Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No effects on fertility and reproductive performance have been found in mice after exposure to 5, 12 or 30 ppm sulfur dioxide. The duration of exposure before mating, however was rather short (9 days) and is not sufficient for detecting effects on spermatogenesis. In a 21 week inhalation study with rats, no histological changes were found in the tests. Exposure to sulfite concentrations relevant for systemic sulfur dioxide exposure did not result in effects on reproductive organs or on fertility.

In rabbits a NOAEC of 70 ppm was established for fetotoxicity and teratogenicity in the absence of signs of maternal toxicity. In mice fetotoxicity was observed but no developmental toxicity, the LOAEC was 25 ppm.

Entry adopted from the OECD SIAR on sulfur dioxide without modification.




Short description of key information:
No effects on fertility and reproductive performance have been found in mice after exposure to 5, 12 or 30 ppmsulfur dioxide.

Effects on developmental toxicity

Description of key information
The effects described in developmental toxicity studies on foetuses were only observed at exposure levels with markedly maternal toxicity.
Additional information

The database is sufficient for evaluation of the developmental toxicity of sulfur dioxide. In rabbits a NOAEC of 70 ppm was established for fetotoxicity and teratogenicity in the absence of signs of maternal toxicity. In mice fetotoxicity was observed but no developmental toxicity, the LOAEC was 25 ppm at signs of maternal toxicity.


Justification for classification or non-classification

Based on the weight of evidence from the available developmental toxicity and studies reporting effects on fertility and the relevant information on the toxicokinetics behaviour in animals, it is concluded that sulfur dioxide does not present a reproductive toxicity hazard. The effects described in developmental toxicity studies on foetuses were only observed at exposure levels with markedly maternal toxicity.

For the reasons presented above, no classification for reproductive toxicity is required.