is currently regulated in Annex III, part 2 under entry 32 on the preliminary

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=360; DOSE=14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day.; EFFECT=SCCS/1365/10 Opinion on 1,5-naphthalenediol ___________________________________________________________________________________________ 20 Ref.: 14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 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; CITATION=Ref.: 14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day; CITATION_NUMBERS=[14,360]; REFERENCE=Ref.: 14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day; DETAILS_JSON={"cas_number":"83-56-7","citation":"Ref.: 14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day","dose":"14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day.","duration":"","effect":"SCCS/1365/10 Opinion on 1,5-naphthalenediol ___________________________________________________________________________________________ 20 Ref.: 14 Comment The NOAEL of embryo/foetotoxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 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","endpoint":"","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"360","page":20,"route":"","species":"human","study_id":"sccs_o_033_noael_003"}

sccs_o_033.pdf

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sccs_o_033.pdf

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sccs_o_033.pdf

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sccs_o_033.pdf

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sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 0.02; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...; EFFECT=oclastogenicity 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 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day study, oral, rat) Margin of Safety NOAEL / SED = 2500 The value obtained for dermal absorption under non-oxidative conditions (1.92 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-56-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","duration":"90-day","effect":"oclastogenicity 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 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day study, oral, rat) Margin of Safety NOAEL / SED = 2500 The value obtained for dermal absorption under non-oxidative conditions (1.92 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given.","endpoint":"dermal absorption","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.02","page":20,"route":"oral","species":"rat","study_id":"sccs_o_033_noael_004"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...; EFFECT=d 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 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day study, oral, rat) Margin of Safety NOAEL / SED = 2500 The value obtained for dermal absorption under non-oxidative conditions (1.92 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-56-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","duration":"90-day","effect":"d 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 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day study, oral, rat) Margin of Safety NOAEL / SED = 2500 The value obtained for dermal absorption under non-oxidative conditions (1.92 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given.","endpoint":"dermal absorption","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":20,"route":"oral","species":"rat","study_id":"sccs_o_033_noael_005"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...; EFFECT=ations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day study, oral, rat) Margin of Safety NOAEL / SED = 2500 The value obtained for dermal absorption under non-oxidative conditions (1.92 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-56-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","duration":"90-day","effect":"ations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 1,5-naphthalenediol (oxidative conditions) Absorption through the skin A (mean + 1SD) = 2.15 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.25 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day study, oral, rat) Margin of Safety NOAEL / SED = 2500 The value obtained for dermal absorption under non-oxidative conditions (1.92 µg/cm²) was comparable to the one used in the calculation above, resulting in a similar MoS. Therefore only the calculation with the higher value under oxidative conditions is given.","endpoint":"dermal absorption","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":20,"route":"oral","species":"rat","study_id":"sccs_o_033_noael_006"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=50; DOSE=helium of the limiting ridge in the stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day.; EFFECT=helium of the limiting ridge in the stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day. Following the recovery period slight degree of brown/black tubular pigment in the kidneys was recorded in 2/5 males at 300 mg/kg bw/day. At 300 mg/kg bw/day one male had corticomedullary basophilia and slight squamous hyperplasia was recorded in 2/5 females after the recovery period. Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-naphthalenediol of 50 mg/kg bw/day was established. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A 018 (1,5-naphthalenediol) Solvent: DMSO Batch: 820211/01 Purity: 99.9 % Concentrations: Experiment I:; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"83-56-7","citation":"Ref.: 12 3","dose":"helium of the limiting ridge in the stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day.","duration":"Chronic","effect":"helium of the limiting ridge in the stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day. Following the recovery period slight degree of brown/black tubular pigment in the kidneys was recorded in 2/5 males at 300 mg/kg bw/day. At 300 mg/kg bw/day one male had corticomedullary basophilia and slight squamous hyperplasia was recorded in 2/5 females after the recovery period. Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-naphthalenediol of 50 mg/kg bw/day was established. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A 018 (1,5-naphthalenediol) Solvent: DMSO Batch: 820211/01 Purity: 99.9 % Concentrations: Experiment I:","endpoint":"genotoxicity","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":15,"route":"","species":"","study_id":"sccs_o_033_noael_001"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=50; DOSE=e stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day.; EFFECT=e stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day. Following the recovery period slight degree of brown/black tubular pigment in the kidneys was recorded in 2/5 males at 300 mg/kg bw/day. At 300 mg/kg bw/day one male had corticomedullary basophilia and slight squamous hyperplasia was recorded in 2/5 females after the recovery period. Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-naphthalenediol of 50 mg/kg bw/day was established. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A 018 (1,5-naphthalenediol) Solvent: DMSO Batch: 820211/01 Purity: 99.9 % Concentrations: Experiment I: 33 - 50; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"83-56-7","citation":"Ref.: 12 3","dose":"e stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day.","duration":"Chronic","effect":"e stomach (minimal to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in 3/12 males and 3/12 females at 100 mg/kg bw/day. Following the recovery period slight degree of brown/black tubular pigment in the kidneys was recorded in 2/5 males at 300 mg/kg bw/day. At 300 mg/kg bw/day one male had corticomedullary basophilia and slight squamous hyperplasia was recorded in 2/5 females after the recovery period. Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-naphthalenediol of 50 mg/kg bw/day was established. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A 018 (1,5-naphthalenediol) Solvent: DMSO Batch: 820211/01 Purity: 99.9 % Concentrations: Experiment I: 33 - 50","endpoint":"genotoxicity","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":15,"route":"","species":"","study_id":"sccs_o_033_noael_002"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=50; DOSE=General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats.; EFFECT=SCCS/1365/10 Opinion on 1,5-naphthalenediol ___________________________________________________________________________________________ 21 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats. In a teratogenicity study in rats the NOAEL of embryo/foeto-toxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the test substance caused irritation to rabbit skin and eye. The results from a LLNA study indicate that 1,5-naphthalenediol is a moderate skin sensitiser. Dermal absor; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-56-7","citation":"","dose":"General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats.","duration":"subchronic","effect":"SCCS/1365/10 Opinion on 1,5-naphthalenediol ___________________________________________________________________________________________ 21 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats. In a teratogenicity study in rats the NOAEL of embryo/foeto-toxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the test substance caused irritation to rabbit skin and eye. The results from a LLNA study indicate that 1,5-naphthalenediol is a moderate skin sensitiser. Dermal absor","endpoint":"repeated dose toxicity","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":21,"route":"oral","species":"rat","study_id":"sccs_o_033_noael_007"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=360; DOSE=General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats.; EFFECT=pinion on 1,5-naphthalenediol ___________________________________________________________________________________________ 21 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats. In a teratogenicity study in rats the NOAEL of embryo/foeto-toxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the test substance caused irritation to rabbit skin and eye. The results from a LLNA study indicate that 1,5-naphthalenediol is a moderate skin sensitiser. Dermal absorption An in vitro dermal absorption study with pig skin under oxidative and non-oxidative conditions has been performed. The amount of 1,5-Naphthalenediol c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-56-7","citation":"","dose":"General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats.","duration":"subchronic","effect":"pinion on 1,5-naphthalenediol ___________________________________________________________________________________________ 21 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats. In a teratogenicity study in rats the NOAEL of embryo/foeto-toxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the test substance caused irritation to rabbit skin and eye. The results from a LLNA study indicate that 1,5-naphthalenediol is a moderate skin sensitiser. Dermal absorption An in vitro dermal absorption study with pig skin under oxidative and non-oxidative conditions has been performed. The amount of 1,5-Naphthalenediol c","endpoint":"repeated dose toxicity","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"360","page":21,"route":"oral","species":"rat","study_id":"sccs_o_033_noael_008"}

sccs_o_033.pdf

SOURCE_SUBDIR=sccs_o_033; REPORT_TITLE=OPINION ON 1,5-Naphthalenediol COLIPA n° A18; OPINION_NUMBER=SCCS/1365/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=360; DOSE=General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats.; EFFECT=_____________________________________________ 21 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats. In a teratogenicity study in rats the NOAEL of embryo/foeto-toxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the test substance caused irritation to rabbit skin and eye. The results from a LLNA study indicate that 1,5-naphthalenediol is a moderate skin sensitiser. Dermal absorption An in vitro dermal absorption study with pig skin under oxidative and non-oxidative conditions has been performed. The amount of 1,5-Naphthalenediol considered as being systemically available from a standard hair dyeing formul; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-56-7","citation":"","dose":"General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats.","duration":"subchronic","effect":"_____________________________________________ 21 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. General toxicity Due to the effects on kidneys and the forestomach a No Observed Adverse Effect Level (NOAEL) for 1,5-Naphthalenediol of 50 mg/kg bw/day was established in a subchronic oral toxicity study in rats. In a teratogenicity study in rats the NOAEL of embryo/foeto-toxicity and teratogenicity was 360 mg/kg bw/day. The NOAEL of maternal toxicity was considered 60 mg/kg bw/day. Irritation / sensitisation Under the conditions of the study, the test substance caused irritation to rabbit skin and eye. The results from a LLNA study indicate that 1,5-naphthalenediol is a moderate skin sensitiser. Dermal absorption An in vitro dermal absorption study with pig skin under oxidative and non-oxidative conditions has been performed. The amount of 1,5-Naphthalenediol considered as being systemically available from a standard hair dyeing formul","endpoint":"repeated dose toxicity","ingredient":"is currently regulated in Annex III, part 2 under entry 32 on the preliminary","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"360","page":21,"route":"oral","species":"rat","study_id":"sccs_o_033_noael_009"}

sccs_o_033.pdf