Hexanoic acid, 3,5,5-trimethyl-, 2,2,6,6-tetramethyl-1-[2-[(3,5,5-trimethyl-1-oxohexyl)oxy]ethyl]-4-piperidinyl ester

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:
- Name of the substance on which testing is proposed to be carried out:
Hexanoic acid, 3,5,5-trimethyl-, 2,2,6,6-tetramethyl-1-[2-[(3,5,5-trimethyl-1-oxohexyl)oxy]ethyl]-4-piperidinyl ester

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Available GLP studies are part of the registration dossier. A GLP-compliant combined repeated dose toxicity / screening for reprotoxicity study according to OECD TG 422 in rats after oral administration is available. However, this data do not fulfil the requirements of a full prenatal developmental toxicity/teratogenicity study in rodents according to OECD TG 414.
- Available non-GLP studies: There are no non-GLP studies regarding the endpoint developmental toxicity/teratogenicity.
- Historical human/control data: Databases containing potential information on developmental toxicity/teratogenicity of the substance in published and internal data on the substance were searched and no contributing information was found.
- (Q)SAR: There are no QSAR models that allow a reliabe and adequate prediction of the potential of developmental toxicity/teratogenicity. Therefore, animal testing can not be replaced.
- In vitro methods: There are no in vitro methods that allow a reliabe and adequate prediction of the potential for developmental toxicity/teratogenicity.
- Weight of evidence: Considering the lack of in-vitro methods, QSAR models and prenatal developmental toxicity/teratogenicity studies on the substance itself and potential analogues, a weight-of-evidence assessment is not possible.
- Grouping and read-across: Since none of potential candidates for read-across has been tested for developmental toxicity/teratogenicity in rodents according to OECD TG 414, read-across is not possible.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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:
Based on the existing data and hazard and use profile of the substance in question, it is not possible to apply specific adaptation possibilities listed in Annexes IX and X. Thus, a GLP-compliant developmental toxicity study in the rat via the oral route following OECD TG 414 is proposed.

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

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate

EC Number:

941-267-1

Cas Number:

1445870-18-7

Molecular formula:

C29H55NO4

IUPAC Name:

2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage