Lithium bis(fluorosulfonyl)imide

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

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: The results from the combined repeated dose/reprotox study (OECD 422) are ambiguous. The NOAEL was set to 90 mg/kg bw due to reprotox effects in the higher dose group (180 mg/kg bw).
Thus adverse effects are already known which should be evaluated further.

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

According to Annex IX of REACH regulation (data requirements for a registration in the tonnage band 100-1000 t/a), section 8.7.3, an Extended One-Generation Reproductive Toxicity Study shall be proposed if available repeated dose toxicity studies (e.g. 28-day or OECD 421/422) indicate adverse effects on reproductive organs or tissues or reveal other concern in relation with reproductive toxicity.
In vitro methods are not an option to waive the in vivo study according to the 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 ‘toxicity to reproduction’. Studies only exist for substances with significantly different structures. For lithium salts reliable studies exist for ‘toxicity to reproduction’. 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 443 (EOGRTS) is proposed.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)

Justification for study design:

In OECD 422 study no specific adverse effects were observed related to nuerotoxicity or immunotoxicity. Thus a basic study design without extension is suggested.

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