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Key value for chemical safety assessment

Effects on fertility

Additional information

Fertility

There are neither data on fertility nor on effects on male and female reproductive organs after

repeated exposure to DMS.

 


Short description of key information:
EU RISK ASSESSMENT – DIMETHYL SULPHATE

Effects on developmental toxicity

Additional information

Developmental toxicity

In a teratogenicity study, pregnant rats (25 per dose group) were exposed nose only to 0, 0.5, 3.7, or 7.9 mg/m3DMS, 6 hours per day during day 6-15 of gestation (Alvarez et al.,1997). In pregnant rats exposed to 3.7 and 7.9 mg/m3a decrease in food consumption and weight gain was reported.

The NOAEL for maternal toxicity was established at 0.5 mg/m3. 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 decrease of fetal weights is reported.

Therefore it is concluded that a NOAEL of 7.9 mg/m3for developmental effects can be derived.

In a publication of Molodkina et al., it is stated that repeated inhalative exposure to 2.64±0.43 and 0.29±0.02 mg/m3of male and female rats for 4 months did not induce toxic effects on reproductive organs, spermatogenesis and sperm morphology. In addition, following repeated exposure of pregnant Wistar rats, SHK- and CBAxC57BC/GI mice to DMS at concentrations of 0.46±0.05, 12.6±2.2, 20.8±4.7 mg/m3(CBA mice) over the whole gestation period (sacrifice of rats on day 21, sacrifice of mice on day 18) no embryotoxic effects were detected in rats and SHK mice at 0.29±0.02 and 2.69±0.43 mg/m3. In CBAxC57BC/GI mice DMS produced an increase in preimplantation and postimplantation loss (20.5 to 29.1%, control: 11.8%, no further details) (Molodkina et al., 1986). The very limited reporting of study design and results makes the evaluation of the study impossible and it has not be used for risk characterisation.

 

Conclusion

It is concluded that DMS only induced slight developmental toxicity after inhalation at maternal toxic concentrations.

Justification for classification or non-classification

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