Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
after final test decision, likely 2018-2019
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 3,5-dimethyl-1,2-dioxolane-3,5-diol (formerly 2,4-pentanedione, peroxide)
- Name of the substance for which the testing proposal will be used [if different from tested substance]: same as above

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: No pre-natal developmental toxicity GLP study is available.
- Available non-GLP studies: No pre-natal developmental toxicity non-GLP study is available.
- Historical human data: Not available.
- (Q)SAR: Not suitable for this endpoint.
- In vitro methods: No in vitro test to address this endpoint is available.
- Weight of evidence: No relevant structural analogs; CAS 1338-23-4 and CAS 24748-23-0 were explored as the best possible candidates, but ruled out after comprehensive analysis of all available phys-chem and toxicological data.
- Grouping and read-across: No relevant structural analogs; CAS 1338-23-4 and CAS 24748-23-0 were explored as the best possible candidates, but ruled out after comprehensive analysis of all available phys-chem and toxicological data.
- Substance-tailored exposure driven testing [if applicable]: Not applicable.
- Approaches in addition to above [if applicable]: None
- Other reasons [if applicable]: 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:
- Specific adaptatoins described in column 2 are not applicable.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]

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

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion