NOAEL Studies
Cosmetic Ingredient
HC Red No. 10 NOAEL Studies
INCI: HC RED NO. 10
CAS: Verify against current CosIng - chemical names listed include 1-Amino-2-nitro-4-(2',3'-dihydroxypropyl)amino-5-chlorobenzene and 1,4-Bis-(2',3'-dihydroxypropyl)amino-2-nitro-5-chlorobenzene
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 48 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | 90-day | irritation | {"dose":"In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL.","effect":"-nitrobenzene (CAS 95576-92- 4), earlier called Red Y, has been submitted in March 1992 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) adopted at its 53rd plenary meeting on 25 June 1993 an opinion (SPC/1076/93) with the final conclusion that: “Red Y was found moderately to slightly toxic in the acute oral toxicity test and slightly toxic after dermal administration to rabbits. Red Y showed no signs of irritation and sensitization. In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL. In the teratogenicity study, no irreversible structural changes were observed in the foetuses of the rat, after administration of 30 mg/kg bw. Red Y has mutagenic potential in in vitro assays, but has to be considered as a non-genotoxic in vivo. The cutaneous absorption was 0.037 % of the administered 14C for hair dyeing formulation I, 0.061 % for formulation II and 0.066 % for the solution. For normal use of hair dye, the following calculation can be made: 1 g Red Y comes in contact with the human skin in perman","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0022 | mg/kg bw | rat | dermal | 90-day | dermal absorption | {"dose":"With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw.","effect":"contact with the human skin in semi-permanent hair dye condition (based on a usage volume 35 ml containing maximal 1 % Red Y). With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw. So a margin of safety of 3934 can be calculated between the figure for human exposure to oxidative hair dye and the no adverse level found in rats in the 90-day study. For the semi-permanent hair dye a safety margin of 18532 can be calculated. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month and human exposure to semi-permanent hair dye is unlikely to be more than once a week.” The “substance” is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 50 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II was submitted in Ju","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_002"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | - | 6 weeks | NOAEL study | {"citation":"Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d","dose":"tes numbers) were not dose-related and within the normal values of this rat strain.","effect":"tes numbers) were not dose-related and within the normal values of this rat strain. Potassium levels were increased and concomitantly the sodium / potassium ratio decreased in males after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.","page":23,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 27 3","dose":"However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced.","effect":"sectio parameters were recorded. Each half of the foetuses was examined for visceral and skeletal abnormalities. Results With the exception of discolouration of the fur and tail and urine in all substance groups no clinical signs were observed. However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced. The sectio data on reproduction and the foetal data were not changed. Evaluation of visceral and skeletal abnormalities revealed no treatment-related findings. The NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. Ref.: 27 3.3.9. Toxicokinetics Bioavailability across the intestinal barrier Guideline: / Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: HC Red n° 10+ HC Red n° 11, WR 23532 Batch: 9375 (Fa. OSL) Purity: HC Red n° 10: 54.8 weight% (HPLC) HC Red n° 11: 29.9 weight% (HPLC) Rot C: 0.22 weight% (HPLC) Concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubati","page":29,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.7 | mg/kg bw/d | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.","page":30,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_006"} |
| SCCS_vision_codex | NOAEL | =10.4 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS =","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.004 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS =...","effect":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 5...","effect":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_010"} |
| SCCS_vision_codex | NOAEL | =7.1 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","effect":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.0006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain pri","page":32,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_012"} |
| SCCS_vision_codex | NOAEL | =35.4 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"0 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has to be pointed out that the bioavailability is measured by a non validated method Margin of Safety calculation For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated","page":33,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_016"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | 90-day | irritation | {"dose":"In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL.","effect":"-nitrobenzene (CAS 95576-92- 4), earlier called Red Y, has been submitted in March 1992 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) adopted at its 53rd plenary meeting on 25 June 1993 an opinion (SPC/1076/93) with the final conclusion that: “Red Y was found moderately to slightly toxic in the acute oral toxicity test and slightly toxic after dermal administration to rabbits. Red Y showed no signs of irritation and sensitization. In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL. In the teratogenicity study, no irreversible structural changes were observed in the foetuses of the rat, after administration of 30 mg/kg bw. Red Y has mutagenic potential in in vitro assays, but has to be considered as a non-genotoxic in vivo. The cutaneous absorption was 0.037 % of the administered 14C for hair dyeing formulation I, 0.061 % for formulation II and 0.066 % for the solution. For normal use of hair dye, the following calculation can be made: 1 g Red Y comes in contact with the human skin in perman","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0022 | mg/kg bw | rat | dermal | 90-day | dermal absorption | {"dose":"With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw.","effect":"contact with the human skin in semi-permanent hair dye condition (based on a usage volume 35 ml containing maximal 1 % Red Y). With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw. So a margin of safety of 3934 can be calculated between the figure for human exposure to oxidative hair dye and the no adverse level found in rats in the 90-day study. For the semi-permanent hair dye a safety margin of 18532 can be calculated. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month and human exposure to semi-permanent hair dye is unlikely to be more than once a week.” The “substance” is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 50 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II was submitted in Ju","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_002"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | 90-day | irritation | {"dose":"In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL.","effect":"-nitrobenzene (CAS 95576-92- 4), earlier called Red Y, has been submitted in March 1992 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) adopted at its 53rd plenary meeting on 25 June 1993 an opinion (SPC/1076/93) with the final conclusion that: “Red Y was found moderately to slightly toxic in the acute oral toxicity test and slightly toxic after dermal administration to rabbits. Red Y showed no signs of irritation and sensitization. In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL. In the teratogenicity study, no irreversible structural changes were observed in the foetuses of the rat, after administration of 30 mg/kg bw. Red Y has mutagenic potential in in vitro assays, but has to be considered as a non-genotoxic in vivo. The cutaneous absorption was 0.037 % of the administered 14C for hair dyeing formulation I, 0.061 % for formulation II and 0.066 % for the solution. For normal use of hair dye, the following calculation can be made: 1 g Red Y comes in contact with the human skin in perman","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0022 | mg/kg bw | rat | dermal | 90-day | dermal absorption | {"dose":"With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw.","effect":"contact with the human skin in semi-permanent hair dye condition (based on a usage volume 35 ml containing maximal 1 % Red Y). With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw. So a margin of safety of 3934 can be calculated between the figure for human exposure to oxidative hair dye and the no adverse level found in rats in the 90-day study. For the semi-permanent hair dye a safety margin of 18532 can be calculated. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month and human exposure to semi-permanent hair dye is unlikely to be more than once a week.” The “substance” is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 50 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II was submitted in Ju","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_002"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | - | 6 weeks | NOAEL study | {"citation":"Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d","dose":"tes numbers) were not dose-related and within the normal values of this rat strain.","effect":"tes numbers) were not dose-related and within the normal values of this rat strain. Potassium levels were increased and concomitantly the sodium / potassium ratio decreased in males after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.","page":23,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 27 3","dose":"However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced.","effect":"sectio parameters were recorded. Each half of the foetuses was examined for visceral and skeletal abnormalities. Results With the exception of discolouration of the fur and tail and urine in all substance groups no clinical signs were observed. However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced. The sectio data on reproduction and the foetal data were not changed. Evaluation of visceral and skeletal abnormalities revealed no treatment-related findings. The NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. Ref.: 27 3.3.9. Toxicokinetics Bioavailability across the intestinal barrier Guideline: / Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: HC Red n° 10+ HC Red n° 11, WR 23532 Batch: 9375 (Fa. OSL) Purity: HC Red n° 10: 54.8 weight% (HPLC) HC Red n° 11: 29.9 weight% (HPLC) Rot C: 0.22 weight% (HPLC) Concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubati","page":29,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.7 | mg/kg bw/d | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.","page":30,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_006"} |
| SCCS_vision_codex | NOAEL | =10.4 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS =","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.004 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS =...","effect":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 5...","effect":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_010"} |
| SCCS_vision_codex | NOAEL | =7.1 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","effect":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.0006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain pri","page":32,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_012"} |
| SCCS_vision_codex | NOAEL | =35.4 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"0 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has to be pointed out that the bioavailability is measured by a non validated method Margin of Safety calculation For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated","page":33,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_016"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | - | 6 weeks | NOAEL study | {"citation":"Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d","dose":"tes numbers) were not dose-related and within the normal values of this rat strain.","effect":"tes numbers) were not dose-related and within the normal values of this rat strain. Potassium levels were increased and concomitantly the sodium / potassium ratio decreased in males after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.","page":23,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 27 3","dose":"However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced.","effect":"sectio parameters were recorded. Each half of the foetuses was examined for visceral and skeletal abnormalities. Results With the exception of discolouration of the fur and tail and urine in all substance groups no clinical signs were observed. However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced. The sectio data on reproduction and the foetal data were not changed. Evaluation of visceral and skeletal abnormalities revealed no treatment-related findings. The NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. Ref.: 27 3.3.9. Toxicokinetics Bioavailability across the intestinal barrier Guideline: / Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: HC Red n° 10+ HC Red n° 11, WR 23532 Batch: 9375 (Fa. OSL) Purity: HC Red n° 10: 54.8 weight% (HPLC) HC Red n° 11: 29.9 weight% (HPLC) Rot C: 0.22 weight% (HPLC) Concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubati","page":29,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.7 | mg/kg bw/d | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.","page":30,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_006"} |
| SCCS_vision_codex | NOAEL | =10.4 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS =","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.004 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS =...","effect":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 5...","effect":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_010"} |
| SCCS_vision_codex | NOAEL | =7.1 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","effect":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.0006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain pri","page":32,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_012"} |
| SCCS_vision_codex | NOAEL | =35.4 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"0 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has to be pointed out that the bioavailability is measured by a non validated method Margin of Safety calculation For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated","page":33,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_016"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | 90-day | irritation | {"dose":"In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL.","effect":"-nitrobenzene (CAS 95576-92- 4), earlier called Red Y, has been submitted in March 1992 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) adopted at its 53rd plenary meeting on 25 June 1993 an opinion (SPC/1076/93) with the final conclusion that: “Red Y was found moderately to slightly toxic in the acute oral toxicity test and slightly toxic after dermal administration to rabbits. Red Y showed no signs of irritation and sensitization. In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL. In the teratogenicity study, no irreversible structural changes were observed in the foetuses of the rat, after administration of 30 mg/kg bw. Red Y has mutagenic potential in in vitro assays, but has to be considered as a non-genotoxic in vivo. The cutaneous absorption was 0.037 % of the administered 14C for hair dyeing formulation I, 0.061 % for formulation II and 0.066 % for the solution. For normal use of hair dye, the following calculation can be made: 1 g Red Y comes in contact with the human skin in perman","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.0022 | mg/kg bw | rat | dermal | 90-day | dermal absorption | {"dose":"With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw.","effect":"contact with the human skin in semi-permanent hair dye condition (based on a usage volume 35 ml containing maximal 1 % Red Y). With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw. So a margin of safety of 3934 can be calculated between the figure for human exposure to oxidative hair dye and the no adverse level found in rats in the 90-day study. For the semi-permanent hair dye a safety margin of 18532 can be calculated. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month and human exposure to semi-permanent hair dye is unlikely to be more than once a week.” The “substance” is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 50 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II was submitted in Ju","page":5,"pdf":"sccp_o_128.pdf","row_type":"noael_study","study_id":"sccp_o_128_noael_002"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | - | 6 weeks | NOAEL study | {"citation":"Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d","dose":"tes numbers) were not dose-related and within the normal values of this rat strain.","effect":"tes numbers) were not dose-related and within the normal values of this rat strain. Potassium levels were increased and concomitantly the sodium / potassium ratio decreased in males after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.","page":23,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 27 3","dose":"However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced.","effect":"sectio parameters were recorded. Each half of the foetuses was examined for visceral and skeletal abnormalities. Results With the exception of discolouration of the fur and tail and urine in all substance groups no clinical signs were observed. However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced. The sectio data on reproduction and the foetal data were not changed. Evaluation of visceral and skeletal abnormalities revealed no treatment-related findings. The NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. Ref.: 27 3.3.9. Toxicokinetics Bioavailability across the intestinal barrier Guideline: / Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: HC Red n° 10+ HC Red n° 11, WR 23532 Batch: 9375 (Fa. OSL) Purity: HC Red n° 10: 54.8 weight% (HPLC) HC Red n° 11: 29.9 weight% (HPLC) Rot C: 0.22 weight% (HPLC) Concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubati","page":29,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.7 | mg/kg bw/d | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.","page":30,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_006"} |
| SCCS_vision_codex | NOAEL | =10.4 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS =","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.004 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS =...","effect":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_008"} |
| SCCS_vision_codex | NOAEL | =0.0008 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 5...","effect":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_010"} |
| SCCS_vision_codex | NOAEL | =7.1 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","effect":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","page":31,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.0006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | {"dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain pri","page":32,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_012"} |
| SCCS_vision_codex | NOAEL | =35.4 | % | - | oral | subchronic | repeated dose toxicity | {"dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","effect":"0 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has to be pointed out that the bioavailability is measured by a non validated method Margin of Safety calculation For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated","page":33,"pdf":"sccs_o_064.pdf","row_type":"noael_study","study_id":"sccs_o_064_noael_016"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 19 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg bw/d | rat | - | 6 weeks | - | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=20; DOSE=tes numbers) were not dose-related and within the normal values of this rat strain.; EFFECT=tes numbers) were not dose-related and within the normal values of this rat strain. Potassium levels were increased and concomitantly the sodium / potassium ratio decreased in males after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.; CITATION=Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d; CITATION_NUMBERS=[21,20]; REFERENCE=Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d; DETAILS_JSON={"cas_number":"95576-89-9","citation":"Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d","dose":"tes numbers) were not dose-related and within the normal values of this rat strain.","duration":"6 weeks","effect":"tes numbers) were not dose-related and within the normal values of this rat strain. Potassium levels were increased and concomitantly the sodium / potassium ratio decreased in males after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.","endpoint":"","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":23,"route":"","species":"rat","study_id":"sccs_o_064_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg bw/d | - | - | 6 weeks | - | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=20; DOSE=ales after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females.; EFFECT=ales after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.; CITATION=Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d; CITATION_NUMBERS=[21,20]; REFERENCE=Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d; DETAILS_JSON={"cas_number":"95576-89-9","citation":"Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d","dose":"ales after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females.","duration":"6 weeks","effect":"ales after 6 weeks at 40 and 60 mg/kg bw/d while this increase was only slight in females. In females of the dose 60 mg/kg bw/d an increase of the absolute and relative liver weight was noted which was not seen in the recovery group. While the study authors proposed a ‘no effect level’ of 40 mg/kg bw/d, the applicant deduced a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry. Ref.: 21 Comment of the SCCS The SCCS agrees with the conservative conclusion of the applicant and sets the NOAEL at 20 mg/kg bw/d.","endpoint":"","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":23,"route":"","species":"","study_id":"sccs_o_064_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg bw/d | human | - | - | - | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=100; DOSE=However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced.; EFFECT=sectio parameters were recorded. Each half of the foetuses was examined for visceral and skeletal abnormalities. Results With the exception of discolouration of the fur and tail and urine in all substance groups no clinical signs were observed. However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced. The sectio data on reproduction and the foetal data were not changed. Evaluation of visceral and skeletal abnormalities revealed no treatment-related findings. The NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. Ref.: 27 3.3.9. Toxicokinetics Bioavailability across the intestinal barrier Guideline: / Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: HC Red n° 10+ HC Red n° 11, WR 23532 Batch: 9375 (Fa. OSL) Purity: HC Red n° 10: 54.8 weight% (HPLC) HC Red n° 11: 29.9 weight% (HPLC) Rot C: 0.22 weight% (HPLC) Concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubati; CITATION=Ref.: 27 3; CITATION_NUMBERS=[27,3]; REFERENCE=Ref.: 27 3; DETAILS_JSON={"cas_number":"95576-89-9","citation":"Ref.: 27 3","dose":"However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced.","duration":"","effect":"sectio parameters were recorded. Each half of the foetuses was examined for visceral and skeletal abnormalities. Results With the exception of discolouration of the fur and tail and urine in all substance groups no clinical signs were observed. However, in the group 300 mg/kg bw/d food consumption (slightly, day 6-12) and body weight gain were reduced. The sectio data on reproduction and the foetal data were not changed. Evaluation of visceral and skeletal abnormalities revealed no treatment-related findings. The NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. Ref.: 27 3.3.9. Toxicokinetics Bioavailability across the intestinal barrier Guideline: / Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: HC Red n° 10+ HC Red n° 11, WR 23532 Batch: 9375 (Fa. OSL) Purity: HC Red n° 10: 54.8 weight% (HPLC) HC Red n° 11: 29.9 weight% (HPLC) Rot C: 0.22 weight% (HPLC) Concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubati","endpoint":"","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":29,"route":"","species":"human","study_id":"sccs_o_064_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 0.0022 | mg/kg bw | rat | dermal | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_128; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCP/1134/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=0.0022; DOSE=With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw.; EFFECT=contact with the human skin in semi-permanent hair dye condition (based on a usage volume 35 ml containing maximal 1 % Red Y). With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw. So a margin of safety of 3934 can be calculated between the figure for human exposure to oxidative hair dye and the no adverse level found in rats in the 90-day study. For the semi-permanent hair dye a safety margin of 18532 can be calculated. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month and human exposure to semi-permanent hair dye is unlikely to be more than once a week.” The “substance” is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 50 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II was submitted in Ju; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw.","duration":"90-day","effect":"contact with the human skin in semi-permanent hair dye condition (based on a usage volume 35 ml containing maximal 1 % Red Y). With a penetration of 0.037 %; this results in a dermal absorption of 0.129 mg per treatment, which is 0.0022 mg/kg bw. So a margin of safety of 3934 can be calculated between the figure for human exposure to oxidative hair dye and the no adverse level found in rats in the 90-day study. For the semi-permanent hair dye a safety margin of 18532 can be calculated. It should be noted that the NOAEL stems from a daily exposure for 90 days, whereas human exposure to permanent hair dye is unlikely to be more frequent than once a month and human exposure to semi-permanent hair dye is unlikely to be more than once a week.” The “substance” is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 50 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II was submitted in Ju","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw","noael_value":"0.0022","page":5,"route":"dermal","species":"rat","study_id":"sccp_o_128_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 0.006; DOSE=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...; EFFECT=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","duration":"90 d","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.006","page":31,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =10.4 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 10.4; DOSE=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...; EFFECT=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS =; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 =...","duration":"90 d","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 31 CALCULATION OF THE MARGIN OF SAFETY HC Red n° 10 Non oxidative conditions Absorption through the skin A = 0.59 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS =","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 10.4","page":31,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.004 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 0.004; DOSE=cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS =...; EFFECT=cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS =...","duration":"90 d","effect":"cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.004","page":31,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =10.4 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 10.4; DOSE=ent SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tr...; EFFECT=ent SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"ent SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tr...","duration":"90 d","effect":"ent SAS x A x 0.001 = 0.34mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 1820 HC Red n° 10 Oxidative conditions Absorption through the skin A = 0.43 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 10.4","page":31,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0008 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 0.0008; DOSE=rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 5...; EFFECT=rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 5...","duration":"90 d","effect":"rmal absorption per treatment SAS x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.0008","page":31,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =7.1 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 7.1; DOSE=x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...; EFFECT=x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","duration":"90 d","effect":"x A x 0.001 = 0.25 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.004 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 10.4 mg/kg bw/d (90 d, oral, rat) MOS = 2500 HC Red n° 11 Non oxidative conditions Absorption through the skin A = 0.08 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.05 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0008 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 900","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 7.1","page":31,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0006 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 0.0006; DOSE=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...; EFFECT=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain pri; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...","duration":"90 d","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain pri","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.0006","page":32,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =7.1 | mg/kg bw/d | rat | oral | 90 d | dermal absorption | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT== 7.1; DOSE=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...; EFFECT=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain primary/s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 6...","duration":"90 d","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 32 HC Red n° 11 Oxidative conditions Absorption through the skin A = 0.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.04 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0006 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 7.1 mg/kg bw/d (90 d, oral, rat) Adjusted for 10% bio-availability = 0.7 MOS = 1030 3.3.14. Discussion Physico-chemical properties HC Red n° 10 + HC Red n° 11 is used as a direct dye in semipermanent hair dye formulations at a maximum on-head concentration of 2%. HC Red n° 10 + HC Red n° 11 is used in oxidative hair dye formulations at a maximum on-head concentration of 1%. Six impurities identified and quantified in HC Red n° 10 and HC Red n° 11 are derivatives of aromatic amines and they contain primary/s","endpoint":"dermal absorption","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 7.1","page":32,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 40 | mg/kg bw | rat | oral | 90-day | irritation | SOURCE_SUBDIR=sccp_o_128; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCP/1134/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=40; DOSE=In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL.; EFFECT=-nitrobenzene (CAS 95576-92- 4), earlier called Red Y, has been submitted in March 1992 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) adopted at its 53rd plenary meeting on 25 June 1993 an opinion (SPC/1076/93) with the final conclusion that: “Red Y was found moderately to slightly toxic in the acute oral toxicity test and slightly toxic after dermal administration to rabbits. Red Y showed no signs of irritation and sensitization. In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL. In the teratogenicity study, no irreversible structural changes were observed in the foetuses of the rat, after administration of 30 mg/kg bw. Red Y has mutagenic potential in in vitro assays, but has to be considered as a non-genotoxic in vivo. The cutaneous absorption was 0.037 % of the administered 14C for hair dyeing formulation I, 0.061 % for formulation II and 0.066 % for the solution. For normal use of hair dye, the following calculation can be made: 1 g Red Y comes in contact with the human skin in perman; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL.","duration":"90-day","effect":"-nitrobenzene (CAS 95576-92- 4), earlier called Red Y, has been submitted in March 1992 by COLIPA1, 2. The Scientific Committee on Cosmetology (SCC) adopted at its 53rd plenary meeting on 25 June 1993 an opinion (SPC/1076/93) with the final conclusion that: “Red Y was found moderately to slightly toxic in the acute oral toxicity test and slightly toxic after dermal administration to rabbits. Red Y showed no signs of irritation and sensitization. In the 90-day study with rats, 40 mg/kg bw was considered to be the NOAEL. In the teratogenicity study, no irreversible structural changes were observed in the foetuses of the rat, after administration of 30 mg/kg bw. Red Y has mutagenic potential in in vitro assays, but has to be considered as a non-genotoxic in vivo. The cutaneous absorption was 0.037 % of the administered 14C for hair dyeing formulation I, 0.061 % for formulation II and 0.066 % for the solution. For normal use of hair dye, the following calculation can be made: 1 g Red Y comes in contact with the human skin in perman","endpoint":"irritation","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":5,"route":"oral","species":"rat","study_id":"sccp_o_128_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/d | human | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=20; DOSE=By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.; EFFECT=Phototoxicity / photomutagenicity / photoclastogenicity 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) For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","duration":"subchronic","effect":"Phototoxicity / photomutagenicity / photoclastogenicity 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) For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":30,"route":"oral","species":"human","study_id":"sccs_o_064_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.7 | mg/kg bw/d | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=0.7; DOSE=By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.; EFFECT=fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","duration":"subchronic","effect":"fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the in vitro study were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate.","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.7","page":30,"route":"oral","species":"","study_id":"sccs_o_064_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=20; DOSE=General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated.; EFFECT=SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 33 may be considered absorbed is 0.50 µg/cm² under oxidative conditions in a hair dye formulation containing a final concentration of 1.0% B71. General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated. From a sub-chronic (90 days) oral toxicity study in rats a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry was deduced. In a developmental toxicity study in rats the NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. No data on reproductive toxicity were submitted. Toxicokinetics in vitro