NOAEL Studies
Cosmetic Ingredient
HC Orange No. 2 NOAEL Studies
INCI: HC ORANGE NO. 2
CAS: 85765-48-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 5 | mg/kg bw/day | rat | oral | 6-19 Gestation day | Developmental | SCCP; G. Chevalier. HC Orange N°2 (B067): Prenatal Developmental Toxicity Study by OralRoute (Gavage) in Rats. CIT Study No. 26898 RSR, 2005 |
SCCS_vision_codex 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 day | dermal absorption | {"dose":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as not irritating to skin and mucous membranes. The evidence of a sensitizing potential is equivocal, thus the substance may be regarded as a potential sensitizer, adequate labelling is recommended. Percutaneous absorption of a formulation was 0.055 % in the presence of hair and 0.084 % in the absence of hair. In the 90 day study 150 mg/kg/day is considered to be the NOAEL. In the teratogenicity study no signs of maternal or foetal toxicity were observed after administration of 100 mg/kg bw.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, part 2 under entry 26 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submission HC Orange n° 2 is used in semi-perman","page":5,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 6 3","dose":"Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded.","effect":"ere observed. Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded. The relative liver weight was higher in 150 mg/kg/day group in females and in both sexes at 500 mg/kg/day group. Significantly higher relative testicular weights were observed at all dose levels. No histological changes were correlated to these findings and they may be attributed to the lower final body weight of the animals. Conclusion Based on the lower body weight gain and lower blood glucose level at 500 mg/kg/day group the NOAEL was set at 150 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: 3 replicates in 3 individual experiments both in the presence and absence of S9-mix. Test substance: Imexine FAB Solvent: DMSO Batch: Op T 13 Purity: 99.5% Concentrations: Experiment 1: 50, 150, 500,","page":16,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"citation":"Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day.","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day. The mean foetal body weight was lower in the 1000 mg/kg/day group. In the 300 and 1000 mg/kg/day group, a delayed ossification of foetuses was observed. Conclusion HC Orange n° 2 was not maternal toxic at all dose levels administered. The LOAEL for maternal toxicity was set at 100 mg/kg bw. The NOAEL was 100 mg/kg/day in terms of embryo-foetal developmental effects. Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; Group size: 24 mated females per dose group Test substance: HC Orange n° 2 Batch: 0508076 Purity: 97.5% Dose: 0, 5, 20, 500 mg/kg bw Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage, 5 ml/kg/day GLP: in compliance Groups of 24 mated female rats of the Sprague-Dawley strain were exposed daily by oral administration at 5, 20 or 500 mg/kg/day from day 6 t","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_003"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | - | - | NOAEL study | {"citation":"Ref.: 12 3","dose":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group.","effect":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.016 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"an data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitro","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_007"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"ility of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"rosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_010"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It","page":23,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_012"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 day | dermal absorption | {"dose":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as not irritating to skin and mucous membranes. The evidence of a sensitizing potential is equivocal, thus the substance may be regarded as a potential sensitizer, adequate labelling is recommended. Percutaneous absorption of a formulation was 0.055 % in the presence of hair and 0.084 % in the absence of hair. In the 90 day study 150 mg/kg/day is considered to be the NOAEL. In the teratogenicity study no signs of maternal or foetal toxicity were observed after administration of 100 mg/kg bw.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, part 2 under entry 26 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submission HC Orange n° 2 is used in semi-perman","page":5,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 6 3","dose":"Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded.","effect":"ere observed. Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded. The relative liver weight was higher in 150 mg/kg/day group in females and in both sexes at 500 mg/kg/day group. Significantly higher relative testicular weights were observed at all dose levels. No histological changes were correlated to these findings and they may be attributed to the lower final body weight of the animals. Conclusion Based on the lower body weight gain and lower blood glucose level at 500 mg/kg/day group the NOAEL was set at 150 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: 3 replicates in 3 individual experiments both in the presence and absence of S9-mix. Test substance: Imexine FAB Solvent: DMSO Batch: Op T 13 Purity: 99.5% Concentrations: Experiment 1: 50, 150, 500,","page":16,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"citation":"Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day.","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day. The mean foetal body weight was lower in the 1000 mg/kg/day group. In the 300 and 1000 mg/kg/day group, a delayed ossification of foetuses was observed. Conclusion HC Orange n° 2 was not maternal toxic at all dose levels administered. The LOAEL for maternal toxicity was set at 100 mg/kg bw. The NOAEL was 100 mg/kg/day in terms of embryo-foetal developmental effects. Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; Group size: 24 mated females per dose group Test substance: HC Orange n° 2 Batch: 0508076 Purity: 97.5% Dose: 0, 5, 20, 500 mg/kg bw Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage, 5 ml/kg/day GLP: in compliance Groups of 24 mated female rats of the Sprague-Dawley strain were exposed daily by oral administration at 5, 20 or 500 mg/kg/day from day 6 t","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_003"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | - | - | NOAEL study | {"citation":"Ref.: 12 3","dose":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group.","effect":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.016 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"an data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitro","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_007"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"ility of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"rosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_010"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It","page":23,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_012"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 day | dermal absorption | {"dose":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as not irritating to skin and mucous membranes. The evidence of a sensitizing potential is equivocal, thus the substance may be regarded as a potential sensitizer, adequate labelling is recommended. Percutaneous absorption of a formulation was 0.055 % in the presence of hair and 0.084 % in the absence of hair. In the 90 day study 150 mg/kg/day is considered to be the NOAEL. In the teratogenicity study no signs of maternal or foetal toxicity were observed after administration of 100 mg/kg bw.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, part 2 under entry 26 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submission HC Orange n° 2 is used in semi-perman","page":5,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 6 3","dose":"Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded.","effect":"ere observed. Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded. The relative liver weight was higher in 150 mg/kg/day group in females and in both sexes at 500 mg/kg/day group. Significantly higher relative testicular weights were observed at all dose levels. No histological changes were correlated to these findings and they may be attributed to the lower final body weight of the animals. Conclusion Based on the lower body weight gain and lower blood glucose level at 500 mg/kg/day group the NOAEL was set at 150 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: 3 replicates in 3 individual experiments both in the presence and absence of S9-mix. Test substance: Imexine FAB Solvent: DMSO Batch: Op T 13 Purity: 99.5% Concentrations: Experiment 1: 50, 150, 500,","page":16,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"citation":"Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day.","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day. The mean foetal body weight was lower in the 1000 mg/kg/day group. In the 300 and 1000 mg/kg/day group, a delayed ossification of foetuses was observed. Conclusion HC Orange n° 2 was not maternal toxic at all dose levels administered. The LOAEL for maternal toxicity was set at 100 mg/kg bw. The NOAEL was 100 mg/kg/day in terms of embryo-foetal developmental effects. Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; Group size: 24 mated females per dose group Test substance: HC Orange n° 2 Batch: 0508076 Purity: 97.5% Dose: 0, 5, 20, 500 mg/kg bw Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage, 5 ml/kg/day GLP: in compliance Groups of 24 mated female rats of the Sprague-Dawley strain were exposed daily by oral administration at 5, 20 or 500 mg/kg/day from day 6 t","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_003"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | - | - | NOAEL study | {"citation":"Ref.: 12 3","dose":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group.","effect":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.016 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"an data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitro","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_007"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"ility of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"rosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_010"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It","page":23,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_012"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 day | dermal absorption | {"dose":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as not irritating to skin and mucous membranes. The evidence of a sensitizing potential is equivocal, thus the substance may be regarded as a potential sensitizer, adequate labelling is recommended. Percutaneous absorption of a formulation was 0.055 % in the presence of hair and 0.084 % in the absence of hair. In the 90 day study 150 mg/kg/day is considered to be the NOAEL. In the teratogenicity study no signs of maternal or foetal toxicity were observed after administration of 100 mg/kg bw.