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Di-n-butylphthalat [MAK Value Documentation in German language, 2017]


Hartwig, Andrea; MAK Commission; et al; Arand, Michael (2017). Di-n-butylphthalat [MAK Value Documentation in German language, 2017]. The MAK Collection for Occupational Health and Safety, 2(1):99-118.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the developmental toxicity of di‐n‐butyl phthalate. Available publications are described in detail. In prenatal developmental toxicity studies in rats, the most sensitive endpoint was altered morphometry (size and organization) of the seminiferous cords, the precursor of the seminiferous tubules, at 50 mg/kg body weight and day and above; the NOAEL was 30 mg/kg body weight and day. In rats, teratogenic effects like hypospadia and underdeveloped or absent epididymides were observed at 250 mg/kg KG body weight and day and above; the NOAEL was 100 mg/kg body weight and day.

In a two‐generation reproduction toxicity study in rats, a LOAEL of 52 mg/kg body weight and day, the lowest dose, could be derived for foetotoxicity and decreased birth weight in the male animals. In rats, the NOAEL for behavioural toxicity is 291 mg/kg body weight and day in male pups. From a one‐generation reproduction toxicity study in mice, a NOAEL of 1410 mg/kg body weight and day could be derived for foetotoxicity and decreased number of live pups. The NOAEL/LOAEL for developmental toxicity and foetotoxicity can be scaled to concentrations of 32/107 and 84/252 mg/m3, respectively, at the workplace. Thus, damage to the embryo or foetus is unlikely when the MAK value of 0.58 mg/m3 is observed, and the classification in Pregnancy Risk Group C is confirmed.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the developmental toxicity of di‐n‐butyl phthalate. Available publications are described in detail. In prenatal developmental toxicity studies in rats, the most sensitive endpoint was altered morphometry (size and organization) of the seminiferous cords, the precursor of the seminiferous tubules, at 50 mg/kg body weight and day and above; the NOAEL was 30 mg/kg body weight and day. In rats, teratogenic effects like hypospadia and underdeveloped or absent epididymides were observed at 250 mg/kg KG body weight and day and above; the NOAEL was 100 mg/kg body weight and day.

In a two‐generation reproduction toxicity study in rats, a LOAEL of 52 mg/kg body weight and day, the lowest dose, could be derived for foetotoxicity and decreased birth weight in the male animals. In rats, the NOAEL for behavioural toxicity is 291 mg/kg body weight and day in male pups. From a one‐generation reproduction toxicity study in mice, a NOAEL of 1410 mg/kg body weight and day could be derived for foetotoxicity and decreased number of live pups. The NOAEL/LOAEL for developmental toxicity and foetotoxicity can be scaled to concentrations of 32/107 and 84/252 mg/m3, respectively, at the workplace. Thus, damage to the embryo or foetus is unlikely when the MAK value of 0.58 mg/m3 is observed, and the classification in Pregnancy Risk Group C is confirmed.

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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:26 January 2017
Deposited On:18 Oct 2019 08:14
Last Modified:18 Oct 2019 08:15
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb8474yold0062

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