NOAEL Studies Cosmetic Ingredient

HC Blue No. 2 NOAEL Studies

INCI: HC BLUE NO. 2

CAS: 33229-34-4

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1992 IARC Monographs {"additional_info":"volume_publication_year=1993","evaluation_year":1992,"source_table":"iarc_classifications","volume":"57"}
NTP_ICE_cancer 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 3 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=6318; Record_ID=cancer_1322; Data_Type=WOE; Formulation_Name=HC Blue 2; Mixture=Chemical; DTXSID=DTXSID6020193; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/75; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020193; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020193
NTP_ICE_cancer Top dose 10000 ppm Rat Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=6321; Record_ID=cancer_1323; Data_Type=In Vivo; Formulation_Name=HC Blue 2; Mixture=Chemical; DTXSID=DTXSID6020193; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=10000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Route=Dosed feed; Reference=TR-293; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr293/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020193; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020193
NTP_ICE_cancer Top dose 20000 ppm Mouse Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=6315; Record_ID=cancer_1321; Data_Type=In Vivo; Formulation_Name=HC Blue 2; Mixture=Chemical; DTXSID=DTXSID6020193; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=20000; Response_Unit=ppm; Species=Mouse; Strain=B6C3F1; Sex=Female; Route=Dosed feed; Reference=TR-293; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr293/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020193; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020193
SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.0004 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used t","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_009"}
SCCS_vision_codex NOAEL =0.0004 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used t","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_009"}
SCCS_vision_codex NOAEL =0.0004 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used t","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_009"}
SCCS_vision_codex NOAEL =0.0004 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used t","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"2 (B037) was 300 mg/kg/day.","effect":"Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determined. The LOAEL is 100 mg/kg bw/day 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6. Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Three plates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9. Assay conditions: Direct pl","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral developmental developmental toxicity {"dose":"The LOAEL in this study was 100 mg/kg/day.","effect":"t. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ab","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_013"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"2 (B037) was 300 mg/kg/day.","effect":"Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determined. The LOAEL is 100 mg/kg bw/day 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6. Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Three plates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9. Assay conditions: Direct pl","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral developmental developmental toxicity {"dose":"The LOAEL in this study was 100 mg/kg/day.","effect":"t. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ab","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_013"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"2 (B037) was 300 mg/kg/day.","effect":"Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determined. The LOAEL is 100 mg/kg bw/day 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6. Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Three plates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9. Assay conditions: Direct pl","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral developmental developmental toxicity {"dose":"The LOAEL in this study was 100 mg/kg/day.","effect":"t. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ab","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_013"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"2 (B037) was 300 mg/kg/day.","effect":"Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determined. The LOAEL is 100 mg/kg bw/day 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6. Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Three plates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9. Assay conditions: Direct pl","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_010"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat oral developmental developmental toxicity {"dose":"The LOAEL in this study was 100 mg/kg/day.","effect":"t. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ab","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - - NOAEL study {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period.","effect":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - - NOAEL study {"dose":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.","effect":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATIO","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_007"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - - NOAEL study {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period.","effect":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - - NOAEL study {"dose":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.","effect":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATIO","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_007"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - - NOAEL study {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period.","effect":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - - NOAEL study {"dose":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.","effect":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATIO","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_007"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - - NOAEL study {"citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period.","effect":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be","page":14,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day human - - NOAEL study {"dose":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.","effect":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATIO","page":25,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_007"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13-week NOAEL study {"dose":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg.","effect":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg. A 13-week oral toxicity (gavage) study clinical signs related to the test compound consisted of ptyalism and purple discolouration of urine, urogenital region, extremities, coat and tail at all dose levels. Increased liver and kidney weights were observed in males and females at 1000 mg/kg/day; these changes were also observed in females at the end of the treatment-free period. The NOAEL could not be determined in this study, since ptyalism is considered a treatment related adverse effect. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal i","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_012"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13-week NOAEL study {"dose":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg.","effect":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg. A 13-week oral toxicity (gavage) study clinical signs related to the test compound consisted of ptyalism and purple discolouration of urine, urogenital region, extremities, coat and tail at all dose levels. Increased liver and kidney weights were observed in males and females at 1000 mg/kg/day; these changes were also observed in females at the end of the treatment-free period. The NOAEL could not be determined in this study, since ptyalism is considered a treatment related adverse effect. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal i","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_012"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13-week NOAEL study {"dose":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg.","effect":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg. A 13-week oral toxicity (gavage) study clinical signs related to the test compound consisted of ptyalism and purple discolouration of urine, urogenital region, extremities, coat and tail at all dose levels. Increased liver and kidney weights were observed in males and females at 1000 mg/kg/day; these changes were also observed in females at the end of the treatment-free period. The NOAEL could not be determined in this study, since ptyalism is considered a treatment related adverse effect. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal i","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_012"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral 13-week NOAEL study {"dose":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg.","effect":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg. A 13-week oral toxicity (gavage) study clinical signs related to the test compound consisted of ptyalism and purple discolouration of urine, urogenital region, extremities, coat and tail at all dose levels. Increased liver and kidney weights were observed in males and females at 1000 mg/kg/day; these changes were also observed in females at the end of the treatment-free period. The NOAEL could not be determined in this study, since ptyalism is considered a treatment related adverse effect. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal i","page":26,"pdf":"sccp_o_084.pdf","row_type":"noael_study","study_id":"sccp_o_084_noael_012"}
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =300 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae1ee4b0a7c65d1c7911; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10531/7/6/2?documentUUID=c251ddff-8f1f-42c5-8077-27652c2d1a18; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=ECHA IUCLID:15831404:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2928cf22f0450fd7516a46b201064248
ToxValDB_ECHA_IUCLID NOEL =1000 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd6c2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10531/7/9/3?documentUUID=c251ddff-8f1f-42c5-8077-27652c2d1a18; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=ECHA IUCLID:15821823:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0baf78f1ed19acf14b6057f66b8cdf4f
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 14 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/day human - - - SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.; EFFECT=SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.","duration":"","effect":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0","endpoint":"","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":25,"route":"","species":"human","study_id":"sccp_o_084_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg/day - - - - SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period.; EFFECT=mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be; CITATION=Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; DETAILS_JSON={"cas_number":"33229-34-4","citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period.","duration":"","effect":"mg/kg/day at the end of the dosing period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be","endpoint":"","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":14,"route":"","species":"","study_id":"sccp_o_084_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg/day - - - - SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=At microscopy no treatment-related findings were observed at any dose-level.; EFFECT=g period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determ; CITATION=Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; DETAILS_JSON={"cas_number":"33229-34-4","citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"At microscopy no treatment-related findings were observed at any dose-level.","duration":"","effect":"g period and were still recorded in females at the end of the recovery period. The increase in liver and kidney weight was not accompanied by histopathological or blood biochemical changes/effects. At the end of both treatment and treatment-free periods, purple colorations of the hair and extremities and some intestinal parts were observed at macroscopy. At microscopy no treatment-related findings were observed at any dose-level. Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determ","endpoint":"","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":14,"route":"","species":"","study_id":"sccp_o_084_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg bw/day human - - - SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.; EFFECT=SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATIO; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs.","duration":"","effect":"SCCP/1035/06 OPINION ON HC BLUE N°2 25 Comment At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal, when compared to controls (22 vs. 11 in controls, p<0.05). Also the (dose-related) excessive salivation in maternal animals at 1000 and 300 mg/kg bw is considered adverse. As a consequence, SCCP derives from this study a foetal NOAEL of 300 mg/kg bw/day in the presence of maternal toxicity. The NOAEL for maternal toxicity is 100 mg/kg bw/day. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. 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) CALCULATIO","endpoint":"","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":25,"route":"","species":"human","study_id":"sccp_o_084_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day rat oral 13-week - SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg.; LOAEL_VALUE=100 mg/kg/day; EFFECT=N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg. A 13-week oral toxicity (gavage) study clinical signs related to the test compound consisted of ptyalism and purple discolouration of urine, urogenital region, extremities, coat and tail at all dose levels. Increased liver and kidney weights were observed in males and females at 1000 mg/kg/day; these changes were also observed in females at the end of the treatment-free period. The NOAEL could not be determined in this study, since ptyalism is considered a treatment related adverse effect. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg.","duration":"13-week","effect":"N°2 26 General toxicity In an acute oral (gavage) toxicity study in rats the maximum non-lethal dose of HC Blue n° 2 was 2000 mg/kg. A 13-week oral toxicity (gavage) study clinical signs related to the test compound consisted of ptyalism and purple discolouration of urine, urogenital region, extremities, coat and tail at all dose levels. Increased liver and kidney weights were observed in males and females at 1000 mg/kg/day; these changes were also observed in females at the end of the treatment-free period. The NOAEL could not be determined in this study, since ptyalism is considered a treatment related adverse effect. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal i","endpoint":"","ingredient":"HC Blue n° 2","loael_value":"100 mg/kg/day","noael_unit":"mg/kg/day","noael_value":"1000","page":26,"route":"oral","species":"rat","study_id":"sccp_o_084_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.0004 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 0.0004; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...; EFFECT=3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","duration":"","effect":"3.3.10.2. 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) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used t","endpoint":"dermal absorption","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0004","page":25,"route":"oral","species":"rat","study_id":"sccp_o_084_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =100 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...; EFFECT=y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","duration":"","effect":"y No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents","endpoint":"dermal absorption","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":25,"route":"oral","species":"rat","study_id":"sccp_o_084_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =100 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...; EFFECT=ata No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed ad...","duration":"","effect":"ata No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A = 0.037 µg/cm2 Skin area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.026 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0004 mg/kg No observed adverse effect level (rat, oral, maternal toxicity) NOAEL = 100 mg/kg Margin of Safety NOAEL/SED = 250000 3.3.14. Discussion Physico-chemical properties HC Blue No.2 is used in semi-permanent hair dye formulations at a maximum concentration of 2.8%. Stability of HC Blue n° 2 in marketed products is not reported. Chemical structure of HC Blue No.2 is comprised of both a secondary and a tertiary amino group. It is therefore prone to nitrosation. Nitrosamine content in HC Blue n° 2 is not reported. HC Blue n° 2 should not be used together with nitrosating agents","endpoint":"dermal absorption","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":25,"route":"oral","species":"rat","study_id":"sccp_o_084_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=The LOAEL in this study was 100 mg/kg/day.; LOAEL_VALUE=100 mg/kg/day; EFFECT=t. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ab; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"The LOAEL in this study was 100 mg/kg/day.","duration":"developmental","effect":"t. The LOAEL in this study was 100 mg/kg/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ab","endpoint":"developmental toxicity","ingredient":"HC Blue n° 2","loael_value":"100 mg/kg/day","noael_unit":"mg/kg/day","noael_value":"100","page":26,"route":"oral","species":"rat","study_id":"sccp_o_084_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=one female given 300 mg/kg/day and of 12/24 females given 1000 mg/kg/day towards the end of gestation.; EFFECT=one female given 300 mg/kg/day and of 12/24 females given 1000 mg/kg/day towards the end of gestation. Excessive salivation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period. 1000 mg/kg/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-foetal development. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was 300 mg/kg/day and the No Observed Effect level (NOEL) for developmental toxicity was 1000 mg/kg/day. Ref: 12; CITATION=Ref: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref: 12; DETAILS_JSON={"cas_number":"33229-34-4","citation":"Ref: 12","dose":"one female given 300 mg/kg/day and of 12/24 females given 1000 mg/kg/day towards the end of gestation.","duration":"developmental","effect":"one female given 300 mg/kg/day and of 12/24 females given 1000 mg/kg/day towards the end of gestation. Excessive salivation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period. 1000 mg/kg/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-foetal development. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was 300 mg/kg/day and the No Observed Effect level (NOEL) for developmental toxicity was 1000 mg/kg/day. Ref: 12","endpoint":"developmental toxicity","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":24,"route":"","species":"","study_id":"sccp_o_084_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=of 12/24 females given 1000 mg/kg/day towards the end of gestation.; EFFECT=of 12/24 females given 1000 mg/kg/day towards the end of gestation. Excessive salivation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period. 1000 mg/kg/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-foetal development. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was 300 mg/kg/day and the No Observed Effect level (NOEL) for developmental toxicity was 1000 mg/kg/day. Ref: 12; CITATION=Ref: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref: 12; DETAILS_JSON={"cas_number":"33229-34-4","citation":"Ref: 12","dose":"of 12/24 females given 1000 mg/kg/day towards the end of gestation.","duration":"developmental","effect":"of 12/24 females given 1000 mg/kg/day towards the end of gestation. Excessive salivation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period. 1000 mg/kg/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-foetal development. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was 300 mg/kg/day and the No Observed Effect level (NOEL) for developmental toxicity was 1000 mg/kg/day. Ref: 12","endpoint":"developmental toxicity","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":24,"route":"","species":"","study_id":"sccp_o_084_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=livation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period.; EFFECT=livation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period. 1000 mg/kg/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-foetal development. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was 300 mg/kg/day and the No Observed Effect level (NOEL) for developmental toxicity was 1000 mg/kg/day. Ref: 12; CITATION=Ref: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref: 12; DETAILS_JSON={"cas_number":"33229-34-4","citation":"Ref: 12","dose":"livation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period.","duration":"developmental","effect":"livation (ptyalism) was observed in 10/24 females given 300 mg/kg/day and 17/24 females given 1000 mg/kg/day, for a few days after start of dosing until the end of the treatment period. 1000 mg/kg/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-foetal development. The No Observed Adverse Effect Level (NOAEL) for maternal toxicity was 300 mg/kg/day and the No Observed Effect level (NOEL) for developmental toxicity was 1000 mg/kg/day. Ref: 12","endpoint":"developmental toxicity","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":24,"route":"","species":"","study_id":"sccp_o_084_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day.; EFFECT=g/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ability to induce gene mutations in bact; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"33229-34-4","citation":"","dose":"Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day.","duration":"developmental","effect":"g/day. Gavage administration of 100, 300 or 1000 mg/kg/day HC Blue n° 2 to pregnant female Sprague-Dawley rats produced ptyalism as well as blue discolouration of urine, extremities and fur at 300 and 1000 mg/kg/day. Lower mean body weight gain and food consumption were observed at 1000 mg/kg/day At 1000 mg/kg/day, there was a statistically significant increase in the foetal incidence of incomplete ossification of the interparietal. Therefore, 100 mg/kg/day was considered the NOAEL for maternal toxicity, while the NOEL for developmental toxicity was set at 300 mg/kg/day. Irritation / sensitisation 3% HC Blue n° 2 was not irritant to rabbit skin. It caused transient irritation to the eye of rabbits. While the data are equivocal, HC Blue n° 2 is considered to have a skin sensitising potential in mice. Dermal absorption The maximum total absorption observed was 0.037 µgeq/cm² which should be used for calculating the MOS. Mutagenicity / Genotoxicity HC Blue n° 2 was investigated for its ability to induce gene mutations in bact","endpoint":"developmental toxicity","ingredient":"HC Blue n° 2","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":26,"route":"oral","species":"rat","study_id":"sccp_o_084_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 100 mg/kg bw/day rat - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_084; REPORT_TITLE=OPINION ON HC BLUE N°2 COLIPA N° B37; OPINION_NUMBER=SCCP/1035/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=2 (B037) was 300 mg/kg/day.; LOAEL_VALUE=100 mg/kg bw/day; EFFECT=Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determined. The LOAEL is 100 mg/kg bw/day 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6. Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Three plates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9. Assay conditions: Direct pl; CITATION=Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; DETAILS_JSON={"cas_number":"33229-34-4","citation":"Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups","dose":"2 (B037) was 300 mg/kg/day.","duration":"Chronic","effect":"Observed Adverse Effect Level (NOAEL) of HC Blue No. 2 (B037) was 300 mg/kg/day. Ref.: 5 Comment Ptyalism is considered an adverse effect for the following reasons: a) it was observed in all animals in all treated groups; b) it is seen early (from week 1) in the highest dose group and later (week 2 or 4) in the lower dose groups c) it is not clear when the observations were performed (and therefore it cannot be assessed whether the effect is directly associated with dosing or is a systemic effect). Therefore the NOAEL in this study cannot be determined. The LOAEL is 100 mg/kg bw/day 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6. Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Three plates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9. Assay conditions: Direct pl","endpoint":"genotoxicity","ingredient":"HC Blue n° 2","loael_value":"100 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"100","page":14,"route":"","species":"rat","study_id":"sccp_o_084_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 6C0EL1931V UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H19N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6C0EL1931V"}
openFDA substances FDA UNII substance identifier 6C0EL1931V UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H19N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6C0EL1931V"}
openFDA substances FDA UNII substance identifier 6C0EL1931V UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H19N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6C0EL1931V"}
openFDA substances FDA UNII substance identifier 6C0EL1931V UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H19N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6C0EL1931V"}