Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available (further information necessary)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral Toxicity

Annex VIII:

An OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) study has been conducted to address this endpoint. However, the study report was provided by the testing laboratory very close to the registration deadline and the content is still under discussion. As such, it is currently not possible to report these results and set final effect levels for this substance. This issue will be revisited once the results are confirmed and an appropriate registration update will be submitted as soon as possible.

Annex IX:

The OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) was only made available very close to the registration deadline. As such, there has not been sufficient time to fully evaluate any effects seen in the study and develop a suitable strategy in order to determine any potential classification and labelling and/or further testing proposals. A registration update will be submitted in due course to address this issue.

Inhalation Toxicity

In accordance with point 8.6.1 and 8.6.2, Column 2 (Specific rules for adaptation from Column 1), of Annexes VIII and IX of Regulation (EC) No. 1907/2006, sub-acute and sub-chronic toxicity studies via the inhalation route do not need to be performed since the substance has a low vapour pressure (< 0.0015 Pa at 25 °C) and use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. On this basis testing via the inhalatory route is considered unnecessary.

Dermal Toxicity

In accordance with point 8.6.1 and 8.6.2, column 1 of Annex IX of Regulation (EC) No. 1907/2006, testing for this endpoint should be performed using an appropriate route of exposure. It is anticipated that a reliable repeat dose oral study will be submitted to fulfil this endpoint. Testing for this endpoint via the dermal route is not considered to be appropriate at this time and is therefore omitted on this basis.


Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
A data waiver has been submitted to address this endpoint.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
A data waiver has been submitted to address this endpoint.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
A data waiver has been submitted to address this endpoint.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
A data waiver has been submitted to address this endpoint.

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for specific organ toxicity, repeated dose.