NOAEL Studies Cosmetic Ingredient

1,2,4-Trihydroxybenzene NOAEL Studies

INCI: 1,2,4-TRIHYDROXYBENZENE

CAS: 533-73-3

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 50 mg/kg bw/day rat oral 91 day Subchronic SCCP; M. Hill. IMEXINE OAM: 13 week oral toxicity study in rats with toxicokinetics. RTCResearch Toxicology Centre, Report N° 7698/T/303/2000, 2001
SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","dose":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","effect":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day. Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According t","page":13,"pdf":"sccp_o_041.pdf","row_type":"noael_study","study_id":"sccp_o_041_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"dose":"d in 1/14 males of the intermediate dose group at termination of the study.","effect":"d in 1/14 males of the intermediate dose group at termination of the study. The histopathological evaluation of the stomach in the remaining animals of the intermediate dose group did not reveal any further treatment-related gastric lesions. Dark brown, microgranular pigmentation was clearly evident in single cells or in the lumen of renal cortical tubes of 10/15 males and 10/15 females of the high dose group and in 2/15 males and 1/15 females of the intermediate dose group. Conclusion The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","page":16,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_001"}
SCCS_vision_codex NOAEL =1452 - - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","effect":"SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical","page":17,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","dose":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","effect":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day. Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According t","page":13,"pdf":"sccp_o_041.pdf","row_type":"noael_study","study_id":"sccp_o_041_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","dose":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","effect":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day. Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According t","page":13,"pdf":"sccp_o_041.pdf","row_type":"noael_study","study_id":"sccp_o_041_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"dose":"d in 1/14 males of the intermediate dose group at termination of the study.","effect":"d in 1/14 males of the intermediate dose group at termination of the study. The histopathological evaluation of the stomach in the remaining animals of the intermediate dose group did not reveal any further treatment-related gastric lesions. Dark brown, microgranular pigmentation was clearly evident in single cells or in the lumen of renal cortical tubes of 10/15 males and 10/15 females of the high dose group and in 2/15 males and 1/15 females of the intermediate dose group. Conclusion The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","page":16,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_001"}
SCCS_vision_codex NOAEL =1452 - - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","effect":"SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical","page":17,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"dose":"d in 1/14 males of the intermediate dose group at termination of the study.","effect":"d in 1/14 males of the intermediate dose group at termination of the study. The histopathological evaluation of the stomach in the remaining animals of the intermediate dose group did not reveal any further treatment-related gastric lesions. Dark brown, microgranular pigmentation was clearly evident in single cells or in the lumen of renal cortical tubes of 10/15 males and 10/15 females of the high dose group and in 2/15 males and 1/15 females of the intermediate dose group. Conclusion The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","page":16,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_001"}
SCCS_vision_codex NOAEL =1452 - - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","effect":"SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical","page":17,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_002"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","dose":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","effect":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day. Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According t","page":13,"pdf":"sccp_o_041.pdf","row_type":"noael_study","study_id":"sccp_o_041_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day - - - NOAEL study {"dose":"d in 1/14 males of the intermediate dose group at termination of the study.","effect":"d in 1/14 males of the intermediate dose group at termination of the study. The histopathological evaluation of the stomach in the remaining animals of the intermediate dose group did not reveal any further treatment-related gastric lesions. Dark brown, microgranular pigmentation was clearly evident in single cells or in the lumen of renal cortical tubes of 10/15 males and 10/15 females of the high dose group and in 2/15 males and 1/15 females of the intermediate dose group. Conclusion The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","page":16,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_001"}
