Registration Dossier
Registration Dossier
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EC number: 201-051-3 | CAS number: 77-71-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity with DMH
Haworth (1982) – reliability 1
Salmonella-microsome pre-incubation assay (Ames test)
Type of genotoxicity: Gene mutation
Type of study: bacterial reverse mutation assay
Jagannath (1978) – reliability 2
Mutagenicity evaluation of dimethylhydantoin in the Ames Salmonella/Microsome plate test
Type of genotoxicity: Gene mutation
Type of study: bacterial reverse mutation assay
Thilagar (1982) – reliability 2
Cytogenicity study Chinese Hamster Ovary (CHO) cells in vitro
Type of genotoxicity: Chromosome aberration
Type of study: In vitro mammalian chromosome aberration test
Kirby (1983) - reliability 2
L5178Y TK+/- Mouse Lymphoma Mutagenesis Assay
Type of genotoxicity: Gene mutation
Type of study: mammalian cell gene mutation assay
Thilagar (1982) - reliability 1
Unscheduled DNA synthesis in primary cultures of rat hepatocytes (by autoradiography)
Type of genotoxicity: DNA damage and/or repair
Type of study: DNA damage and/or repair, Unscheduled DNA synthesis in mammalian cells in vitro
Genetic toxicity studies carried out on NaDMH
Thompson & Bowles(2006) – reliability 1
Reverse Mutation Assay using Salmonella Typhimurium (Ames Test)
Type of genotoxicity: Gene mutation
Type of study: bacterial reverse mutation assay
Wright/Durward(2007) – reliability 1
Chromosome aberation test in human lymphocytes in vitro
Type of genotoxicity: Chromosome aberration
Type of study: In vitro mammalian chromosome aberration test
Conclusion:
All studies were in agreement, all 5 studies demonstrated the dimethyhydantoin exhibited no genotoxic effects.
The studies carried out on the analogue NaDMH deonstrated that 5,5 -dimethylhydantion, sodium salt exhibited no genotoxic effects and confirmed the non genotoxic effects of DMH.
The british HSE accepted in 2006 read accross data generated with DMH for the ELINCS notification of NaDMH
Short description of key information:
The genotoxicity of DMH has been investigated using four assays: the Ames test and the Mouse Lymphoma mutagenesis assay for gene mutation, the cytogenicity study on ovary cells in vitro for chromosome aberration and the Unscheduled DNA synthesis assay in rat hepatocytes. In all assays DMH did not cause any genotoxic effects via gene mutation, chromosome aberration, cytogenicity or Unscheduled DNA synthesis.
Further assays were carried out on the analogue chemical NaDMH, the Ames test with 5 strains and the chromosome aberration assay with human lymphocytes. Both tests did not cause any genotoxic effects. This confirms the results performed with DMH
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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