Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Study period:
subject to ECHA approval
Justification for type of information:
A pre-natal developmental toxicity study in the rat (OECD Test Guideline 414) is proposed on Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine and used as read-across to characterise the prenatal developmental toxicity of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine.

TESTING PROPOSAL ON VERTEBRATE ANIMALS
A pre-natal developmental toxicity study in the rat (OECD Test Guideline 414) is proposed.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine
- Name of the substance for which the testing proposal will be used: Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine

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 GLP studies available for the corresponding endpoint
- Available non-GLP studies: No non-GLP studies available for the corresponding endpoint
- Historical human data : No data available
- (Q)SAR: No Reliable QSAR available
- In vitro methods: No reliable in vitro methods are available for the corresponding enpoint
- Weight of evidence: No data available
- Grouping and read-across: used as mentioned below
- Substance-tailored exposure driven testing: Not applicable
- Approaches in addition to above Not applicable
- Other reasons Not applicable


REPORTING FORMAT FOR THE ANALOGUE APPROACH
The full read-across justification document is attached in section 13 of the present IUCLID file.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion