Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
TESTING ON VERTEBRATE ANIMALS

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Pre-existing data:
There are no pre-existing data available that would address the study endpoint (GLP or non-GLP). There are no Historical human data that could be used in place of this study.
- (Q)SAR
There are no accepted QSAR approaches for predicting the outcome of this endpoint
- In vitro methods
There are no accepted in vitro approaches for predicting the outcome of this endpoint
- Weight of evidence
There are no data from which to generate a weight of evidence
- Grouping and read-across
We have not identified any suitable analogues that could be used to provide data for this endpoint.
- Substance-tailored exposure driven testing
Exposure-based waiving is not relevant for this substance.


CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Column 2 considerations are not relevant for this substance.

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santoflex 14

Results and discussion

Applicant's summary and conclusion