The bioavailability of HC Red n° 10 and HC Red n° 11 across the intestinal barrier was investigated in human intestinal epithelial (TC-7) cells in vitro. HC Red n° 10 was classified to be of high permeability, indicating a ne; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated.","duration":"sub-chronic","effect":"SCCS/1406/11 Opinion on HC Red n° 10 + HC Red n° 11 ___________________________________________________________________________________________ 33 may be considered absorbed is 0.50 µg/cm² under oxidative conditions in a hair dye formulation containing a final concentration of 1.0% B71. General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated. From a sub-chronic (90 days) oral toxicity study in rats a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry was deduced. In a developmental toxicity study in rats the NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. No data on reproductive toxicity were submitted. Toxicokinetics in vitro The bioavailability of HC Red n° 10 and HC Red n° 11 across the intestinal barrier was investigated in human intestinal epithelial (TC-7) cells in vitro. HC Red n° 10 was classified to be of high permeability, indicating a ne","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":33,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=100; DOSE=General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated.; EFFECT=_______________________________________________ 33 may be considered absorbed is 0.50 µg/cm² under oxidative conditions in a hair dye formulation containing a final concentration of 1.0% B71. General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated. From a sub-chronic (90 days) oral toxicity study in rats a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry was deduced. In a developmental toxicity study in rats the NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. No data on reproductive toxicity were submitted. Toxicokinetics in vitro The bioavailability of HC Red n° 10 and HC Red n° 11 across the intestinal barrier was investigated in human intestinal epithelial (TC-7) cells in vitro. HC Red n° 10 was classified to be of high permeability, indicating a nearly 100 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated.","duration":"sub-chronic","effect":"_______________________________________________ 33 may be considered absorbed is 0.50 µg/cm² under oxidative conditions in a hair dye formulation containing a final concentration of 1.0% B71. General toxicity From studies on the acute oral toxicity in rats and mice LD50-values of 1830 to 2200 mg/kg bw were calculated. From a sub-chronic (90 days) oral toxicity study in rats a conservative NOAEL of 20 mg/kg bw/d due to the variations in clinical chemistry was deduced. In a developmental toxicity study in rats the NOAEL for maternal effects was 100 mg/kg bw/d and for embryotoxicity/teratogenicity 300 mg/kg bw/d. No data on reproductive toxicity were submitted. Toxicokinetics in vitro The bioavailability of HC Red n° 10 and HC Red n° 11 across the intestinal barrier was investigated in human intestinal epithelial (TC-7) cells in vitro. HC Red n° 10 was classified to be of high permeability, indicating a nearly 100 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has t","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":33,"route":"oral","species":"rat","study_id":"sccs_o_064_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 35.4 | % | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=35.4; DOSE=By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.; EFFECT=0 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has to be pointed out that the bioavailability is measured by a non validated method Margin of Safety calculation For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","duration":"subchronic","effect":"0 % absorption from the gastro-intestinal tract whereas HC Red n° 11 was classified to be of low permeability. It has to be pointed out that the bioavailability is measured by a non validated method Margin of Safety calculation For the calculation of the Margin of Safety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"%","noael_value":"35.4","page":33,"route":"oral","species":"","study_id":"sccs_o_064_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.7 | mg/kg bw/d | - | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_064; REPORT_TITLE=OPINION ON HC Red n° 10 + HC Red n° 11 COLIPA n° B71; OPINION_NUMBER=SCCS/1406/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=20 September 2011; VALUE_TEXT=0.7; DOSE=By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.; EFFECT=fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Red n° 10 + HC Red n° 11 induced mutations both in a bacterial gene mutation test as well as in a gene mutation test in mammalian cells. However; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95576-89-9","citation":"","dose":"By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11.","duration":"subchronic","effect":"fety, it was taken into consideration that the dye is a mixture of mainly two components. In the calculation, it is assumed that the toxicity is triggered either by HC Red n° 10 (content 51.8%) or HC Red n° 11 (content 35.4%) alone. By doing this, the NOAEL of the subchronic toxicity study (20 mg/kg bw/d) is adjusted to 10.4 mg/kg bw/d for HC Red n° 10 and 7.1 mg/kg bw/d for HC Red n° 11. Furthermore, the different oral bioavailabilities found in the study in vitro were taken into account. To account for this, the NOAEL figure for HC RED n° 11 was further adjusted to 0.7 mg/kg bw/d assuming a 10% oral absorption rate. The MOS values obtained were between 900 and 2500. Mutagenicity Overall, the genotoxicity of HC Red n° 10 + HC Red n° 11 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Red n° 10 + HC Red n° 11 induced mutations both in a bacterial gene mutation test as well as in a gene mutation test in mammalian cells. However","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 10","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.7","page":33,"route":"oral","species":"","study_id":"sccs_o_064_noael_017"} |