Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Remarks:
A study proposal is submitted for the source substance (Wax, rice bran, oxidized - 1883583-80-9)
Study period:
after receipt of the final ECHA decision
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS


NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Wax, rice bran, oxidized - 1883583-80-9

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: not available
- Available non-GLP studies: not available
- Historical human data: not available
- (Q)SAR: not suitable
- In vitro methods: not suitable
- Weight of evidence: no data available
- Grouping and read-across: read-across is performed here to Wax, rice, bran, oxidized (see attached justification)

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: flakes

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion