NOAEL Studies Cosmetic Ingredient

Basic Orange 69 NOAEL Studies

INCI: BASIC ORANGE 69

CAS: Verify via CosIng (not confirmed in available sources)

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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SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =10 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 14 Comment","dose":"to be significant in the highest dose group.","effect":"to be significant in the highest dose group. There were no statistically significant differences in the number of corpora lutea, implantation sites and live foetuses among the treated and control groups. The 25 mg/kg bw/day dosage was associated with early (3 dams) or late (1 dam) total resorptions and significant reduced foetal body weight per litter. No anomalies were observed at foetal examination. Incomplete ossification was observed in the highest dose group and was related to the lower mean foetal weight. A NOAEL for maternal toxicity and embryotoxicity of 10 mg/kg bw/day was derived. Ref.: 14 Comment","page":19,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_001"}
SCCS_vision_codex NOAEL =3.5 mg/kg bw mouse - - NOAEL study {"dose":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls.","effect":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls. The body weight gain in this treatment group, however, was also lower than in the controls. The SCCP therefore sets the NOAEL for maternal toxicity at 3.5 mg/kg bw. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Study 1 Guideline: OECD 432 (2003) Species/strain: Balb 3T3 mouse fibroblasts, clone A31 Test substance: Basic Orange 69 Batch: RD 110/009 Purity: / Controls: solvent, chlorpromazine Concentration: 0.001 %, 0.0025 %, 0.005 %, 0.01 %, 0.025 %, 0.05 %, 0.1 % in PBS (v/v) GLP: in compliance The phototoxicity and cytotoxicity potential of","page":20,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral chronic repeated dose toxicity {"dose":"LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.","effect":"ated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of the skin and crust at challenge at 50% were more frequent in test","page":22,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_004"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 14 Comment","dose":"to be significant in the highest dose group.","effect":"to be significant in the highest dose group. There were no statistically significant differences in the number of corpora lutea, implantation sites and live foetuses among the treated and control groups. The 25 mg/kg bw/day dosage was associated with early (3 dams) or late (1 dam) total resorptions and significant reduced foetal body weight per litter. No anomalies were observed at foetal examination. Incomplete ossification was observed in the highest dose group and was related to the lower mean foetal weight. A NOAEL for maternal toxicity and embryotoxicity of 10 mg/kg bw/day was derived. Ref.: 14 Comment","page":19,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_001"}
SCCS_vision_codex NOAEL =3.5 mg/kg bw mouse - - NOAEL study {"dose":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls.","effect":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls. The body weight gain in this treatment group, however, was also lower than in the controls. The SCCP therefore sets the NOAEL for maternal toxicity at 3.5 mg/kg bw. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Study 1 Guideline: OECD 432 (2003) Species/strain: Balb 3T3 mouse fibroblasts, clone A31 Test substance: Basic Orange 69 Batch: RD 110/009 Purity: / Controls: solvent, chlorpromazine Concentration: 0.001 %, 0.0025 %, 0.005 %, 0.01 %, 0.025 %, 0.05 %, 0.1 % in PBS (v/v) GLP: in compliance The phototoxicity and cytotoxicity potential of","page":20,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral chronic repeated dose toxicity {"dose":"LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.","effect":"ated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of the skin and crust at challenge at 50% were more frequent in test","page":22,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_004"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 14 Comment","dose":"to be significant in the highest dose group.","effect":"to be significant in the highest dose group. There were no statistically significant differences in the number of corpora lutea, implantation sites and live foetuses among the treated and control groups. The 25 mg/kg bw/day dosage was associated with early (3 dams) or late (1 dam) total resorptions and significant reduced foetal body weight per litter. No anomalies were observed at foetal examination. Incomplete ossification was observed in the highest dose group and was related to the lower mean foetal weight. A NOAEL for maternal toxicity and embryotoxicity of 10 mg/kg bw/day was derived. Ref.: 14 Comment","page":19,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_001"}
