NOAEL Studies Cosmetic Ingredient

2,7-Naphthalenediol NOAEL Studies

INCI: 2,7-NAPHTHALENEDIOL

CAS: 582-17-2

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

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COSMOS_DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 195 mg/kg bw/day rat oral 5-19 Gestation day Developmental SCCS; Patel, M.V. Prenatal developmental toxicity study of A 019 in rats. Jai Research Foundation, Valvada, India, internal study code: 4745. Archive code at Henkel KGaA, Düsseldorf, Report No. R 0500011
COSMOS_DB NOAEL 65 mg/kg bw/day rat oral 5-19 Gestation day Developmental SCCS; Patel, M.V. Prenatal developmental toxicity study of A 019 in rats. Jai Research Foundation, Valvada, India, internal study code: 4745. Archive code at Henkel KGaA, Düsseldorf, Report No. R 0500011
SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =60 mg/kg/day rat oral 5 weeks NOAEL study {"citation":"Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery","dose":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension).","effect":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,","page":15,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_001"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - 90 days NOAEL study {"citation":"Ref.: 11","dose":"Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...","effect":"livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11","page":16,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_002"}
SCCS_vision_codex NOAEL =65 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"gical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_005"}
SCCS_vision_codex NOAEL =585 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"on) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"on) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_007"}
SCCS_vision_codex NOAEL =0.06 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"n on 2,7-naphthalenediol ___________________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_008"}
SCCS_vision_codex NOAEL =65 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"___________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_009"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral - dermal absorption {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 58...","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes,","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_011"}
SCCS_vision_codex NOAEL =60 mg/kg/day rat oral 5 weeks NOAEL study {"citation":"Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery","dose":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension).","effect":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,","page":15,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_001"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - 90 days NOAEL study {"citation":"Ref.: 11","dose":"Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...","effect":"livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11","page":16,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_002"}
SCCS_vision_codex NOAEL =65 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"gical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_005"}
SCCS_vision_codex NOAEL =585 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"on) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"on) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_007"}
SCCS_vision_codex NOAEL =60 mg/kg/day rat oral 5 weeks NOAEL study {"citation":"Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery","dose":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension).","effect":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,","page":15,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_001"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - 90 days NOAEL study {"citation":"Ref.: 11","dose":"Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...","effect":"livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11","page":16,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_002"}
SCCS_vision_codex NOAEL =65 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"gical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_005"}
SCCS_vision_codex NOAEL =585 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"on) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"on) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_007"}
SCCS_vision_codex NOAEL =0.06 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"n on 2,7-naphthalenediol ___________________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_008"}
SCCS_vision_codex NOAEL =65 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"___________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_009"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral - dermal absorption {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 58...","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes,","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_011"}
SCCS_vision_codex NOAEL =0.06 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"n on 2,7-naphthalenediol ___________________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_008"}
SCCS_vision_codex NOAEL =65 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"___________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_009"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral - dermal absorption {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 58...","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes,","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_011"}
SCCS_vision_codex NOAEL =60 mg/kg/day rat oral 5 weeks NOAEL study {"citation":"Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery","dose":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension).","effect":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,","page":15,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_001"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - 90 days NOAEL study {"citation":"Ref.: 11","dose":"Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...","effect":"livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11","page":16,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_002"}
SCCS_vision_codex NOAEL =65 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"gical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_005"}
SCCS_vision_codex NOAEL =585 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 12 3","dose":"on) found in the 2 high dose females that died during the study were considered to be treatment-related.","effect":"on) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","page":22,"pdf":"sccp_o_091.pdf","row_type":"noael_study","study_id":"sccp_o_091_noael_007"}
SCCS_vision_codex NOAEL =0.06 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"n on 2,7-naphthalenediol ___________________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_008"}
SCCS_vision_codex NOAEL =65 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","effect":"___________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_009"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral - dermal absorption {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 58...","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes,","page":22,"pdf":"sccs_o_034.pdf","row_type":"noael_study","study_id":"sccs_o_034_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 60 mg/kg/day rat oral 5 weeks - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=60; DOSE=tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension).; EFFECT=tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,; CITATION=Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery; CITATION_NUMBERS=[11,232,99,408,1998,20,10,24,12]; REFERENCE=Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery","dose":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension).","duration":"5 weeks","effect":"tar rats (Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg/day","noael_value":"60","page":15,"route":"oral","species":"rat","study_id":"sccp_o_091_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 70 mg/kg bw/day rat - 90 days - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=70; DOSE=Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...; EFFECT=livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11; CITATION=Ref.: 11; CITATION_NUMBERS=[11]; REFERENCE=Ref.: 11; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 11","dose":"Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...","duration":"90 days","effect":"livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":16,"route":"","species":"rat","study_id":"sccp_o_091_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 70 mg/kg bw/day rat - 90 days - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=70; DOSE=hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of k...; EFFECT=hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11; CITATION=Ref.: 11; CITATION_NUMBERS=[11]; REFERENCE=Ref.: 11; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 11","dose":"hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of k...","duration":"90 days","effect":"hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":16,"route":"","species":"rat","study_id":"sccp_o_091_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 60 mg/kg rat oral 11 week - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=60; DOSE=Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg showed at the highest test dose a slight retardation of average body weight during the treatment.; EFFECT=SCCNFP/0232/99) Comment The test is not considered relevant for safety assessment. 3.3.8.2. Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg showed at the highest test dose a slight retardation of average body weight during the treatment. No other difference was observed for other teratogenicity and embryotoxicity parameters. The dose of 60 mg/kg was the NOAEL. Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 Purity: 99.9% Doses: 0, 65, 195 and 585 mg/kg bw/day; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose (CMC) GLP: In compliance The females were paired with male rats of the same strain one to one with the day of mating determined by the vaginal plugs or sperm in the vaginal smear. The doses of test substance; CITATION=Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 P; CITATION_NUMBERS=[16,232,99,414,2001,25,11,19,402,32,2002,517]; REFERENCE=Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 P; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 P","dose":"Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg showed at the highest test dose a slight retardation of average body weight during the treatment.","duration":"11 week","effect":"SCCNFP/0232/99) Comment The test is not considered relevant for safety assessment. 3.3.8.2. Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg showed at the highest test dose a slight retardation of average body weight during the treatment. No other difference was observed for other teratogenicity and embryotoxicity parameters. The dose of 60 mg/kg was the NOAEL. Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 Purity: 99.9% Doses: 0, 65, 195 and 585 mg/kg bw/day; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose (CMC) GLP: In compliance The females were paired with male rats of the same strain one to one with the day of mating determined by the vaginal plugs or sperm in the vaginal smear. The doses of test substance","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg","noael_value":"60","page":21,"route":"oral","species":"rat","study_id":"sccp_o_091_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 65 mg/kg bw/day human - - - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=65; DOSE=However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.; EFFECT=gical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","duration":"","effect":"gical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":22,"route":"","species":"human","study_id":"sccp_o_091_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 65 mg/kg bw/day human - - - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=65; DOSE=However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.; EFFECT=t were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","duration":"","effect":"t were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":22,"route":"","species":"human","study_id":"sccp_o_091_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 585 mg/kg bw/day human - - - SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=585; DOSE=on) found in the 2 high dose females that died during the study were considered to be treatment-related.; EFFECT=on) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 12 3","dose":"on) found in the 2 high dose females that died during the study were considered to be treatment-related.","duration":"","effect":"on) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant difference in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"585","page":22,"route":"","species":"human","study_id":"sccp_o_091_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 60 mg/kg bw/day rat oral 5 weeks - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=60; DOSE=(Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg bw in aqueous suspension).; EFFECT=(Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg bw in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg bw/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg bw/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,; CITATION=Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery; CITATION_NUMBERS=[11,232,99,408,1998,20,10,24,12]; REFERENCE=Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery","dose":"(Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg bw in aqueous suspension).","duration":"5 weeks","effect":"(Mu Ra Han 67 SPF) for each group, at dose levels of 0-20-60-180 (5.5 weeks) /360 (6.5 weeks) mg/kg bw/day (10 ml/kg bw in aqueous suspension). The highest test dose produced weight increase in liver, spleen and kidney, liver pigmentation, increased haematopoiesis in the spleen, and hyaline deposition in the kidney. The other doses (20 and 60 mg/kg bw/day) did not show clinical, biochemical and pathological-anatomical signs of a systemic cumulative toxicity. The dose of 60 mg/kg bw/day represents the dose with the NOAEL. Ref.: 11 (opinion SCCNFP/0232/99) New study Guideline: OECD 408 (1998) Species/strain: Rat, Wistar (HsdBrlHan:WIST) Group size: 20 (10 per sex), except high dose 24 (12 per sex) Recovery group: High dose 24 (12 per sex), control 20 (10 per sex) Test substance: A 019 (2,7-naphthalenediol) Batch: 20020517 Purity: 99.9% (HPLC) Doses: 0, 70, 210 and 630 mg/kg bw; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose GLP: in compliance Twenty rats (10 per sex) were used per dose and the control group,","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":14,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 70 mg/kg bw/day rat - 90 days - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=70; DOSE=Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...; EFFECT=livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 11 3","dose":"Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cor...","duration":"90 days","effect":"livation and lacrimation. Histopathology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":15,"route":"","species":"rat","study_id":"sccs_o_034_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 70 mg/kg bw/day rat - 90 days - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=70; DOSE=hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of k...; EFFECT=hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 11 3","dose":"hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of k...","duration":"90 days","effect":"hology of the high dose group showed some treatment related changes: degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extramedullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney. These histopathological changes in liver and kidneys were reversible. Conclusion Based on the effects on the spleen and liver, the No Observed Adverse Effect Level (NOAEL) of 2,7-Naphthalenediol in Wistar rats exposed over a period of 90 days is considered to be 70 mg/kg bw/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":15,"route":"","species":"rat","study_id":"sccs_o_034_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 60 mg/kg bw rat oral 11 week - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=60; DOSE=Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg bw showed at the highest test dose a slight retardation of average body weight during the treatment.; EFFECT=/0232/99) Comment The test is not considered relevant for safety assessment. 3.3.8.2. Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg bw showed at the highest test dose a slight retardation of average body weight during the treatment. No other difference was observed for other teratogenicity and embryotoxicity parameters. The dose of 60 mg/kg bw was the NOAEL. Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 Purity: 99.9% Doses: 0, 65, 195 and 585 mg/kg bw/day; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose (CMC) GLP: In compliance The females were paired with male rats of the same strain one to one with the day of mating determined by the vaginal plugs or sperm in the vaginal smear. The doses of test substance; CITATION=Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 P; CITATION_NUMBERS=[16,232,99,414,2001,25,11,19,402,32,2002,517]; REFERENCE=Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 P; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 P","dose":"Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg bw showed at the highest test dose a slight retardation of average body weight during the treatment.","duration":"11 week","effect":"/0232/99) Comment The test is not considered relevant for safety assessment. 3.3.8.2. Teratogenicity Taken from SCCNFP/0232/99 2,7-Dihydroxynaphthalene administered daily by oral gavage to groups of 30 pregnant CD Sprague Dawley rats from day 5 to 15 of gestation at doses of 0-20-60-360 mg/kg bw showed at the highest test dose a slight retardation of average body weight during the treatment. No other difference was observed for other teratogenicity and embryotoxicity parameters. The dose of 60 mg/kg bw was the NOAEL. Ref.: 16 (opinion SCCNFP/0232/99) New study Guideline: OECD 414 (2001) Species/strain: Rat, Wistar Group size: 25 (female 11 week old) Test substance: A 019/ SAT 040232 Batch: 20020517 Purity: 99.9% Doses: 0, 65, 195 and 585 mg/kg bw/day; 10 ml/kg bw by gavage Vehicle: 0.5% aqueous carboxymethylcellulose (CMC) GLP: In compliance The females were paired with male rats of the same strain one to one with the day of mating determined by the vaginal plugs or sperm in the vaginal smear. The doses of test substance","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"60","page":20,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 65 mg/kg bw/day human - - - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=65; DOSE=However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.; EFFECT=ical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant differences in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","duration":"","effect":"ical changes/lesions observed that were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant differences in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":21,"route":"","species":"human","study_id":"sccs_o_034_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 65 mg/kg bw/day human - - - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=65; DOSE=However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.; EFFECT=were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant differences in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 12 3","dose":"However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related.","duration":"","effect":"were considered treatment-related. However, the lesions (lung- congestion/oedema; liver - pallor, mottling; brain – congestion) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant differences in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":21,"route":"","species":"human","study_id":"sccs_o_034_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 585 mg/kg bw/day human - - - SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=585; DOSE=n) found in the 2 high dose females that died during the study were considered to be treatment-related.; EFFECT=n) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant differences in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"582-17-2","citation":"Ref.: 12 3","dose":"n) found in the 2 high dose females that died during the study were considered to be treatment-related.","duration":"","effect":"n) found in the 2 high dose females that died during the study were considered to be treatment-related. Conclusion The test substance did not exhibit any adverse effect on pregnancy rates. There were no significant differences in the incidences of malformation or birth defects between control and the groups dosed with the test substance. In this study, the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of 2,7- Naphthalenediol was determined to be 65 mg/kg bw/day, based on post-dosing symptoms. The NOAEL for foetal toxicity was 585 mg/kg bw/day. Ref.: 12 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","endpoint":"","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"585","page":21,"route":"","species":"human","study_id":"sccs_o_034_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 70 mg/kg bw/day rat dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=70; DOSE=weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.; EFFECT=weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Dermal absorption The maximum absorption observed in the e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.","duration":"90 day","effect":"weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Dermal absorption The maximum absorption observed in the e","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":23,"route":"dermal","species":"rat","study_id":"sccp_o_091_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 65 mg/kg bw/day rat dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=65; DOSE=of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.; EFFECT=of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Dermal absorption The maximum absorption observed in the experiment was 11.4 µg/cm². However, the study is inadequate because of (i) too few skin samples w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.","duration":"90 day","effect":"of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Dermal absorption The maximum absorption observed in the experiment was 11.4 µg/cm². However, the study is inadequate because of (i) too few skin samples w","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":23,"route":"dermal","species":"rat","study_id":"sccp_o_091_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.06 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 0.06; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...; EFFECT=n on 2,7-naphthalenediol ___________________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","duration":"","effect":"n on 2,7-naphthalenediol ___________________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.06","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =65 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 65; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...; EFFECT=___________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","duration":"","effect":"___________________________________________________________________________________ 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 65","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =65 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 65; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...; EFFECT=. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","duration":"","effect":". Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2,7-naphthalenediol (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 6.10 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.54 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test s","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 65","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.04 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 0.04; DOSE=body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 58...; EFFECT=body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 58...","duration":"","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes,","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.04","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =65 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 65; DOSE=temic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...; EFFECT=temic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"temic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...","duration":"","effect":"temic