Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
to be agreed by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
99422018

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION

- available GLP studies: None

- available non-GLP studies: None

- historical human data: None

- (Q)SAR: According to ECHA guidance, QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction. (ECHA guidance R.7a, October 2015, page 382).

- in vitro methods:
In vitro studies are not available on the test substance.
Some in vitro test methods have been developped, however, according to Chapter R 7a Version 4.1, the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information (ECHA guidance R.7a, October 2015, page 381).

- weight of evidence: No data is available which allow a weight of evidence approach

- grouping and read-across: not found

- substance-tailored exposure driven testing : Not applicable
- approaches in addition to above: Not applicable
- other reasons: None


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:
Test proposal is fully compliant with ECHA guidance R 7.a (july 2017, version 6). No specific adaptation possibilities of Annexes VI to X (and column 2 thereof) are applicable.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Developmental toxicity study in rat according to OECD guideline


Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion