Decanal

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

The test will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006 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: Decanal (CAS 112-31-2)

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 adressing developmental toxicity are available with the test substance.
- Available non-GLP studies: No adequate and reliable non-GLP studies adressing developmental toxicity are available with the test substance.
- Historical human/control data: no data available
- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of developmental toxicity.
- In vitro methods: No validated in vitro methods to assess developmental toxicity are available so far.
- Weight of evidence: So far there is no information available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: No suitable read-across options are available.

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:
- In order to fulfil the standard information requirements, a GLP-compliant pre-natal developmental toxicity study in rats via the oral route following OECD guideline 414 is proposed according to Annex IX, Column 1, Section 8.7.2.
Column 2 adaption possibilities at the Annex IX level where considered and do not apply: Based on the available data the test substance is not regarded as CMR substance. In particular it is not known to be a genotoxic carcinogen or germ cell mutagen. In addition it is not classified for reproductive toxicity Cat 1A or 1B in accordance with Regulation (EC) No. 1272/2008. In addition, there are no toxicokinetic studies available which could justify the absence of systemic absorption.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: none

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Version / remarks:

June 2018

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanal

EC Number:

203-957-4

EC Name:

Decanal

Cas Number:

112-31-2

Molecular formula:

C10H20O

IUPAC Name:

decanal

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage