Methyl benzoylformate

Developmental toxicity / teratogenicity

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:
methyl benzoylformate
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
None available
- Available non-GLP studies
None available
- Historical human/control data
None available
- (Q)SAR
No similar substances with data endpoints available. There are no QSAR models available for this higher tier human health endpoint that are sufficiently validated and acceptable (according to OECD Q/SAR validation criteria).
- In vitro methods
No in vitro methods available for this endpoint.
- Weight of evidence
No similar substances with data endpoints available.
- Grouping and read-across
No similar substances with data endpoints available.
- Substance-tailored exposure driven testing [if applicable]
Not applicable
- Approaches in addition to above [if applicable]
Not applicable
- Other reasons [if applicable]
Not applicable

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 study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:

The registrant proposes to conduct the OECD 414 study as described in the guideline according to GLP at a recognised and reputable testing laboratory. The study will be conducted on the registered substance. The study would be conducted administering doses via gavage seven days per week to ensure that palatability does not interfere with the dose received, normal nutrition, or water intake. The study is proposed to be conducted in the rat as the preferred species of the OECD 414 guideline.
A reliable OECD 421 study is available. No effects were observed in the OECD 421 study. The dose levels for the OED 421 study were 100, 300, and 1000 mg/kg bw/day as derived from a range-finder study. Dose levels for the proposed OECD 414 study are also proposed at 100, 300, and 1000 mg/kg bw/day.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl benzoylformate

EC Number:

239-263-3

EC Name:

Methyl benzoylformate

Cas Number:

15206-55-0

Molecular formula:

C9H8O3

IUPAC Name:

methyl oxo(phenyl)acetate

Test animals

Species:

rat