SCCS_vision_codex NOAEL =1452 - - - - NOAEL study {"citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","effect":"SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical","page":17,"pdf":"sccs_o_113.pdf","row_type":"noael_study","study_id":"sccs_o_113_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/day - - - - SOURCE_SUBDIR=sccp_o_041; REPORT_TITLE=Opinion on 1,2,4-Trihydroxybenzene COLIPA N° A33; OPINION_NUMBER=SCCP/0962/05; COMMITTEE=SCCP; REPORT_DATE=18 March 2006; VALUE_TEXT=50; DOSE=SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.; EFFECT=SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day. Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According t; CITATION=Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study; CITATION_NUMBERS=[6]; REFERENCE=Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study; DETAILS_JSON={"cas_number":"533-73-3","citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","dose":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","duration":"","effect":"SCCP/0962/05 Opinion on 1,2,4-trihydroxybenzene ____________________________________________________________________________________________ 13 The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day. Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According t","endpoint":"","ingredient":"1,2,4-Trihydroxybenzene (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":13,"route":"","species":"","study_id":"sccp_o_041_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/day rat oral 90-day - SOURCE_SUBDIR=sccp_o_041; REPORT_TITLE=Opinion on 1,2,4-Trihydroxybenzene COLIPA N° A33; OPINION_NUMBER=SCCP/0962/05; COMMITTEE=SCCP; REPORT_DATE=18 March 2006; VALUE_TEXT=50; DOSE=Toxicity A No Observable Adverse Effect Level (NOAEL) of 50 mg/kg bw/day (90-day, oral, rat) was proposed by the applicant.; EFFECT=itted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion Physico-chemical specifications The characterisation of batch 0502124 was limited to HPTLC only. The quantification by HPLC would be desirable for batch 0502124. Batch OP29 was investigated using HPLC for quantification in several studies, resulting in yields from 99.4 to 99.8%. Stability in market formulation is not reported. Toxicity A No Observable Adverse Effect Level (NOAEL) of 50 mg/kg bw/day (90-day, oral, rat) was proposed by the applicant. The SCCP disagreed with this since the relative organ weight was increased significantly in the spleen of male rats treated with 50 mg/kg bw/day. This increase continued dose dependently in male rats treated with either 100 or 200 mg/kg bw/day. The absolute organ weight of the spleen increased also in male rats but this increase was not significant at the dose of 50 mg/kg bw/day. Therefore, the dose of 50 mg/kg bw/day was considered as Lowest O; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"533-73-3","citation":"","dose":"Toxicity A No Observable Adverse Effect Level (NOAEL) of 50 mg/kg bw/day (90-day, oral, rat) was proposed by the applicant.","duration":"90-day","effect":"itted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion Physico-chemical specifications The characterisation of batch 0502124 was limited to HPTLC only. The quantification by HPLC would be desirable for batch 0502124. Batch OP29 was investigated using HPLC for quantification in several studies, resulting in yields from 99.4 to 99.8%. Stability in market formulation is not reported. Toxicity A No Observable Adverse Effect Level (NOAEL) of 50 mg/kg bw/day (90-day, oral, rat) was proposed by the applicant. The SCCP disagreed with this since the relative organ weight was increased significantly in the spleen of male rats treated with 50 mg/kg bw/day. This increase continued dose dependently in male rats treated with either 100 or 200 mg/kg bw/day. The absolute organ weight of the spleen increased also in male rats but this increase was not significant at the dose of 50 mg/kg bw/day. Therefore, the dose of 50 mg/kg bw/day was considered as Lowest O","endpoint":"","ingredient":"1,2,4-Trihydroxybenzene (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":19,"route":"oral","species":"rat","study_id":"sccp_o_041_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_113; REPORT_TITLE=OPINION ON 1,2,4-Trihydroxybenzene COLIPA n° A33; OPINION_NUMBER=SCCS/1452/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=50; DOSE=d in 1/14 males of the intermediate dose group at termination of the study.; EFFECT=d in 1/14 males of the intermediate dose group at termination of the study. The histopathological evaluation of the stomach in the remaining animals of the intermediate dose group did not reveal any further treatment-related gastric lesions. Dark brown, microgranular pigmentation was clearly evident in single cells or in the lumen of renal cortical tubes of 10/15 males and 10/15 females of the high dose group and in 2/15 males and 1/15 females of the intermediate dose group. Conclusion The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"533-73-3","citation":"","dose":"d in 1/14 males of the intermediate dose group at termination of the study.","duration":"","effect":"d in 1/14 males of the intermediate dose group at termination of the study. The histopathological evaluation of the stomach in the remaining animals of the intermediate dose group did not reveal any further treatment-related gastric lesions. Dark brown, microgranular pigmentation was clearly evident in single cells or in the lumen of renal cortical tubes of 10/15 males and 10/15 females of the high dose group and in 2/15 males and 1/15 females of the intermediate dose group. Conclusion The investigators deduced a No Observed Adverse Effect Level of 50 mg/kg bw/day.","endpoint":"","ingredient":"1,2,4-Trihydroxybenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":16,"route":"","species":"","study_id":"sccs_o_113_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1452 - - - - - SOURCE_SUBDIR=sccs_o_113; REPORT_TITLE=OPINION ON 1,2,4-Trihydroxybenzene COLIPA n° A33; OPINION_NUMBER=SCCS/1452/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=unclear:SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical; EFFECT=SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical; CITATION=Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study; CITATION_NUMBERS=[6]; REFERENCE=Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study; DETAILS_JSON={"cas_number":"533-73-3","citation":"Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study","dose":"","duration":"","effect":"SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical","endpoint":"","ingredient":"1,2,4-Trihydroxybenzene","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1452/11 Opinion on 1,2,4-trihydroxybenzene ___________________________________________________________________________________________ 17 Ref.: 6 Comment SCCP concluded that no NOAEL can be derived in this study. The content of the test solution has been analysed thrice for 1,2,4-trihydroxybenzene (day 1, week 4, week 13). However, no data on purity were given in this report or in the analytical file. The analytical file stated “In accordance with the specification – one main spot” for batch 0502124. The data on toxicokinetics were scheduled for day 1 of treatment and week 13 of treatment using satellite groups of animals. According to the investigators “analyses, carried out by the Analytical","page":17,"route":"","species":"","study_id":"sccs_o_113_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 50 mg/kg bw/day rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_113; REPORT_TITLE=OPINION ON 1,2,4-Trihydroxybenzene COLIPA n° A33; OPINION_NUMBER=SCCS/1452/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=50; DOSE=Toxicity An acute dermal toxicity study in rats was performed, and the maximal non-lethal dose of 1,2,4-trihydroxybenzene was found to be 2000 mg/kg bw.; EFFECT=ety assessment of 1,2,4-trihydroxybenzene, dermal absorption data not only for 1,2,4-trihydroxybenzene, but also for its dimer and the final colour by reaction with ammonia, under the use conditions of hair dye formulation, are required. Stability of 1,2,4-trihydroxybenzene in typical hair dye formulations was not reported. Toxicity An acute dermal toxicity study in rats was performed, and the maximal non-lethal dose of 1,2,4-trihydroxybenzene was found to be 2000 mg/kg bw. A No Observable Adverse Effect Level (NOAEL) of 50 mg/kg bw/day (90-day, oral, rat) was proposed by the applicant. The SCCP disagreed with this since the relative organ weight was increased significantly in the spleen of male rats treated with 50 mg/kg bw/day. This increase continued dose dependently in male rats treated with either 100 or 200 mg/kg bw/day. The absolute organ weight of the spleen increased also in male rats but this increase was not significant at the dose of 50 mg/kg bw/day. Therefore, the dose of 50 mg/kg bw/day was considered as Lowest O; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"533-73-3","citation":"","dose":"Toxicity An acute dermal toxicity study in rats was performed, and the maximal non-lethal dose of 1,2,4-trihydroxybenzene was found to be 2000 mg/kg bw.","duration":"90-day","effect":"ety assessment of 1,2,4-trihydroxybenzene, dermal absorption data not only for 1,2,4-trihydroxybenzene, but also for its dimer and the final colour by reaction with ammonia, under the use conditions of hair dye formulation, are required. Stability of 1,2,4-trihydroxybenzene in typical hair dye formulations was not reported. Toxicity An acute dermal toxicity study in rats was performed, and the maximal non-lethal dose of 1,2,4-trihydroxybenzene was found to be 2000 mg/kg bw. A No Observable Adverse Effect Level (NOAEL) of 50 mg/kg bw/day (90-day, oral, rat) was proposed by the applicant. The SCCP disagreed with this since the relative organ weight was increased significantly in the spleen of male rats treated with 50 mg/kg bw/day. This increase continued dose dependently in male rats treated with either 100 or 200 mg/kg bw/day. The absolute organ weight of the spleen increased also in male rats but this increase was not significant at the dose of 50 mg/kg bw/day. Therefore, the dose of 50 mg/kg bw/day was considered as Lowest O","endpoint":"dermal absorption","ingredient":"1,2,4-Trihydroxybenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":25,"route":"oral","species":"rat","study_id":"sccs_o_113_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 173O8B04RD UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"173O8B04RD"}
openFDA substances FDA UNII substance identifier 173O8B04RD UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"173O8B04RD"}
openFDA substances FDA UNII substance identifier 173O8B04RD UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"173O8B04RD"}
openFDA substances FDA UNII substance identifier 173O8B04RD UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"173O8B04RD"}