Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

One study on reproduction toxicity of DMS published by Bishop et al. in 1997 is available with a reliability score of 3. DMS at a nominal concentration of 75 mg/kg bw was given i.p. to female mice. 15 days after injection, females were euthanised by cervical dislocation and their ovaries removed. After staining, the number of small follicles, medium-sized follicles and large follicles were counted. The size of litters was slightly, but significantly lower and were associated with small follicles. Since only one dose levels was tested, no NOAEL could be derived. The route of application is regarded as not relevant, and thus the study could be regarded as supportive only.

Effects on developmental toxicity

Additional information

One key study with inhalation exposure was identified. In pregnant rats exposed to 0.77 and 1.43 ppm by inhalation, a decrease in food consumption and weight gain of dams was reported. Thus, the NOAEL for maternal toxicity was established at 0.12 ppm. No significant differences in malformations and variations were reported between the fetuses in the control and the experimental groups. At the highest concentration tested, a very slight (not statistically significant) decrease of fetal weights was reported which was regarded as not of toxicological relevance. Therefore, it was concluded that the NOAELfor developmental toxicity can be expected above the highest concentration tested (>1.43 ppm).

Two supportive studies with i.p. injection of DMS are availble and rated with a reliability score of 3. DMS (25 mg/kg bw i.p.) induced significant effects when administered post mating. Pre-implantation loss and post-implantation mortality were significantly with a substantial number of fetal death at 1 h (85%) and at 6 h (74%) post mating and an essential number of deaths at 9h (62% ) post mating. DMS is a strong inducer of anomalies in the classes mid- and late gestational death and to a lesser extend hydrops. It is concluded that the mid- and late gestational death and hydrops are not attributable to structural or numerical chromosome aberrations .

Justification for classification or non-classification

A classification and labelling according to regulation (EC) 1272/2008 is considered not to be required DMS produce only induced slight developmental toxicity after inhalation at maternal toxic concentrations. It is assumed that DMS produces developmental toxicity solely as a secondary consequence of maternal toxicity.