Lithium bis(fluorosulfonyl)imide

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:
- Name of the substance on which testing is proposed to be carried out: substance itself [Lithium bis(fluorosulfonyl)imide]


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 available GLP studies on the substances for the endpoint ‘developmental toxicity / teratogenicity’.
- Available non-GLP studies: No available non-GLP studies on the substances for the endpoint ‘developmental toxicity / teratogenicity’.
- Historical human/control data: No human data exist on the substance for the endpoint ‘developmental toxicity / teratogenicity’.
- (Q)SAR: No validated (Q)SAR models exist for the bis(fluorosulfonyl)imide moiety of this molecule regarding ‘developmental toxicity / teratogenicity’.
- In vitro methods:

According to Annex IX of REACH regulation (data requirements for a registration in the tonnage band 100-1000 t/a), section 8.7.2, the standard information required is a pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure.
In vitro methods are not an option to waive the in vivo study according tot he data requirements defined under REACH.

- Weight of evidence: The date found for this substance are insufficient to apply a weight of evidence approach.
- Grouping and read-across: For the bis(fluorosulfonyl)imide moiety no studies exist for structural similar substances for ‘developmental toxicity / teratogenicity’. Studies only exist for substances with significantly different structures. For lithium salts reliable studies exist for ‘developmental toxicity / teratogenicity’. Nevertheless as in the registrant's opinion and according to the guidance documents this is not sufficient to cover the data requirements, no read-across-approach is suggested.
- Substance-tailored exposure driven testing: Not applicable – substance is used in wide-dispersive uses
- Approaches in addition to above: 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:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and
this endpoint.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The oral route is considered to be the most appropiate route of administration.
Thus a study according to OECD 414 Prenatal Development Toxicity Study is proposed. Rat ist he preferred species for this guideline

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

Constituent 1

Reference substance name:

Lithium bis(fluorosulfonyl)imide

EC Number:

686-526-7

Cas Number:

171611-11-3

Molecular formula:

F2 H N O4 S2 . Li

IUPAC Name:

Lithium bis(fluorosulfonyl)imide

Test material form:

solid: bulk

Test animals

Species:

rat