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Naled [MAK value documentation, 2018]


Hartwig, A; MAK Commission; Arand, Michael; et al (2019). Naled [MAK value documentation, 2018]. The MAK Collection for Occupational Health and Safety, 4(3):1171-1177.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the maximum concentration at the work place (MAK value) and the Pregnancy Risk Group of naled [300‐76‐5].

Naled is a cholinesterase inhibitor. In an 13‐week study in rats at 1 mg/m3 there was a 18% inhibition of the cholinesterase activity in erythrocytes. The calculated lower 95% confidence limit of the benchmark dose (BMDL) for a 30% inhibition, which is regarded as not adverse, was 2 mg/m3. A MAK value of 1 mg/m3 was established for the inhalable fraction. It is now lowered to 0.5 mg/m3 taking into account the increased respiratory volume at the workplace (see List of MAK and BAT Values, Sections I b and I c). Since a systemic effect is the critical effect, Peak Limitation Category II is retained and the default excursion factor of 2 confirmed.

For rats, the NOAEL for developmental toxicity was 8 mg/kg body weight and day. Naled was assigned to Pregnancy Risk Group C because the difference between the MAK value and the NOAEL scaled to a concentration in the workplace air was sufficient. There are no new data on developmental toxicity. This classification is retained since now the difference to the MAK value is twice as high.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the maximum concentration at the work place (MAK value) and the Pregnancy Risk Group of naled [300‐76‐5].

Naled is a cholinesterase inhibitor. In an 13‐week study in rats at 1 mg/m3 there was a 18% inhibition of the cholinesterase activity in erythrocytes. The calculated lower 95% confidence limit of the benchmark dose (BMDL) for a 30% inhibition, which is regarded as not adverse, was 2 mg/m3. A MAK value of 1 mg/m3 was established for the inhalable fraction. It is now lowered to 0.5 mg/m3 taking into account the increased respiratory volume at the workplace (see List of MAK and BAT Values, Sections I b and I c). Since a systemic effect is the critical effect, Peak Limitation Category II is retained and the default excursion factor of 2 confirmed.

For rats, the NOAEL for developmental toxicity was 8 mg/kg body weight and day. Naled was assigned to Pregnancy Risk Group C because the difference between the MAK value and the NOAEL scaled to a concentration in the workplace air was sufficient. There are no new data on developmental toxicity. This classification is retained since now the difference to the MAK value is twice as high.

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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:22 Nov 2019 15:53
Last Modified:29 Jul 2020 11:44
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb30076e6519

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