| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
>80 |
% |
rabbit |
dermal |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=> 80; DOSE=Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group.; EFFECT=t be related to the test substance. Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group. The only findings at necropsy were a blue discolouration of the digestive tract observed for a few animals given 950 mg active dye/kg/day. No relevant histopathological changes were noted at examination of tissues and organs of treated animals. The No Observed Adverse Effect Level (NOAEL) was reported to be 950 mg active dye/kg bw. The SCCP, however, considers the effects on mean clotting time to be adverse and sets the NOAEL to 285 mg active dye/kg bw. Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No. 2 Batch: / Purity: > 80 %; CITATION=Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No; CITATION_NUMBERS=[6,5,10]; REFERENCE=Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No","dose":"Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group.","duration":"","effect":"t be related to the test substance. Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group. The only findings at necropsy were a blue discolouration of the digestive tract observed for a few animals given 950 mg active dye/kg/day. No relevant histopathological changes were noted at examination of tissues and organs of treated animals. The No Observed Adverse Effect Level (NOAEL) was reported to be 950 mg active dye/kg bw. The SCCP, however, considers the effects on mean clotting time to be adverse and sets the NOAEL to 285 mg active dye/kg bw. Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No. 2 Batch: / Purity: > 80 %","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"> 80","page":13,"route":"dermal","species":"rabbit","study_id":"sccp_o_048_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
>80 |
% |
rabbit |
dermal |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=> 80; DOSE=Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group.; EFFECT=. Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group. The only findings at necropsy were a blue discolouration of the digestive tract observed for a few animals given 950 mg active dye/kg/day. No relevant histopathological changes were noted at examination of tissues and organs of treated animals. The No Observed Adverse Effect Level (NOAEL) was reported to be 950 mg active dye/kg bw. The SCCP, however, considers the effects on mean clotting time to be adverse and sets the NOAEL to 285 mg active dye/kg bw. Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No. 2 Batch: / Purity: > 80 %; CITATION=Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No; CITATION_NUMBERS=[6,5,10]; REFERENCE=Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No","dose":"Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group.","duration":"","effect":". Moderate but statistically significant changes in several clinical laboratory parameters including increases in mean clotting time values and in activated partial thromboplastin time in males were reported for the highest dose group. The only findings at necropsy were a blue discolouration of the digestive tract observed for a few animals given 950 mg active dye/kg/day. No relevant histopathological changes were noted at examination of tissues and organs of treated animals. The No Observed Adverse Effect Level (NOAEL) was reported to be 950 mg active dye/kg bw. The SCCP, however, considers the effects on mean clotting time to be adverse and sets the NOAEL to 285 mg active dye/kg bw. Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No. 2 Batch: / Purity: > 80 %","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"> 80","page":13,"route":"dermal","species":"rabbit","study_id":"sccp_o_048_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
>80 |
% |
rabbit |
dermal |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=> 80; DOSE=and in activated partial thromboplastin time in males were reported for the highest dose group.; EFFECT=and in activated partial thromboplastin time in males were reported for the highest dose group. The only findings at necropsy were a blue discolouration of the digestive tract observed for a few animals given 950 mg active dye/kg/day. No relevant histopathological changes were noted at examination of tissues and organs of treated animals. The No Observed Adverse Effect Level (NOAEL) was reported to be 950 mg active dye/kg bw. The SCCP, however, considers the effects on mean clotting time to be adverse and sets the NOAEL to 285 mg active dye/kg bw. Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No. 2 Batch: / Purity: > 80 %; CITATION=Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No; CITATION_NUMBERS=[6,5,10]; REFERENCE=Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No","dose":"and in activated partial thromboplastin time in males were reported for the highest dose group.","duration":"","effect":"and in activated partial thromboplastin time in males were reported for the highest dose group. The only findings at necropsy were a blue discolouration of the digestive tract observed for a few animals given 950 mg active dye/kg/day. No relevant histopathological changes were noted at examination of tissues and organs of treated animals. The No Observed Adverse Effect Level (NOAEL) was reported to be 950 mg active dye/kg bw. The SCCP, however, considers the effects on mean clotting time to be adverse and sets the NOAEL to 285 mg active dye/kg bw. Ref.: 6 Dermal Guideline: / Species/strain: male albino rabbits Group size: 5 animals per treatment group, 10 animals in control group Test substance: External D&C Violet No. 2 Batch: / Purity: > 80 %","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"> 80","page":13,"route":"dermal","species":"rabbit","study_id":"sccp_o_048_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