SCCS_vision_codex NOAEL =3.5 mg/kg bw mouse - - NOAEL study {"dose":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls.","effect":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls. The body weight gain in this treatment group, however, was also lower than in the controls. The SCCP therefore sets the NOAEL for maternal toxicity at 3.5 mg/kg bw. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Study 1 Guideline: OECD 432 (2003) Species/strain: Balb 3T3 mouse fibroblasts, clone A31 Test substance: Basic Orange 69 Batch: RD 110/009 Purity: / Controls: solvent, chlorpromazine Concentration: 0.001 %, 0.0025 %, 0.005 %, 0.01 %, 0.025 %, 0.05 %, 0.1 % in PBS (v/v) GLP: in compliance The phototoxicity and cytotoxicity potential of","page":20,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral chronic repeated dose toxicity {"dose":"LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.","effect":"ated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of the skin and crust at challenge at 50% were more frequent in test","page":22,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_004"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 14 Comment","dose":"to be significant in the highest dose group.","effect":"to be significant in the highest dose group. There were no statistically significant differences in the number of corpora lutea, implantation sites and live foetuses among the treated and control groups. The 25 mg/kg bw/day dosage was associated with early (3 dams) or late (1 dam) total resorptions and significant reduced foetal body weight per litter. No anomalies were observed at foetal examination. Incomplete ossification was observed in the highest dose group and was related to the lower mean foetal weight. A NOAEL for maternal toxicity and embryotoxicity of 10 mg/kg bw/day was derived. Ref.: 14 Comment","page":19,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_001"}
SCCS_vision_codex NOAEL =3.5 mg/kg bw mouse - - NOAEL study {"dose":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls.","effect":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls. The body weight gain in this treatment group, however, was also lower than in the controls. The SCCP therefore sets the NOAEL for maternal toxicity at 3.5 mg/kg bw. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Study 1 Guideline: OECD 432 (2003) Species/strain: Balb 3T3 mouse fibroblasts, clone A31 Test substance: Basic Orange 69 Batch: RD 110/009 Purity: / Controls: solvent, chlorpromazine Concentration: 0.001 %, 0.0025 %, 0.005 %, 0.01 %, 0.025 %, 0.05 %, 0.1 % in PBS (v/v) GLP: in compliance The phototoxicity and cytotoxicity potential of","page":20,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_002"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral chronic repeated dose toxicity {"dose":"LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.","effect":"ated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of the skin and crust at challenge at 50% were more frequent in test","page":22,"pdf":"sccp_o_147.pdf","row_type":"noael_study","study_id":"sccp_o_147_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 10 mg/kg bw/day - - - - SOURCE_SUBDIR=sccp_o_147; REPORT_TITLE=OPINION ON Basic Orange 69; OPINION_NUMBER=SCCP/1116/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=10; DOSE=to be significant in the highest dose group.; EFFECT=to be significant in the highest dose group. There were no statistically significant differences in the number of corpora lutea, implantation sites and live foetuses among the treated and control groups. The 25 mg/kg bw/day dosage was associated with early (3 dams) or late (1 dam) total resorptions and significant reduced foetal body weight per litter. No anomalies were observed at foetal examination. Incomplete ossification was observed in the highest dose group and was related to the lower mean foetal weight. A NOAEL for maternal toxicity and embryotoxicity of 10 mg/kg bw/day was derived. Ref.: 14 Comment; CITATION=Ref.: 14 Comment; CITATION_NUMBERS=[14]; REFERENCE=Ref.: 14 Comment; DETAILS_JSON={"cas_number":"226940-14-3","citation":"Ref.: 14 Comment","dose":"to be significant in the highest dose group.","duration":"","effect":"to be significant in the highest dose group. There were no statistically significant differences in the number of corpora lutea, implantation sites and live foetuses among the treated and control groups. The 25 mg/kg bw/day dosage was associated with early (3 dams) or late (1 dam) total resorptions and significant reduced foetal body weight per litter. No anomalies were observed at foetal examination. Incomplete ossification was observed in the highest dose group and was related to the lower mean foetal weight. A NOAEL for maternal toxicity and embryotoxicity of 10 mg/kg bw/day was derived. Ref.: 14 Comment","endpoint":"","ingredient":"Basic Orange 69","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":19,"route":"","species":"","study_id":"sccp_o_147_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 3.5 mg/kg bw mouse - - - SOURCE_SUBDIR=sccp_o_147; REPORT_TITLE=OPINION ON Basic Orange 69; OPINION_NUMBER=SCCP/1116/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=3.5; DOSE=SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls.; EFFECT=SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls. The body weight gain in this treatment group, however, was also lower than in the controls. The SCCP therefore sets the NOAEL for maternal toxicity at 3.5 mg/kg bw. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Study 1 Guideline: OECD 432 (2003) Species/strain: Balb 3T3 mouse fibroblasts, clone A31 Test substance: Basic Orange 69 Batch: RD 110/009 Purity: / Controls: solvent, chlorpromazine Concentration: 0.001 %, 0.0025 %, 0.005 %, 0.01 %, 0.025 %, 0.05 %, 0.1 % in PBS (v/v) GLP: in compliance The phototoxicity and cytotoxicity potential of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"226940-14-3","citation":"","dose":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls.","duration":"","effect":"SCCP/1116/07 Opinion on Basic Orange 69 20 The authors considered the increase in maternal body weight in the 10 mg/kg bw/day group not to be related to the test substance as mean body weight at the beginning of treatment in this group was lower than in untreated controls. The body weight gain in this treatment group, however, was also lower than in the controls. The SCCP therefore sets the NOAEL for maternal toxicity at 3.5 mg/kg bw. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Study 1 Guideline: OECD 432 (2003) Species/strain: Balb 3T3 mouse fibroblasts, clone A31 Test substance: Basic Orange 69 Batch: RD 110/009 Purity: / Controls: solvent, chlorpromazine Concentration: 0.001 %, 0.0025 %, 0.005 %, 0.01 %, 0.025 %, 0.05 %, 0.1 % in PBS (v/v) GLP: in compliance The phototoxicity and cytotoxicity potential of","endpoint":"","ingredient":"Basic Orange 69","loael_value":"","noael_unit":"mg/kg bw","noael_value":"3.5","page":20,"route":"","species":"mouse","study_id":"sccp_o_147_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 3.5 mg/kg bw rat oral chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_147; REPORT_TITLE=OPINION ON Basic Orange 69; OPINION_NUMBER=SCCP/1116/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=3.5; DOSE=LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.; EFFECT=1116/07 Opinion on Basic Orange 69 22 Acute toxicity was investigated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"226940-14-3","citation":"","dose":"LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.","duration":"chronic","effect":"1116/07 Opinion on Basic Orange 69 22 Acute toxicity was investigated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of","endpoint":"repeated dose toxicity","ingredient":"Basic Orange 69","loael_value":"","noael_unit":"mg/kg bw","noael_value":"3.5","page":22,"route":"oral","species":"rat","study_id":"sccp_o_147_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 10 mg/kg bw rat oral chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_147; REPORT_TITLE=OPINION ON Basic Orange 69; OPINION_NUMBER=SCCP/1116/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=10; DOSE=LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.; EFFECT=ated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of the skin and crust at challenge at 50% were more frequent in test; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"226940-14-3","citation":"","dose":"LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application.","duration":"chronic","effect":"ated in rats and mice. LD50 for rats is in the range of 50 to 500 mg/kg bw Zn Basic Orange 69 or 5 to 50 mg/kg bw Basic Orange 69 after oral administration and >2000 mg/kg bw Basic Orange 69 after dermal application. In mice LD50 after oral administration was reported to be in the range of 50 to 300 mg/kg bw Basic Orange 69. No data on repeated dose toxicity or on chronic toxicity was submitted. From a study on teratogenicity with Basic Orange 69 a NOAEL of 3.5 mg/kg bw could be derived for maternal toxicity and a NOAEL of 10 mg/kg bw for embryotoxicity. Irritation / Sensitisation Zn Basic Orange 69 was not irritant in the rabbit. However, the substance was irritant to the rabbit eye. Zn Basic Orange 69 did not induce delayed contact hypersensitivity in guinea pigs at a concentration of 1 %. At the challenge concentration of 50 %, sensitisation could not be excluded. In the opinion of the SCCP, a conclusion concerning sensitisation cannot be drawn. Coloration of the skin and crust at challenge at 50% were more frequent in test","endpoint":"repeated dose toxicity","ingredient":"Basic Orange 69","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":22,"route":"oral","species":"rat","study_id":"sccp_o_147_noael_004"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier T2X8Y3QKX8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H23N4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T2X8Y3QKX8"}
openFDA substances FDA UNII substance identifier T2X8Y3QKX8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H23N4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T2X8Y3QKX8"}
openFDA substances FDA UNII substance identifier T2X8Y3QKX8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H23N4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T2X8Y3QKX8"}
openFDA substances FDA UNII substance identifier T2X8Y3QKX8 UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H23N4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T2X8Y3QKX8"}