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, part 2 under entry 26 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submission HC Orange n° 2 is used in semi-perman","page":5,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 6 3","dose":"Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded.","effect":"ere observed. Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded. The relative liver weight was higher in 150 mg/kg/day group in females and in both sexes at 500 mg/kg/day group. Significantly higher relative testicular weights were observed at all dose levels. No histological changes were correlated to these findings and they may be attributed to the lower final body weight of the animals. Conclusion Based on the lower body weight gain and lower blood glucose level at 500 mg/kg/day group the NOAEL was set at 150 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: 3 replicates in 3 individual experiments both in the presence and absence of S9-mix. Test substance: Imexine FAB Solvent: DMSO Batch: Op T 13 Purity: 99.5% Concentrations: Experiment 1: 50, 150, 500,","page":16,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | developmental | developmental toxicity | {"citation":"Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day.","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day. The mean foetal body weight was lower in the 1000 mg/kg/day group. In the 300 and 1000 mg/kg/day group, a delayed ossification of foetuses was observed. Conclusion HC Orange n° 2 was not maternal toxic at all dose levels administered. The LOAEL for maternal toxicity was set at 100 mg/kg bw. The NOAEL was 100 mg/kg/day in terms of embryo-foetal developmental effects. Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; Group size: 24 mated females per dose group Test substance: HC Orange n° 2 Batch: 0508076 Purity: 97.5% Dose: 0, 5, 20, 500 mg/kg bw Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage, 5 ml/kg/day GLP: in compliance Groups of 24 mated female rats of the Sprague-Dawley strain were exposed daily by oral administration at 5, 20 or 500 mg/kg/day from day 6 t","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_003"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | - | - | NOAEL study | {"citation":"Ref.: 12 3","dose":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group.","effect":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.016 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","effect":"an data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitro","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_007"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"ility of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | - | - | 90-day | NOAEL study | {"dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","effect":"rosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","page":22,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_010"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | {"dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It","page":23,"pdf":"sccp_o_116.pdf","row_type":"noael_study","study_id":"sccp_o_116_noael_012"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group.; EFFECT=ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"85765-48-6","citation":"Ref.: 12 3","dose":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group.","duration":"","effect":"ed incidence of orange/red-coloured extremities, and red-coloration of the fur and ptyalism at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":21,"route":"","species":"","study_id":"sccp_o_116_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=500; DOSE=m at the 500 mg/kg/day group.; EFFECT=m at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"85765-48-6","citation":"Ref.: 12 3","dose":"m at the 500 mg/kg/day group.","duration":"","effect":"m at the 500 mg/kg/day group. Maternal effects observed were reduced body weight gain and reduced food consumption at 500 mg/kg/day group. High incidence of orange-coloured contents of the stomach was observed at 500 mg/kg/day group. None of the litter parameters evaluated were affected. There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion The NOAEL for maternal toxicity was 20 mg/kg/day, and the dose-level of 500 mg/kg/day was the NOEL for embryo-foetal toxicity. Ref.: 12 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"500","page":21,"route":"","species":"","study_id":"sccp_o_116_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw | - | - | 90-day | - | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=150; DOSE=General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.; EFFECT=ility of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","duration":"90-day","effect":"ility of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","endpoint":"","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg bw","noael_value":"150","page":22,"route":"","species":"","study_id":"sccp_o_116_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg bw/day | - | - | 90-day | - | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.; EFFECT=rosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw.","duration":"90-day","effect":"rosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Orange n° 2 was greater than 5000 mg/kg bw. The data of the 90-day study indicated a lower body weight gain and a lower blood glucose level in the 500 mg/kg bw/day dose group. Therefore, the NOAEL was set at 150 mg/kg bw per day. Two studies were submitted on maternal and/or embryo-toxicity. In study 1, HC Orange n° 2 was maternal toxic at all dose levels administered. The NOAEL was 100 mg/kg bw/day in","endpoint":"","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":22,"route":"","species":"","study_id":"sccp_o_116_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 150 | mg/kg/day | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=150; DOSE=“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat.; EFFECT=“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as not irritating to skin and mucous membranes. The evidence of a sensitizing potential is equivocal, thus the substance may be regarded as a potential sensitizer, adequate labelling is recommended. Percutaneous absorption of a formulation was 0.055 % in the presence of hair and 0.084 % in the absence of hair. In the 90 day study 150 mg/kg/day is considered to be the NOAEL. In the teratogenicity study no signs of maternal or foetal toxicity were observed after administration of 100 mg/kg bw.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, part 2 under entry 26 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submission HC Orange n° 2 is used in semi-perman; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat.","duration":"90 day","effect":"“1-(ß-aminoethylamino)-4-(ß-hydroxyethyloxy)-2-nitrobenzene has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as not irritating to skin and mucous membranes. The evidence of a sensitizing potential is equivocal, thus the substance may be regarded as a potential sensitizer, adequate labelling is recommended. Percutaneous absorption of a formulation was 0.055 % in the presence of hair and 0.084 % in the absence of hair. In the 90 day study 150 mg/kg/day is considered to be the NOAEL. In the teratogenicity study no signs of maternal or foetal toxicity were observed after administration of 100 mg/kg bw.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, part 2 under entry 26 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II for this substance was submitted in July 2005 by COLIPA. According to this submission HC Orange n° 2 is used in semi-perman","endpoint":"dermal absorption","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"150","page":5,"route":"oral","species":"rat","study_id":"sccp_o_116_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.016 | mg/kg | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 0.016; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...; EFFECT=y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","duration":"","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on","endpoint":"dermal absorption","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.016","page":22,"route":"oral","species":"rat","study_id":"sccp_o_116_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...; EFFECT=an data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","duration":"","effect":"an data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitro","endpoint":"dermal absorption","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":22,"route":"oral","species":"rat","study_id":"sccp_o_116_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...; EFFECT=ubmitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Or; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic expo...","duration":"","effect":"ubmitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Orange n° 2) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.41 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.987 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.016 mg/kg No observed adverse effect level NOAEL = 20 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1250 3.3.14. Discussion Physico-chemical properties HC Orange n° 2 is used in non-oxidative (semi-permanent) hair colouring products at a maximum concentration of 1.0%. The stability of the test substance in marketed products is not reported. The test substance is a secondary amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be <50 ppb. Data on nitrosamine content is not provided. General toxicity The LD50 for HC Or","endpoint":"dermal absorption","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":22,"route":"oral","species":"rat","study_id":"sccp_o_116_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day.; LOAEL_VALUE=100 mg/kg bw; EFFECT=SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day. The mean foetal body weight was lower in the 1000 mg/kg/day group. In the 300 and 1000 mg/kg/day group, a delayed ossification of foetuses was observed. Conclusion HC Orange n° 2 was not maternal toxic at all dose levels administered. The LOAEL for maternal toxicity was set at 100 mg/kg bw. The NOAEL was 100 mg/kg/day in terms of embryo-foetal developmental effects. Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; Group size: 24 mated females per dose group Test substance: HC Orange n° 2 Batch: 0508076 Purity: 97.5% Dose: 0, 5, 20, 500 mg/kg bw Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage, 5 ml/kg/day GLP: in compliance Groups of 24 mated female rats of the Sprague-Dawley strain were exposed daily by oral administration at 5, 20 or 500 mg/kg/day from day 6 t; CITATION=Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; CITATION_NUMBERS=[11,2,414]; REFERENCE=Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; DETAILS_JSON={"cas_number":"85765-48-6","citation":"Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day.","duration":"developmental","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 21 loss was observed at 300 and 1000 mg/kg/day. The mean foetal body weight was lower in the 1000 mg/kg/day group. In the 300 and 1000 mg/kg/day group, a delayed ossification of foetuses was observed. Conclusion HC Orange n° 2 was not maternal toxic at all dose levels administered. The LOAEL for maternal toxicity was set at 100 mg/kg bw. The NOAEL was 100 mg/kg/day in terms of embryo-foetal developmental effects. Ref.: 11 Study 2 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; Group size: 24 mated females per dose group Test substance: HC Orange n° 2 Batch: 0508076 Purity: 97.5% Dose: 0, 5, 20, 