Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
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: levulinic acid

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: not available
- Available non-GLP studies: not available
- Historical human data: not available
- (Q)SAR: not available
- In vitro methods: not available
- Weight of evidence: no other data is available and a weight of evidence is not applicable.
- Grouping and read-across: no read across data available
- Substance-tailored exposure driven testing: significant exposure may not be excluded

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:
- The reproductive toxicity study needs to be conducted as the substance is not known to be a genotoxic carcinogen nor a germ cell mutagen. The substance is also not of low toxicological acitivity as it is classified in Category 4 for Acute Toxicity.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: OECD 414 methodology

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Principles of method if other than guideline:
OECD 414

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion