Registration Dossier

Administrative data

Description of key information

A retrospective data audit conducted on a final draft two-year chronic oral toxicity study in rat with 1,3-Dioxolane in drinking water is available. Although the study has never been finalised, it is conclude din the audit that the final draft report contained accurate toxicological information.
Repeated dose toxicity studies by oral and inhalation route are also available.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rat
Quality of whole database:
Two-year chronic study was evaluated as Klimisch 2.

Additional information

In the audit of the final draft 2 year chronic study in rats exposed via drinking water to 0%, 0.003% or 0.1% 1,3 -Dioxolane it was concluded that, although the study has never been finalised, the study contains accurate toxicological information concerning long-term exposure to 1,3 -Dioxolane (administered to the drinking water). An increase in tumour incidence was not reported.

In addition, from the repeated dose toxicity studies (oral and inhalation), no indication for a carcinogenis potential was observed.

As a result of the absence of carcinogenic effects in the repeeated dose toxicity studies, including the chronic study, 1,3 -Dioxolane is considered to be non-carcinogenic.


Justification for selection of carcinogenicity via oral route endpoint:
In the audit of the final draft 2 year chronic study in rats exposed via drinking water to 0%, 0.003% or 0.1% 1,3 -Dioxolane it was concluded that, although the study has never been finalised, the study contains accurate toxicological information concerning long-term exposure to 1,3 -Dioxolane (administered to the drinking water). An increase in tumour incidence was not reported.
In addition, from the repeated dose toxicity studies (oral and inhalation), no indication for a carcinogenis potential was observed.
As a result of the absence of carcinogenic effects in the repeeated dose toxicity studies, including the chronic study, 1,3 -Dioxolane is considered to be non-carcinogenic.

Justification for classification or non-classification

1,3 -Dioxolane is not considered a systemic carcinogen and does not need to be classified for this endpoint (DSD and CLP).