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N-Cyclohexylhydroxy-diazene-1-oxide, potassium salt [MAK Value Documentation, 2013]


Hartwig, A; MAK Commission; et al; Arand, Michael (2016). N-Cyclohexylhydroxy-diazene-1-oxide, potassium salt [MAK Value Documentation, 2013]. The MAK Collection for Occupational Health and Safety, 1(3):1662-1676.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt to derive a maximum concentration at the workplace (MAK value), considering all toxicity endpoints. Available unpublished study reports and publications are described in detail. A gavage study with rats given daily doses of the substance for 3 months yielded a NOAEL of 25 mg/kg body weight and day; effects on the blood and liver and mortality occurred at 50 mg/kg body weight and day. Based on this NOAEL, a MAK value of 10 mg/m3 has been established for the inhalable fraction of N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt. The MAK value was derived from a systemic NOAEL; therefore, N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt is classified in Peak Limitation Category II with a default excursion factor of 2 as sufficient toxicokinetic data are not available. Calculations of dermal absorption based on in vitro studies show that dermal absorption would contribute substantially to the systemic toxicity. Therefore, N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt has been designated with an “H”. N‐Cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt is not genotoxic or carcinogenic and limited data show no sensitizing potential in mice. Because there are no studies on developmental toxicity of N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt, it is assigned to Pregnancy Risk Group D.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt to derive a maximum concentration at the workplace (MAK value), considering all toxicity endpoints. Available unpublished study reports and publications are described in detail. A gavage study with rats given daily doses of the substance for 3 months yielded a NOAEL of 25 mg/kg body weight and day; effects on the blood and liver and mortality occurred at 50 mg/kg body weight and day. Based on this NOAEL, a MAK value of 10 mg/m3 has been established for the inhalable fraction of N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt. The MAK value was derived from a systemic NOAEL; therefore, N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt is classified in Peak Limitation Category II with a default excursion factor of 2 as sufficient toxicokinetic data are not available. Calculations of dermal absorption based on in vitro studies show that dermal absorption would contribute substantially to the systemic toxicity. Therefore, N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt has been designated with an “H”. N‐Cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt is not genotoxic or carcinogenic and limited data show no sensitizing potential in mice. Because there are no studies on developmental toxicity of N‐cyclohexylhydroxy‐diazene‐1‐oxide, potassium salt, it is assigned to Pregnancy Risk Group D.

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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:English
Date:25 July 2016
Deposited On:17 Oct 2019 12:22
Last Modified:17 Oct 2019 12:23
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb6660310kse5516

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