Registration Dossier

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:
- Testing is proposed for Soybean oil, polymerized

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION :
- Available GLP studies: Read Across (Linseed oil, polymerized) combined 28 day repeated dose and repro/developm (OECD422)
- Available non-GLP studies: none
- Historical human data: none
- (Q)SAR: none
- In vitro methods: none
- Weight of evidence: none
- Grouping and read-across: see test substance
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable] : 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 a literature search in the public domain, it was concluded that available literature on developmental toxicity lacks in general sufficient information to clearly identify the test material. This means the literature is considered not reliable for the purpose of fulfilling the current Annex IX requirements.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed. see REACH registration dossier on Linseed oil, polymerized.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Soybean oil, polymerized
- Physical state: liquid

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