Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The study will be initiated after a final decision from ECHA and can be finalized within 30 months after the final decision.
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 3-methyl-5-phenylpent-2-enenitrile (EC 299-682-2)


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no GLP studies available covering the information requirements.
- Available non-GLP studies: There are no non-GLP studies available covering the information requirements.
- Historical human data: There are no historical human data available for the substance.
- (Q)SAR: The large number of potential targets/mechanisms associated with reproductive toxicity cannot be adequately covered by a battery of QSAR models. (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chaper R 7a: Endpoint specific guidance)
- In vitro methods: There are currently no validated in vitro tests covering all potential targets/mechanisms associated with reproductive toxicity.
- Weight of evidence: There is no data available which is sufficient for weight of evidence approach.
- Grouping and read-across: There is no data available which is sufficient for a grouping or read-across approach.


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:
- No specific adaptions of the REACH regulation are adequate to generate the necessary information for the test substance in regard to toxicity to reproduction.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed
- Species: rat
- Route of application: oral (gavage)

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
Principles of method if other than guideline:
No data on developmental toxicity is available, therefore an OECD 414 prenatal developmental toxicity study (oral, rat) is proposed to fullfill the requirements of Annex VIII of REACH.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylpent-2-enenitrile
EC Number:
299-682-2
EC Name:
3-methyl-5-phenylpent-2-enenitrile
Cas Number:
93893-89-1
Molecular formula:
C12 H13 N
IUPAC Name:
(2E)-3-methyl-5-phenylpent-2-enenitrile

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion