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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