Registration Dossier
Registration Dossier
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EC number: 701-252-0 | CAS number: -
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:
- 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
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Soybean oil, polymerized
- EC Number:
- 614-279-7
- Cas Number:
- 68122-64-5
- Molecular formula:
- Not applicable for UVCB
- IUPAC Name:
- Soybean oil, polymerized
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Soybean oil, polymerized
- Physical state: liquid
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
