NOAEL Studies Cosmetic Ingredient

2-Methylresorcinol NOAEL Studies

INCI: 2-METHYLRESORCINOL

CAS: 608-25-3

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 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 100 mg/kg bw/day rat oral 90 day Subchronic SCCP; van Otterdijk, F.M. (2005). Repeated dose 90-day oral toxicity study with A 044 bydaily gavage in the rat followed by a 28-day recovery period. NOTOX, internal study code: 426757, Report No. 0500261
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =200 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_8326; row=813; data_type=In Vivo; mixture=Chemical; chemical_name=2-Methyl-1,3-benzenediol; preferred_name=2-Methyl-1,3-benzenediol; dtxsid=DTXSID0025571; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0025571; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID0025571; source_file=acute_oral.xlsx
SCCS_vision_codex 40 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 11 3","dose":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw.","effect":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline OECD 471 Species/strain Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates Two independent tests with and without S9 mix (plate incorporation test and a pre-incubation test) Test substance: A 044 in ethanol Batch: 221201 Purity: 98.6% (","page":14,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"4 or 1.5% of 2- methylresorcinol in the diet during the period of major organogenesis. The analyses were carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol","page":18,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_002"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_003"}
SCCS_vision_codex NOAEL =0.024 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"______________________________________________________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting poi","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"_____________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the subs","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_006"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic NOAEL study {"citation":"Ref.: 11 3","dose":"Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed.","effect":"e. Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":14,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 19 carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol Dose levels: 0, 40, 200 and 400 mg/kg/day Treatment period: day 6 - 20 post-coitum, inclusive GLP: in compliance The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a preliminary study in rats. Maternal evaluations and measureme","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_003"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_004"}
SCCS_vision_codex NOAEL =0.024 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"icity 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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physic","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_006"}
SCCS_vision_codex NOAEL =0.14 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substanc","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 11 3","dose":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw.","effect":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline OECD 471 Species/strain Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates Two independent tests with and without S9 mix (plate incorporation test and a pre-incubation test) Test substance: A 044 in ethanol Batch: 221201 Purity: 98.6% (","page":14,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"4 or 1.5% of 2- methylresorcinol in the diet during the period of major organogenesis. The analyses were carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol","page":18,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_002"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_003"}
SCCS_vision_codex NOAEL =0.024 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"______________________________________________________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting poi","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"_____________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the subs","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_006"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 11 3","dose":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw.","effect":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline OECD 471 Species/strain Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates Two independent tests with and without S9 mix (plate incorporation test and a pre-incubation test) Test substance: A 044 in ethanol Batch: 221201 Purity: 98.6% (","page":14,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"4 or 1.5% of 2- methylresorcinol in the diet during the period of major organogenesis. The analyses were carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol","page":18,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_002"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_003"}
SCCS_vision_codex NOAEL =0.024 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"______________________________________________________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting poi","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"_____________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the subs","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_006"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic NOAEL study {"citation":"Ref.: 11 3","dose":"Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed.","effect":"e. Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":14,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 19 carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol Dose levels: 0, 40, 200 and 400 mg/kg/day Treatment period: day 6 - 20 post-coitum, inclusive GLP: in compliance The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a preliminary study in rats. Maternal evaluations and measureme","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_003"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_004"}
SCCS_vision_codex NOAEL =0.024 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"icity 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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physic","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_006"}
