Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
2020
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2-PENTENE, 1,1,1,2,3,4,5,5,5(OR 1,1,1,3,4,4,5,5,5)-NONAFLUORO-4(OR 2)-(TRIFLUOROMETHYL)-

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: No GLP prenatal developmental toxicity studies are available for the test substance.
- Available non-GLP studies: Non GLP prenatal developmental toxicity studies are not available for the test substance.
- Historical human data: No historical human data pertaining to prenatal developmental toxicity are available for the test substance.
- (Q)SAR: The chemical class to which the test article belongs is not well represented in current (Q)SAR models and due to the large number of data points required to build a robust model, one cannot be created for this endpoint that would be appropriate for this chemical class.
- In vitro methods: Robust, predictive in vitro methods are not yet available to predict prenatal developmental toxicity.
- Weight of evidence: The reproductive/developmental toxicity screening study conducted on the test substance did not result in adverse effects to reproductive organs or developmental parameters.
- Grouping and read-across: Prenatal developmental toxicity data is unavailable for structural analogs.

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:- There are no Column 2 waviers at Annex IX for a prenatal developmental toxicity study.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design: The study will be conducted via inhalation according to OECD Test Guideline 414: Prenatal Developmental Toxicity Study.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): MTDID 948
- Substance type: Mono-contituent
- Physical state: Liquid
- Analytical purity: 94.11%
- Purity test date: 18 October, 2004
- Lot/batch No.: PDC Lot 4
- Expiration date of the lot/batch: October 2006
- Storage condition of test material: Room temperature
- Other:

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion