Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
Waiting for ECHA feedback
Justification for type of information:
CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION


PUBLIC SUBSTANCE NAME: 1,4-PHENYLENE BIS[(4-PHENOXYPHENYL)-METHANONE]

EC Number: 620-097-9
CAS Number: 54299-17-1

Date of considerations: 5 November 2019

Hazard endpoint for which vertebrate testing was proposed:

Reproductive toxicity (oral pre-natal developmental toxicity in rats, OECD TG no. 414) with the registered substance;

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were 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 R.7a (October 2015, page 382), QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction.

• 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 (October 2015, page 381), the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information.

• weight of evidence
No data is available which allow a weight of evidence approach.

• grouping and read-across
No data is available which allow a read across approach.

• substance-tailored exposure driven testing [if applicable]
Not applicable

• [approaches in addition to above [if applicable]
Not applicable

• other reasons [if applicable]
None


Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:

Test proposal is fully compliant with ECHA guidance R 7.a (Octobre 2015, page 373). No specific adaptation possibilities of Annexes VI to X (and column 2 thereof) are applicable.

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:
solid

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion