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Di-n-butyl phthalate [MAK Value Documentation, 2015]


Hartwig, A; MAK Commission, t; et al; Arand, Michael (2016). Di-n-butyl phthalate [MAK Value Documentation, 2015]. The MAK Collection for Occupational Health and Safety, 1(4):2571-2586.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the carcinogenicity and developmental toxicity of di‐n‐butyl phthalate. The literature has been checked for new studies relevant to the evaluation considering all toxicological endpoints.

The assumption made in the documentation from 2010 that the squamous metaplasia in the larynx of rats in the 29‐day inhalation study will not increase over time is supported by the results of inhalation studies with glycerine and butynediol. The maximum concentration at the workplace (MAK value) of 0,05 ml/m3 and the assignment to peak limitation category I with an excursion factor of 2 have therefore been retained.

In the previous documentation, merely sporadic Leydig cell adenomas were reported in the offspring of rats exposed in utero. From a study in B6C3F1 mice with numerous shortcomings and co‐exposure to other substances, a carcinogenic potential of di‐n‐butyl phthalate cannot be derived. Di‐n‐butyl phthalate, like Di(2‐ethylhexyl) phthalate, activates various receptors, which are assumed to be involved in carcinogenicity. Therefore, di‐n‐butyl phthalate is suspected to be a non‐genotoxic carcinogen and is classified in Carcinogen category 3B. No classification as germ cell mutagen as well as assignment to Pregnancy Risk Group C are confirmed.

Skin absorption does not contribute significantly to systemic toxicity. The substance is not sensitising to skin or airways.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the carcinogenicity and developmental toxicity of di‐n‐butyl phthalate. The literature has been checked for new studies relevant to the evaluation considering all toxicological endpoints.

The assumption made in the documentation from 2010 that the squamous metaplasia in the larynx of rats in the 29‐day inhalation study will not increase over time is supported by the results of inhalation studies with glycerine and butynediol. The maximum concentration at the workplace (MAK value) of 0,05 ml/m3 and the assignment to peak limitation category I with an excursion factor of 2 have therefore been retained.

In the previous documentation, merely sporadic Leydig cell adenomas were reported in the offspring of rats exposed in utero. From a study in B6C3F1 mice with numerous shortcomings and co‐exposure to other substances, a carcinogenic potential of di‐n‐butyl phthalate cannot be derived. Di‐n‐butyl phthalate, like Di(2‐ethylhexyl) phthalate, activates various receptors, which are assumed to be involved in carcinogenicity. Therefore, di‐n‐butyl phthalate is suspected to be a non‐genotoxic carcinogen and is classified in Carcinogen category 3B. No classification as germ cell mutagen as well as assignment to Pregnancy Risk Group C are confirmed.

Skin absorption does not contribute significantly to systemic toxicity. The substance is not sensitising to skin or airways.

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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:English
Date:26 October 2016
Deposited On:17 Oct 2019 12:49
Last Modified:17 Oct 2019 12:51
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb8474yole5816

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