SCCS_vision_codex NOAEL =0.14 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substanc","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic NOAEL study {"citation":"Ref.: 11 3","dose":"Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed.","effect":"e. Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":14,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 19 carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol Dose levels: 0, 40, 200 and 400 mg/kg/day Treatment period: day 6 - 20 post-coitum, inclusive GLP: in compliance The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a preliminary study in rats. Maternal evaluations and measureme","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_003"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_004"}
SCCS_vision_codex NOAEL =0.024 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"icity 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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physic","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_006"}
SCCS_vision_codex NOAEL =0.14 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substanc","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_009"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 11 3","dose":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw.","effect":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline OECD 471 Species/strain Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates Two independent tests with and without S9 mix (plate incorporation test and a pre-incubation test) Test substance: A 044 in ethanol Batch: 221201 Purity: 98.6% (","page":14,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"4 or 1.5% of 2- methylresorcinol in the diet during the period of major organogenesis. The analyses were carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol","page":18,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_002"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_003"}
SCCS_vision_codex NOAEL =0.024 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"______________________________________________________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting poi","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"_____________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the subs","page":20,"pdf":"sccp_o_071.pdf","row_type":"noael_study","study_id":"sccp_o_071_noael_006"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - Chronic NOAEL study {"citation":"Ref.: 11 3","dose":"Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed.","effect":"e. Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":14,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_001"}
SCCS_vision_codex NOAEL =900 mg/kg bw rat oral - developmental toxicity {"dose":"The dose of 1.5% (i.e.","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 19 carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol Dose levels: 0, 40, 200 and 400 mg/kg/day Treatment period: day 6 - 20 post-coitum, inclusive GLP: in compliance The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a preliminary study in rats. Maternal evaluations and measureme","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_003"}
SCCS_vision_codex NOAEL =400 mg/kg bw/day - - developmental reproductive toxicity {"citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","page":19,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_004"}
SCCS_vision_codex NOAEL =0.024 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"icity 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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physic","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_006"}
SCCS_vision_codex NOAEL =0.14 mg/kg bw human dermal Sub-chronic repeated dose toxicity {"dose":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substanc","page":20,"pdf":"sccp_o_151.pdf","row_type":"noael_study","study_id":"sccp_o_151_noael_009"}
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =100 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae7ee4b0a7c65d1c9831; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5570/7/6/2?documentUUID=2108d37c-25f6-41fe-8b0c-e011db1dd3b5; YEAR=2014; ORIGINAL_YEAR=2014; STUDY_GROUP=ECHA IUCLID:15845829:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d298ac954f591a57852dda6f36ef9d9a
ToxValDB_ECHA_IUCLID NOAEL =400 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab1ae4b0a7c65d1b8d82; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5570/7/9/2?documentUUID=2108d37c-25f6-41fe-8b0c-e011db1dd3b5; YEAR=2014; ORIGINAL_YEAR=2014; STUDY_GROUP=ECHA IUCLID:15857170:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e597db18e42dd3b361ab83a4d9a03470
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =4.93 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15631264:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_700cfe813d5f6e0f5d7d7024dbafd021
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw - - Chronic - SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=100; DOSE=Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed.; EFFECT=e. Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. 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":"608-25-3","citation":"Ref.: 11 3","dose":"Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed.","duration":"Chronic","effect":"e. Slight increase in body weight in males of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":14,"route":"","species":"","study_id":"sccp_o_151_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw - - Chronic - SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=100; DOSE=s of the 450 and 200 mg/kg/day group was observed.; EFFECT=s of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. 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":"608-25-3","citation":"Ref.: 11 3","dose":"s of the 450 and 200 mg/kg/day group was observed.","duration":"Chronic","effect":"s of the 450 and 200 mg/kg/day group was observed. In these groups, also the relative liver weight was increased (although not statistically significant). There was an increased glucose level in males at 450 mg/kg/day. Increased ASAT and/or ALAT levels were noted in 1 male of the 100 mg/kg bw group, 2 males from the 200 mg/kg group and 2 males from the 450 mg/kg group. All these effects were not observed after the recovery phase. Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":14,"route":"","species":"","study_id":"sccp_o_151_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 400 mg/kg bw/day mouse dermal 90-day dermal absorption SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=400; DOSE=SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.; EFFECT=SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a moderate sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment was performed. Dermal absorption The amount of test substance systemically available from a standard cream formulati; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.","duration":"90-day","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a moderate sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment was performed. Dermal absorption The amount of test substance systemically available from a standard cream formulati","endpoint":"dermal absorption","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":21,"route":"dermal","species":"mouse","study_id":"sccp_o_151_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 900 mg/kg bw rat oral - developmental toxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=900; DOSE=The dose of 1.5% (i.e.; EFFECT=4 or 1.5% of 2- methylresorcinol in the diet during the period of major organogenesis. The analyses were carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"The dose of 1.5% (i.e.","duration":"","effect":"4 or 1.5% of 2- methylresorcinol in the diet during the period of major organogenesis. The analyses were carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol","endpoint":"developmental toxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"900","page":18,"route":"oral","species":"rat","study_id":"sccp_o_071_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 900 mg/kg bw rat oral - developmental toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=900; DOSE=The dose of 1.5% (i.e.; EFFECT=SCCP/1206/08 Opinion on 2-methylresorcinol 19 carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol Dose levels: 0, 40, 200 and 400 mg/kg/day Treatment period: day 6 - 20 post-coitum, inclusive GLP: in compliance The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a preliminary study in rats. Maternal evaluations and measureme; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"The dose of 1.5% (i.e.","duration":"","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 19 carried out on day 20 of gestation. At the doses of 0.4 or 1.5%, a slight increase (not significant statistically) was observed in the mean post-implantation loss with corresponding decrease in the number of viable foetuses and implantation sites. This result was considered to represent biological variance. The compound was neither embryotoxic nor teratogenic. The dose of 1.5% (i.e. 900 mg/kg bw) represents the NOAEL. Study 3 Guideline: OECD 414 Species/strain: Wistar rats Crl (WI) BR Group size: 25 females Test substance: A44 Batch number: 221201 Purity: >98.6 % (HPLC) Vehicle: propylene glycol Dose levels: 0, 40, 200 and 400 mg/kg/day Treatment period: day 6 - 20 post-coitum, inclusive GLP: in compliance The test substance was given in propylene glycol daily at dose volumes of 10 ml/kg bw by oral gavage. The doses were selected on the basis of the results of a preliminary study in rats. Maternal evaluations and measureme","endpoint":"developmental toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"900","page":19,"route":"oral","species":"rat","study_id":"sccp_o_151_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 100 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=100; DOSE=SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw.; EFFECT=SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline OECD 471 Species/strain Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates Two independent tests with and without S9 mix (plate incorporation test and a pre-incubation test) Test substance: A 044 in ethanol Batch: 221201 Purity: 98.6% (; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"608-25-3","citation":"Ref.: 11 3","dose":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw.","duration":"Chronic","effect":"SCCP/1002/06 Opinion on 2-methylresorcinol ____________________________________________________________________________________________ 14 Based on the effects on the body weight, the NOAEL in this study is 100 mg/kg bw. The NOEL is lower than 100 mg/kg bw. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline OECD 471 Species/strain Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates Two independent tests with and without S9 mix (plate incorporation test and a pre-incubation test) Test substance: A 044 in ethanol Batch: 221201 Purity: 98.6% (","endpoint":"genotoxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":14,"route":"","species":"","study_id":"sccp_o_071_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw rabbit - 90-day irritation SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=100; DOSE=General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.; EFFECT=is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.","duration":"90-day","effect":"is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1","endpoint":"irritation","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":20,"route":"","species":"rabbit","study_id":"sccp_o_071_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw mouse - 90-day irritation SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=100; DOSE=General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.; EFFECT=and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.","duration":"90-day","effect":"and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment","endpoint":"irritation","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":20,"route":"","species":"mouse","study_id":"sccp_o_071_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw mouse - 90-day irritation SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=100; DOSE=General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.; EFFECT=ion in the melting point of the substance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment was performed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.","duration":"90-day","effect":"ion in the melting point of the substance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment was performed.","endpoint":"irritation","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":20,"route":"","species":"mouse","study_id":"sccp_o_071_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 400 mg/kg bw/day mouse - 90-day irritation SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=400; DOSE=General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.; EFFECT=bstance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment was performed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.","duration":"90-day","effect":"bstance may indicate variable amounts of impurities in the test substance. General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a sensitizer when tested at 50% (w/v) in acetone:olive oil (4:1) in mice; no concurrent positive control experiment was performed.","endpoint":"irritation","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":20,"route":"","species":"mouse","study_id":"sccp_o_071_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 100 mg/kg bw rabbit - 90-day irritation SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=100; DOSE=SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.; EFFECT=SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a moderate sensitizer when tested at 50% (w/v) in acetone:oliv; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study.","duration":"90-day","effect":"SCCP/1206/08 Opinion on 2-methylresorcinol 21 General toxicity LD50 from the only acute study available from 1976 was very low compared with the dose levels used in the 90-day study. This might be explained by (unknown) impurities in the batch used for the LD50 study. Based on the effects on body weight, the NOAEL in a 90-day study was set at 100 mg/kg bw. The NOEL was lower than 100 mg/kg bw. Based on the embryotoxicity and teratogenicity studies, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Irritation, sensitisation The test substance applied undiluted to rabbit skin showed mild and transient skin irritation. Undiluted test substance was severely irritant to the rabbit eye. The test substance was a moderate sensitizer when tested at 50% (w/v) in acetone:oliv","endpoint":"irritation","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":21,"route":"","species":"rabbit","study_id":"sccp_o_151_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =0.024 mg/kg human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT== 0.024; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=______________________________________________________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting poi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"Sub-chronic","effect":"______________________________________________________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting poi","endpoint":"repeated dose toxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.024","page":20,"route":"dermal","species":"human","study_id":"sccp_o_071_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =100 mg/kg human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=_____________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the subs; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"Sub-chronic","effect":"_____________________________________ 20 3.3.11. Human data / 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the subs","endpoint":"repeated dose toxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":20,"route":"dermal","species":"human","study_id":"sccp_o_071_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =100 mg/kg human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=/ 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the te; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"Sub-chronic","effect":"/ 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg No observed adverse effect level (mg/kg) NOAEL = 100 mg/kg (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative hair dye formulations at a maximum concentration of 1.8%, after mixing with peroxide developer. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116-123°C) of 2- methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the te","endpoint":"repeated dose toxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":20,"route":"dermal","species":"human","study_id":"sccp_o_071_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =0.024 mg/kg bw human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT== 0.024; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=icity 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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"Sub-chronic","effect":"icity 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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physic","endpoint":"repeated dose toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.024","page":20,"route":"dermal","species":"human","study_id":"sccp_o_151_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =100 mg/kg bw human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chem; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"Sub-chronic","effect":"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 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chem","endpoint":"repeated dose toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 100","page":20,"route":"dermal","species":"human","study_id":"sccp_o_151_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =100 mg/kg bw human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative an; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"Sub-chronic","effect":"No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methylresorcinol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 2.07 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.449 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative an","endpoint":"repeated dose toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 100","page":20,"route":"dermal","species":"human","study_id":"sccp_o_151_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =0.14 mg/kg bw human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT== 0.14; DOSE=49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 7...; EFFECT=49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substanc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 7...","duration":"Sub-chronic","effect":"49 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substanc","endpoint":"repeated dose toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.14","page":20,"route":"dermal","species":"human","study_id":"sccp_o_151_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =100 mg/kg bw human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT== 100; DOSE=n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per trea...; EFFECT=n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":"n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per trea...","duration":"Sub-chronic","effect":"n = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may","endpoint":"repeated dose toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 100","page":20,"route":"dermal","species":"human","study_id":"sccp_o_151_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =100 mg/kg bw human dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT== 100; DOSE=.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human...; EFFECT=.024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the test substance.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"608-25-3","citation":"","dose":".024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human...","duration":"Sub-chronic","effect":".024 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 4167 (non-oxidative / semi permanent) Maximum absorption through the skin A (μg/cm2) = 12.09 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.46 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.14 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw (Sub-chronic toxicity) Margin of Safety NOAEL / SED = 714 3.3.14. Discussion Physico-chemical specifications 2-Methylresorcinol is used in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1.8%. Stability of 2-methylresorcinol in test solutions and in marketed products is not reported. Two different melting points (65°C and 116- 123°C) of 2-methylresorcinol are reported in the submission documents. A large variation in the melting point of the substance may indicate variable amounts of impurities in the test substance.","endpoint":"repeated dose toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 100","page":20,"route":"dermal","species":"human","study_id":"sccp_o_151_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 400 mg/kg bw/day - - developmental reproductive toxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=400; DOSE=Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.; EFFECT=body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics; CITATION=Ref.: 13 Comment The dose levels were based on a range finding study; CITATION_NUMBERS=[13]; REFERENCE=Ref.: 13 Comment The dose levels were based on a range finding study; DETAILS_JSON={"cas_number":"608-25-3","citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","duration":"developmental","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","endpoint":"reproductive toxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":19,"route":"","species":"","study_id":"sccp_o_071_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 400 mg/kg bw/day - - developmental reproductive toxicity SOURCE_SUBDIR=sccp_o_071; REPORT_TITLE=Opinion on 2-Methylresorcinol COLIPA N° A44; OPINION_NUMBER=SCCP/1002/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=400; DOSE=Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.; EFFECT=d macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics / 3.3.; CITATION=Ref.: 13 Comment The dose levels were based on a range finding study; CITATION_NUMBERS=[13]; REFERENCE=Ref.: 13 Comment The dose levels were based on a range finding study; DETAILS_JSON={"cas_number":"608-25-3","citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","duration":"developmental","effect":"d macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post- implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics / 3.3.","endpoint":"reproductive toxicity","ingredient":"2-Methylresorcinol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":19,"route":"","species":"","study_id":"sccp_o_071_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 400 mg/kg bw/day - - developmental reproductive toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=400; DOSE=Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.; EFFECT=body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics; CITATION=Ref.: 13 Comment The dose levels were based on a range finding study; CITATION_NUMBERS=[13]; REFERENCE=Ref.: 13 Comment The dose levels were based on a range finding study; DETAILS_JSON={"cas_number":"608-25-3","citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","duration":"developmental","effect":"body weights, food consumption, and macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics","endpoint":"reproductive toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":19,"route":"","species":"","study_id":"sccp_o_151_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 400 mg/kg bw/day - - developmental reproductive toxicity SOURCE_SUBDIR=sccp_o_151; REPORT_TITLE=OPINION ON 2-Methylresorcinol COLIPA n° A44; OPINION_NUMBER=SCCP/1206/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 10 October 2006; VALUE_TEXT=400; DOSE=Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.; EFFECT=nd macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics No data; CITATION=Ref.: 13 Comment The dose levels were based on a range finding study; CITATION_NUMBERS=[13]; REFERENCE=Ref.: 13 Comment The dose levels were based on a range finding study; DETAILS_JSON={"cas_number":"608-25-3","citation":"Ref.: 13 Comment The dose levels were based on a range finding study","dose":"Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day.","duration":"developmental","effect":"nd macroscopic examination were unaffected by exposure to the test substance. No reproductive toxicity was observed, as no effects were noted on pregnancy outcome, post-implantation loss, litter size, and sex distribution. No developmental toxicity was observed, as foetal body weights, placental weights, and external, visceral and skeletal examination did not reveal any adverse effects of the test substance. Based on the results in this embryotoxicity and teratogenicity study, the No Observed Adverse Effect Level (NOAEL) for teratogenicity and maternal toxicity was 400 mg/kg bw/day. Ref.: 13 Comment The dose levels were based on a range finding study. In this study severe clinical effects were noted at a dose level of 1000 and 500 mg/kg bw (after observation of the effects in the 1000 mg/kg dose group, the dose level was adjusted to 500 mg/kg bw on the second day of administration). It is remarkable that in the present study no maternal toxicity was observed up to a dose level of 400 mg/kg bw/day. 3.3.9. Toxicokinetics No data","endpoint":"reproductive toxicity","ingredient":"is currently regulated by the Cosmetic Directive (76/768/EC), Annex III, Part","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":19,"route":"","species":"","study_id":"sccp_o_151_noael_005"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 32W7044A3T UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"32W7044A3T"}
openFDA substances FDA UNII substance identifier 32W7044A3T UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"32W7044A3T"}
openFDA substances FDA UNII substance identifier 32W7044A3T UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"32W7044A3T"}
openFDA substances FDA UNII substance identifier 32W7044A3T UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"32W7044A3T"}