-6-ethylamino-4-nitrophenol revealed neither maternal toxic effects nor did it induce embryotoxicity or teratogenicity in female rats on the highest exposure level used (90 mg/kg bw). Based on this the NOAEL for both maternal and developmental toxicity was a dose of 90 mg/kg bw administered during organogenesis. Toxico-kinetics 2-Chloro-6-ethylamino-4-nitrophenol given orally to rats is quickly absorbed and practically completely excreted within 72 h, with the majority eliminated within 24 h after application. Excretion takes place predominantly (62%) via urine. After dermal administration (vehicle/water/DMSO) up to 66.31 µg/cm², equal to 2.8% are absorbed through the skin and become systemically available. Lower fig; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131657-78-8","citation":"","dose":"The acute median lethal dermal dose (LD50) of 2-chloro-6-ethylamino-4- nitrophenol was > 2000 mg/kg bw in both sexes of rats.","duration":"90 days","effect":"bw for both sexes. The acute median lethal dermal dose (LD50) of 2-chloro-6-ethylamino-4- nitrophenol was > 2000 mg/kg bw in both sexes of rats. Due to statistically significantly increased liver weight in male rats observed at 30 and 90 mg/kg bw after the 90 days exposure a NOAEL of 10 mg/kg bw was deduced. 2-Chloro-6-ethylamino-4-nitrophenol revealed neither maternal toxic effects nor did it induce embryotoxicity or teratogenicity in female rats on the highest exposure level used (90 mg/kg bw). Based on this the NOAEL for both maternal and developmental toxicity was a dose of 90 mg/kg bw administered during organogenesis. Toxico-kinetics 2-Chloro-6-ethylamino-4-nitrophenol given orally to rats is quickly absorbed and practically completely excreted within 72 h, with the majority eliminated within 24 h after application. Excretion takes place predominantly (62%) via urine. After dermal administration (vehicle/water/DMSO) up to 66.31 µg/cm², equal to 2.8% are absorbed through the skin and become systemically available. Lower fig","endpoint":"developmental toxicity","ingredient":"2-Chloro-6-ethylamino-4-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":28,"route":"dermal","species":"rat","study_id":"sccp_o_118_noael_008"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 5LIV96LADQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H9ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5LIV96LADQ"}
openFDA substances FDA UNII substance identifier 5LIV96LADQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H9ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5LIV96LADQ"}
openFDA substances FDA UNII substance identifier 5LIV96LADQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H9ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5LIV96LADQ"}
openFDA substances FDA UNII substance identifier 5LIV96LADQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H9ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5LIV96LADQ"}