500 mg/kg bw Route: oral, in carboxymethylcellulose 0.5% Exposure: by oral gavage, 5 ml/kg/day GLP: in compliance Groups of 24 mated female rats of the Sprague-Dawley strain were exposed daily by oral administration at 5, 20 or 500 mg/kg/day from day 6 t","endpoint":"developmental toxicity","ingredient":"HC Orange No. 2","loael_value":"100 mg/kg bw","noael_unit":"mg/kg/day","noael_value":"100","page":21,"route":"oral","species":"rat","study_id":"sccp_o_116_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 20 | mg/kg/day | rabbit | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;; EFFECT=SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","duration":"developmental","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit e","endpoint":"developmental toxicity","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":23,"route":"","species":"rabbit","study_id":"sccp_o_116_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 500 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=500; DOSE=In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;; EFFECT=SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","duration":"developmental","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It","endpoint":"developmental toxicity","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":23,"route":"","species":"rabbit","study_id":"sccp_o_116_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/day | rabbit | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;; EFFECT=SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It induced contact hypersensitivity in the LLNA assay. According to th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"85765-48-6","citation":"","dose":"In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day;","duration":"developmental","effect":"SCCP/1103/07 Opinion on HC Orange n° 2 23 terms of embryo-foetal developmental effects. In study 2, the NOAEL for maternal toxicity was 20 mg/kg/day; 500 mg/kg bw/day was considered to be the NOEL for embryo-foetal toxicity. On the basis of both studies, the NOAEL was 100 mg/kg bw/day for embryo-foetal and 20 mg/kg bw/day for maternal toxicity. Irritation / sensitisation HC Orange n° 2, at a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, showed moderately irritant effects. At a concentration of 5% in an aqueous solution of carboxymethylcellulose at 0.5%, it was not irritant to the rabbit eye. HC Orange n° 2 was a moderate skin sensitiser in a Guinea pig maximisation test. It induced contact hypersensitivity in the LLNA assay. According to th","endpoint":"developmental toxicity","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":23,"route":"","species":"rabbit","study_id":"sccp_o_116_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 500 | mg/kg/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_116; REPORT_TITLE=OPINION ON HC Orange n° 2 COLIPA n° B67; OPINION_NUMBER=SCCP/1103/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=500; DOSE=Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded.; EFFECT=ere observed. Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded. The relative liver weight was higher in 150 mg/kg/day group in females and in both sexes at 500 mg/kg/day group. Significantly higher relative testicular weights were observed at all dose levels. No histological changes were correlated to these findings and they may be attributed to the lower final body weight of the animals. Conclusion Based on the lower body weight gain and lower blood glucose level at 500 mg/kg/day group the NOAEL was set at 150 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: 3 replicates in 3 individual experiments both in the presence and absence of S9-mix. Test substance: Imexine FAB Solvent: DMSO Batch: Op T 13 Purity: 99.5% Concentrations: Experiment 1: 50, 150, 500,; CITATION=Ref.: 6 3; CITATION_NUMBERS=[6,3]; REFERENCE=Ref.: 6 3; DETAILS_JSON={"cas_number":"85765-48-6","citation":"Ref.: 6 3","dose":"Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded.","duration":"Chronic","effect":"ere observed. Lower blood glucose levels in both sexes at 500 mg/kg/day were recorded. The relative liver weight was higher in 150 mg/kg/day group in females and in both sexes at 500 mg/kg/day group. Significantly higher relative testicular weights were observed at all dose levels. No histological changes were correlated to these findings and they may be attributed to the lower final body weight of the animals. Conclusion Based on the lower body weight gain and lower blood glucose level at 500 mg/kg/day group the NOAEL was set at 150 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: 3 replicates in 3 individual experiments both in the presence and absence of S9-mix. Test substance: Imexine FAB Solvent: DMSO Batch: Op T 13 Purity: 99.5% Concentrations: Experiment 1: 50, 150, 500,","endpoint":"genotoxicity","ingredient":"HC Orange No. 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"500","page":16,"route":"","species":"","study_id":"sccp_o_116_noael_002"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 86WS98470U | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H15N3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"86WS98470U"} |
| openFDA substances | FDA UNII substance identifier | 86WS98470U | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H15N3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"86WS98470U"} |
| openFDA substances | FDA UNII substance identifier | 86WS98470U | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H15N3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"86WS98470U"} |
| openFDA substances | FDA UNII substance identifier | 86WS98470U | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H15N3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"86WS98470U"} |