exposure dose (SED) SAS x A x 0.001/60 = 0.06 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 65","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =65 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 65; DOSE=NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...; EFFECT=NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED...","duration":"","effect":"NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1083 (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.31 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.50 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No observed adverse effect level NOAEL = 65 mg/kg bw/d (maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 1625 3.3.14. Discussion Physico-chemical specifications The stability of the test substance in typical hair dye formulations was not reported. The impurity ‘2-naphthol’ is banned according to Directive 768/76/EEC on cosmetic products (Annex 2, entry n° 241). General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis","endpoint":"dermal absorption","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 65","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 70 mg/kg bw/day rat oral 90 day irritation SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=70; DOSE=General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial ce...; EFFECT=General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Der; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial ce...","duration":"90 day","effect":"General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Der","endpoint":"irritation","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":23,"route":"oral","species":"rat","study_id":"sccp_o_091_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 70 mg/kg bw/day rat dermal 90 day irritation SOURCE_SUBDIR=sccp_o_091; REPORT_TITLE=OPINION ON 2,7-NAPHTHALENEDIOL COLIPA n° A19; OPINION_NUMBER=SCCP/1061/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 February 1991; VALUE_TEXT=70; DOSE=udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex...; EFFECT=udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Dermal abs; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex...","duration":"90 day","effect":"udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes. The EC3 value calculated (2.8%) from the LLNA showed that 2,7-naphthalenediol was a moderate sensitizer. Dermal abs","endpoint":"irritation","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":23,"route":"dermal","species":"rat","study_id":"sccp_o_091_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 70 mg/kg bw/day rat oral 90 day irritation SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=70; DOSE=General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial ce...; EFFECT=General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial ce...","duration":"90 day","effect":"General toxicity In all oral studies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.","endpoint":"irritation","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":22,"route":"oral","species":"rat","study_id":"sccs_o_034_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 70 mg/kg bw/day rat - 90 day irritation SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=70; DOSE=udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex...; EFFECT=udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex...","duration":"90 day","effect":"udies, 2,7-naphthalenediol caused decreased bodyweight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.","endpoint":"irritation","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":22,"route":"","species":"rat","study_id":"sccs_o_034_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 70 mg/kg bw/day rat - 90 day irritation SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=70; DOSE=weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.; EFFECT=weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.","duration":"90 day","effect":"weight, oedema in lungs, degeneration and necrosis of hepatocytes, bile duct hyperplasia and foci of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.","endpoint":"irritation","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":22,"route":"","species":"rat","study_id":"sccs_o_034_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 65 mg/kg bw/day rat - 90 day irritation SOURCE_SUBDIR=sccs_o_034; REPORT_TITLE=OPINION ON 2,7-Naphthalenediol COLIPA n° A19; OPINION_NUMBER=SCCS/1366/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=65; DOSE=of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.; EFFECT=of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"582-17-2","citation":"","dose":"of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups.","duration":"90 day","effect":"of erythropoiesis in liver; increased extra-medullary haematopoiesis with connective tissue proliferation in spleen and degeneration and necrosis of tubular epithelial cells in outer medulla and cortex of kidney in the mid and high dose groups. The histopathological changes in liver and kidneys were reversible. In a 90 day rat study, the No Observed Adverse Effect Level (NOAEL) is considered to be 70 mg/kg bw/day. The NOAEL for maternal toxicity of 2,7- naphthalenediol was determined to be 65 mg/kg bw/day and the NOAEL for foetal toxicity was 585 mg/kg bw/day. Irritation / sensitisation Under the conditions of the test, 2,7-naphthalenediol was not irritant to the rabbit skin. Instilled in the eyes as a neat powder, it is extremely irritant and corrosive to rabbit eyes.","endpoint":"irritation","ingredient":"2,7-Naphthalenediol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":22,"route":"","species":"rat","study_id":"sccs_o_034_noael_017"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 0TO8E448UD UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0TO8E448UD"}
openFDA substances FDA UNII substance identifier 0TO8E448UD UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0TO8E448UD"}
openFDA substances FDA UNII substance identifier 0TO8E448UD UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0TO8E448UD"}
openFDA substances FDA UNII substance identifier 0TO8E448UD UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0TO8E448UD"}