Registration Dossier

Administrative data

Description of key information

No specific carcinogenicity data are available on sulfolane, however, their simple chemical structures with no reactive groups and no structural alerts for likely genotoxic carcinogenic activity, together with the conclusion that sulfolane is not genotoxic, provide a strong case for concluding that none will show any significant carcinogenic activity.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no carcinogenicity studies available for sulfolane. However, a consideration of the simple chemical structure, which has no reactive groups and carries no alerts for likely genotoxic carcinogenic activity from established Structure Activity Relationship analysis (Ashby and Tennant, 1988), together with the conclusion that sulfolane is not genotoxic, provide a strong case for concluding that sulfolane will not show any significant carcinogenic activity. Taking these data into account, together with the general lack of toxicity across other endpoints, it is considered that there is no justification for conducting further animal carcinogenicity studies. The above reasoning leads to the conclusion that sulfolane can be considered to have low concern for human carcinogenicity.

References

Ashby J and Tennant RW (1988) Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U. S. NCI/NTP. Mutat Res 204: 17-115.

Justification for classification or non-classification

In accordance with section 1 of REACH Annex XI, testing does not appear to be scientifically necessary since negative genotoxicity data and consideration of their simple chemical structures provide sufficient weight of evidence to conclude sulfolane is unlikely to show any significant carcinogenic activity.

Sulfolane has a low potential for carcinogenicity and therefore do not warrant classification under GHS/CLP.