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1,2-Dimethylhydrazine: MAK Value Documentation, addendum - Translation of the German version from 2021
1Institute of Applied Biosciences. Department of Food Chemistry and Toxicology. Karlsruhe Institute of Technology (KIT) Adenauerring 20a, Building 50.41 76131 Karlsruhe Germany.
1,2-dimethylhydrazine is a carcinogen causing intestinal and vascular tumors in animals. Due to its genotoxic effects and potential for skin sensitization, a maximum workplace concentration (MAK value) cannot be established.
Area of Science:
- Toxicology
- Occupational Health
- Carcinogenesis
Background:
- The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) re-evaluated 1,2-dimethylhydrazine.
- Previous assessments considered various toxicological endpoints.
Purpose of the Study:
- To re-evaluate the occupational exposure limit value (MAK value) for 1,2-dimethylhydrazine.
- To assess its carcinogenic potential and other toxicological effects.
Main Methods:
- Literature search to identify relevant toxicological studies.
- Review of carcinogenicity, genotoxicity, and other toxicity data in animal models.
Main Results:
- 1,2-dimethylhydrazine induced liver, heart, and kidney effects in mice, and liver/bile duct effects in mini-pigs and guinea pigs.
- Carcinogenicity studies showed intestinal, vascular, and lung tumors in rodents, with high rates of colon carcinomas in rats.
- Classified as Carcinogen Category 2 and Germ Cell Mutagenicity Category 3A due to genotoxic and mutagenic properties.
Conclusions:
- 1,2-dimethylhydrazine is a potent carcinogen and mutagen, necessitating its classification in Carcinogen Category 2.
- A MAK value cannot be derived due to its carcinogenic and genotoxic effects.
- Retains 'H' and 'Sh' designations due to dermal absorption potential and structural similarity to known sensitizers.
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