Registration Dossier

Administrative data

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
other justification
Justification for data waiving:
Reason / purpose:
data waiving: supporting information
sub-chronic toxicity: oral
Type of information:
experimental study planned
Study period:
Study will be conducted upon approval of ECHA.
Justification for type of information:
Hazard endpoint for which vertebrate testing was proposed:
Repeat dose toxicity.

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information:

available GLP studies
No available GLP studies on the substances for the endpoint ‘repeat dose toxicity’.

available non-GLP studies
No reliable non-GLP studies are avaialable for the endpoint ‘ repeat dose toxicity’.

historical human data
No human data suggesting repeat dose toxicity are available for this substance.

No validated (Q)SAR’s exist for this endpoint for this substance

in vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a. With regards to in vitro studies for repeat dose toxicity, the regulatory acceptance of these studies and approaches to replace the animal testing for repeat dose toxicity has not been achieved as
they do not provide equivalent information and thus, cannot be used alone for classification and labelling and/or risk assessment.

weight of evidence
No available studies on the substances for the endpoint ‘repeat dose toxicity’.

No further data exists on analogous substances.

substance-tailored exposure driven testing [if applicable]
Based on existng exposure senario information thiis substance does not qualify for this exemption.

[approaches in addition to above [if applicable]
Not applicable

other reasons [if applicable]
Not applicable

Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.
according to
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion