Octanoic acid, monoester with glycerol

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

The test will be conducted after a final decision on the requirement to carry out the proposed test has been taken and a deadline to submit the information required has been set by the Agency.

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: octanoic acid, monoester with glycerol

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing prenatal developmental toxicity in the rat are available with the registered substance.
- Available non-GLP studies: No non-GLP studies addressing prenatal developmental toxicity in the rat are available with the registered substance.
- Historical human/control data: Historical human data is not available.
- (Q)SAR: The available Q(SAR) methods are not applicable as none of the methods will assess the full scope of prenatal developmental toxicity.
- In vitro methods: No validated in vitro methods to assess prenatal developmental toxicity are available.
- Weight of evidence: There is no information (QSAR, in vitro data, developmental toxicity or fertility data) available that is suitable to assess the prenatal developmental toxicity potential in the rat in a weight of evidence approach.
- Grouping and read-across: There is no data available for suitable source substances addressing prenatal developmental toxicity in the rat.
- Substance-tailored exposure driven testing: This option is not relevant.
- Approaches in addition to above: There are no known alternative approaches to meeting the data requirements according to Annex IX of the REACH Regulation (EC) No. 1907/2006.
- Other reasons: There are no known alternative approaches to meeting the data requirements according to Annex IX of the REACH Regulation (EC) No. 1907/2006.

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 prenatal developmental toxicity study in a first species is a standard information requirement under Annex IX of the REACH Regulation (EC) No. 1907/2006. There is no guideline-compliant data available on prenatal developmental toxicity with the registered substance or suitable source substances. Validated or regulatory accepted alternative methods are not available for replacing animal testing with respect to prenatal developmental toxicity.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: A Prenatal Developmental Toxicity study (OECD TG 414) by oral route will be conducted in the rat with octanoic acid, monoester with glycerol (CAS 26402-26-6, EC 247-668-1).

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

Constituent 1

Reference substance name:

Octanoic acid, monoester with glycerol

EC Number:

247-668-1

EC Name:

Octanoic acid, monoester with glycerol

Cas Number:

26402-26-6

Molecular formula:

C11H22O4

IUPAC Name:

1,3-dihydroxypropan-2-yl octanoate; 2,3-dihydroxypropyl octanoate

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage