NOAEL Studies Cosmetic Ingredient

Basic Blue 124 NOAEL Studies

INCI: BASIC BLUE 124

CAS: 67846-56-4

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

Back to parent ingredient page
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral 28-day repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen.","effect":", body weight loss/stasis, reduced food consumption, changes in clinical pathology parameters, enlargement of the spleen and increased spleen weight. At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen. At 10 mg/kg bw/day, no test item-related toxicity was noted. Conclusion Under the conditions of this dose-range finding toxicity study, the no-observed-adverse- effect level (NOAEL) for the test item FAT 31’048/I Maxilon Blau M -2G was 10 mg/kg bw/day for female rats. Dose levels of 3, 10 and 30 mg/kg bw/day were selected for the subsequent 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test. Ref: NOTOX B.V. (2011a) 3.3.5.2 Repeated Dose (28 days) oral toxicity Guideline: OECD 422; US EPA OPPTS 870.3650 Species/strain: Wistar Han rat Group size: 10 animals/sex/dose level","page":32,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat oral sub-acute repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats.","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 35 Table: Haematology parameters after daily (sub-acute) oral gavage treatment Table: Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. For reproductive and/or developmental effects see Section 3.3.8.2. Ref: NOTOX B.V. (2011b)","page":35,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_002"}
SCCS_vision_codex NOAEL =12 mg/kg bw/day rat oral developmental developmental toxicity {"dose":"Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoc","page":56,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_008"}
SCCS_vision_codex NOAEL =0.00032 mg/kg bw rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"____________________________________________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical r","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_010"}
SCCS_vision_codex NOAEL =3 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"___________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_011"}
SCCS_vision_codex NOAEL =1.5 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"ation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports were not conducted under GLP. Analytical data were obtained using internal standard operating procedures (","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_012"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral 28-day repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen.","effect":", body weight loss/stasis, reduced food consumption, changes in clinical pathology parameters, enlargement of the spleen and increased spleen weight. At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen. At 10 mg/kg bw/day, no test item-related toxicity was noted. Conclusion Under the conditions of this dose-range finding toxicity study, the no-observed-adverse- effect level (NOAEL) for the test item FAT 31’048/I Maxilon Blau M -2G was 10 mg/kg bw/day for female rats. Dose levels of 3, 10 and 30 mg/kg bw/day were selected for the subsequent 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test. Ref: NOTOX B.V. (2011a) 3.3.5.2 Repeated Dose (28 days) oral toxicity Guideline: OECD 422; US EPA OPPTS 870.3650 Species/strain: Wistar Han rat Group size: 10 animals/sex/dose level","page":32,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat oral sub-acute repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats.","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 35 Table: Haematology parameters after daily (sub-acute) oral gavage treatment Table: Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. For reproductive and/or developmental effects see Section 3.3.8.2. Ref: NOTOX B.V. (2011b)","page":35,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_002"}
SCCS_vision_codex NOAEL =12 mg/kg bw/day rat oral developmental developmental toxicity {"dose":"Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoc","page":56,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_008"}
SCCS_vision_codex NOAEL =0.00032 mg/kg bw rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"____________________________________________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical r","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_010"}
SCCS_vision_codex NOAEL =3 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"___________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_011"}
SCCS_vision_codex NOAEL =1.5 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"ation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports were not conducted under GLP. Analytical data were obtained using internal standard operating procedures (","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_012"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral 28-day repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen.","effect":", body weight loss/stasis, reduced food consumption, changes in clinical pathology parameters, enlargement of the spleen and increased spleen weight. At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen. At 10 mg/kg bw/day, no test item-related toxicity was noted. Conclusion Under the conditions of this dose-range finding toxicity study, the no-observed-adverse- effect level (NOAEL) for the test item FAT 31’048/I Maxilon Blau M -2G was 10 mg/kg bw/day for female rats. Dose levels of 3, 10 and 30 mg/kg bw/day were selected for the subsequent 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test. Ref: NOTOX B.V. (2011a) 3.3.5.2 Repeated Dose (28 days) oral toxicity Guideline: OECD 422; US EPA OPPTS 870.3650 Species/strain: Wistar Han rat Group size: 10 animals/sex/dose level","page":32,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat oral sub-acute repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats.","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 35 Table: Haematology parameters after daily (sub-acute) oral gavage treatment Table: Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. For reproductive and/or developmental effects see Section 3.3.8.2. Ref: NOTOX B.V. (2011b)","page":35,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_002"}