95 |
% |
rat |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=95; DOSE=: a decrease in inorganic phosphorus content for males in all dose groups; in the highest dose group decreases in values for leukocytes, lymphocytes, urea, alkaline phosphatase and alanine aminotransferase for males and decrease in glucose content for females.; EFFECT=: a decrease in inorganic phosphorus content for males in all dose groups; in the highest dose group decreases in values for leukocytes, lymphocytes, urea, alkaline phosphatase and alanine aminotransferase for males and decrease in glucose content for females. Furthermore in this group increases in mean clotting time values (males and females), activated partial thromboplastin time and mean cell haemoglobin concentration (males) were noted as well as increases in fibrinogen content and pH of urine in females. The No Observed Adverse Effect Level was 109 mg active dye/kg bw. Ref.: 5 Oral, study 2 Guideline: OECD 408 Species/strain: Wistar rats Group size: 10 animals per sex and group Test substance: External D&C Violet No. 2 Batch: 0609RA Purity: 95% Dose: 0, 95, 285 or 950 mg active dye/kg bw/day in 1% aqueous solution of carboxymethylcellulose (10 ml/kg) by gavage Exposure period: 13 weeks; CITATION=Ref.: 5 Oral, study 2 Guideline: OECD 408 Species/strain: Wistar rats Group size: 10 animals per sex and group Test substance: External D&C Violet No; CITATION_NUMBERS=[5,2,408,10]; REFERENCE=Ref.: 5 Oral, study 2 Guideline: OECD 408 Species/strain: Wistar rats Group size: 10 animals per sex and group Test substance: External D&C Violet No; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 5 Oral, study 2 Guideline: OECD 408 Species/strain: Wistar rats Group size: 10 animals per sex and group Test substance: External D&C Violet No","dose":": a decrease in inorganic phosphorus content for males in all dose groups; in the highest dose group decreases in values for leukocytes, lymphocytes, urea, alkaline phosphatase and alanine aminotransferase for males and decrease in glucose content for females.","duration":"13 weeks","effect":": a decrease in inorganic phosphorus content for males in all dose groups; in the highest dose group decreases in values for leukocytes, lymphocytes, urea, alkaline phosphatase and alanine aminotransferase for males and decrease in glucose content for females. Furthermore in this group increases in mean clotting time values (males and females), activated partial thromboplastin time and mean cell haemoglobin concentration (males) were noted as well as increases in fibrinogen content and pH of urine in females. The No Observed Adverse Effect Level was 109 mg active dye/kg bw. Ref.: 5 Oral, study 2 Guideline: OECD 408 Species/strain: Wistar rats Group size: 10 animals per sex and group Test substance: External D&C Violet No. 2 Batch: 0609RA Purity: 95% Dose: 0, 95, 285 or 950 mg active dye/kg bw/day in 1% aqueous solution of carboxymethylcellulose (10 ml/kg) by gavage Exposure period: 13 weeks","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"95","page":12,"route":"oral","species":"rat","study_id":"sccp_o_048_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
95 |
% |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=95; DOSE=Discoloration of placenta was also noted in the highest dose group.; EFFECT=re 18, 23, 21 and 21 pregnant females in the 0, 27, 109 and 435 mg active dye/kg/day groups, respectively. No deaths were reported. Clinical signs were increased salivation at 435 mg active dye/kg/day and discoloured faeces at 109 mg active dye/kg/day and higher. Discoloration of placenta was also noted in the highest dose group. No effects on litter parameters or foetal weight were observed. There were no external soft tissue or skeletal anomalies that could be attributed to treatment with the test substance. The No Observed Adverse Effect Level (NOAEL) is 435 mg active dye/kg/day for teratogenicity and for maternal toxicity. Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext. D&C Violet No. 2 Batch: 0609RA Purity: 95 % Dose: 0, 95, 285, and 950 mg active dye/kg/day Treatment: day 6 - 17 of gestation GLP: in compliance The test substance (in 1% carboxymethylcellulose in water) was given daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a; CITATION=Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext; CITATION_NUMBERS=[15,2,414,22]; REFERENCE=Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext","dose":"Discoloration of placenta was also noted in the highest dose group.","duration":"","effect":"re 18, 23, 21 and 21 pregnant females in the 0, 27, 109 and 435 mg active dye/kg/day groups, respectively. No deaths were reported. Clinical signs were increased salivation at 435 mg active dye/kg/day and discoloured faeces at 109 mg active dye/kg/day and higher. Discoloration of placenta was also noted in the highest dose group. No effects on litter parameters or foetal weight were observed. There were no external soft tissue or skeletal anomalies that could be attributed to treatment with the test substance. The No Observed Adverse Effect Level (NOAEL) is 435 mg active dye/kg/day for teratogenicity and for maternal toxicity. Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext. D&C Violet No. 2 Batch: 0609RA Purity: 95 % Dose: 0, 95, 285, and 950 mg active dye/kg/day Treatment: day 6 - 17 of gestation GLP: in compliance The test substance (in 1% carboxymethylcellulose in water) was given daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"95","page":21,"route":"oral","species":"rat","study_id":"sccp_o_048_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
95 |
% |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=95; DOSE=Discoloration of placenta was also noted in the highest dose group.; EFFECT=les in the 0, 27, 109 and 435 mg active dye/kg/day groups, respectively. No deaths were reported. Clinical signs were increased salivation at 435 mg active dye/kg/day and discoloured faeces at 109 mg active dye/kg/day and higher. Discoloration of placenta was also noted in the highest dose group. No effects on litter parameters or foetal weight were observed. There were no external soft tissue or skeletal anomalies that could be attributed to treatment with the test substance. The No Observed Adverse Effect Level (NOAEL) is 435 mg active dye/kg/day for teratogenicity and for maternal toxicity. Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext. D&C Violet No. 2 Batch: 0609RA Purity: 95 % Dose: 0, 95, 285, and 950 mg active dye/kg/day Treatment: day 6 - 17 of gestation GLP: in compliance The test substance (in 1% carboxymethylcellulose in water) was given daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a prelimi; CITATION=Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext; CITATION_NUMBERS=[15,2,414,22]; REFERENCE=Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext","dose":"Discoloration of placenta was also noted in the highest dose group.","duration":"","effect":"les in the 0, 27, 109 and 435 mg active dye/kg/day groups, respectively. No deaths were reported. Clinical signs were increased salivation at 435 mg active dye/kg/day and discoloured faeces at 109 mg active dye/kg/day and higher. Discoloration of placenta was also noted in the highest dose group. No effects on litter parameters or foetal weight were observed. There were no external soft tissue or skeletal anomalies that could be attributed to treatment with the test substance. The No Observed Adverse Effect Level (NOAEL) is 435 mg active dye/kg/day for teratogenicity and for maternal toxicity. Ref.: 15 Study 2 Guideline: OECD 414 Species/strain: Wistar rats Group size: 22 females Test substance: Ext. D&C Violet No. 2 Batch: 0609RA Purity: 95 % Dose: 0, 95, 285, and 950 mg active dye/kg/day Treatment: day 6 - 17 of gestation GLP: in compliance The test substance (in 1% carboxymethylcellulose in water) was given daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a prelimi","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"95","page":21,"route":"oral","species":"rat","study_id":"sccp_o_048_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
950 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=unclear:wo females were not pregnant, one female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16; DOSE=These findings were considered to be incidental as a dose relation was missing.; EFFECT=wo females were not pregnant, one female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16; CITATION=Ref.: 16; CITATION_NUMBERS=[16]; REFERENCE=Ref.: 16; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 16","dose":"These findings were considered to be incidental as a dose relation was missing.","duration":"","effect":"wo females were not pregnant, one female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:wo females were not pregnant, one female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16","page":21,"route":"","species":"","study_id":"sccp_o_048_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
950 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=unclear:female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16; DOSE=These findings were considered to be incidental as a dose relation was missing.; EFFECT=female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16; CITATION=Ref.: 16; CITATION_NUMBERS=[16]; REFERENCE=Ref.: 16; DETAILS_JSON={"cas_number":"4430-18-6","citation":"Ref.: 16","dose":"These findings were considered to be incidental as a dose relation was missing.","duration":"","effect":"female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16","endpoint":"","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered to be incidental as a dose relation was missing. No deaths were reported, and clinical signs were limited to discoloured faeces at 950 mg active dye/kg/day. No effects on litter parameters or foetal weight were observed. Foetal and litter incidences of external, soft tissue and skeletal anomalies were similar for control and treated groups. The No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity is 950 mg active dye/kg/day. Ref.: 16","page":21,"route":"","species":"","study_id":"sccp_o_048_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1 |
% |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=1; DOSE=SCCP/0964/05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext.; EFFECT=SCCP/0964/05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext. D&C Violet No. 2 was higher than 4640 mg active dye/kg. In the in vivo/in vitro UDS assay with Jarocol Violet 43, however, the Maximal Tolerated Dose was 816 mg active dye/kg bw in rats. In two separate oral toxicity studies in rats subchronic effects were evaluated. No Observed Adverse Effect Level (NOAEL) derived were 109 mg active dye/kg/day for Jarocol Violet 43 and 285 mg active dye/kg/day for Ext. D&C Violet No. 2. Both test substances were not embryotoxic or teratogenic up to 435 mg active dye/kg/day for Jarocol Violet 43 and 950 mg active dye/kg/day for Ext. D&C Violet No. 2. Irritation / sensitisation Irritation studies showed that at 1% active dye is not irritant to rabbit skin (Ext. D&C Violet No. 2) and rabbit eye (Jarocol Violet 43). Jarocol Violet 43 was considered to be non-sensitising when te; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4430-18-6","citation":"","dose":"SCCP/0964/05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext.","duration":"subchronic","effect":"SCCP/0964/05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext. D&C Violet No. 2 was higher than 4640 mg active dye/kg. In the in vivo/in vitro UDS assay with Jarocol Violet 43, however, the Maximal Tolerated Dose was 816 mg active dye/kg bw in rats. In two separate oral toxicity studies in rats subchronic effects were evaluated. No Observed Adverse Effect Level (NOAEL) derived were 109 mg active dye/kg/day for Jarocol Violet 43 and 285 mg active dye/kg/day for Ext. D&C Violet No. 2. Both test substances were not embryotoxic or teratogenic up to 435 mg active dye/kg/day for Jarocol Violet 43 and 950 mg active dye/kg/day for Ext. D&C Violet No. 2. Irritation / sensitisation Irritation studies showed that at 1% active dye is not irritant to rabbit skin (Ext. D&C Violet No. 2) and rabbit eye (Jarocol Violet 43). Jarocol Violet 43 was considered to be non-sensitising when te","endpoint":"repeated dose toxicity","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"1","page":23,"route":"oral","species":"rat","study_id":"sccp_o_048_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1 |
% |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_048; REPORT_TITLE=Opinion on Acid Violet 43 COLIPA N° C63; OPINION_NUMBER=SCCP/0964/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=1; DOSE=05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext.; EFFECT=05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext. D&C Violet No. 2 was higher than 4640 mg active dye/kg. In the in vivo/in vitro UDS assay with Jarocol Violet 43, however, the Maximal Tolerated Dose was 816 mg active dye/kg bw in rats. In two separate oral toxicity studies in rats subchronic effects were evaluated. No Observed Adverse Effect Level (NOAEL) derived were 109 mg active dye/kg/day for Jarocol Violet 43 and 285 mg active dye/kg/day for Ext. D&C Violet No. 2. Both test substances were not embryotoxic or teratogenic up to 435 mg active dye/kg/day for Jarocol Violet 43 and 950 mg active dye/kg/day for Ext. D&C Violet No. 2. Irritation / sensitisation Irritation studies showed that at 1% active dye is not irritant to rabbit skin (Ext. D&C Violet No. 2) and rabbit eye (Jarocol Violet 43). Jarocol Violet 43 was considered to be non-sensitising when tested in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4430-18-6","citation":"","dose":"05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext.","duration":"subchronic","effect":"05 Opinion on Acid Violet 43 ____________________________________________________________________________________________ 23 General toxicity In an acute oral toxicity study in rats, the maximal non-lethal dose Ext. D&C Violet No. 2 was higher than 4640 mg active dye/kg. In the in vivo/in vitro UDS assay with Jarocol Violet 43, however, the Maximal Tolerated Dose was 816 mg active dye/kg bw in rats. In two separate oral toxicity studies in rats subchronic effects were evaluated. No Observed Adverse Effect Level (NOAEL) derived were 109 mg active dye/kg/day for Jarocol Violet 43 and 285 mg active dye/kg/day for Ext. D&C Violet No. 2. Both test substances were not embryotoxic or teratogenic up to 435 mg active dye/kg/day for Jarocol Violet 43 and 950 mg active dye/kg/day for Ext. D&C Violet No. 2. Irritation / sensitisation Irritation studies showed that at 1% active dye is not irritant to rabbit skin (Ext. D&C Violet No. 2) and rabbit eye (Jarocol Violet 43). Jarocol Violet 43 was considered to be non-sensitising when tested in","endpoint":"repeated dose toxicity","ingredient":"Acid Violet 43 (INCI name)","loael_value":"","noael_unit":"%","noael_value":"1","page":23,"route":"oral","species":"rat","study_id":"sccp_o_048_noael_010"} |