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Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] [MAK value documentation, 2018]


Hartwig, A; MAK Commission; Arand, Michael; et al (2019). Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] [MAK value documentation, 2018]. The MAK Collection for Occupational Health and Safety, 4(3):1201-1219.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated thiodiethylene bis[3‐(3,5‐di‐tert‐butyl‐4‐hydroxyphenyl)propionate] [41484‐35‐9] to derive a maximum concentration at the workplace (MAK value), considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. Critical effects are hepatic hypertrophy and increased liver weight in male rats in a subchronic feeding study with a NOAEL (no observed adverse effect level) of 12.5 mg/kg body weight and day. As there is no irritating potential, the oral study can be used to derive a MAK value of 2 mg/m3 for the inhalable fraction. As the critical effect is systemic, Peak Limitation Category II is assigned. The default excursion factor of 2 is set as no half‐life in blood is known. Classification in Pregnancy Risk Group D is indicated because developmental toxicity studies are lacking. Thiodiethylene bis[3‐(3,5‐di‐tert‐butyl‐4‐hydroxyphenyl)propionate] is not genotoxic. Carcinogenicity studies are not available. The substance is not a contact sensitizer in humans and guinea pigs. Skin contact is not expected to contribute significantly to systemic toxicity.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated thiodiethylene bis[3‐(3,5‐di‐tert‐butyl‐4‐hydroxyphenyl)propionate] [41484‐35‐9] to derive a maximum concentration at the workplace (MAK value), considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. Critical effects are hepatic hypertrophy and increased liver weight in male rats in a subchronic feeding study with a NOAEL (no observed adverse effect level) of 12.5 mg/kg body weight and day. As there is no irritating potential, the oral study can be used to derive a MAK value of 2 mg/m3 for the inhalable fraction. As the critical effect is systemic, Peak Limitation Category II is assigned. The default excursion factor of 2 is set as no half‐life in blood is known. Classification in Pregnancy Risk Group D is indicated because developmental toxicity studies are lacking. Thiodiethylene bis[3‐(3,5‐di‐tert‐butyl‐4‐hydroxyphenyl)propionate] is not genotoxic. Carcinogenicity studies are not available. The substance is not a contact sensitizer in humans and guinea pigs. Skin contact is not expected to contribute significantly to systemic toxicity.

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Additional indexing

Item Type:Journal Article, not_refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Pharmacology and Toxicology
07 Faculty of Science > Institute of Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Language:German
Date:25 July 2019
Deposited On:21 Nov 2019 15:40
Last Modified:05 Dec 2019 08:09
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb4148435e6519

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