SCCS_vision_codex NOAEL =12 mg/kg bw/day rat oral developmental developmental toxicity {"dose":"Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoc","page":56,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_008"}
SCCS_vision_codex NOAEL =0.00032 mg/kg bw rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"____________________________________________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical r","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_010"}
SCCS_vision_codex NOAEL =3 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"___________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_011"}
SCCS_vision_codex NOAEL =1.5 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"ation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports were not conducted under GLP. Analytical data were obtained using internal standard operating procedures (","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_012"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral 28-day repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen.","effect":", body weight loss/stasis, reduced food consumption, changes in clinical pathology parameters, enlargement of the spleen and increased spleen weight. At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen. At 10 mg/kg bw/day, no test item-related toxicity was noted. Conclusion Under the conditions of this dose-range finding toxicity study, the no-observed-adverse- effect level (NOAEL) for the test item FAT 31’048/I Maxilon Blau M -2G was 10 mg/kg bw/day for female rats. Dose levels of 3, 10 and 30 mg/kg bw/day were selected for the subsequent 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test. Ref: NOTOX B.V. (2011a) 3.3.5.2 Repeated Dose (28 days) oral toxicity Guideline: OECD 422; US EPA OPPTS 870.3650 Species/strain: Wistar Han rat Group size: 10 animals/sex/dose level","page":32,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat oral sub-acute repeated dose toxicity {"citation":"Ref: NOTOX B","dose":"Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats.","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 35 Table: Haematology parameters after daily (sub-acute) oral gavage treatment Table: Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. For reproductive and/or developmental effects see Section 3.3.8.2. Ref: NOTOX B.V. (2011b)","page":35,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_002"}
SCCS_vision_codex NOAEL =12 mg/kg bw/day rat oral developmental developmental toxicity {"dose":"Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoc","page":56,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_008"}
SCCS_vision_codex NOAEL =0.00032 mg/kg bw rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"____________________________________________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical r","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_010"}
SCCS_vision_codex NOAEL =3 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"___________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_011"}
SCCS_vision_codex NOAEL =1.5 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","effect":"ation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports were not conducted under GLP. Analytical data were obtained using internal standard operating procedures (","page":57,"pdf":"sccs_o_179.pdf","row_type":"noael_study","study_id":"sccs_o_179_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.00032 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT== 0.00032; DOSE=0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...; EFFECT=____________________________________________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","duration":"90-day","effect":"____________________________________________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical r","endpoint":"dermal absorption","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.00032","page":57,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =3 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT== 3; DOSE=0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...; EFFECT=___________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","duration":"90-day","effect":"___________________ 57 3.3.12 Special investigations No data. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports","endpoint":"dermal absorption","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 3","page":57,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =1.5 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT== 1.5; DOSE=0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...; EFFECT=ation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports were not conducted under GLP. Analytical data were obtained using internal standard operating procedures (; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 m...","duration":"90-day","effect":"ation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Only semi-permanent, non-oxidative conditions) (on head concentration max. 0.5%) Absorption through the skin A = 0.033 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.019 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00032 mg/kg bw No observed adverse effect level NOAEL = 3 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 1.5 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 4700 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Blue 124 is an organic salt and moderately soluble in water and several alcohols. Water solubility has not been determined by EC Method A.6 Purity has been described to be 95% and higher. Most analytical reports were not conducted under GLP. Analytical data were obtained using internal standard operating procedures (","endpoint":"dermal absorption","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 1.5","page":57,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 12 mg/kg bw/day rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=12; DOSE=Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...; EFFECT=SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...","duration":"developmental","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoc","endpoint":"developmental toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12","page":56,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 12 mg/kg bw/day rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=12; DOSE=Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...; EFFECT=Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data No da; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was se...","duration":"developmental","effect":"Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 56 Table: Haematology parameters in pregnant rats at necropsy following daily oral gavage treatment from days of gestation 6 through 20 (DGs 6-20) Conclusion Based on the effects of the test item Maxilon Blau M -2G on food consumption, body weights and haematology parameters of pregnant females the maternal no-observed- adverse-effect level (NOAEL) was set at 12 mg/kg bw/day. The NOAEL for developmental effects/teratogenicity was established at the high-dose level of 40 mg/kg bw/day due to the lack of relevant adverse embryo-foetal effects under the conditions of this study. Harlan Laboratories Ltd. (2013) 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity No data. 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data No da","endpoint":"developmental toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12","page":56,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 3 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects.; EFFECT=and kidney are target organs of Basic Blue 124 at these doses. Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects. However, although some of these effects are statistically significant, they are variable between studies and genders and not consistent. Taken together, even when assuming mild haematotoxic effects or slight histopathological effects in spleen and kidney, these effects are not considered adverse at a dose of 3 mg/kg bw/day. Therefore, a NOAEL of 3 mg/kg bw/day can be used for the calculation of the MoS. 3.3.5.4 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Reverse mutation assay using bacteria (Salmonella typhimurium and Escherichia coli) Guideline: OECD 471; Commission Regulation (EC) No 440/2008, B.13/B.14; US EPA OPPTS 870.5100 Species/strain: Salmonella typhimurium TA1535, TA100, TA1537, TA98 and E. coli WP2 uvrA Replicates: triplicates in 2 individual experiments both i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects.","duration":"Chronic","effect":"and kidney are target organs of Basic Blue 124 at these doses. Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects. However, although some of these effects are statistically significant, they are variable between studies and genders and not consistent. Taken together, even when assuming mild haematotoxic effects or slight histopathological effects in spleen and kidney, these effects are not considered adverse at a dose of 3 mg/kg bw/day. Therefore, a NOAEL of 3 mg/kg bw/day can be used for the calculation of the MoS. 3.3.5.4 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Reverse mutation assay using bacteria (Salmonella typhimurium and Escherichia coli) Guideline: OECD 471; Commission Regulation (EC) No 440/2008, B.13/B.14; US EPA OPPTS 870.5100 Species/strain: Salmonella typhimurium TA1535, TA100, TA1537, TA98 and E. coli WP2 uvrA Replicates: triplicates in 2 individual experiments both i","endpoint":"genotoxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":40,"route":"","species":"","study_id":"sccs_o_179_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 3 mg/kg bw/day - - - genotoxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects.; EFFECT=nd kidney are target organs of Basic Blue 124 at these doses. Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects. However, although some of these effects are statistically significant, they are variables between studies and genders and inconsistencies. Taken together, even when assuming mild haematotoxic effects or slight histopathological effects in spleen and kidney, these effects are not considered adverse at a dose of 3 mg/kg bw/day. Therefore, a NOAEL of 3 mg/kg bw/day can be used for the calculation of the MoS. Mutagenicity Overall, the genotoxicity of Maxilon Blau M-2G, Basic Blue 124 is investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. Maxilon Blau M-2G, Basic Blue 124 was positive in a gene mutation test in bacteria but did not induce an increase in the gene mutation frequency in 2 different gene mutation tests in mammalian cells. Maxilon Blau M-2G, Basic Blue 124 exposure; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects.","duration":"","effect":"nd kidney are target organs of Basic Blue 124 at these doses. Moreover, at the doses of 3 or 1 mg/kg bw/day, single parameters of haematotoxicity parameters suggest mild effects. However, although some of these effects are statistically significant, they are variables between studies and genders and inconsistencies. Taken together, even when assuming mild haematotoxic effects or slight histopathological effects in spleen and kidney, these effects are not considered adverse at a dose of 3 mg/kg bw/day. Therefore, a NOAEL of 3 mg/kg bw/day can be used for the calculation of the MoS. Mutagenicity Overall, the genotoxicity of Maxilon Blau M-2G, Basic Blue 124 is investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. Maxilon Blau M-2G, Basic Blue 124 was positive in a gene mutation test in bacteria but did not induce an increase in the gene mutation frequency in 2 different gene mutation tests in mammalian cells. Maxilon Blau M-2G, Basic Blue 124 exposure","endpoint":"genotoxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":59,"route":"","species":"","study_id":"sccs_o_179_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 10 mg/kg bw/day rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=10; DOSE=At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen.; EFFECT=, body weight loss/stasis, reduced food consumption, changes in clinical pathology parameters, enlargement of the spleen and increased spleen weight. At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen. At 10 mg/kg bw/day, no test item-related toxicity was noted. Conclusion Under the conditions of this dose-range finding toxicity study, the no-observed-adverse- effect level (NOAEL) for the test item FAT 31’048/I Maxilon Blau M -2G was 10 mg/kg bw/day for female rats. Dose levels of 3, 10 and 30 mg/kg bw/day were selected for the subsequent 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test. Ref: NOTOX B.V. (2011a) 3.3.5.2 Repeated Dose (28 days) oral toxicity Guideline: OECD 422; US EPA OPPTS 870.3650 Species/strain: Wistar Han rat Group size: 10 animals/sex/dose level; CITATION=Ref: NOTOX B; CITATION_NUMBERS=[]; REFERENCE=Ref: NOTOX B; DETAILS_JSON={"cas_number":"67846-56-4","citation":"Ref: NOTOX B","dose":"At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen.","duration":"28-day","effect":", body weight loss/stasis, reduced food consumption, changes in clinical pathology parameters, enlargement of the spleen and increased spleen weight. At 30 mg/kg bw/day, test item-related findings included bodyweight loss/stasis, slightly reduced food consumption, minor changes in clinical pathology parameters and enlargement of the spleen. At 10 mg/kg bw/day, no test item-related toxicity was noted. Conclusion Under the conditions of this dose-range finding toxicity study, the no-observed-adverse- effect level (NOAEL) for the test item FAT 31’048/I Maxilon Blau M -2G was 10 mg/kg bw/day for female rats. Dose levels of 3, 10 and 30 mg/kg bw/day were selected for the subsequent 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test. Ref: NOTOX B.V. (2011a) 3.3.5.2 Repeated Dose (28 days) oral toxicity Guideline: OECD 422; US EPA OPPTS 870.3650 Species/strain: Wistar Han rat Group size: 10 animals/sex/dose level","endpoint":"repeated dose toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":32,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 3 mg/kg bw/day rat oral sub-acute repeated dose toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats.; EFFECT=SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 35 Table: Haematology parameters after daily (sub-acute) oral gavage treatment Table: Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. For reproductive and/or developmental effects see Section 3.3.8.2. Ref: NOTOX B.V. (2011b); CITATION=Ref: NOTOX B; CITATION_NUMBERS=[]; REFERENCE=Ref: NOTOX B; DETAILS_JSON={"cas_number":"67846-56-4","citation":"Ref: NOTOX B","dose":"Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats.","duration":"sub-acute","effect":"SCCS/1542/14 Revision of the opinion on Basic Blue 124 ___________________________________________________________________________________________ 35 Table: Haematology parameters after daily (sub-acute) oral gavage treatment Table: Rat spleen weights after daily (sub-acute) oral gavage treatment Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. For reproductive and/or developmental effects see Section 3.3.8.2. Ref: NOTOX B.V. (2011b)","endpoint":"repeated dose toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":35,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 3 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=All dose formulation samples met the acceptance criterion for homogeneity (≤15 %).; EFFECT=evealed all actual concentrations were within the acceptance criterion of ±20 % of the nominal concentrations. All dose formulation samples met the acceptance criterion for homogeneity (≤15 %). The test item was found to be stable in dose formulations when kept for 6 hours at room temperature due to recoveries which met the variation limit of 10% from the time-zero (homogeneity) mean value. Conclusion Under the conditions of this subchronic repeated dose oral toxicity study, the no-observed- adverse-effect level (NOAEL) for the test item Maxilon Blau M -2G, Basic Blue 124 was established at 3 mg/kg bw/day for male and female rats. The spleen and the haematopoietic system as well as the kidneys and the urinary bladder were identified as targets of repeated oral exposure to Basic Blue 124. Ref.: Harlan Laboratories Ltd. (2014) SCCS comment For dose formulations, the acceptance criterion of ±20% of the nominal concentrations of the test substance is considered ample. The study plan was not provided. The SCCS does not consider an; CITATION=Ref.: Harlan Laboratories Ltd; CITATION_NUMBERS=[]; REFERENCE=Ref.: Harlan Laboratories Ltd; DETAILS_JSON={"cas_number":"67846-56-4","citation":"Ref.: Harlan Laboratories Ltd","dose":"All dose formulation samples met the acceptance criterion for homogeneity (≤15 %).","duration":"subchronic","effect":"evealed all actual concentrations were within the acceptance criterion of ±20 % of the nominal concentrations. All dose formulation samples met the acceptance criterion for homogeneity (≤15 %). The test item was found to be stable in dose formulations when kept for 6 hours at room temperature due to recoveries which met the variation limit of 10% from the time-zero (homogeneity) mean value. Conclusion Under the conditions of this subchronic repeated dose oral toxicity study, the no-observed- adverse-effect level (NOAEL) for the test item Maxilon Blau M -2G, Basic Blue 124 was established at 3 mg/kg bw/day for male and female rats. The spleen and the haematopoietic system as well as the kidneys and the urinary bladder were identified as targets of repeated oral exposure to Basic Blue 124. Ref.: Harlan Laboratories Ltd. (2014) SCCS comment For dose formulations, the acceptance criterion of ±20% of the nominal concentrations of the test substance is considered ample. The study plan was not provided. The SCCS does not consider an","endpoint":"repeated dose toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":39,"route":"oral","species":"rat","study_id":"sccs_o_179_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 3 mg/kg bw/day rat - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=The concentrations analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %).; EFFECT=n this study. The concentrations analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %). The test item was homogeneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %). Formulations at the entire concentration range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours. Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. Due to the lack of adverse effects, the NOAEL for reproductive and/or developmental effects was set at the high dose level of 30 mg/kg bw/day. NOTOX B.V. (2011b) 3.3.8.3 Developmental Toxicity Guideline: OECD 414; US EPA OPPTS 870.3700; MAFF 12 Nohsan 8147 Species/strain: Han Wistar rat Group size: 10 animals/sex/dose level Test substance: FAT 31’048/I Maxilon Blau M -2G Batc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"The concentrations analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %).","duration":"developmental","effect":"n this study. The concentrations analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %). The test item was homogeneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %). Formulations at the entire concentration range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours. Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. Due to the lack of adverse effects, the NOAEL for reproductive and/or developmental effects was set at the high dose level of 30 mg/kg bw/day. NOTOX B.V. (2011b) 3.3.8.3 Developmental Toxicity Guideline: OECD 414; US EPA OPPTS 870.3700; MAFF 12 Nohsan 8147 Species/strain: Han Wistar rat Group size: 10 animals/sex/dose level Test substance: FAT 31’048/I Maxilon Blau M -2G Batc","endpoint":"reproductive toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":53,"route":"","species":"rat","study_id":"sccs_o_179_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 3 mg/kg bw/day rat - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %).; EFFECT=analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %). The test item was homogeneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %). Formulations at the entire concentration range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours. Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. Due to the lack of adverse effects, the NOAEL for reproductive and/or developmental effects was set at the high dose level of 30 mg/kg bw/day. NOTOX B.V. (2011b) 3.3.8.3 Developmental Toxicity Guideline: OECD 414; US EPA OPPTS 870.3700; MAFF 12 Nohsan 8147 Species/strain: Han Wistar rat Group size: 10 animals/sex/dose level Test substance: FAT 31’048/I Maxilon Blau M -2G Batch: LIA0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %).","duration":"developmental","effect":"analysed in the dose formulations for all dose levels were in agreement with the target concentrations (i.e. mean accuracies were between 85 % and 115 %). The test item was homogeneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %). Formulations at the entire concentration range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours. Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. Due to the lack of adverse effects, the NOAEL for reproductive and/or developmental effects was set at the high dose level of 30 mg/kg bw/day. NOTOX B.V. (2011b) 3.3.8.3 Developmental Toxicity Guideline: OECD 414; US EPA OPPTS 870.3700; MAFF 12 Nohsan 8147 Species/strain: Han Wistar rat Group size: 10 animals/sex/dose level Test substance: FAT 31’048/I Maxilon Blau M -2G Batch: LIA0","endpoint":"reproductive toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":53,"route":"","species":"rat","study_id":"sccs_o_179_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 3 mg/kg bw/day rat - developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_179; REPORT_TITLE=OPINION ON Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride); OPINION_NUMBER=SCCS/1542/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 March 2016; VALUE_TEXT=3; DOSE=geneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %).; EFFECT=geneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %). Formulations at the entire concentration range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours. Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. Due to the lack of adverse effects, the NOAEL for reproductive and/or developmental effects was set at the high dose level of 30 mg/kg bw/day. NOTOX B.V. (2011b) 3.3.8.3 Developmental Toxicity Guideline: OECD 414; US EPA OPPTS 870.3700; MAFF 12 Nohsan 8147 Species/strain: Han Wistar rat Group size: 10 animals/sex/dose level Test substance: FAT 31’048/I Maxilon Blau M -2G Batch: LIA09G044/2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"67846-56-4","citation":"","dose":"geneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %).","duration":"developmental","effect":"geneously distributed in low- and high-dose group formulations (i.e. coefficient of variation ≤ 10 %). Formulations at the entire concentration range were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours. Conclusion Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for parental effects of the test item FAT 31’048/I Maxilon Blau M -2G was established at 3 mg/kg bw/day for male and female rats. Due to the lack of adverse effects, the NOAEL for reproductive and/or developmental effects was set at the high dose level of 30 mg/kg bw/day. NOTOX B.V. (2011b) 3.3.8.3 Developmental Toxicity Guideline: OECD 414; US EPA OPPTS 870.3700; MAFF 12 Nohsan 8147 Species/strain: Han Wistar rat Group size: 10 animals/sex/dose level Test substance: FAT 31’048/I Maxilon Blau M -2G Batch: LIA09G044/2","endpoint":"reproductive toxicity","ingredient":"Basic Blue 124","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":53,"route":"","species":"rat","study_id":"sccs_o_179_noael_007"}