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Carcinogenicity

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Description of key information

Two carcinogenicity studies have been performed with DMH with both the rat and mouse. The substance is not considered to be oncogenic neither in rat nor in mice. NOAEL > 1000 mg/kg bw/day.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Justification for classification or non-classification

The substance is not considered to be oncogenic neither in rat nor in mice. NOAEL > 1000 mg/kg bw/day. Therefore classification is not required.

As previously stated these studies have been performed on DMH (Dimethyl Hydantoin) and have been used for read-across purposes. A summary of data for read-across of NaDMH with DMH is given in Section 13.

Additional information

The estimation of No Observed Effect Level of DMH greater than 1000 mg/kg bw/day was based upon the observation of no-effect in the neoplastic histopathological data of the high dose group. The absence of effect was due to non-statistically significant observations in the test.

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