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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
after final decision received
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- ethyl 2-cyano-3,3-diphenylacrylate

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: There are no GLP studies available covering prenatal developmental toxicity information requirements.
- Available non-GLP studies: There are no non-GLP studies available covering prenatal developmental toxicity information requirements.
- Historical human data: There are no historical human data available on prenatal developmental toxicity for the substance.
- (Q)SAR: The available methods are currently not sufficient to address the complex endpoints on reproductive toxicity to replace an animal test (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chaper R 7a)
- In vitro methods: The available methods are currently not sufficient to address the complex endpoints on reproductive toxicity to replace an animal test (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chaper R 7a)
- Weight of evidence: There are no data available which are sufficient for a weight of evidence approach.
- Grouping and read-across: No substances or category of substances are known which apply for read across addressing prenatal developmantal toxicity.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: not applicable

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:
According to Column 2 Annex IX of REACH Regulation a prenatal developmental toxicity study does not need to be conducted if:
the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or
– the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or
– the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.
None of the points above apply for the test substance. Thus, in order to fulfill information requirements stated in column 1 Annex IX of REACH Regulation for substances manufactured or imported in quantities of 100 tpa or more, a prenatal developmental toxicity study (90-days) is proposed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The protocol as described in OECD guideline 414 with rats by the oral route is proposed

Data source

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Etocrilene
EC Number:
226-029-0
EC Name:
Etocrilene
Cas Number:
5232-99-5
Molecular formula:
C18H15NO2
IUPAC Name:
etocrilene

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion