NOAEL Studies Cosmetic Ingredient

2,6-Dihydroxy-3,4-Dimethylpyridine NOAEL Studies

INCI: 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE

CAS: 84540-47-6

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

Back to parent ingredient page
COSMOS_DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 160 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCP; Marburger, A. and Flade, D. (2005). Prenatal developmental toxicity study in the Han Wistar rat. RCC Ltd, Itingen, Switzerland, internal study code 854665. Archive code at Henkel KGaA, Düsseldorf, Report No. R 0500122
COSMOS_DB NOAEL 80 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCP; Marburger, A. and Flade, D. (2005). Prenatal developmental toxicity study in the Han Wistar rat. RCC Ltd, Itingen, Switzerland, internal study code 854665. Archive code at Henkel KGaA, Düsseldorf, Report No. R 0500122
SCCS_vision_codex 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 11 3","dose":"However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day).","effect":"s were not reported. However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day). The histopathological evaluation was done only for kidneys and osmonephrotic effects consisting of tubular vacuolization and accompanying epithelial hypertrophy were reported at doses 300 and 1000 mg/kg day. Also hyaline inclusions and tubular basophilia were increased in 1000 mg/kg day group. The NOAEL was defined at 100 mg/kg bw per day. Ref.: 11 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 20 animals per dosage Test substance: 2,6-Dihydroxy-3,4-dimethylpyridine (DDP) Batch: 0120081229 Purity: >98 % Dose: 0, 100, 200 and 400 mg/kg day Route: Oral Exposure: 91 days in 1.0 % aqueous carboxymethylcellulose and 0.5% Tween 80 GLP: in compliance The subchronic toxicity of DDP was investigated in a 91 days by gavage toxicity study in Wista","page":14,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight.","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 15 The following histopathological findings were reported in the highest exposure group; an increased extramedullary hemopoiesis in spleen, increased erythropoiesis in bone marrow, increased mean grade and incidence of vacuolization in the adrenal cortices and follicular hypertrophy in the thyroids. The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 98, TA 100, TA 102, TA 1535, and TA 1537 Replicates: Triplicates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9 Assay conditions: Plate incorporation method","page":15,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_002"}
SCCS_vision_codex NOAEL =80 mg/kg human oral - developmental toxicity {"citation":"Ref.: 14 3","dose":"Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.","effect":"an effect to the sex ratio and the mean foetal body weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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","page":20,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_003"}
SCCS_vision_codex NOAEL =0.017 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydro","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit oral 90 days dermal absorption {"dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","effect":"oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + rec","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 11 3","dose":"However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day).","effect":"s were not reported. However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day). The histopathological evaluation was done only for kidneys and osmonephrotic effects consisting of tubular vacuolization and accompanying epithelial hypertrophy were reported at doses 300 and 1000 mg/kg day. Also hyaline inclusions and tubular basophilia were increased in 1000 mg/kg day group. The NOAEL was defined at 100 mg/kg bw per day. Ref.: 11 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 20 animals per dosage Test substance: 2,6-Dihydroxy-3,4-dimethylpyridine (DDP) Batch: 0120081229 Purity: >98 % Dose: 0, 100, 200 and 400 mg/kg day Route: Oral Exposure: 91 days in 1.0 % aqueous carboxymethylcellulose and 0.5% Tween 80 GLP: in compliance The subchronic toxicity of DDP was investigated in a 91 days by gavage toxicity study in Wista","page":14,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight.","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 15 The following histopathological findings were reported in the highest exposure group; an increased extramedullary hemopoiesis in spleen, increased erythropoiesis in bone marrow, increased mean grade and incidence of vacuolization in the adrenal cortices and follicular hypertrophy in the thyroids. The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 98, TA 100, TA 102, TA 1535, and TA 1537 Replicates: Triplicates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9 Assay conditions: Plate incorporation method","page":15,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_002"}
SCCS_vision_codex NOAEL =80 mg/kg human oral - developmental toxicity {"citation":"Ref.: 14 3","dose":"Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.","effect":"an effect to the sex ratio and the mean foetal body weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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","page":20,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_003"}
SCCS_vision_codex NOAEL =0.017 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydro","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit oral 90 days dermal absorption {"dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","effect":"oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + rec","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 11 3","dose":"However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day).","effect":"s were not reported. However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day). The histopathological evaluation was done only for kidneys and osmonephrotic effects consisting of tubular vacuolization and accompanying epithelial hypertrophy were reported at doses 300 and 1000 mg/kg day. Also hyaline inclusions and tubular basophilia were increased in 1000 mg/kg day group. The NOAEL was defined at 100 mg/kg bw per day. Ref.: 11 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 20 animals per dosage Test substance: 2,6-Dihydroxy-3,4-dimethylpyridine (DDP) Batch: 0120081229 Purity: >98 % Dose: 0, 100, 200 and 400 mg/kg day Route: Oral Exposure: 91 days in 1.0 % aqueous carboxymethylcellulose and 0.5% Tween 80 GLP: in compliance The subchronic toxicity of DDP was investigated in a 91 days by gavage toxicity study in Wista","page":14,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight.","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 15 The following histopathological findings were reported in the highest exposure group; an increased extramedullary hemopoiesis in spleen, increased erythropoiesis in bone marrow, increased mean grade and incidence of vacuolization in the adrenal cortices and follicular hypertrophy in the thyroids. The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 98, TA 100, TA 102, TA 1535, and TA 1537 Replicates: Triplicates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9 Assay conditions: Plate incorporation method","page":15,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_002"}
SCCS_vision_codex NOAEL =80 mg/kg human oral - developmental toxicity {"citation":"Ref.: 14 3","dose":"Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.","effect":"an effect to the sex ratio and the mean foetal body weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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","page":20,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_003"}
SCCS_vision_codex NOAEL =0.017 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydro","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit oral 90 days dermal absorption {"dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","effect":"oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + rec","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 11 3","dose":"However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day).","effect":"s were not reported. However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day). The histopathological evaluation was done only for kidneys and osmonephrotic effects consisting of tubular vacuolization and accompanying epithelial hypertrophy were reported at doses 300 and 1000 mg/kg day. Also hyaline inclusions and tubular basophilia were increased in 1000 mg/kg day group. The NOAEL was defined at 100 mg/kg bw per day. Ref.: 11 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 20 animals per dosage Test substance: 2,6-Dihydroxy-3,4-dimethylpyridine (DDP) Batch: 0120081229 Purity: >98 % Dose: 0, 100, 200 and 400 mg/kg day Route: Oral Exposure: 91 days in 1.0 % aqueous carboxymethylcellulose and 0.5% Tween 80 GLP: in compliance The subchronic toxicity of DDP was investigated in a 91 days by gavage toxicity study in Wista","page":14,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat - Chronic genotoxicity {"citation":"Ref.: 12 3","dose":"The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight.","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 15 The following histopathological findings were reported in the highest exposure group; an increased extramedullary hemopoiesis in spleen, increased erythropoiesis in bone marrow, increased mean grade and incidence of vacuolization in the adrenal cortices and follicular hypertrophy in the thyroids. The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 98, TA 100, TA 102, TA 1535, and TA 1537 Replicates: Triplicates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9 Assay conditions: Plate incorporation method","page":15,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_002"}
SCCS_vision_codex NOAEL =80 mg/kg human oral - developmental toxicity {"citation":"Ref.: 14 3","dose":"Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.","effect":"an effect to the sex ratio and the mean foetal body weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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","page":20,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_003"}
SCCS_vision_codex NOAEL =0.017 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydro","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg rabbit oral 90 days dermal absorption {"dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","effect":"oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + rec","page":21,"pdf":"sccp_o_086.pdf","row_type":"noael_study","study_id":"sccp_o_086_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.017 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 0.017; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...; EFFECT=SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-47-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","duration":"","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydro","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.017","page":21,"route":"oral","species":"rat","study_id":"sccp_o_086_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...; EFFECT=34/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethy; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-47-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","duration":"","effect":"34/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 21 No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethy","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"= 80","page":21,"route":"oral","species":"rat","study_id":"sccp_o_086_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...; EFFECT=bmitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantifi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-47-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure d...","duration":"","effect":"bmitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxy-3,4-dimethylpyridine) (Oxidative/permanent) Maximum absorption through the skin A = 1.43 µg/cm² Skin Area surface SAS = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.001 mg Typical body weight of human = 60 kg Systemic exposure dosage (SED) SAS x A x 0.001/60 = 0.017 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 4706 3.3.14. Discussion Physico-chemical properties 2,6-Dihydroxy-3,4-dimethylpyridine is used in oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantifi","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"= 80","page":21,"route":"oral","species":"rat","study_id":"sccp_o_086_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 100 mg/kg rabbit oral 90 days dermal absorption SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.; EFFECT=oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + rec; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-47-6","citation":"","dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","duration":"90 days","effect":"oxidative hair dye formulations at a maximum final concentration of 1%, after mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + rec","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":21,"route":"oral","species":"rabbit","study_id":"sccp_o_086_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 80 mg/kg rabbit oral 90 days dermal absorption SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=80; DOSE=Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.; EFFECT=ter mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + receptor fluid) in the presence of developer containing H2O2, i.e. 1.43 µg/cm; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-47-6","citation":"","dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","duration":"90 days","effect":"ter mixing with hydrogen peroxide. The reported solubility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + receptor fluid) in the presence of developer containing H2O2, i.e. 1.43 µg/cm","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"80","page":21,"route":"oral","species":"rabbit","study_id":"sccp_o_086_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 80 mg/kg rabbit oral 90 days dermal absorption SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=80; DOSE=Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.; EFFECT=ility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + receptor fluid) in the presence of developer containing H2O2, i.e. 1.43 µg/cm2 should be used for the calculation of the margin of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84540-47-6","citation":"","dose":"Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw.","duration":"90 days","effect":"ility data of 2,6-Dihydroxy-3,4-dimethylpyridine is inadequate. Experimental Log Pow, and stability of 2,6-Dihydroxy-3,4-dimethylpyridine in marketed products are not reported. Impurities in 2,6-dihydroxy-3,4-dimethylpyridine, revealed by HPLC, have not been identified and quantified General toxicity LD50 was determined to be between 2500 and 5000 mg/kg bw. In 90 days oral toxicity study, NOAEL was set at 100 mg/kg/bw for the increased liver and kidney weights. NOAEL for maternal toxicity was 80 mg/kg/bw, and the NOAEL of foetal toxicity was considered to be 480 mg/kg bw. Irritation / sensitisation 2,6-Dihydroxy-3,4-dimethylpyridine is not an irritant to rabbit skin. It is an irritant to rabbit eye. 2,6-Dihydroxy-3,4-dimethylpyridine is considered to be a possible skin sensitiser. Dermal absorption The maximum amount of 2,6-Dihydroxy-3,4-dimethylpyridine absorbed into the skin (Epidermis + dermis + receptor fluid) in the presence of developer containing H2O2, i.e. 1.43 µg/cm2 should be used for the calculation of the margin of","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"80","page":21,"route":"oral","species":"rabbit","study_id":"sccp_o_086_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 80 mg/kg human oral - developmental toxicity SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=80; DOSE=Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.; EFFECT=an effect to the sex ratio and the mean foetal body weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"84540-47-6","citation":"Ref.: 14 3","dose":"Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.","duration":"","effect":"an effect to the sex ratio and the mean foetal body weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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","endpoint":"developmental toxicity","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"80","page":20,"route":"oral","species":"human","study_id":"sccp_o_086_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 80 mg/kg human oral - developmental toxicity SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=80; DOSE=Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.; EFFECT=ody weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"84540-47-6","citation":"Ref.: 14 3","dose":"Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams.","duration":"","effect":"ody weights were similar in all groups. No abnormalities related to treatment were noted in foetal external examinations. In addition, DDP related findings were not noted in visceral, skeletal and cartilage examinations. Oral administration of DDP at the dose levels of 160 and 480 mg/kg bw caused reduced food consumption and reduced body weight gain in dams. DDP was not embryolethal, embryotoxic or teratogenic in any doses tested. Based on the maternal toxicity the NOAEL can be considered to be 80 mg/kg day. The NOAEL for foetal toxicity was considered to be 480 mg/kg/bw, as no teratogenic potential of the test substance was observed in any dose group. Ref.: 14 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","endpoint":"developmental toxicity","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"80","page":20,"route":"oral","species":"human","study_id":"sccp_o_086_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 100 mg/kg bw rat - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight.; EFFECT=SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 15 The following histopathological findings were reported in the highest exposure group; an increased extramedullary hemopoiesis in spleen, increased erythropoiesis in bone marrow, increased mean grade and incidence of vacuolization in the adrenal cortices and follicular hypertrophy in the thyroids. The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 98, TA 100, TA 102, TA 1535, and TA 1537 Replicates: Triplicates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9 Assay conditions: Plate incorporation method; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"84540-47-6","citation":"Ref.: 12 3","dose":"The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight.","duration":"Chronic","effect":"SCCP/1034/06 OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE 15 The following histopathological findings were reported in the highest exposure group; an increased extramedullary hemopoiesis in spleen, increased erythropoiesis in bone marrow, increased mean grade and incidence of vacuolization in the adrenal cortices and follicular hypertrophy in the thyroids. The NOAEL was defined at 100 mg/kg bw per day, based on liver and kidney weight. Ref.: 12 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA 98, TA 100, TA 102, TA 1535, and TA 1537 Replicates: Triplicates per concentration in two independent experiments both in the presence and absence of Aroclor 1254 induced rat liver S9 Assay conditions: Plate incorporation method","endpoint":"genotoxicity","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":15,"route":"","species":"rat","study_id":"sccp_o_086_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg - oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_086; REPORT_TITLE=OPINION ON 2,6-DIHYDROXY-3,4-DIMETHYLPYRIDINE COLIPA N° A99; OPINION_NUMBER=SCCP/1034/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day).; EFFECT=s were not reported. However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day). The histopathological evaluation was done only for kidneys and osmonephrotic effects consisting of tubular vacuolization and accompanying epithelial hypertrophy were reported at doses 300 and 1000 mg/kg day. Also hyaline inclusions and tubular basophilia were increased in 1000 mg/kg day group. The NOAEL was defined at 100 mg/kg bw per day. Ref.: 11 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 20 animals per dosage Test substance: 2,6-Dihydroxy-3,4-dimethylpyridine (DDP) Batch: 0120081229 Purity: >98 % Dose: 0, 100, 200 and 400 mg/kg day Route: Oral Exposure: 91 days in 1.0 % aqueous carboxymethylcellulose and 0.5% Tween 80 GLP: in compliance The subchronic toxicity of DDP was investigated in a 91 days by gavage toxicity study in Wista; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"84540-47-6","citation":"Ref.: 11 3","dose":"However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day).","duration":"Sub-chronic","effect":"s were not reported. However, some organ weights were affected; liver (increased at 300 and 1000 mg/kg day), thymus (decreased at 1000 mg/kg day) kidneys (increased at 300 and 1000 mg/kg day and spleen (1000 mg/kg day). The histopathological evaluation was done only for kidneys and osmonephrotic effects consisting of tubular vacuolization and accompanying epithelial hypertrophy were reported at doses 300 and 1000 mg/kg day. Also hyaline inclusions and tubular basophilia were increased in 1000 mg/kg day group. The NOAEL was defined at 100 mg/kg bw per day. Ref.: 11 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 20 animals per dosage Test substance: 2,6-Dihydroxy-3,4-dimethylpyridine (DDP) Batch: 0120081229 Purity: >98 % Dose: 0, 100, 200 and 400 mg/kg day Route: Oral Exposure: 91 days in 1.0 % aqueous carboxymethylcellulose and 0.5% Tween 80 GLP: in compliance The subchronic toxicity of DDP was investigated in a 91 days by gavage toxicity study in Wista","endpoint":"repeated dose toxicity","ingredient":"2,6-Dihydroxy-3,4-dimethylpyridine","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":14,"route":"oral","species":"","study_id":"sccp_o_086_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3VDO3A5MTW UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3VDO3A5MTW"}
openFDA substances FDA UNII substance identifier 3VDO3A5MTW UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3VDO3A5MTW"}
openFDA substances FDA UNII substance identifier 3VDO3A5MTW UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3VDO3A5MTW"}
openFDA substances FDA UNII substance identifier 3VDO3A5MTW UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3VDO3A5MTW"}