Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS :
This testing proposal has been written to address the information requirements applicable to the substance 1-dodecene, dimer (CAS# 62132-67-6, EC# 814-509-8), as outlined by REACH in Annex IX . The REACH registration dossier for 1-dodecene, dimer was reviewed by lead registrant, member of the HOPA REACH Consortium in order to assess the availability and adequacy of the data for each of the REACH Annex IX requirements, and to identify those endpoints for which additional testing is needed. Consequently, the developmental toxicity in first species data gap endpoint was identified and the testing proposal covering this testing is proposed to support mammalian toxicity endpoint in the registration dossier.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : 1-dodecene, dimer (CAS# 62132-67-6, EC# 814-509-8)
- Name of the substance for which the testing proposal will be used: 1-dodecene, dimer (CAS# 62132-67-6, EC# 814-509-8)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: There are no OECD Guideline 414 studies with rodent species available for 1-dodecene, dimer to evaluate the developmental toxicity endpoint. OECD 414 studies in non-rodents are not available to satisfy the developmental toxicity endpoint in REACH Annex IX. An OECD 415 one generation reproductive toxicity study in rats is available, but this test is not meant to provide complete information on all aspects of developmental toxicity hazards.
- Available non-GLP studies: There are no ‘non-GLP’ studies available for for 1-dodecene, dimer to evaluate the developmental toxicity endpoint in rodent or non-rodent species.
- Historical human data: No human data exist for for 1-dodecene, dimer to evaluate developmental toxicity hazard.
- (Q)SAR: There are no recognised (Q)SAR methods available for reliable prediction of developmental toxicity.
- In vitro methods: There are no in vitro methods that are currently established as reliable predictors of developmental toxicity.
- Weight of evidence: Currently there are insufficient data available to develop a robust weight of evidence approach for the developmental toxicity of for 1-dodecene, dimer.
- Grouping and read-across: this dossier is for a UVCB substance, 1-dodecene, dimer, which is a part of Poly-alfa olefins category approach
- Substance-tailored exposure driven testing: Insufficient data available
- Approaches in addition to above: None applicable
- Other reasons: None identified


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:
- not applicable

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed:
Developmental toxicity testing of 1-dodecene, dimer (CAS number 62132-67-6) via the oral (gavage) route in the rat is proposed. The study will be conducted in accordance with GLP and follow the technical requirements of method B.31 of the Commission Regulation on test methods (as specified in REACH Article 13(3)), equivalent to OECD Test Guideline 414).

Data source

Materials and methods

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

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion