NOAEL Studies
Antioxidant
Butylated Hydroxytoluene NOAEL Studies
INCI: BHT
CAS: 128-37-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 800 | mg/kg bw/day | mouse | oral | 7-13 Gestation day | Developmental | PAFA; ASP |
| COSMOS_DB | NOAEL | 300 | mg/kg bw/day | rat | oral | 175 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | rat | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 200 | mg/kg bw/day | rat | oral | 560 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 50 | mg/kg bw/day | rat | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 6 | mg/kg bw/day | rat | oral | 365 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 750 | mg/kg bw/day | mouse | oral | 1036 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 150 | mg/kg bw/day | mouse | oral | 700 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 250 | mg/kg bw/day | rat | oral | 224 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 12.5 | mg/kg bw/day | rat | oral | 175 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 450 | mg/kg bw/day | mouse | oral | 756 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 600 | mg/kg bw/day | mouse | oral | 672 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 75 | mg/kg bw/day | mouse | oral | 305 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 160 | mg/kg bw/day | rat | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 790 | mg/kg bw/day | dog | oral | 365 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 4 | mg/kg bw/day | dog | oral | 365 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 660 | mg/kg bw/day | rat | oral | 161 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 100 | mg/kg bw/day | rat | oral | 49 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 620 | mg/kg bw/day | rat | oral | 49 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 465 | mg/kg bw/day | mouse | oral | 49 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 700 | mg/kg bw/day | rat | oral | 28 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 180 | mg/kg bw/day | mouse | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 225 | mg/kg bw/day | rat | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 280 | mg/kg bw/day | hamster | oral | 5 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 3.2 | mg/kg bw/day | rabbit | oral | 13 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 85 | mg/kg bw/day | guinea pig | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 408 | mg/kg bw/day | guinea pig | oral | 17 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 240 | mg/kg bw/day | mouse | oral | 7 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 608 | mg/kg bw/day | mouse | oral | NA | Multigeneration Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 698 | mg/kg bw/day | rat | oral | 28 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 25 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 918 | mg/kg bw/day | rat | oral | 7 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 330 | mg/kg bw/day | rat | oral | 224 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 34 | mg/kg bw/day | chinese hamster | oral | 14 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 58 | mg/kg bw/day | mouse | oral | 14 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 400 | mg/kg bw/day | mouse | oral | 1 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =25 | mg/kg bw/day | Rat | oral: feed | - | reproduction toxicity | EFSA ANS - 2012 - OutputID 490 - development - developmental - Scientific Opinion on the re-evaluation of butylated hydroxytoluene BHT (E 321) as a food additive - doi:10.2903/j.efsa.2012.2588 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =25 | mg/kg bw/day | Rat | oral: feed | - | reproduction toxicity | EFSA ANS - 2012 - OutputID 490 - development - developmental - Scientific Opinion on the re-evaluation of butylated hydroxytoluene BHT (E 321) as a food additive - doi:10.2903/j.efsa.2012.2588 |
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =0.25 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2012 - OutputID 490 - Consumers - Scientific Opinion on the re-evaluation of butylated hydroxytoluene BHT (E 321) as a food additive - doi:10.2903/j.efsa.2012.2588 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =0.25 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2012 - OutputID 490 - Consumers - Scientific Opinion on the re-evaluation of butylated hydroxytoluene BHT (E 321) as a food additive - doi:10.2903/j.efsa.2012.2588 |
IARC Monographs 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1987 | IARC Monographs | {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"40, Sup 7"} |
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1987 | IARC Monographs | {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"40, Sup 7"} |
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1987 | IARC Monographs | {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"40, Sup 7"} |
NTP_ICE_acute_oral 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =890 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_2094; row=3749; data_type=In Vivo; mixture=Chemical; chemical_name=Butylated hydroxytoluene; preferred_name=Butylated hydroxytoluene; dtxsid=DTXSID2020216; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020216; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2020216; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | >6000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_2096; row=3750; data_type=In Vivo; mixture=Chemical; chemical_name=Butylated hydroxytoluene; preferred_name=Butylated hydroxytoluene; dtxsid=DTXSID2020216; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020216; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2020216; source_file=acute_oral.xlsx |
NTP_ICE_cancer 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_cancer | IARC group | 3 | unitless | - | - | - | WOE; IARC Carcinogenicity | sheet=Data; excel_row=2277; Record_ID=cancer_6431; Data_Type=WOE; Formulation_Name=Butylated hydroxytoluene; Mixture=Chemical; DTXSID=DTXSID2020216; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/58; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020216; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2020216 |
| NTP_ICE_cancer | Top dose | 6000 | ppm | Rat | - | - | In Vivo; NTP Carcinogenicity | sheet=Data; excel_row=2269; Record_ID=cancer_6432; Data_Type=In Vivo; Formulation_Name=Butylated hydroxytoluene; Mixture=Chemical; DTXSID=DTXSID2020216; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=6000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Reference=TR-150; URL=https://ntp.niehs.nih.gov/publications/reports/tr/100s/tr150/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020216; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2020216 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=5902; RecordID=ARPathway2016_761; DatasetName=ARPathway2016; DTXSID=DTXSID2020216; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020216; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2020216 |
SCCS_vision_codex 120 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/day | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: EFSA 2012","dose":"In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal.","effect":"n. In addition, BHT has been shown to increase the relative thyroid and adrenal weight in rats. In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal. EFSA concluded that none of the studies available could be used to derive a NOAEL. Ref.: EFSA 2012; ANSES 2016 SCCS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg b","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_001"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw | rat | - | Chronic | reproductive toxicity | {"dose":"3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.","effect":"CS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) wer","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_002"} |
| SCCS_vision_codex | NOAEL | =38 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: EFSA 2012","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"s on genotoxicity (Ma et al. 2017, Negritto et al. 2017), retrieved in the systematic literature searches performed by VKM, did not provide evidence of genotoxicity. Ref.: EFSA 2012; Ma 2017; Negritto 2017; VKM 2019 SCCS comment The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_005"} |
| SCCS_vision_codex | NOAEL | =247 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: Brooks 1976","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"y. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study. Ref.: Brooks 1976; Olsen 1986; EFSA 2012","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/day | rat | - | - | carcinogenicity | {"dose":"The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.","effect":"mice, rats and chickens. BHT has been shown to increase the relative thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT","page":25,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 90 days | NOAEL study | {"dose":"Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al.","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 32 ANNEX 1: Table A-1. Summary of level 3-5 in vivo animal studies with emphasis on effects on liver (LE), thyroid (TE) and adrenals (AE) and indicated NOAEL’s (including studies with ≥2 doses only). Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al. 1989 Rat m oral highes t tolerat ed doses for 30 days 0.5% dietary BHT No detectable ↑ in 3H- thymidine labelling Time-limite","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_013"} |
| SCCS_vision_codex | NOAEL | =1636 | - | rat | oral | 144 wk | NOAEL study | {"dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m p...","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_014"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | rat | - | 24 wk | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al.","effect":"al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al. 2008 rat 6 m per dose 28 days feedin g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_017"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses.","effect":"g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_018"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_019"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | - | - | NOAEL study | {"effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hydroalcoholic based fragrances | 0.8 | 4.67 | 0.00015 | 25 | 167 291","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_020"} |
| SCCS_vision_codex | NOAEL | =32 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_041"} |
| SCCS_vision_codex | NOAEL | =67 | - | rat | - | - | NOAEL study | {"dose":"Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","effect":"Unlabeled table on page 32: Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_042"} |
| SCCS_vision_codex | NOAEL | =33 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_045"} |
| SCCS_vision_codex | NOAEL | =500 | - | rat | oral | 14 wk | NOAEL study | {"dose":"1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_046"} |
| SCCS_vision_codex | NOAEL | =100 | - | rat | oral | 22 weeks | NOAEL study | {"effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 7M/5 0F F0 Oral F1 postn atal expos ure, | Main study Necrop sied at 22 weeks post weanin g | F0 0, 25, 100, 500 F1 0, 25, 100, 250 | at ≥500 F0 dams ↑ weight Abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 100 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_048"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | rat | - | 8 wk | NOAEL study | {"dose":"Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","effect":"Unlabeled table on page 33: Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_050"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | 4 wk | NOAEL study | {"dose":"Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","effect":"Unlabeled table on page 33: Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_053"} |
| SCCS_vision_codex | NOAEL | =34 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_054"} |
| SCCS_vision_codex | NOAEL | =225 | - | rat | - | 105 wk | NOAEL study | {"dose":"NCI 1979a | rat 20-50 m/f per dose;","effect":"Unlabeled table on page 34: NCI 1979a | rat 20-50 m/f per dose; Interi m sacrifi ces | 105 wk feedin g | 225, 450 | weight: no data tumors: not sign. | c-cell hyperplasia in males at ≥ 225 mg; no tumor induction | Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human health. | 225 (LOAEL, TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_056"} |
| SCCS_vision_codex | NOAEL | =515 | - | - | - | 107 wk | NOAEL study | {"dose":"NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m:","effect":"Unlabeled table on page 34: NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m: 0, 515, 1029 f: 0, 518, 1037 | weight: no data ↑ incidence of hepatocytomegaly and nonneoplastic lesions (peliosis, hepatocellular degeneration/necrosis, cytoplasmic vacuolation in males) | ‘no effects’ | ‘no effects’ | 515 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_057"} |
| SCCS_vision_codex | NOAEL | =30 | - | rat | - | 8 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Fulton et al. 1980 | Rat 10 m | 8 wk feedin g | 0, 30, 151, 755, 1132 | Weight (abs↑ and rel↑) | 30 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_058"} |
| SCCS_vision_codex | NOAEL | =125 | - | rat | - | 104 wk | NOAEL study | {"dose":"1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","effect":"Unlabeled table on page 34: Hirose et al. 1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_059"} |
| SCCS_vision_codex | NOAEL | =250 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 34: no effect on enzyme act. T3/T4 | 250 (TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_061"} |
| SCCS_vision_codex | NOAEL | =15 | - | rat | - | 18 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Furuka wa et al. 19844 | rat 10 m/gro up | 18 wk feedin g | 15, 50, 150, 300 | weight ↑ histopath (enlargement of hep. at ≥ 150 mg) | 15 (LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_062"} |
| SCCS_vision_codex | NOAEL | =1640 | - | - | - | 104 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Inai et al. | mous e, 50 | 104 wk | m: 1640, | ↑ weight m proliferation (foci), | not affected or | no effects on | 1640 (LOAEL,","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_064"} |
| SCCS_vision_codex | NOAEL | =35 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_065"} |
| SCCS_vision_codex | NOAEL | =75 | - | rat | - | 76 wk | NOAEL study | {"effect":"Unlabeled table on page 35: William s et al. 1990 | rat males ; interi m sacrifi ces | 76 wk 110 wk feedin g | 7.5, 23, 75, 225, 450 900 (only 110 wk) | weight ↑ (at ≥ 450mg) no morphological changes | no effects (tumor induction) no effects (tumor induction) | no effects (tumors induction) no effects (tumor induction) | 75 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_066"} |
| SCCS_vision_codex | NOAEL | =200 | - | rat | - | 24 wk | NOAEL study | {"dose":"Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","effect":"Unlabeled table on page 35: Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_067"} |
| SCCS_vision_codex | NOAEL | =28 | - | rat | - | 28 days | NOAEL study | {"dose":"2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","effect":"Unlabeled table on page 35: Stieru m et al. 2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_068"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/day | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: EFSA 2012","dose":"In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal.","effect":"n. In addition, BHT has been shown to increase the relative thyroid and adrenal weight in rats. In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal. EFSA concluded that none of the studies available could be used to derive a NOAEL. Ref.: EFSA 2012; ANSES 2016 SCCS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg b","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_001"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw | rat | - | Chronic | reproductive toxicity | {"dose":"3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.","effect":"CS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) wer","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_002"} |
| SCCS_vision_codex | NOAEL | =38 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: EFSA 2012","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"s on genotoxicity (Ma et al. 2017, Negritto et al. 2017), retrieved in the systematic literature searches performed by VKM, did not provide evidence of genotoxicity. Ref.: EFSA 2012; Ma 2017; Negritto 2017; VKM 2019 SCCS comment The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_005"} |
| SCCS_vision_codex | NOAEL | =247 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: Brooks 1976","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"y. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study. Ref.: Brooks 1976; Olsen 1986; EFSA 2012","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/day | rat | - | - | carcinogenicity | {"dose":"The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.","effect":"mice, rats and chickens. BHT has been shown to increase the relative thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT","page":25,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 90 days | NOAEL study | {"dose":"Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al.","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 32 ANNEX 1: Table A-1. Summary of level 3-5 in vivo animal studies with emphasis on effects on liver (LE), thyroid (TE) and adrenals (AE) and indicated NOAEL’s (including studies with ≥2 doses only). Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al. 1989 Rat m oral highes t tolerat ed doses for 30 days 0.5% dietary BHT No detectable ↑ in 3H- thymidine labelling Time-limite","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_013"} |
| SCCS_vision_codex | NOAEL | =1636 | - | rat | oral | 144 wk | NOAEL study | {"dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m p...","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_014"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | rat | - | 24 wk | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al.","effect":"al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al. 2008 rat 6 m per dose 28 days feedin g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_017"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses.","effect":"g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_018"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_019"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | - | - | NOAEL study | {"effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hydroalcoholic based fragrances | 0.8 | 4.67 | 0.00015 | 25 | 167 291","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_020"} |
| SCCS_vision_codex | NOAEL | =32 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_041"} |
| SCCS_vision_codex | NOAEL | =67 | - | rat | - | - | NOAEL study | {"dose":"Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","effect":"Unlabeled table on page 32: Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_042"} |
| SCCS_vision_codex | NOAEL | =33 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_045"} |
| SCCS_vision_codex | NOAEL | =500 | - | rat | oral | 14 wk | NOAEL study | {"dose":"1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_046"} |
| SCCS_vision_codex | NOAEL | =100 | - | rat | oral | 22 weeks | NOAEL study | {"effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 7M/5 0F F0 Oral F1 postn atal expos ure, | Main study Necrop sied at 22 weeks post weanin g | F0 0, 25, 100, 500 F1 0, 25, 100, 250 | at ≥500 F0 dams ↑ weight Abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 100 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_048"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | rat | - | 8 wk | NOAEL study | {"dose":"Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","effect":"Unlabeled table on page 33: Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_050"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | 4 wk | NOAEL study | {"dose":"Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","effect":"Unlabeled table on page 33: Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_053"} |
| SCCS_vision_codex | NOAEL | =34 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_054"} |
| SCCS_vision_codex | NOAEL | =225 | - | rat | - | 105 wk | NOAEL study | {"dose":"NCI 1979a | rat 20-50 m/f per dose;","effect":"Unlabeled table on page 34: NCI 1979a | rat 20-50 m/f per dose; Interi m sacrifi ces | 105 wk feedin g | 225, 450 | weight: no data tumors: not sign. | c-cell hyperplasia in males at ≥ 225 mg; no tumor induction | Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human health. | 225 (LOAEL, TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_056"} |
| SCCS_vision_codex | NOAEL | =515 | - | - | - | 107 wk | NOAEL study | {"dose":"NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m:","effect":"Unlabeled table on page 34: NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m: 0, 515, 1029 f: 0, 518, 1037 | weight: no data ↑ incidence of hepatocytomegaly and nonneoplastic lesions (peliosis, hepatocellular degeneration/necrosis, cytoplasmic vacuolation in males) | ‘no effects’ | ‘no effects’ | 515 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_057"} |
| SCCS_vision_codex | NOAEL | =30 | - | rat | - | 8 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Fulton et al. 1980 | Rat 10 m | 8 wk feedin g | 0, 30, 151, 755, 1132 | Weight (abs↑ and rel↑) | 30 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_058"} |
| SCCS_vision_codex | NOAEL | =125 | - | rat | - | 104 wk | NOAEL study | {"dose":"1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","effect":"Unlabeled table on page 34: Hirose et al. 1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_059"} |
| SCCS_vision_codex | NOAEL | =250 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 34: no effect on enzyme act. T3/T4 | 250 (TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_061"} |
| SCCS_vision_codex | NOAEL | =15 | - | rat | - | 18 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Furuka wa et al. 19844 | rat 10 m/gro up | 18 wk feedin g | 15, 50, 150, 300 | weight ↑ histopath (enlargement of hep. at ≥ 150 mg) | 15 (LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_062"} |
| SCCS_vision_codex | NOAEL | =1640 | - | - | - | 104 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Inai et al. | mous e, 50 | 104 wk | m: 1640, | ↑ weight m proliferation (foci), | not affected or | no effects on | 1640 (LOAEL,","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_064"} |
| SCCS_vision_codex | NOAEL | =35 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_065"} |
| SCCS_vision_codex | NOAEL | =75 | - | rat | - | 76 wk | NOAEL study | {"effect":"Unlabeled table on page 35: William s et al. 1990 | rat males ; interi m sacrifi ces | 76 wk 110 wk feedin g | 7.5, 23, 75, 225, 450 900 (only 110 wk) | weight ↑ (at ≥ 450mg) no morphological changes | no effects (tumor induction) no effects (tumor induction) | no effects (tumors induction) no effects (tumor induction) | 75 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_066"} |
| SCCS_vision_codex | NOAEL | =200 | - | rat | - | 24 wk | NOAEL study | {"dose":"Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","effect":"Unlabeled table on page 35: Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_067"} |
| SCCS_vision_codex | NOAEL | =28 | - | rat | - | 28 days | NOAEL study | {"dose":"2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","effect":"Unlabeled table on page 35: Stieru m et al. 2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_068"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/day | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: EFSA 2012","dose":"In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal.","effect":"n. In addition, BHT has been shown to increase the relative thyroid and adrenal weight in rats. In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal. EFSA concluded that none of the studies available could be used to derive a NOAEL. Ref.: EFSA 2012; ANSES 2016 SCCS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg b","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_001"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw | rat | - | Chronic | reproductive toxicity | {"dose":"3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.","effect":"CS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) wer","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_002"} |
| SCCS_vision_codex | NOAEL | =38 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: EFSA 2012","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"s on genotoxicity (Ma et al. 2017, Negritto et al. 2017), retrieved in the systematic literature searches performed by VKM, did not provide evidence of genotoxicity. Ref.: EFSA 2012; Ma 2017; Negritto 2017; VKM 2019 SCCS comment The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_005"} |
| SCCS_vision_codex | NOAEL | =247 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: Brooks 1976","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"y. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study. Ref.: Brooks 1976; Olsen 1986; EFSA 2012","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/day | rat | - | - | carcinogenicity | {"dose":"The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.","effect":"mice, rats and chickens. BHT has been shown to increase the relative thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT","page":25,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 90 days | NOAEL study | {"dose":"Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al.","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 32 ANNEX 1: Table A-1. Summary of level 3-5 in vivo animal studies with emphasis on effects on liver (LE), thyroid (TE) and adrenals (AE) and indicated NOAEL’s (including studies with ≥2 doses only). Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al. 1989 Rat m oral highes t tolerat ed doses for 30 days 0.5% dietary BHT No detectable ↑ in 3H- thymidine labelling Time-limite","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_013"} |
| SCCS_vision_codex | NOAEL | =1636 | - | rat | oral | 144 wk | NOAEL study | {"dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m p...","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_014"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | rat | - | 24 wk | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al.","effect":"al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al. 2008 rat 6 m per dose 28 days feedin g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_017"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses.","effect":"g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_018"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_019"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | - | - | NOAEL study | {"effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hydroalcoholic based fragrances | 0.8 | 4.67 | 0.00015 | 25 | 167 291","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_020"} |
| SCCS_vision_codex | NOAEL | =32 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_041"} |
| SCCS_vision_codex | NOAEL | =67 | - | rat | - | - | NOAEL study | {"dose":"Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","effect":"Unlabeled table on page 32: Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_042"} |
| SCCS_vision_codex | NOAEL | =33 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_045"} |
| SCCS_vision_codex | NOAEL | =500 | - | rat | oral | 14 wk | NOAEL study | {"dose":"1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_046"} |
| SCCS_vision_codex | NOAEL | =100 | - | rat | oral | 22 weeks | NOAEL study | {"effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 7M/5 0F F0 Oral F1 postn atal expos ure, | Main study Necrop sied at 22 weeks post weanin g | F0 0, 25, 100, 500 F1 0, 25, 100, 250 | at ≥500 F0 dams ↑ weight Abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 100 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_048"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | rat | - | 8 wk | NOAEL study | {"dose":"Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","effect":"Unlabeled table on page 33: Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_050"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | 4 wk | NOAEL study | {"dose":"Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","effect":"Unlabeled table on page 33: Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_053"} |
| SCCS_vision_codex | NOAEL | =34 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_054"} |
| SCCS_vision_codex | NOAEL | =225 | - | rat | - | 105 wk | NOAEL study | {"dose":"NCI 1979a | rat 20-50 m/f per dose;","effect":"Unlabeled table on page 34: NCI 1979a | rat 20-50 m/f per dose; Interi m sacrifi ces | 105 wk feedin g | 225, 450 | weight: no data tumors: not sign. | c-cell hyperplasia in males at ≥ 225 mg; no tumor induction | Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human health. | 225 (LOAEL, TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_056"} |
| SCCS_vision_codex | NOAEL | =515 | - | - | - | 107 wk | NOAEL study | {"dose":"NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m:","effect":"Unlabeled table on page 34: NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m: 0, 515, 1029 f: 0, 518, 1037 | weight: no data ↑ incidence of hepatocytomegaly and nonneoplastic lesions (peliosis, hepatocellular degeneration/necrosis, cytoplasmic vacuolation in males) | ‘no effects’ | ‘no effects’ | 515 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_057"} |
| SCCS_vision_codex | NOAEL | =30 | - | rat | - | 8 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Fulton et al. 1980 | Rat 10 m | 8 wk feedin g | 0, 30, 151, 755, 1132 | Weight (abs↑ and rel↑) | 30 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_058"} |
| SCCS_vision_codex | NOAEL | =125 | - | rat | - | 104 wk | NOAEL study | {"dose":"1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","effect":"Unlabeled table on page 34: Hirose et al. 1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_059"} |
| SCCS_vision_codex | NOAEL | =250 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 34: no effect on enzyme act. T3/T4 | 250 (TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_061"} |
| SCCS_vision_codex | NOAEL | =15 | - | rat | - | 18 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Furuka wa et al. 19844 | rat 10 m/gro up | 18 wk feedin g | 15, 50, 150, 300 | weight ↑ histopath (enlargement of hep. at ≥ 150 mg) | 15 (LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_062"} |
| SCCS_vision_codex | NOAEL | =1640 | - | - | - | 104 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Inai et al. | mous e, 50 | 104 wk | m: 1640, | ↑ weight m proliferation (foci), | not affected or | no effects on | 1640 (LOAEL,","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_064"} |
| SCCS_vision_codex | NOAEL | =35 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_065"} |
| SCCS_vision_codex | NOAEL | =75 | - | rat | - | 76 wk | NOAEL study | {"effect":"Unlabeled table on page 35: William s et al. 1990 | rat males ; interi m sacrifi ces | 76 wk 110 wk feedin g | 7.5, 23, 75, 225, 450 900 (only 110 wk) | weight ↑ (at ≥ 450mg) no morphological changes | no effects (tumor induction) no effects (tumor induction) | no effects (tumors induction) no effects (tumor induction) | 75 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_066"} |
| SCCS_vision_codex | NOAEL | =200 | - | rat | - | 24 wk | NOAEL study | {"dose":"Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","effect":"Unlabeled table on page 35: Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_067"} |
| SCCS_vision_codex | NOAEL | =28 | - | rat | - | 28 days | NOAEL study | {"dose":"2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","effect":"Unlabeled table on page 35: Stieru m et al. 2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_068"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/day | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: EFSA 2012","dose":"In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal.","effect":"n. In addition, BHT has been shown to increase the relative thyroid and adrenal weight in rats. In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal. EFSA concluded that none of the studies available could be used to derive a NOAEL. Ref.: EFSA 2012; ANSES 2016 SCCS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg b","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_001"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw | rat | - | Chronic | reproductive toxicity | {"dose":"3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.","effect":"CS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) wer","page":17,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_002"} |
| SCCS_vision_codex | NOAEL | =38 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: EFSA 2012","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"s on genotoxicity (Ma et al. 2017, Negritto et al. 2017), retrieved in the systematic literature searches performed by VKM, did not provide evidence of genotoxicity. Ref.: EFSA 2012; Ma 2017; Negritto 2017; VKM 2019 SCCS comment The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_005"} |
| SCCS_vision_codex | NOAEL | =247 | mg/kg bw/day | rat | - | - | carcinogenicity | {"citation":"Ref.: Brooks 1976","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","effect":"y. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study. Ref.: Brooks 1976; Olsen 1986; EFSA 2012","page":19,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/day | rat | - | - | carcinogenicity | {"dose":"The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.","effect":"mice, rats and chickens. BHT has been shown to increase the relative thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT","page":25,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 90 days | NOAEL study | {"dose":"Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al.","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 32 ANNEX 1: Table A-1. Summary of level 3-5 in vivo animal studies with emphasis on effects on liver (LE), thyroid (TE) and adrenals (AE) and indicated NOAEL’s (including studies with ≥2 doses only). Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al. 1989 Rat m oral highes t tolerat ed doses for 30 days 0.5% dietary BHT No detectable ↑ in 3H- thymidine labelling Time-limite","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_013"} |
| SCCS_vision_codex | NOAEL | =1636 | - | rat | oral | 144 wk | NOAEL study | {"dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m p...","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_014"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | rat | - | 24 wk | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al.","effect":"al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al. 2008 rat 6 m per dose 28 days feedin g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_017"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref.: Modified from EDC dossier 2019","dose":"3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses.","effect":"g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_018"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_019"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | - | - | NOAEL study | {"effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hydroalcoholic based fragrances | 0.8 | 4.67 | 0.00015 | 25 | 167 291","page":24,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_020"} |
| SCCS_vision_codex | NOAEL | =32 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_041"} |
| SCCS_vision_codex | NOAEL | =67 | - | rat | - | - | NOAEL study | {"dose":"Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","effect":"Unlabeled table on page 32: Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","page":32,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_042"} |
| SCCS_vision_codex | NOAEL | =33 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_045"} |
| SCCS_vision_codex | NOAEL | =500 | - | rat | oral | 14 wk | NOAEL study | {"dose":"1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_046"} |
| SCCS_vision_codex | NOAEL | =100 | - | rat | oral | 22 weeks | NOAEL study | {"effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 7M/5 0F F0 Oral F1 postn atal expos ure, | Main study Necrop sied at 22 weeks post weanin g | F0 0, 25, 100, 500 F1 0, 25, 100, 250 | at ≥500 F0 dams ↑ weight Abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 100 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_048"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | rat | - | 8 wk | NOAEL study | {"dose":"Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","effect":"Unlabeled table on page 33: Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_050"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | 4 wk | NOAEL study | {"dose":"Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","effect":"Unlabeled table on page 33: Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","page":33,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_053"} |
| SCCS_vision_codex | NOAEL | =34 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_054"} |
| SCCS_vision_codex | NOAEL | =225 | - | rat | - | 105 wk | NOAEL study | {"dose":"NCI 1979a | rat 20-50 m/f per dose;","effect":"Unlabeled table on page 34: NCI 1979a | rat 20-50 m/f per dose; Interi m sacrifi ces | 105 wk feedin g | 225, 450 | weight: no data tumors: not sign. | c-cell hyperplasia in males at ≥ 225 mg; no tumor induction | Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human health. | 225 (LOAEL, TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_056"} |
| SCCS_vision_codex | NOAEL | =515 | - | - | - | 107 wk | NOAEL study | {"dose":"NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m:","effect":"Unlabeled table on page 34: NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m: 0, 515, 1029 f: 0, 518, 1037 | weight: no data ↑ incidence of hepatocytomegaly and nonneoplastic lesions (peliosis, hepatocellular degeneration/necrosis, cytoplasmic vacuolation in males) | ‘no effects’ | ‘no effects’ | 515 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_057"} |
| SCCS_vision_codex | NOAEL | =30 | - | rat | - | 8 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Fulton et al. 1980 | Rat 10 m | 8 wk feedin g | 0, 30, 151, 755, 1132 | Weight (abs↑ and rel↑) | 30 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_058"} |
| SCCS_vision_codex | NOAEL | =125 | - | rat | - | 104 wk | NOAEL study | {"dose":"1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","effect":"Unlabeled table on page 34: Hirose et al. 1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_059"} |
| SCCS_vision_codex | NOAEL | =250 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 34: no effect on enzyme act. T3/T4 | 250 (TE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_061"} |
| SCCS_vision_codex | NOAEL | =15 | - | rat | - | 18 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Furuka wa et al. 19844 | rat 10 m/gro up | 18 wk feedin g | 15, 50, 150, 300 | weight ↑ histopath (enlargement of hep. at ≥ 150 mg) | 15 (LE)","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_062"} |
| SCCS_vision_codex | NOAEL | =1640 | - | - | - | 104 wk | NOAEL study | {"effect":"Unlabeled table on page 34: Inai et al. | mous e, 50 | 104 wk | m: 1640, | ↑ weight m proliferation (foci), | not affected or | no effects on | 1640 (LOAEL,","page":34,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_064"} |
| SCCS_vision_codex | NOAEL | =35 | - | - | - | - | NOAEL study | {"dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_065"} |
| SCCS_vision_codex | NOAEL | =75 | - | rat | - | 76 wk | NOAEL study | {"effect":"Unlabeled table on page 35: William s et al. 1990 | rat males ; interi m sacrifi ces | 76 wk 110 wk feedin g | 7.5, 23, 75, 225, 450 900 (only 110 wk) | weight ↑ (at ≥ 450mg) no morphological changes | no effects (tumor induction) no effects (tumor induction) | no effects (tumors induction) no effects (tumor induction) | 75 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_066"} |
| SCCS_vision_codex | NOAEL | =200 | - | rat | - | 24 wk | NOAEL study | {"dose":"Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","effect":"Unlabeled table on page 35: Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_067"} |
| SCCS_vision_codex | NOAEL | =28 | - | rat | - | 28 days | NOAEL study | {"dose":"2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","effect":"Unlabeled table on page 35: Stieru m et al. 2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","page":35,"pdf":"sccs_o_257.pdf","row_type":"noael_study","study_id":"sccs_o_257_noael_068"} |
ToxValDB_ECHA_IUCLID 53 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =538.05 | mg/m3 | Mouse | inhalation | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/3/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15799127:M:--; 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_1c30238f73d43f4a98d6c0a1d77b046a |
| ToxValDB_ECHA_IUCLID | LEL | =10700 | mg/kg bw/day | Guinea Pig | oral | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/3/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15804472:-:--; 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_8560478a155fa1656021f0a2b666fffa |
| ToxValDB_ECHA_IUCLID | LEL | >=940 | mg/kg bw/day | Cat | oral | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/3/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15813947_15813948: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_82bf96c31b6e00b8d1645b558d944b74 |
| ToxValDB_ECHA_IUCLID | LEL | <=2100 | mg/kg bw/day | Cat | oral | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/3/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15813947_15813948: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_ab2d9b69d14394eeca3d18feb482c5ef |
| ToxValDB_ECHA_IUCLID | LEL | <=3200 | mg/kg bw/day | Rabbit | oral | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/3/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15814231_15814232:-:--; 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_31d6e17bf4b42a6d96095e7deec5c999 |
| ToxValDB_ECHA_IUCLID | LEL | =200 | mg/kg bw/day | Mouse | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61ccce4b096bca8773732; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/3/5?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15815633:M:--; 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_ac169636416b41379879986676b41e66 |
| ToxValDB_ECHA_IUCLID | LEL | ~900 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30db; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817032_15817033_15817034: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_4ec4bff2ee4d149b1bb082f65e40708b |
| ToxValDB_ECHA_IUCLID | LEL | =185 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c80fe4b0a7c65d2165fe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817340_15819075: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_57dd9810fa29a267880f6d2a3d71a748 |
| ToxValDB_ECHA_IUCLID | LEL | =925 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c80fe4b0a7c65d2165fe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817341_15819073_15819074: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_8dffa2a399b222ca14440350d1a6bb49 |
| ToxValDB_ECHA_IUCLID | LEL | =250 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818421_15818745_15819262:M:--; 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_c6bd4bc4b469efb7ee4af6c3daa3d980 |
| ToxValDB_ECHA_IUCLID | LEL | >=23 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf69; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823212_15823213:F:-maternal; 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_f3bb95b8169bcffc8589edebe7fa64a7 |
| ToxValDB_ECHA_IUCLID | LEL | <=608 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf69; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823212_15823213:F:-maternal; 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_2e8f36e341d14c87a3b4d9dccf6f65a1 |
| ToxValDB_ECHA_IUCLID | LEL | =125 | mg/kg bw/day | Rat | oral | chronic; 104 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2cd1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15836171_15836172: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_8cc5b5ad30e23f32a84de95593eec04e |
| ToxValDB_ECHA_IUCLID | LEL | =500 | mg/kg bw/day | Rat | oral | chronic; 104 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2cd1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15836171_15836172: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_13732e713ffd1458ac315b3bc7cd1403 |
| ToxValDB_ECHA_IUCLID | LEL | =100 | mg/kg bw/day | Rat | oral | chronic; 14 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2ce3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15839242_15839243_15839244: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_0ba5cb63e1e2e154f72de49b0c9180c1 |
| ToxValDB_ECHA_IUCLID | LEL | >=669 | mg/kg bw/day | Rat | oral | subchronic; 40 days | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d2217c8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15838212_15846931_15846932:M:--; 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_89f82654065851e39533ddaa6b9abaf3 |
| ToxValDB_ECHA_IUCLID | LEL | <=864 | mg/kg bw/day | Rat | oral | subchronic; 40 days | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d2217c8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15838212_15846931_15846932:M:--; 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_29cb12c26eb646665c4b76dfb6245dc2 |
| ToxValDB_ECHA_IUCLID | LEL | >=3480 | mg/kg bw/day | Mouse | oral | subchronic; 10 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2cef; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847149_15847150: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_38737647da1e5c51c1ddbd541e7ce52f |
| ToxValDB_ECHA_IUCLID | LEL | <=4130 | mg/kg bw/day | Mouse | oral | subchronic; 10 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2cef; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847149_15847150: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_73e0dfbbda4767f0ddb4f19c09429c6c |
| ToxValDB_ECHA_IUCLID | LEL | ~333 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa8be4b0a7c65d1b653c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15857319_15857783:M/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_a714264d32c1633a0bbf283312fbe4b2 |
| ToxValDB_ECHA_IUCLID | LEL | =3000 | ppm | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c8afe4b0a7c65d219b52; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15857764_15857840:M/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_571cf0f90f60b5f56bdb27299f9fcdc0 |
| ToxValDB_ECHA_IUCLID | LOAEL | ~450 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30db; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15817032_15817033_15817034: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_ccb14b723c979f40c81be4dba74f71ae |
| ToxValDB_ECHA_IUCLID | LOAEL | ~3480 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c80fe4b0a7c65d216600; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15819076:M:--; 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_8c3f461e1a9b4ff98c3d47bbb7b07331 |
| ToxValDB_ECHA_IUCLID | LOAEL | =160 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30e7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15819203_15819204_15819205:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c2f287b3d730d69085595c5a21872abd |
| ToxValDB_ECHA_IUCLID | LOAEL | =225 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15819246_15819247_15819879_15819880_15819881_15819882:M:--; 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_ef3deb0ba0e5763df86c7bee9e8c7516 |
| ToxValDB_ECHA_IUCLID | LOAEL | =250 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac4ae4b0a7c65d1be4e9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/34499/7/9/3?documentUUID=c664dab6-36ff-4cc4-8d00-5af27c01d424; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=fetus: fetal/pup body weight changes|fetus: changes in litter size and weights; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15820919:M/F:-fetal; 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_0b9d8c2541461882640346477335cc38 |
| ToxValDB_ECHA_IUCLID | LOAEL | =500 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf79; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=fetus: fetal/pup body weight changes; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821618:-:-fetal; 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_a61f90ee852f512237ce2e957ddbf2b0 |
| ToxValDB_ECHA_IUCLID | LOAEL | =750 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac4ae4b0a7c65d1be4ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/34499/7/9/3?documentUUID=c664dab6-36ff-4cc4-8d00-5af27c01d424; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=maternal: early or late resorptions|maternal: total litter losses by resorption; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15822516:F:-maternal; 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_c00b667e74b37110a0bf43df57930267 |
| ToxValDB_ECHA_IUCLID | LOAEL | =167 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf6f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822124_15822786_15822868_15823121:F:-maternal; 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_a5b40da71847064f9aecfa9f6e39862b |
| ToxValDB_ECHA_IUCLID | LOAEL | =1000 | mg/kg bw/day | Rat | oral | short-term; 7 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d2217b4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=liver: body weight and weight gain|haematology|mortality|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=hematology|mortality/survival|organ weight; STUDY_GROUP=ECHA IUCLID:15831095:M:--; 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_0fa36b77f1bbc161bd5d51d12dc2a38d |
| ToxValDB_ECHA_IUCLID | LOAEL | =15 | mg/kg bw/day | Rat | oral | short-term; 1 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d2217c2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834865_15834866:M:--; 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_48590910ad932865d8b2c26379c9953c |
| ToxValDB_ECHA_IUCLID | LOAEL | =326 | mg/kg bw/day | Rat | oral | short-term; 1 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d2217c2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834865_15834866:M:--; 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_f399e980ea3322ed7becae5adb0fe155 |
| ToxValDB_ECHA_IUCLID | LOAEL | =100 | mg/kg bw/day | Rat | oral | short-term; 3 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d221812; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15837763_15837764_15837765:M:--; 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_096258fbb862dcaa9032c4195ed00b5c |
| ToxValDB_ECHA_IUCLID | LOAEL | =643 | mg/kg bw/day | Rat | oral | short-term; 3 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d221880; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=blood: haematology|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=hematology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15845166:M:--; 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_6445ec1d097fa0aa9535ca852622e998 |
| ToxValDB_ECHA_IUCLID | LOEL | =462.5 | mg/kg bw/day | Mouse | oral | chronic; 18 months | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2ced; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15841838: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_1c8635fc672547335c4ac0904fabaec8 |
| ToxValDB_ECHA_IUCLID | LOEL | =500 | mg/kg bw/day | Rat | oral | acute; 1 days | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d221891; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15845816:M:--; 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_0a8e02a7064950c7de65b069216ca26d |
| ToxValDB_ECHA_IUCLID | NOAEL | =25 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30dd; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=liver: clinical biochemistry|histopathology: non-neoplastic|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID:15817283: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_58cc9f0de4e1bce14c26039c6535f9eb |
| ToxValDB_ECHA_IUCLID | NOAEL | =10 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30e7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15819203_15819204_15819205: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_b65091e0820e9c95e384f5621e546bc9 |
| ToxValDB_ECHA_IUCLID | NOAEL | =75 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9d8e4b0a7c65d1b30ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/8?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15819246_15819247_15819879_15819880_15819881_15819882:M:--; 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_047848372848aa2c9165bfb0a5c4aa4f |
| ToxValDB_ECHA_IUCLID | NOAEL | =800 | mg/kg bw/day | Mouse | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf65; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15820723_15821516:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_219dfd5f9e22b598198702a6ce53f9cf |
| ToxValDB_ECHA_IUCLID | NOAEL | =225 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf61; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821931_15822612:F:-maternal; 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_6693b6d1d597155a72303c566a299526 |
| ToxValDB_ECHA_IUCLID | NOAEL | =180 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbf67; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822077_15822824:F:-maternal; 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_6c069c37238be5920deb8d6c0635e2ec |
| ToxValDB_ECHA_IUCLID | NOAEL | =500 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1a6e4b0a7c65d22f7b1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822124_15822786_15822868_15823121:F:-maternal; 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_93fe5d3629e5dc5cda6754d833e7e5b4 |
| ToxValDB_ECHA_IUCLID | NOAEL | =280 | mg/kg bw/day | Hamster | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1a6e4b0a7c65d22f7cb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822134_15822289:F:-maternal; 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_4aff9a1b1de7d4a81d60453f1df6f733 |
| ToxValDB_ECHA_IUCLID | NOAEL | =50 | mg/kg bw/day | Monkey | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1a6e4b0a7c65d22f7cf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/3?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822398_15822799:F:-maternal; 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_114f2e063eb4e71d34999adea4d8b9a9 |
| ToxValDB_ECHA_IUCLID | NOAEL | =23.4 | mg/kg bw/day | Rat | oral | chronic; 18 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2caf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15830440:M:--; 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_0e4ef6b35aa1b5a6f3b1845a8e62e5c0 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~70 | mg/kg bw/day | Rat | oral | short-term; 1 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d2217df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15837605:M:--; 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_a7bd396475fa4fe6df4fbeeab96e43fa |
| ToxValDB_ECHA_IUCLID | NOAEL | =660 | mg/kg bw/day | Mouse | oral | short-term; 30 days | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2ce5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15839620:M:--; 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_1733d00ae3fda40e561ac43697e14b3d |
| ToxValDB_ECHA_IUCLID | NOAEL | >=61 | mg/kg bw/day | Pig | oral | subchronic; 42 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d221878; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15844980: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_1967e043e200445686e8b93db79be32b |
| ToxValDB_ECHA_IUCLID | NOAEL | =27.8 | mg/kg bw/day | Rat | oral | short-term; 4 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead28e4b0a7c65d1c2cf5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15846300:M:--; 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_24bb0d5f15f0b640699f54d6f545cacd |
| ToxValDB_ECHA_IUCLID | NOAEL | =100 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa8be4b0a7c65d1b653e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855410_15856228_15857465_15857899_15857912_15857930:M/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_be24d92faeb4548826d7e72b1fbe3dcc |
| ToxValDB_ECHA_IUCLID | NOAEL | =608 | mg/kg bw/day | Mouse | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa8be4b0a7c65d1b6538; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/9/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=F2: developmental neurotoxicity; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15860198:M/F:F2-; 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_c8d6baf77658fd234f254ee191658fbb |
| ToxValDB_ECHA_IUCLID | NOEL | =10 | mg/kg bw/day | Rat | oral | short-term; 3 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca5de4b0a7c65d221812; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15975/7/6/2?documentUUID=81337846-206f-4eb9-8fb6-19030540d018; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=ECHA IUCLID:15837762: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_f39b7d691ff490703fac65b834ed8ecb |
ToxValDB_ECOTOX 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =1 | % | Rat | oral | subchronic; 56 days | subchronic | LONG_REF=Toxicol. Lett.55(3): 263-272 Shibata,M.A., E. Asakawa, A. Hagiwara, Y. Kurata, and S. Fukushima DNA Synthesis and Scanning Electron Microscopic Lesions in Renal Pelvic Epithelium of Rats Treated with Bladder Cancer Promoters 1991; TITLE=DNA Synthesis and Scanning Electron Microscopic Lesions in Renal Pelvic Epithelium of Rats Treated with Bladder Cancer Promoters; AUTHOR=Shibata,M.A., E. Asakawa, A. Hagiwara, Y. Kurata, and S. Fukushima; DOI=10.1016/0378-4274(91)90006-r; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107545; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15594699_15594700:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=2ca1b8b7e050a958d47ae76b15d17eb5 |
| ToxValDB_ECOTOX | LOEL | =100 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603124_15603125:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=2a06e71228789dc971eb8c4afd6d07bc |
| ToxValDB_ECOTOX | NOEL | =900 | mg/kg bw/day | Rat | oral | short-term; 1.625 days | short-term | LONG_REF=Mutat. Res.320(3): 189-205 Uno,Y., H. Takasawa, M. Miyagawa, Y. Inoue, T. Murata, and K. Yoshikawa An In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test Using Rat Hepatocytes as an Early Prediction Assay for Nongenotoxic Hepatocarcinogens Screening of 22 Known Positive and 25 Noncarcinogens 1994; TITLE=An In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test Using Rat Hepatocytes as an Early Prediction Assay for Nongenotoxic Hepatocarcinogens Screening of 22 Known Positive and 25 Noncarcinogens; AUTHOR=Uno,Y., H. Takasawa, M. Miyagawa, Y. Inoue, T. Murata, and K. Yoshikawa; DOI=10.1016/0165-1218(94)90046-9; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75058; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=Cell(s): Viability; STUDY_GROUP=ECOTOX:15599293:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9d4aa838b928802667ea70ef7074a504 |
| ToxValDB_ECOTOX | NOEL | =1000 | mg/kg bw/day | Mouse | oral | short-term; 2 days | short-term | LONG_REF=Mutat. Res.343(2/3): 157-183 Miyagawa,M., H. Takasawa, A. Sugiyama, Y. Inoue, T. Murata, Y. Uno, and K. Yoshikawa The In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test with Hepatocytes Prepared from Male B6C3F1 Mice as an Early Prediction Assay for Putative Nongenotoxic (Ames-Negative) Mouse Hepatocarcinogens 1995; TITLE=The In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test with Hepatocytes Prepared from Male B6C3F1 Mice as an Early Prediction Assay for Putative Nongenotoxic (Ames-Negative) Mouse Hepatocarcinogens; AUTHOR=Miyagawa,M., H. Takasawa, A. Sugiyama, Y. Inoue, T. Murata, Y. Uno, and K. Yoshikawa; DOI=10.1016/0165-1218(95)90082-9; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=75052; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=Cell(s): Viability; STUDY_GROUP=ECOTOX:15600045:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8bdc4b118257ddb5ba1d4e8de3ab69e5 |
| ToxValDB_ECOTOX | NOEL | =10 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603124_15603125:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=c82c6e5b9f35fe860115fa0763315ca6 |
ToxValDB_EFSA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | NOAEL | =25 | mg/kg bw/day | Rat | oral | - | developmental | LONG_REF=EFSA ANS (2012). Scientific Opinion on the re-evaluation of butylated hydroxytoluene BHT (E 321) as a food additive. doi:10.2903/j.efsa.2012.2588.; TITLE=Scientific Opinion on the re-evaluation of butylated hydroxytoluene BHT (E 321) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2012.2588; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=development; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=EFSA:15614340: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_0144a6ce3f3b00a57f7c5a829ddb999c |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =1.76 | 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:15631031:-:--; 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_0828a1c059bd09eec7cf03170b731d05 |
ToxValDB_PPRTV_(CPHEA) 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_PPRTV_(CPHEA) | RfD (provisional) | =0.3 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=Olsen et al. 1986; AUTHOR=Olsen et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b379; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1615; TOXICOLOGICAL_EFFECT=Decreased F1 adult weight at 138 weeks in male/female rats; STUDY_GROUP=PPRTV (CPHEA)_dup_PPRTV Summary_15653687_15653771:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2bff1d6d1c25603e1efde4d3ea29f288 |
| ToxValDB_PPRTV_(CPHEA) | RfD (provisional) | =1 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=Olsen et al. 1986; AUTHOR=Olsen et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b379; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1615; TOXICOLOGICAL_EFFECT=Decreased F1 adult weight at 9 weeks in male/female rats; STUDY_GROUP=PPRTV (CPHEA)_dup_PPRTV Summary_15653687_15653771:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2c2ba44f53b00fdbc281ceeab762debe |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 68 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=(1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day.; EFFECT=___________________________________________________________________________ _________________________________________________________________________ 24 3.4 SAFETY EVALUATION (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY MoS calculations for separate product types and aggregated exposures are shown in Table 7. Based on effects on litter size and pup body weight gain during the lactation period, in the reproduction segment of the study Olsen et al. (1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day. This NOAEL also covers the observed increase in hepatocellular adenomas and carcinomas. Table 7. MoS calculations for the different product types and aggregated exposures Product category Conc. BHT (%) Eproduct 1 (mg/kg bw/d) SED (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Dermal Oral Hydroalcoholic based fragrances 0.8 4.67 0.00015 25 167 291 Shower gel 0.8 2.79 0.00009 25 280 018 Hand wash soap 0.8 3.33 0.00011 25 234 610 Shampoo 0.8 1.51 0.00005 25 517 384 H; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"(1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day.","duration":"","effect":"___________________________________________________________________________ _________________________________________________________________________ 24 3.4 SAFETY EVALUATION (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY MoS calculations for separate product types and aggregated exposures are shown in Table 7. Based on effects on litter size and pup body weight gain during the lactation period, in the reproduction segment of the study Olsen et al. (1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day. This NOAEL also covers the observed increase in hepatocellular adenomas and carcinomas. Table 7. MoS calculations for the different product types and aggregated exposures Product category Conc. BHT (%) Eproduct 1 (mg/kg bw/d) SED (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Dermal Oral Hydroalcoholic based fragrances 0.8 4.67 0.00015 25 167 291 Shower gel 0.8 2.79 0.00009 25 280 018 Hand wash soap 0.8 3.33 0.00011 25 234 610 Shampoo 0.8 1.51 0.00005 25 517 384 H","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":24,"route":"oral","species":"","study_id":"sccs_o_257_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=(1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day.; EFFECT=____________ _________________________________________________________________________ 24 3.4 SAFETY EVALUATION (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY MoS calculations for separate product types and aggregated exposures are shown in Table 7. Based on effects on litter size and pup body weight gain during the lactation period, in the reproduction segment of the study Olsen et al. (1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day. This NOAEL also covers the observed increase in hepatocellular adenomas and carcinomas. Table 7. MoS calculations for the different product types and aggregated exposures Product category Conc. BHT (%) Eproduct 1 (mg/kg bw/d) SED (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Dermal Oral Hydroalcoholic based fragrances 0.8 4.67 0.00015 25 167 291 Shower gel 0.8 2.79 0.00009 25 280 018 Hand wash soap 0.8 3.33 0.00011 25 234 610 Shampoo 0.8 1.51 0.00005 25 517 384 Hair conditioner 0.8 0.67 0.00002 25 1 166 045 Body lotion 0.8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"(1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day.","duration":"","effect":"____________ _________________________________________________________________________ 24 3.4 SAFETY EVALUATION (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY MoS calculations for separate product types and aggregated exposures are shown in Table 7. Based on effects on litter size and pup body weight gain during the lactation period, in the reproduction segment of the study Olsen et al. (1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day. This NOAEL also covers the observed increase in hepatocellular adenomas and carcinomas. Table 7. MoS calculations for the different product types and aggregated exposures Product category Conc. BHT (%) Eproduct 1 (mg/kg bw/d) SED (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Dermal Oral Hydroalcoholic based fragrances 0.8 4.67 0.00015 25 167 291 Shower gel 0.8 2.79 0.00009 25 280 018 Hand wash soap 0.8 3.33 0.00011 25 234 610 Shampoo 0.8 1.51 0.00005 25 517 384 Hair conditioner 0.8 0.67 0.00002 25 1 166 045 Body lotion 0.8","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":24,"route":"oral","species":"","study_id":"sccs_o_257_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=(1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day.; EFFECT=ated exposures are shown in Table 7. Based on effects on litter size and pup body weight gain during the lactation period, in the reproduction segment of the study Olsen et al. (1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day. This NOAEL also covers the observed increase in hepatocellular adenomas and carcinomas. Table 7. MoS calculations for the different product types and aggregated exposures Product category Conc. BHT (%) Eproduct 1 (mg/kg bw/d) SED (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Dermal Oral Hydroalcoholic based fragrances 0.8 4.67 0.00015 25 167 291 Shower gel 0.8 2.79 0.00009 25 280 018 Hand wash soap 0.8 3.33 0.00011 25 234 610 Shampoo 0.8 1.51 0.00005 25 517 384 Hair conditioner 0.8 0.67 0.00002 25 1 166 045 Body lotion 0.8 123.2 0.00394 25 6 341 Face cream 0.8 24.14 0.00077 25 32 363 Hand cream 0.8 32.7 0.00105 25 23 891 Deodorant non-spray 0.8 22.08 0.00071 25 35 383 Hair styling 0.8 5.74 0.00018 25 136 106 Liquid foundation 0.8 7.9 0.00025 25 98 892 M; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"(1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day.","duration":"","effect":"ated exposures are shown in Table 7. Based on effects on litter size and pup body weight gain during the lactation period, in the reproduction segment of the study Olsen et al. (1986; described in the EFSA 2012), the NOAEL for non-neoplastic effects was 25 mg/kg bw per day. This NOAEL also covers the observed increase in hepatocellular adenomas and carcinomas. Table 7. MoS calculations for the different product types and aggregated exposures Product category Conc. BHT (%) Eproduct 1 (mg/kg bw/d) SED (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Dermal Oral Hydroalcoholic based fragrances 0.8 4.67 0.00015 25 167 291 Shower gel 0.8 2.79 0.00009 25 280 018 Hand wash soap 0.8 3.33 0.00011 25 234 610 Shampoo 0.8 1.51 0.00005 25 517 384 Hair conditioner 0.8 0.67 0.00002 25 1 166 045 Body lotion 0.8 123.2 0.00394 25 6 341 Face cream 0.8 24.14 0.00077 25 32 363 Hand cream 0.8 32.7 0.00105 25 23 891 Deodorant non-spray 0.8 22.08 0.00071 25 35 383 Hair styling 0.8 5.74 0.00018 25 136 106 Liquid foundation 0.8 7.9 0.00025 25 98 892 M","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":24,"route":"oral","species":"","study_id":"sccs_o_257_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.5 | % | rat | oral | 90 days | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=0.5; DOSE=Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al.; EFFECT=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 32 ANNEX 1: Table A-1. Summary of level 3-5 in vivo animal studies with emphasis on effects on liver (LE), thyroid (TE) and adrenals (AE) and indicated NOAEL’s (including studies with ≥2 doses only). Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al. 1989 Rat m oral highes t tolerat ed doses for 30 days 0.5% dietary BHT No detectable ↑ in 3H- thymidine labelling Time-limite; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al.","duration":"90 days","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 32 ANNEX 1: Table A-1. Summary of level 3-5 in vivo animal studies with emphasis on effects on liver (LE), thyroid (TE) and adrenals (AE) and indicated NOAEL’s (including studies with ≥2 doses only). Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Level 3 Sønder gaard & Olsen, 19821 Rat oral 8, 26 or 90 days 0, 25, 250 ↑ uptake of 125I by the thyroid at all time period studied No effects on T3 and T4 levels ↑ thyroxine half-life after 13 days returning to normal after 75 days Briggs et al. 1989 Rat m oral highes t tolerat ed doses for 30 days 0.5% dietary BHT No detectable ↑ in 3H- thymidine labelling Time-limite","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"%","noael_value":"0.5","page":32,"route":"oral","species":"rat","study_id":"sccs_o_257_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1636 | - | rat | oral | 144 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e; DOSE=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m p...; EFFECT=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m p...","duration":"144 wk","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 33 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1994 11-19 most m per dose per group tion study, F1 up to 144 wk feedin g 100, 250 (in utero 500) centrilobular enlargement and eosinophilia noduli, foci at 250 mg (hyperactiv ity) (histopath) enzyme induction in all dose groups no effects (T4 induction) McFarla ne et al. 1997 Rat 2M/1 6F F0 oral F1 lactati on Dose rangin g study 14 wk 0, 500, 750, 1000 ↑ weight F0 dams at ≥500 500 (LOAEL) At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) 500 (maternal /fetal) McFarla ne e","page":33,"route":"oral","species":"rat","study_id":"sccs_o_257_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1636 | - | rat | - | 104 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 34 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Hiraga 19783 rat 5- 15 m/f per dose interi m sacrifi ces up to 104 wk feedin g 2.5, 10, 160 weight ↑ liver weight increased (at 160 mg) no tumor induction no clear tendency (weight, histopath) no clear tendency (weight, histopath) 10 (LE) NCI 1979a rat 20-50 m/f per dose; Interi m sacrifi ces 105 wk feedin g 225, 450 weight: no data tumors: not sign. c-cell hyperplasia in males at ≥ 225 mg; no tumor induction Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human he; DOSE=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 34 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Hiraga 19783 rat 5-...; EFFECT=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 34 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Hiraga 19783 rat 5- 15 m/f per dose interi m sacrifi ces up to 104 wk feedin g 2.5, 10, 160 weight ↑ liver weight increased (at 160 mg) no tumor induction no clear tendency (weight, histopath) no clear tendency (weight, histopath) 10 (LE) NCI 1979a rat 20-50 m/f per dose; Interi m sacrifi ces 105 wk feedin g 225, 450 weight: no data tumors: not sign. c-cell hyperplasia in males at ≥ 225 mg; no tumor induction Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human he; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 34 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Hiraga 19783 rat 5-...","duration":"104 wk","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 34 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Hiraga 19783 rat 5- 15 m/f per dose interi m sacrifi ces up to 104 wk feedin g 2.5, 10, 160 weight ↑ liver weight increased (at 160 mg) no tumor induction no clear tendency (weight, histopath) no clear tendency (weight, histopath) 10 (LE) NCI 1979a rat 20-50 m/f per dose; Interi m sacrifi ces 105 wk feedin g 225, 450 weight: no data tumors: not sign. c-cell hyperplasia in males at ≥ 225 mg; no tumor induction Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human he","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 34 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) Hiraga 19783 rat 5- 15 m/f per dose interi m sacrifi ces up to 104 wk feedin g 2.5, 10, 160 weight ↑ liver weight increased (at 160 mg) no tumor induction no clear tendency (weight, histopath) no clear tendency (weight, histopath) 10 (LE) NCI 1979a rat 20-50 m/f per dose; Interi m sacrifi ces 105 wk feedin g 225, 450 weight: no data tumors: not sign. c-cell hyperplasia in males at ≥ 225 mg; no tumor induction Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human he","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1636 | - | rat | oral | 16 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 35 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1988 m/f per dose; feedin g + 16 wk plain diet 3480 f: 1750, 4230 adenoma - only males no effects in females not examined amyloidosis LE) William s et al. 1990 rat males ; interi m sacrifi ces 76 wk 110 wk feedin g 7.5, 23, 75, 225, 450 900 (only 110 wk) weight ↑ (at ≥ 450mg) no morphological changes no effects (tumor induction) no effects (tumor induction) no effects (tumors induction) no effects (tumor induction) 75 (LE) Tanaka et al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 //; DOSE=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 35 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1988 m/f per dose;...; EFFECT=SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 35 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1988 m/f per dose; feedin g + 16 wk plain diet 3480 f: 1750, 4230 adenoma - only males no effects in females not examined amyloidosis LE) William s et al. 1990 rat males ; interi m sacrifi ces 76 wk 110 wk feedin g 7.5, 23, 75, 225, 450 900 (only 110 wk) weight ↑ (at ≥ 450mg) no morphological changes no effects (tumor induction) no effects (tumor induction) no effects (tumors induction) no effects (tumor induction) 75 (LE) Tanaka et al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 //; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 35 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1988 m/f per dose;...","duration":"16 wk","effect":"SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 35 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1988 m/f per dose; feedin g + 16 wk plain diet 3480 f: 1750, 4230 adenoma - only males no effects in females not examined amyloidosis LE) William s et al. 1990 rat males ; interi m sacrifi ces 76 wk 110 wk feedin g 7.5, 23, 75, 225, 450 900 (only 110 wk) weight ↑ (at ≥ 450mg) no morphological changes no effects (tumor induction) no effects (tumor induction) no effects (tumors induction) no effects (tumor induction) 75 (LE) Tanaka et al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 //","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1636/21 Final version Opinion on Butylated hydroxytoluene (BHT) ___________________________________________________________________________________________ _________________________________________________________________________ 35 Refere nce Speci es Expos ure Doses (mg/k g bw) liver thyroid adrenals NOAEL (mg/kg bw/d) 1988 m/f per dose; feedin g + 16 wk plain diet 3480 f: 1750, 4230 adenoma - only males no effects in females not examined amyloidosis LE) William s et al. 1990 rat males ; interi m sacrifi ces 76 wk 110 wk feedin g 7.5, 23, 75, 225, 450 900 (only 110 wk) weight ↑ (at ≥ 450mg) no morphological changes no effects (tumor induction) no effects (tumor induction) no effects (tumors induction) no effects (tumor induction) 75 (LE) Tanaka et al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 //","page":35,"route":"oral","species":"rat","study_id":"sccs_o_257_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 10 | mg/kg bw/day | rat | - | 24 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=10; DOSE=1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al.; EFFECT=al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al. 2008 rat 6 m per dose 28 days feedin g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019; CITATION=Ref.: Modified from EDC dossier 2019; CITATION_NUMBERS=[2019]; REFERENCE=Ref.: Modified from EDC dossier 2019; DETAILS_JSON={"cas_number":"128-37-0","citation":"Ref.: Modified from EDC dossier 2019","dose":"1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al.","duration":"24 wk","effect":"al. 1993 Mous e 10 m/f per dose genera tion study 23, 68, 203, 608 // Safer & Al- Nugha mish 1999 rat, 10 m/ dose (2/ti me point) 6-24 wk feedin g 200, 400, 800 weight (abs↑) hypertrophy, degenerative figures no tumors 200 (LOAEL, LE) Stieru m et al. 2008 rat 6 m per dose 28 days feedin g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":35,"route":"","species":"rat","study_id":"sccs_o_257_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=15; DOSE=3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses.; EFFECT=g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019; CITATION=Ref.: Modified from EDC dossier 2019; CITATION_NUMBERS=[2019]; REFERENCE=Ref.: Modified from EDC dossier 2019; DETAILS_JSON={"cas_number":"128-37-0","citation":"Ref.: Modified from EDC dossier 2019","dose":"3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses.","duration":"","effect":"g 28, 88, 167, 321, 1159 weight, histopath effects at 1159 mg 28 (LE) enzyme induction 1According to the dossier, the study has severe technical limitations. 2According to the dossier, the study was poorly reported in Romanian. 3A NOAEL of 10 mg/kg bw/day was not applied by the SCCS due to the great difference between the two highest exposure doses. 4The report is in Japanese and the findings are poorly described in the EDC dossier. Since the SCCS have not been able to verify the results reported in the dossier, a NOAEL of 15 mg/kg bw/day will not be applied. Ref.: Modified from EDC dossier 2019","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":35,"route":"","species":"","study_id":"sccs_o_257_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 7 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; DOSE=BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:Table 7. MoS calculations for the different product types and aggregated exposures: Product category | Conc. BHT (%) | Eproduct 1 (mg/kg bw/d) | SED (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Hydroalcoholic based fragrances | 0.8 | 4.67 | 0.00015 | 25 | 167 291; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hydroalcoholic based fragrances | 0.8 | 4.67 | 0.00015 | 25 | 167 291","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Shower gel | 0.8 | 2.79 | 0.00009 | 25 | 280 018; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Shower gel | 0.8 | 2.79 | 0.00009 | 25 | 280 018","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Hand wash soap | 0.8 | 3.33 | 0.00011 | 25 | 234 610; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hand wash soap | 0.8 | 3.33 | 0.00011 | 25 | 234 610","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Shampoo | 0.8 | 1.51 | 0.00005 | 25 | 517 384; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Shampoo | 0.8 | 1.51 | 0.00005 | 25 | 517 384","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Hair conditioner | 0.8 | 0.67 | 0.00002 | 25 | 1 166 045; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hair conditioner | 0.8 | 0.67 | 0.00002 | 25 | 1 166 045","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Body lotion | 0.8 | 123.2 | 0.00394 | 25 | 6 341; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Body lotion | 0.8 | 123.2 | 0.00394 | 25 | 6 341","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Face cream | 0.8 | 24.14 | 0.00077 | 25 | 32 363; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Face cream | 0.8 | 24.14 | 0.00077 | 25 | 32 363","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Hand cream | 0.8 | 32.7 | 0.00105 | 25 | 23 891; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hand cream | 0.8 | 32.7 | 0.00105 | 25 | 23 891","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Deodorant non-spray | 0.8 | 22.08 | 0.00071 | 25 | 35 383; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Deodorant non-spray | 0.8 | 22.08 | 0.00071 | 25 | 35 383","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Hair styling | 0.8 | 5.74 | 0.00018 | 25 | 136 106; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Hair styling | 0.8 | 5.74 | 0.00018 | 25 | 136 106","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Liquid foundation | 0.8 | 7.9 | 0.00025 | 25 | 98 892; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Liquid foundation | 0.8 | 7.9 | 0.00025 | 25 | 98 892","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Make-up remover | 0.8 | 8.33 | 0.00027 | 25 | 93 788; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Make-up remover | 0.8 | 8.33 | 0.00027 | 25 | 93 788","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Eye make-up | 0.8 | 0.33 | 0.00001 | 25 | 2 367 424; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Eye make-up | 0.8 | 0.33 | 0.00001 | 25 | 2 367 424","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Mascara | 0.8 | 0.42 | 0.00001 | 25 | 1 860 119; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Mascara | 0.8 | 0.42 | 0.00001 | 25 | 1 860 119","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Eyeliner | 0.8 | 0.08 | 0.000003 | 25 | 9 765 625; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Eyeliner | 0.8 | 0.08 | 0.000003 | 25 | 9 765 625","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Toothpaste | 0.1 | 2.16 | 0.00216 | 25 | 11 574; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Toothpaste | 0.1 | 2.16 | 0.00216 | 25 | 11 574","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Mouthwash | 0.001 | 32.54 | 0.00033 | 25 | 76 829; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Mouthwash | 0.001 | 32.54 | 0.00033 | 25 | 76 829","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Lipstick | 0.8 | 0.90 | 0.00720 | 25 | 3 472; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Lipstick | 0.8 | 0.90 | 0.00720 | 25 | 3 472","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Aggregated exposure: dermal | 237.89 | 0.00761 | 25 | 3 285; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Aggregated exposure: dermal | 237.89 | 0.00761 | 25 | 3 285","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"dermal","species":"","study_id":"sccs_o_257_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Aggregated exposure: oral | 35.60 | 0.00969 | 25 | 2 580; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Aggregated exposure: oral | 35.60 | 0.00969 | 25 | 2 580","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"oral","species":"","study_id":"sccs_o_257_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; EFFECT=Table 7. MoS calculations for the different product types and aggregated exposures: Aggregated exposure: total | 273.49 | 0.00761 | 0.00969 | 25 | 1 445; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Table 7. MoS calculations for the different product types and aggregated exposures: Aggregated exposure: total | 273.49 | 0.00761 | 0.00969 | 25 | 1 445","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25","page":24,"route":"","species":"","study_id":"sccs_o_257_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 32 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); DOSE=Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 32: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":32,"route":"","species":"","study_id":"sccs_o_257_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 67 | - | rat | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=67 (LE); DOSE=Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE); EFFECT=Unlabeled table on page 32: Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","duration":"","effect":"Unlabeled table on page 32: Frawley et al., 1965 | rat 16 m/f per dose | genera tion study; final sacrific e at week 42 for F0 and F1 | 20, 67, 200 | weight ↑ serum cholesterol wk 28 ↑ histopath: no effects | no effects (weight and histopath) | no effects (weight and histopath) | 67 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"67 (LE)","page":32,"route":"","species":"rat","study_id":"sccs_o_257_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | rat | - | 144 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25 (LE); DOSE=1986 | rat 40- 100 m/f per dose divide d in subgr oups | genera tion study;; EFFECT=Unlabeled table on page 32: Olsen et al. 1986 | rat 40- 100 m/f per dose divide d in subgr oups | genera tion study; F1 up to 144 wk feedin g | 25, 100, 250 (in utero 500) | adenoma and carcinoma, late (≥ wk 115) significant ↑at 250 mg | no effects (tumor induction) | no effects (tumor induction) | 25 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"1986 | rat 40- 100 m/f per dose divide d in subgr oups | genera tion study;","duration":"144 wk","effect":"Unlabeled table on page 32: Olsen et al. 1986 | rat 40- 100 m/f per dose divide d in subgr oups | genera tion study; F1 up to 144 wk feedin g | 25, 100, 250 (in utero 500) | adenoma and carcinoma, late (≥ wk 115) significant ↑at 250 mg | no effects (tumor induction) | no effects (tumor induction) | 25 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25 (LE)","page":32,"route":"","species":"rat","study_id":"sccs_o_257_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | rat | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25 (TE); EFFECT=Unlabeled table on page 32: Price | rat | genera | 25, | weight (rel↑), | histopath | no effects | 25 (TE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 32: Price | rat | genera | 25, | weight (rel↑), | histopath | no effects | 25 (TE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25 (TE)","page":32,"route":"","species":"rat","study_id":"sccs_o_257_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 33 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); DOSE=Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 33: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":33,"route":"","species":"","study_id":"sccs_o_257_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | - | rat | oral | 14 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=500 (LOAEL); DOSE=1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL); EFFECT=Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","duration":"14 wk","effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 2M/1 6F F0 oral F1 lactati on | Dose rangin g study 14 wk | 0, 500, 750, 1000 | ↑ weight F0 dams at ≥500 | 500 (LOAEL)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"500 (LOAEL)","page":33,"route":"oral","species":"rat","study_id":"sccs_o_257_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=500 (maternal /fetal); EFFECT=Unlabeled table on page 33: At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 500 (maternal /fetal); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 33: At ≥750: abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 500 (maternal /fetal)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"500 (maternal /fetal)","page":33,"route":"","species":"","study_id":"sccs_o_257_noael_047"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | - | rat | oral | 22 weeks | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=100 (LE); EFFECT=Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 7M/5 0F F0 Oral F1 postn atal expos ure, | Main study Necrop sied at 22 weeks post weanin g | F0 0, 25, 100, 500 F1 0, 25, 100, 250 | at ≥500 F0 dams ↑ weight Abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 100 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"22 weeks","effect":"Unlabeled table on page 33: McFarla ne et al. 1997 | Rat 7M/5 0F F0 Oral F1 postn atal expos ure, | Main study Necrop sied at 22 weeks post weanin g | F0 0, 25, 100, 500 F1 0, 25, 100, 250 | at ≥500 F0 dams ↑ weight Abnormal hepatocytes (enlarged, vacuolized, proliferation of ER) | 100 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"100 (LE)","page":33,"route":"oral","species":"rat","study_id":"sccs_o_257_noael_048"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25 (LE); EFFECT=Unlabeled table on page 33: At ≥100 F1 pups ↑ weight abnormal hepatocytes | 25 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 33: At ≥100 F1 pups ↑ weight abnormal hepatocytes | 25 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25 (LE)","page":33,"route":"","species":"","study_id":"sccs_o_257_noael_049"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg/day | rat | - | 8 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=20; DOSE=Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //; EFFECT=Unlabeled table on page 33: Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","duration":"8 wk","effect":"Unlabeled table on page 33: Sporn & Schöbe sch 19612 | young rat 8/dos e | 8 wk? | 20, 200 | nitrogen content ‘greatly reduced’ at 20 mg/kg/day | non- significant increase in weight | //","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":33,"route":"","species":"rat","study_id":"sccs_o_257_noael_050"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | - | rat | - | 6 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=100 (LOAEL, AR); DOSE=Johnso n & Hewgill 1961 | rat weanl ing 3 m/f per dose ‘genet ic effect led to some variat ions in litters ’ | 6 wk | 100, 200, 300, 400, 500 | weight (rel↑) (at ≥ 200 mg) | weight (rel↑, only males), histopath: no changes | 100 (LOAEL, AR); EFFECT=Unlabeled table on page 33: Johnso n & Hewgill 1961 | rat weanl ing 3 m/f per dose ‘genet ic effect led to some variat ions in litters ’ | 6 wk | 100, 200, 300, 400, 500 | weight (rel↑) (at ≥ 200 mg) | weight (rel↑, only males), histopath: no changes | 100 (LOAEL, AR); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Johnso n & Hewgill 1961 | rat weanl ing 3 m/f per dose ‘genet ic effect led to some variat ions in litters ’ | 6 wk | 100, 200, 300, 400, 500 | weight (rel↑) (at ≥ 200 mg) | weight (rel↑, only males), histopath: no changes | 100 (LOAEL, AR)","duration":"6 wk","effect":"Unlabeled table on page 33: Johnso n & Hewgill 1961 | rat weanl ing 3 m/f per dose ‘genet ic effect led to some variat ions in litters ’ | 6 wk | 100, 200, 300, 400, 500 | weight (rel↑) (at ≥ 200 mg) | weight (rel↑, only males), histopath: no changes | 100 (LOAEL, AR)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"100 (LOAEL, AR)","page":33,"route":"","species":"rat","study_id":"sccs_o_257_noael_051"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=100 (LOAEL, LE); EFFECT=Unlabeled table on page 33: serum cholesterol ↑ (at all doses) | adrenal cholesterol ↑ (at ≥ 300 mg) | 100 (LOAEL, LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 33: serum cholesterol ↑ (at all doses) | adrenal cholesterol ↑ (at ≥ 300 mg) | 100 (LOAEL, LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"100 (LOAEL, LE)","page":33,"route":"","species":"","study_id":"sccs_o_257_noael_052"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | - | - | - | 4 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=50 (LE); DOSE=Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE); EFFECT=Unlabeled table on page 33: Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","duration":"4 wk","effect":"Unlabeled table on page 33: Allan & Engblo m 1972 | monk ey, 2- 3 per dose | 4 wk gavag e | 50, 500 | histopath (slight decrease in smooth ER, lipid droplets at 500 mg) no stat. sign. tumors in males/females | “no effect on other organs” | “no effect on other organs” | 50 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"50 (LE)","page":33,"route":"","species":"","study_id":"sccs_o_257_noael_053"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 34 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); DOSE=Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 34: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":34,"route":"","species":"","study_id":"sccs_o_257_noael_054"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 10 | - | rat | - | 104 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=10 (LE); DOSE=Hiraga 19783 | rat 5- 15 m/f per dose interi m sacrifi ces | up to 104 wk feedin g | 2.5, 10, 160 | weight ↑ liver weight increased (at 160 mg) no tumor induction | no clear tendency (weight, histopath) | no clear tendency (weight, histopath) | 10 (LE); EFFECT=Unlabeled table on page 34: Hiraga 19783 | rat 5- 15 m/f per dose interi m sacrifi ces | up to 104 wk feedin g | 2.5, 10, 160 | weight ↑ liver weight increased (at 160 mg) no tumor induction | no clear tendency (weight, histopath) | no clear tendency (weight, histopath) | 10 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Hiraga 19783 | rat 5- 15 m/f per dose interi m sacrifi ces | up to 104 wk feedin g | 2.5, 10, 160 | weight ↑ liver weight increased (at 160 mg) no tumor induction | no clear tendency (weight, histopath) | no clear tendency (weight, histopath) | 10 (LE)","duration":"104 wk","effect":"Unlabeled table on page 34: Hiraga 19783 | rat 5- 15 m/f per dose interi m sacrifi ces | up to 104 wk feedin g | 2.5, 10, 160 | weight ↑ liver weight increased (at 160 mg) no tumor induction | no clear tendency (weight, histopath) | no clear tendency (weight, histopath) | 10 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"10 (LE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_055"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 225 | - | rat | - | 105 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=225 (LOAEL, TE); DOSE=NCI 1979a | rat 20-50 m/f per dose;; EFFECT=Unlabeled table on page 34: NCI 1979a | rat 20-50 m/f per dose; Interi m sacrifi ces | 105 wk feedin g | 225, 450 | weight: no data tumors: not sign. | c-cell hyperplasia in males at ≥ 225 mg; no tumor induction | Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human health. | 225 (LOAEL, TE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"NCI 1979a | rat 20-50 m/f per dose;","duration":"105 wk","effect":"Unlabeled table on page 34: NCI 1979a | rat 20-50 m/f per dose; Interi m sacrifi ces | 105 wk feedin g | 225, 450 | weight: no data tumors: not sign. | c-cell hyperplasia in males at ≥ 225 mg; no tumor induction | Phaeochro mo-cytoma in males at ≥ 225 mg – not significant and not significant for human health. | 225 (LOAEL, TE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"225 (LOAEL, TE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_056"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 515 | - | - | - | 107 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=515 (LOAEL, LE); DOSE=NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m:; EFFECT=Unlabeled table on page 34: NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m: 0, 515, 1029 f: 0, 518, 1037 | weight: no data ↑ incidence of hepatocytomegaly and nonneoplastic lesions (peliosis, hepatocellular degeneration/necrosis, cytoplasmic vacuolation in males) | ‘no effects’ | ‘no effects’ | 515 (LOAEL, LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m:","duration":"107 wk","effect":"Unlabeled table on page 34: NCI 1979b | mous e, 50 m/f per dose; interi m sacrifi ces | 107 wk feedin g | m: 0, 515, 1029 f: 0, 518, 1037 | weight: no data ↑ incidence of hepatocytomegaly and nonneoplastic lesions (peliosis, hepatocellular degeneration/necrosis, cytoplasmic vacuolation in males) | ‘no effects’ | ‘no effects’ | 515 (LOAEL, LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"515 (LOAEL, LE)","page":34,"route":"","species":"","study_id":"sccs_o_257_noael_057"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 30 | - | rat | - | 8 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=30 (LOAEL, LE); EFFECT=Unlabeled table on page 34: Fulton et al. 1980 | Rat 10 m | 8 wk feedin g | 0, 30, 151, 755, 1132 | Weight (abs↑ and rel↑) | 30 (LOAEL, LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"8 wk","effect":"Unlabeled table on page 34: Fulton et al. 1980 | Rat 10 m | 8 wk feedin g | 0, 30, 151, 755, 1132 | Weight (abs↑ and rel↑) | 30 (LOAEL, LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"30 (LOAEL, LE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_058"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 125 | - | rat | - | 104 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=125 (LOAEL, LE); DOSE=1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE); EFFECT=Unlabeled table on page 34: Hirose et al. 1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","duration":"104 wk","effect":"Unlabeled table on page 34: Hirose et al. 1981 | rat 36-57 m/f per dose | 104 wk feedin g | 125, 500 | weight m (rel↑) no morphological changes | no effects (tumor induction) | no effects (tumor induction) | 125 (LOAEL, LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"125 (LOAEL, LE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_059"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | rat | - | 90 days | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25 (LE); DOSE=Sønder gaard & Olsen 19821 | rat 10-30 m per dose; | up to 90 days feedin g | 25, 250 | weight (rel↑) at 250 mg | weight (rel↑) | 25 (LE); EFFECT=Unlabeled table on page 34: Sønder gaard & Olsen 19821 | rat 10-30 m per dose; | up to 90 days feedin g | 25, 250 | weight (rel↑) at 250 mg | weight (rel↑) | 25 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Sønder gaard & Olsen 19821 | rat 10-30 m per dose; | up to 90 days feedin g | 25, 250 | weight (rel↑) at 250 mg | weight (rel↑) | 25 (LE)","duration":"90 days","effect":"Unlabeled table on page 34: Sønder gaard & Olsen 19821 | rat 10-30 m per dose; | up to 90 days feedin g | 25, 250 | weight (rel↑) at 250 mg | weight (rel↑) | 25 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25 (LE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_060"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 250 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=250 (TE); EFFECT=Unlabeled table on page 34: no effect on enzyme act. T3/T4 | 250 (TE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 34: no effect on enzyme act. T3/T4 | 250 (TE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"250 (TE)","page":34,"route":"","species":"","study_id":"sccs_o_257_noael_061"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | - | rat | - | 18 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=15 (LE); EFFECT=Unlabeled table on page 34: Furuka wa et al. 19844 | rat 10 m/gro up | 18 wk feedin g | 15, 50, 150, 300 | weight ↑ histopath (enlargement of hep. at ≥ 150 mg) | 15 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"18 wk","effect":"Unlabeled table on page 34: Furuka wa et al. 19844 | rat 10 m/gro up | 18 wk feedin g | 15, 50, 150, 300 | weight ↑ histopath (enlargement of hep. at ≥ 150 mg) | 15 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"15 (LE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_062"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | - | rat | - | 28 days | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25 (LE); DOSE=Powell et al., 1986 | rat 10 m per dose | 28 days gavag e | 25, 150, 500 | weight (rel↑), hepatomegaly, necrosis at 500 mg | 25 (LE); EFFECT=Unlabeled table on page 34: Powell et al., 1986 | rat 10 m per dose | 28 days gavag e | 25, 150, 500 | weight (rel↑), hepatomegaly, necrosis at 500 mg | 25 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Powell et al., 1986 | rat 10 m per dose | 28 days gavag e | 25, 150, 500 | weight (rel↑), hepatomegaly, necrosis at 500 mg | 25 (LE)","duration":"28 days","effect":"Unlabeled table on page 34: Powell et al., 1986 | rat 10 m per dose | 28 days gavag e | 25, 150, 500 | weight (rel↑), hepatomegaly, necrosis at 500 mg | 25 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"25 (LE)","page":34,"route":"","species":"rat","study_id":"sccs_o_257_noael_063"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1640 | - | - | - | 104 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=1640 (LOAEL,; EFFECT=Unlabeled table on page 34: Inai et al. | mous e, 50 | 104 wk | m: 1640, | ↑ weight m proliferation (foci), | not affected or | no effects on | 1640 (LOAEL,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"104 wk","effect":"Unlabeled table on page 34: Inai et al. | mous e, 50 | 104 wk | m: 1640, | ↑ weight m proliferation (foci), | not affected or | no effects on | 1640 (LOAEL,","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"1640 (LOAEL,","page":34,"route":"","species":"","study_id":"sccs_o_257_noael_064"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 35 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=unclear:Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); DOSE=Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 35: Refere nce | Speci es | Expos ure | Doses (mg/k g bw) | liver | thyroid | adrenals | NOAEL (mg/kg bw/d)","page":35,"route":"","species":"","study_id":"sccs_o_257_noael_065"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 75 | - | rat | - | 76 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=75 (LE); EFFECT=Unlabeled table on page 35: William s et al. 1990 | rat males ; interi m sacrifi ces | 76 wk 110 wk feedin g | 7.5, 23, 75, 225, 450 900 (only 110 wk) | weight ↑ (at ≥ 450mg) no morphological changes | no effects (tumor induction) no effects (tumor induction) | no effects (tumors induction) no effects (tumor induction) | 75 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"","duration":"76 wk","effect":"Unlabeled table on page 35: William s et al. 1990 | rat males ; interi m sacrifi ces | 76 wk 110 wk feedin g | 7.5, 23, 75, 225, 450 900 (only 110 wk) | weight ↑ (at ≥ 450mg) no morphological changes | no effects (tumor induction) no effects (tumor induction) | no effects (tumors induction) no effects (tumor induction) | 75 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"75 (LE)","page":35,"route":"","species":"rat","study_id":"sccs_o_257_noael_066"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 200 | - | rat | - | 24 wk | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=200 (LOAEL, LE); DOSE=Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE); EFFECT=Unlabeled table on page 35: Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","duration":"24 wk","effect":"Unlabeled table on page 35: Safer & Al- Nugha mish 1999 | rat, 10 m/ dose (2/ti me point) | 6-24 wk feedin g | 200, 400, 800 | weight (abs↑) hypertrophy, degenerative figures no tumors | 200 (LOAEL, LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"200 (LOAEL, LE)","page":35,"route":"","species":"rat","study_id":"sccs_o_257_noael_067"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 28 | - | rat | - | 28 days | - | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=28 (LE); DOSE=2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE); EFFECT=Unlabeled table on page 35: Stieru m et al. 2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","duration":"28 days","effect":"Unlabeled table on page 35: Stieru m et al. 2008 | rat 6 m per dose | 28 days feedin g | 28, 88, 167, 321, 1159 | weight, histopath effects at 1159 mg | 28 (LE)","endpoint":"","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"","noael_value":"28 (LE)","page":35,"route":"","species":"rat","study_id":"sccs_o_257_noael_068"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 38 | mg/kg bw/day | rat | - | - | carcinogenicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=38; DOSE=(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.; EFFECT=s on genotoxicity (Ma et al. 2017, Negritto et al. 2017), retrieved in the systematic literature searches performed by VKM, did not provide evidence of genotoxicity. Ref.: EFSA 2012; Ma 2017; Negritto 2017; VKM 2019 SCCS comment The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the; CITATION=Ref.: EFSA 2012; CITATION_NUMBERS=[2012]; REFERENCE=Ref.: EFSA 2012; DETAILS_JSON={"cas_number":"128-37-0","citation":"Ref.: EFSA 2012","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","duration":"","effect":"s on genotoxicity (Ma et al. 2017, Negritto et al. 2017), retrieved in the systematic literature searches performed by VKM, did not provide evidence of genotoxicity. Ref.: EFSA 2012; Ma 2017; Negritto 2017; VKM 2019 SCCS comment The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the","endpoint":"carcinogenicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"38","page":19,"route":"","species":"rat","study_id":"sccs_o_257_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 247 | mg/kg bw/day | rat | - | - | carcinogenicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=247; DOSE=(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.; EFFECT=y. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study. Ref.: Brooks 1976; Olsen 1986; EFSA 2012; CITATION=Ref.: Brooks 1976; CITATION_NUMBERS=[1976]; REFERENCE=Ref.: Brooks 1976; DETAILS_JSON={"cas_number":"128-37-0","citation":"Ref.: Brooks 1976","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","duration":"","effect":"y. 3.3.7 Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. The NOAEL for non-neoplastic effects in the study of Olsen et al. (1986) was 25 mg/kg bw/day, based on the effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study. Ref.: Brooks 1976; Olsen 1986; EFSA 2012","endpoint":"carcinogenicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"247","page":19,"route":"","species":"rat","study_id":"sccs_o_257_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 25 | mg/kg bw/day | rat | - | - | carcinogenicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.; EFFECT=mice, rats and chickens. BHT has been shown to increase the relative thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.","duration":"","effect":"mice, rats and chickens. BHT has been shown to increase the relative thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT","endpoint":"carcinogenicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":25,"route":"","species":"rat","study_id":"sccs_o_257_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 25 | mg/kg bw/day | rat | - | - | carcinogenicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.; EFFECT=ve thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal mo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al.","duration":"","effect":"ve thyroid and adrenal weight in rats. In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. None of the studies available can be used to derive a NOAEL. The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day derived from two 2-generation study in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal mo","endpoint":"carcinogenicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":25,"route":"","species":"rat","study_id":"sccs_o_257_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 38 | mg/kg bw/day | rat | - | - | carcinogenicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=38; DOSE=(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.; EFFECT=tudy in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. Photo-induced toxicity /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"(1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al.","duration":"","effect":"tudy in rats by Olsen et al. (1986), based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MOS calculations. Mutagenicity / genotoxicity The SCCS concurs with the conclusions of EFSA (2012) and VKM (2019) that BHT is not of concern with regard to genotoxicity. Carcinogenicity According to EFSA, BHT in high doses can exert tumour-promoting effects in some animal models. The data do not allow the establishment of a NOAEL for a carcinogen-promotional effect. BMD analyses of the data reported by Brooks et al. (1976) on the incidence of lung neoplasia in mice induced by BHT revealed a BMDL10 of 38 mg/kg bw/day, and of the data reported by Olsen et al. (1986) on the incidence of hepatocellular carcinomas in male rats induced by BHT a BMDL10 of 247 mg/kg bw/day. Photo-induced toxicity /","endpoint":"carcinogenicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"38","page":25,"route":"","species":"rat","study_id":"sccs_o_257_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 450 | mg/kg bw/day | rat | - | Chronic | reproductive toxicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=450; DOSE=In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal.; EFFECT=n. In addition, BHT has been shown to increase the relative thyroid and adrenal weight in rats. In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal. EFSA concluded that none of the studies available could be used to derive a NOAEL. Ref.: EFSA 2012; ANSES 2016 SCCS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg b; CITATION=Ref.: EFSA 2012; CITATION_NUMBERS=[2012]; REFERENCE=Ref.: EFSA 2012; DETAILS_JSON={"cas_number":"128-37-0","citation":"Ref.: EFSA 2012","dose":"In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal.","duration":"Chronic","effect":"n. In addition, BHT has been shown to increase the relative thyroid and adrenal weight in rats. In rats, BHT given orally to male for 7 consecutive days at dose levels of 75 or 450 mg/kg bw/day induced hepatocellular proliferation, increased hepatocyte apoptosis, and elevated immunoreactivity for transforming growth factor (TGF)-β1 in the liver during the treatment, and resulted in hepatocellular inhibition of mitosis following withdrawal. EFSA concluded that none of the studies available could be used to derive a NOAEL. Ref.: EFSA 2012; ANSES 2016 SCCS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg b","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"450","page":17,"route":"","species":"rat","study_id":"sccs_o_257_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 25 | mg/kg bw | rat | - | Chronic | reproductive toxicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.; EFFECT=CS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) wer; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.","duration":"Chronic","effect":"CS comment In two old studies cited in ANSES (2016) (Johnson & Hewgill 1961; Gaunt et al. 1965), effects on adrenal weight without any histological changes were observed, whereas no effects on adrenal was observed in Price (1994). ANSES, therefore, considered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) wer","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":17,"route":"","species":"rat","study_id":"sccs_o_257_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 25 | mg/kg bw | rat | - | Chronic | reproductive toxicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.; EFFECT=onsidered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) were fed BHT at intake doses of 0, 25, 108, or 276 mg/kg bw/day for male rats and of 0, 26, 106 and 287 mg/kg bw/day for female rats, respectively. The F0 rats were mated after 13 weeks of treatment. The F1 groups consisted of 100, 80, 80, and 100 F1 ra; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-37-0","citation":"","dose":"3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day.","duration":"Chronic","effect":"onsidered that the effects of BHT on the weight of adrenals in different strains of rats are of no relevant significance. 3.3.4.3 Chronic (> 12 months) toxicity and reproductive toxicity EFSA established an ADI for BHT of 0.25 mg/kg bw per day. The ADI was based on a NOAEL of 25 mg/kg bw per day derived from a 2-generation study in rats based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, using an uncertainty factor of 100. This NOAEL also covers the effects on hepatic enzyme induction (and consequent thyroid hyperactivity), as well as the increase in hepatocellular adenomas and carcinomas. In the 2-generation study by Olsen et al. (1986), groups of 60, 40, 40, or 60 Wistar rats of each sex (F0) were fed BHT at intake doses of 0, 25, 108, or 276 mg/kg bw/day for male rats and of 0, 26, 106 and 287 mg/kg bw/day for female rats, respectively. The F0 rats were mated after 13 weeks of treatment. The F1 groups consisted of 100, 80, 80, and 100 F1 ra","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":17,"route":"","species":"rat","study_id":"sccs_o_257_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 25 | mg/kg bw/day | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_257; REPORT_TITLE=OPINION on Butylated Hydroxytoluene (BHT); OPINION_NUMBER=SCCS/1636/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=25; DOSE=VKM 2019 SCCS comment The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day, derived from two 2-generation study in rats by Olsen et al.; EFFECT=___________________________________________________ _________________________________________________________________________ 19 the ADI established by EFSA needed to be revised. One original study (Pop et al., 2013) was qualified for a risk of bias, relevance of endpoint and weight of evidence evaluation. The results reported by Pop et al. (2013) did not indicate that the ADI established by EFSA needed to be revised. Ref.: Pop 2013; VKM 2019 SCCS comment The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day, derived from two 2-generation study in rats by Olsen et al. (1986) based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MoS calculations. 3.3.5 Reproductive toxicity See section 3.3.4. 3.3.6 Mutagenicity / genotoxicity According to EFSA, the majority of evidence indicates a lack of potential for BHT to induce point mutations or chromosomal aberrations, or to interact with or damage DNA. Pos; CITATION=Ref.: Pop 2013; CITATION_NUMBERS=[2013]; REFERENCE=Ref.: Pop 2013; DETAILS_JSON={"cas_number":"128-37-0","citation":"Ref.: Pop 2013","dose":"VKM 2019 SCCS comment The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day, derived from two 2-generation study in rats by Olsen et al.","duration":"","effect":"___________________________________________________ _________________________________________________________________________ 19 the ADI established by EFSA needed to be revised. One original study (Pop et al., 2013) was qualified for a risk of bias, relevance of endpoint and weight of evidence evaluation. The results reported by Pop et al. (2013) did not indicate that the ADI established by EFSA needed to be revised. Ref.: Pop 2013; VKM 2019 SCCS comment The SCCS concurs with the conclusion of EFSA (2012) and a NOAEL of 25 mg/kg bw/day, derived from two 2-generation study in rats by Olsen et al. (1986) based on effects on litter size, sex ratio and pup body weight gain during the lactation period in the reproduction segment of the study, will be used for MoS calculations. 3.3.5 Reproductive toxicity See section 3.3.4. 3.3.6 Mutagenicity / genotoxicity According to EFSA, the majority of evidence indicates a lack of potential for BHT to induce point mutations or chromosomal aberrations, or to interact with or damage DNA. Pos","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":19,"route":"","species":"rat","study_id":"sccs_o_257_noael_004"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 1P9D0Z171K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C15H24O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1P9D0Z171K"} |
| openFDA substances | FDA UNII substance identifier | 1P9D0Z171K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C15H24O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1P9D0Z171K"} |
| openFDA substances | FDA UNII substance identifier | 1P9D0Z171K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C15H24O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1P9D0Z171K"} |
| openFDA substances | FDA UNII substance identifier | 1P9D0Z171K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C15H24O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1P9D0Z171K"} |