Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The study will be available dependent on ECHA 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: ditetradecyl peroxydicarbonate (EC: 258-436-4)

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 as addressed under Annex IX Column 2 8.7 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:
- Study: Pre-natal developmental toxicity study, according to OECD 414
- Species: rat
- Route of application: oral (gavage)

It should further be noted that data of a prenatal developmental / teratogenicity study conducted with the test item will also be applicable for a structural analogue substance that is also registered under Annex IX of REACH (for more details please refer to read-across justification attached to IUCLID Section 13). Therefore, considering animal welfar reasons, the obtained data will be of enhanced use.

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 animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion