Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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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:
- Name of the substance on which testing is proposed to be carried out: NExBTL Renewable Diesel
- Name of the substance for which the testing proposal will be used: Not applicable

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: A guideline OECD 416 study is available in the rat that indicates the NExBTL does not cause significant effects on foetal development. No guideline studies are available to evaluate developmental toxicity in the rabbit.
- Available non-GLP studies: There are no 'non-GLP' studies available to evaluate developmental toxicity in the rabbit
- Historical human data: There are no human data available to evaluate developmental toxicity hazard.
- (Q)SAR: There are no recognised (Q)SAR methods available for reliable prediction of developmental toxicity in the rabbit.
- In vitro methods: Alternative in-vitro strategies to address REACH requirements for developmental toxicity testing in a second mammalian species were considered, including the feasibility of undertaking the Whole Embryo Test in the rabbit (Penman et al. 2016, SOT Abstract 3614, March 2016. Unfortunately, there are however no currently recognised, commercially available, in-vitro methods for reliable prediction of reproductive toxicity in the rabbit.
- Weight of evidence: There are insufficient data available currently to develop a robust weight of evidence approach.
- Grouping and read-across: No data have been identified on structural analogues / surrogates that can be used to predict the developmental toxicity in the rabbit.
- 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:
- NExBTL Renewable Diesel can be used in applications where human exposure may occur. The substance is not a genotoxic carcinogen or a germ cell mutagen. Although existing data indicate that NExBTL is of low toxicological activity, insufficient toxicokinetic data are available to demonstrate that no systemic absorption occurs via relevant routes of exposure.

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:
liquid

Test animals

Species:
rabbit

Results and discussion

Applicant's summary and conclusion