NOAEL Studies
Cosmetic Ingredient
HC Yellow No. 9 NOAEL Studies
INCI: HC YELLOW NO. 9
CAS: 86419-69-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 20 (subm","dose":"Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male.","effect":"issue for histological examination. This seems to be an unsatisfactory explanation. Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male. Minimal to moderate basophilia (in some cases unilateral) were seen in 3/6 males at 300 mg/kg bw/day and in one control male and one female. The other organ weights and microscopic findings were comparable with the controls. No treatment related microscopic findings were noted. The NOAEL was considered as 100 mg/kg bw/day. Ref.: 20 (subm. III) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0680/03 Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD(SD) BR Group size: 10 males + 10 females Test substance: HC Yellow n° 9 suspended in 0.5% aqueous carboxymethylcellulose Batch: op.26 Purity: 99.6% Dose: 0, 25, 80 and 250 mg/kg bw/day Exposure period: 13 weeks (7 days per week) GLP: In compliance Groups of 10 male and 10 female rats were dosed","page":18,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 5 (subm","dose":"Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day.","effect":"SCCS-rejected applicant NOAEL: ly in this strain. Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day. This lesion was not considered treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Conseque","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_002"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 5 (subm","dose":"The study authors concluded that the compound was clinically well tolerated at all dose levels.","effect":"d treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity /","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_003"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 10 (subm","dose":"The treated groups did not differ significantly from control.","effect":"SCCS/1301/10 Opinion on HC Yellow n° 9 ___________________________________________________________________________________________ 24 observed which was within the normal range. The treated groups did not differ significantly from control. The test substance elicited maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOEL for maternal toxicity was considered to be 70 mg/kg bw/day. Ref.: 10 (subm. III) Comment The SCCS considers 70 mg/kg bw/d to be the NOAEL for maternal toxicity. 3.3.9. Toxicokinetics The plasma toxicokinetic profile of HC Yellow n° 9 was investigated after single oral administration (gavage) to CD1 mice. Given the aim of the present study, the experimental conditions used (animal species, strain, age, dose-level, route, vehicle, dosage volume, dosage form preparation) were similar to those used in the mouse mi","page":24,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"_______________________________________________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_006"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"______________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techni","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_007"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | {"dose":"was found to be between 200 and 500 mg/kg bw.","effect":"was found to be between 200 and 500 mg/kg bw. In the subchronic oral toxicity study in rats statistically significant increases in mean absolute and relative adrenal weights were found in females treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was a","page":26,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 20 (subm","dose":"Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male.","effect":"issue for histological examination. This seems to be an unsatisfactory explanation. Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male. Minimal to moderate basophilia (in some cases unilateral) were seen in 3/6 males at 300 mg/kg bw/day and in one control male and one female. The other organ weights and microscopic findings were comparable with the controls. No treatment related microscopic findings were noted. The NOAEL was considered as 100 mg/kg bw/day. Ref.: 20 (subm. III) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0680/03 Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD(SD) BR Group size: 10 males + 10 females Test substance: HC Yellow n° 9 suspended in 0.5% aqueous carboxymethylcellulose Batch: op.26 Purity: 99.6% Dose: 0, 25, 80 and 250 mg/kg bw/day Exposure period: 13 weeks (7 days per week) GLP: In compliance Groups of 10 male and 10 female rats were dosed","page":18,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 5 (subm","dose":"Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day.","effect":"SCCS-rejected applicant NOAEL: ly in this strain. Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day. This lesion was not considered treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Conseque","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_002"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 5 (subm","dose":"The study authors concluded that the compound was clinically well tolerated at all dose levels.","effect":"d treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity /","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_003"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 10 (subm","dose":"The treated groups did not differ significantly from control.","effect":"SCCS/1301/10 Opinion on HC Yellow n° 9 ___________________________________________________________________________________________ 24 observed which was within the normal range. The treated groups did not differ significantly from control. The test substance elicited maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOEL for maternal toxicity was considered to be 70 mg/kg bw/day. Ref.: 10 (subm. III) Comment The SCCS considers 70 mg/kg bw/d to be the NOAEL for maternal toxicity. 3.3.9. Toxicokinetics The plasma toxicokinetic profile of HC Yellow n° 9 was investigated after single oral administration (gavage) to CD1 mice. Given the aim of the present study, the experimental conditions used (animal species, strain, age, dose-level, route, vehicle, dosage volume, dosage form preparation) were similar to those used in the mouse mi","page":24,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"_______________________________________________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_006"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"______________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techni","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_007"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | {"dose":"was found to be between 200 and 500 mg/kg bw.","effect":"was found to be between 200 and 500 mg/kg bw. In the subchronic oral toxicity study in rats statistically significant increases in mean absolute and relative adrenal weights were found in females treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was a","page":26,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 20 (subm","dose":"Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male.","effect":"issue for histological examination. This seems to be an unsatisfactory explanation. Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male. Minimal to moderate basophilia (in some cases unilateral) were seen in 3/6 males at 300 mg/kg bw/day and in one control male and one female. The other organ weights and microscopic findings were comparable with the controls. No treatment related microscopic findings were noted. The NOAEL was considered as 100 mg/kg bw/day. Ref.: 20 (subm. III) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0680/03 Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD(SD) BR Group size: 10 males + 10 females Test substance: HC Yellow n° 9 suspended in 0.5% aqueous carboxymethylcellulose Batch: op.26 Purity: 99.6% Dose: 0, 25, 80 and 250 mg/kg bw/day Exposure period: 13 weeks (7 days per week) GLP: In compliance Groups of 10 male and 10 female rats were dosed","page":18,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 5 (subm","dose":"Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day.","effect":"SCCS-rejected applicant NOAEL: ly in this strain. Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day. This lesion was not considered treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Conseque","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_002"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 5 (subm","dose":"The study authors concluded that the compound was clinically well tolerated at all dose levels.","effect":"d treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity /","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_003"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 10 (subm","dose":"The treated groups did not differ significantly from control.","effect":"SCCS/1301/10 Opinion on HC Yellow n° 9 ___________________________________________________________________________________________ 24 observed which was within the normal range. The treated groups did not differ significantly from control. The test substance elicited maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOEL for maternal toxicity was considered to be 70 mg/kg bw/day. Ref.: 10 (subm. III) Comment The SCCS considers 70 mg/kg bw/d to be the NOAEL for maternal toxicity. 3.3.9. Toxicokinetics The plasma toxicokinetic profile of HC Yellow n° 9 was investigated after single oral administration (gavage) to CD1 mice. Given the aim of the present study, the experimental conditions used (animal species, strain, age, dose-level, route, vehicle, dosage volume, dosage form preparation) were similar to those used in the mouse mi","page":24,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"_______________________________________________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_006"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"______________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techni","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_007"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | {"dose":"was found to be between 200 and 500 mg/kg bw.","effect":"was found to be between 200 and 500 mg/kg bw. In the subchronic oral toxicity study in rats statistically significant increases in mean absolute and relative adrenal weights were found in females treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was a","page":26,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_009"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 20 (subm","dose":"Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male.","effect":"issue for histological examination. This seems to be an unsatisfactory explanation. Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male. Minimal to moderate basophilia (in some cases unilateral) were seen in 3/6 males at 300 mg/kg bw/day and in one control male and one female. The other organ weights and microscopic findings were comparable with the controls. No treatment related microscopic findings were noted. The NOAEL was considered as 100 mg/kg bw/day. Ref.: 20 (subm. III) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0680/03 Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD(SD) BR Group size: 10 males + 10 females Test substance: HC Yellow n° 9 suspended in 0.5% aqueous carboxymethylcellulose Batch: op.26 Purity: 99.6% Dose: 0, 25, 80 and 250 mg/kg bw/day Exposure period: 13 weeks (7 days per week) GLP: In compliance Groups of 10 male and 10 female rats were dosed","page":18,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 5 (subm","dose":"Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day.","effect":"SCCS-rejected applicant NOAEL: ly in this strain. Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day. This lesion was not considered treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Conseque","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_002"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 5 (subm","dose":"The study authors concluded that the compound was clinically well tolerated at all dose levels.","effect":"d treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity /","page":19,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_003"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/day | mouse | oral | - | developmental toxicity | {"citation":"Ref.: 10 (subm","dose":"The treated groups did not differ significantly from control.","effect":"SCCS/1301/10 Opinion on HC Yellow n° 9 ___________________________________________________________________________________________ 24 observed which was within the normal range. The treated groups did not differ significantly from control. The test substance elicited maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOEL for maternal toxicity was considered to be 70 mg/kg bw/day. Ref.: 10 (subm. III) Comment The SCCS considers 70 mg/kg bw/d to be the NOAEL for maternal toxicity. 3.3.9. Toxicokinetics The plasma toxicokinetic profile of HC Yellow n° 9 was investigated after single oral administration (gavage) to CD1 mice. Given the aim of the present study, the experimental conditions used (animal species, strain, age, dose-level, route, vehicle, dosage volume, dosage form preparation) were similar to those used in the mouse mi","page":24,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"_______________________________________________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_006"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | rat | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","effect":"______________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techni","page":25,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_007"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | {"dose":"was found to be between 200 and 500 mg/kg bw.","effect":"was found to be between 200 and 500 mg/kg bw. In the subchronic oral toxicity study in rats statistically significant increases in mean absolute and relative adrenal weights were found in females treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was a","page":26,"pdf":"sccs_o_026.pdf","row_type":"noael_study","study_id":"sccs_o_026_noael_009"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 250 | mg/kg bw/day | rat | - | - | - | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=250; DOSE=Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: ly in this strain. Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day. This lesion was not considered treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Conseque; CITATION=Ref.: 5 (subm; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 (subm; DETAILS_JSON={"cas_number":"86419-69-4","citation":"Ref.: 5 (subm","dose":"Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day.","duration":"","effect":"SCCS-rejected applicant NOAEL: ly in this strain. Ulceration of the forestomach was reported in one female in the group treated with 80 mg/kg bw/day. This lesion was not considered treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Conseque","endpoint":"","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":19,"route":"","species":"rat","study_id":"sccs_o_026_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.09 | mg/kg bw | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT== 0.09; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...; EFFECT=_______________________________________________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"86419-69-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","duration":"","effect":"_______________________________________________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic","endpoint":"dermal absorption","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.09","page":25,"route":"dermal","species":"rat","study_id":"sccs_o_026_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =70 | mg/kg bw/d | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT== 70; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...; EFFECT=______________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techni; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"86419-69-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","duration":"","effect":"______________________________________ 25 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 Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techni","endpoint":"dermal absorption","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 70","page":25,"route":"dermal","species":"rat","study_id":"sccs_o_026_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =70 | mg/kg bw/d | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT== 70; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...; EFFECT=estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techniques are the predominating impurities. No toxicity data have been supplied for th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"86419-69-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 =...","duration":"","effect":"estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 9) Absorption through the skin A (mean + 2 SD) = 9.51 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.52 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.09 mg/kg bw No observed adverse effect level NOAEL = 70 mg/kg bw/d (maternal toxicity, teratogenicity, rat) Margin of Safety NOAEL / SED = 761 3.3.14. Discussion Physico-chemical properties HC Yellow n° 9 is an ingredient used in semi-permanent hair colouring products. Chemical identity of HC Yellow n° 9 is well documented. Results of HPLC and Potentiometry are in agreement with respect to the purity of HC Yellow n° 9 batches. The impurities of HC Yellow n° 9 account for 0.25 to 1.7%. Organic substances which have been characterized with chromatographic techniques are the predominating impurities. No toxicity data have been supplied for th","endpoint":"dermal absorption","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 70","page":25,"route":"dermal","species":"rat","study_id":"sccs_o_026_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 70 | mg/kg bw/day | mouse | oral | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=70; DOSE=The treated groups did not differ significantly from control.; EFFECT=SCCS/1301/10 Opinion on HC Yellow n° 9 ___________________________________________________________________________________________ 24 observed which was within the normal range. The treated groups did not differ significantly from control. The test substance elicited maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOEL for maternal toxicity was considered to be 70 mg/kg bw/day. Ref.: 10 (subm. III) Comment The SCCS considers 70 mg/kg bw/d to be the NOAEL for maternal toxicity. 3.3.9. Toxicokinetics The plasma toxicokinetic profile of HC Yellow n° 9 was investigated after single oral administration (gavage) to CD1 mice. Given the aim of the present study, the experimental conditions used (animal species, strain, age, dose-level, route, vehicle, dosage volume, dosage form preparation) were similar to those used in the mouse mi; CITATION=Ref.: 10 (subm; CITATION_NUMBERS=[10]; REFERENCE=Ref.: 10 (subm; DETAILS_JSON={"cas_number":"86419-69-4","citation":"Ref.: 10 (subm","dose":"The treated groups did not differ significantly from control.","duration":"","effect":"SCCS/1301/10 Opinion on HC Yellow n° 9 ___________________________________________________________________________________________ 24 observed which was within the normal range. The treated groups did not differ significantly from control. The test substance elicited maternal toxicity at 250 mg/kg bw/day but was not embryo-toxic or teratogenic at the doses tested. The NOEL for maternal toxicity was considered to be 70 mg/kg bw/day. Ref.: 10 (subm. III) Comment The SCCS considers 70 mg/kg bw/d to be the NOAEL for maternal toxicity. 3.3.9. Toxicokinetics The plasma toxicokinetic profile of HC Yellow n° 9 was investigated after single oral administration (gavage) to CD1 mice. Given the aim of the present study, the experimental conditions used (animal species, strain, age, dose-level, route, vehicle, dosage volume, dosage form preparation) were similar to those used in the mouse mi","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":24,"route":"oral","species":"mouse","study_id":"sccs_o_026_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 80 | mg/kg bw/day | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=80; DOSE=The study authors concluded that the compound was clinically well tolerated at all dose levels.; EFFECT=d treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity /; CITATION=Ref.: 5 (subm; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 (subm; DETAILS_JSON={"cas_number":"86419-69-4","citation":"Ref.: 5 (subm","dose":"The study authors concluded that the compound was clinically well tolerated at all dose levels.","duration":"Chronic","effect":"d treatment related, since it can occur spontaneously in this strain. The study authors concluded that the compound was clinically well tolerated at all dose levels. Microscopic findings of minor toxicological significance were noted in the kidneys of males given 80 or 250 mg/kg bw/day, but these were considered to be specific sex-related phenomena to the male rat. The NOAEL was set at 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity /","endpoint":"genotoxicity","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":19,"route":"","species":"rat","study_id":"sccs_o_026_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 250 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=250; DOSE=III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights.; EFFECT=t 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 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 Assay Guideline: OECD 471 (1983 and revised draft 1994) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA Replicates: triplicates in 2 independent experiments Test substance: Imexine FAD Batch: opT 37 Purity: 101% Vehicle: DMSO Concentration: 62.5, 125,; CITATION=Ref.: 5 (subm; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 (subm; DETAILS_JSON={"cas_number":"86419-69-4","citation":"Ref.: 5 (subm","dose":"III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights.","duration":"Chronic","effect":"t 250 mg/kg bw/day. Ref.: 5 (subm. III) Comment of the SCCS In its opinion of 2003 (SCCNFP/0680/03), the SCCNFP considered that the NOAEL should be 80 mg/kg bw/day, based upon the changes in adrenal weights. In submission III, contemporaneous historical control data on adrenal weights at the testing laboratory were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/day HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/day. Ref.: 24 (subm. III) 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 Assay Guideline: OECD 471 (1983 and revised draft 1994) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA Replicates: triplicates in 2 independent experiments Test substance: Imexine FAD Batch: opT 37 Purity: 101% Vehicle: DMSO Concentration: 62.5, 125,","endpoint":"genotoxicity","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":19,"route":"","species":"","study_id":"sccs_o_026_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=100; DOSE=Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male.; EFFECT=issue for histological examination. This seems to be an unsatisfactory explanation. Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male. Minimal to moderate basophilia (in some cases unilateral) were seen in 3/6 males at 300 mg/kg bw/day and in one control male and one female. The other organ weights and microscopic findings were comparable with the controls. No treatment related microscopic findings were noted. The NOAEL was considered as 100 mg/kg bw/day. Ref.: 20 (subm. III) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0680/03 Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD(SD) BR Group size: 10 males + 10 females Test substance: HC Yellow n° 9 suspended in 0.5% aqueous carboxymethylcellulose Batch: op.26 Purity: 99.6% Dose: 0, 25, 80 and 250 mg/kg bw/day Exposure period: 13 weeks (7 days per week) GLP: In compliance Groups of 10 male and 10 female rats were dosed; CITATION=Ref.: 20 (subm; CITATION_NUMBERS=[20]; REFERENCE=Ref.: 20 (subm; DETAILS_JSON={"cas_number":"86419-69-4","citation":"Ref.: 20 (subm","dose":"Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male.","duration":"Sub-chronic","effect":"issue for histological examination. This seems to be an unsatisfactory explanation. Minimal to moderate acidophilic globule incidence was noted in the cortical tubular epithelium in 3/6 males at 300 mg/kg bw/day and in one control male. Minimal to moderate basophilia (in some cases unilateral) were seen in 3/6 males at 300 mg/kg bw/day and in one control male and one female. The other organ weights and microscopic findings were comparable with the controls. No treatment related microscopic findings were noted. The NOAEL was considered as 100 mg/kg bw/day. Ref.: 20 (subm. III) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0680/03 Guideline: OECD 408 (1981) Species/strain: Sprague Dawley rat, Crl:CD(SD) BR Group size: 10 males + 10 females Test substance: HC Yellow n° 9 suspended in 0.5% aqueous carboxymethylcellulose Batch: op.26 Purity: 99.6% Dose: 0, 25, 80 and 250 mg/kg bw/day Exposure period: 13 weeks (7 days per week) GLP: In compliance Groups of 10 male and 10 female rats were dosed","endpoint":"repeated dose toxicity","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":18,"route":"oral","species":"rat","study_id":"sccs_o_026_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 250 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=250; DOSE=was found to be between 200 and 500 mg/kg bw.; EFFECT=was found to be between 200 and 500 mg/kg bw. In the subchronic oral toxicity study in rats statistically significant increases in mean absolute and relative adrenal weights were found in females treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"86419-69-4","citation":"","dose":"was found to be between 200 and 500 mg/kg bw.","duration":"subchronic","effect":"was found to be between 200 and 500 mg/kg bw. In the subchronic oral toxicity study in rats statistically significant increases in mean absolute and relative adrenal weights were found in females treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was a","endpoint":"repeated dose toxicity","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":26,"route":"oral","species":"rat","study_id":"sccs_o_026_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 70 | mg/kg bw/d | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_026; REPORT_TITLE=OPINION ON HC Yellow n° 9 COLIPA n° B69; OPINION_NUMBER=SCCS/1301/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=70; DOSE=treated with 250 mg/kg bw/d.; EFFECT=treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was above quantifiable limits (0.2 µg/mL) in the plasma until 4 hours post-dosing for both sexes, the plasma levels were characterized by a fast absorption phase and the Cmax was reached at 0.25 hour; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"86419-69-4","citation":"","dose":"treated with 250 mg/kg bw/d.","duration":"","effect":"treated with 250 mg/kg bw/d. However, contemporaneous historical control data on adrenal weights at the test institute were provided. These data demonstrate that the mean relative adrenal weight of the female historical controls is equal to the value found for females after 250 mg/kg bw/d HC Yellow n° 9. Consequently, the NOAEL is set to 250 mg/kg bw/d. In a teratogenicity study in rats the test substance elicited maternal toxicity at 250 mg/kg bw/d but was not embryotoxic or teratogenic at the doses tested. The NOAEL for maternal toxicity was considered to be 70 mg/kg bw/d. No reproductive toxicity study was provided. Toxicokinetics The toxicokinetics study showed that the animals were systemically exposed to HC Yellow n° 9 following oral administration at the dose level 100 mg/kg bw in 0.5% carboxymethylcellulose. The test item was above quantifiable limits (0.2 µg/mL) in the plasma until 4 hours post-dosing for both sexes, the plasma levels were characterized by a fast absorption phase and the Cmax was reached at 0.25 hour","endpoint":"reproductive toxicity","ingredient":"HC Yellow No. 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"70","page":26,"route":"oral","species":"rat","study_id":"sccs_o_026_noael_010"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 91P0Z9H61V | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H13N3O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"91P0Z9H61V"} |
| openFDA substances | FDA UNII substance identifier | 91P0Z9H61V | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H13N3O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"91P0Z9H61V"} |
| openFDA substances | FDA UNII substance identifier | 91P0Z9H61V | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H13N3O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"91P0Z9H61V"} |
| openFDA substances | FDA UNII substance identifier | 91P0Z9H61V | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H13N3O3.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"91P0Z9H61V"} |