Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation testing is currently ongoing for lithium myristate, lithium docosanoate and lithium 12 -hydroxystearate and the endpoint will be updated when the results are available. Data have also been read across from fatty acids C18 -(unsaturated) lithium salts, which falls within the definition of the lithium salts of monocarboxylic acids C14 -C22 category.

The substances in the category are considered to be similar on the basis that they have common structures of a lithium ion varying only by the length of the fatty acid chain and the presence of unsaturated and/or hydroxyl functional groups. As a result, it is expected that the substances will have similar, predictable properties. Due to the close structural similarity and the narrow range of carbon chain numbers covered in this category, the sensitisation potential is expected to be similar across the category.

Although fatty acids C18 (unsaturated) lithium salts is not in the list of substances being registered, this substance falls within the definition of the lithium salts of fatty acids C14-C22 category (see Category Justification Document) by virtue of its chemical structure and therefore read across from data on fatty acids C18 (unsaturated) lithium salts to other members of the category is considered to be justified.

C18 (unsaturated) lithium salts was subjected to a Local Lymph Node Assay in mice according to OECD Guideline 429. The test material was considered to be a non-sensitiser under the conditions of the test with the highest Stimulation Index of 1.68 at 10% concentration in ethanol/distilled water.

A number of additional supporting studies on the skin sensitisation potential of lithium 12 -hydroxystearate in a grease base using the Magnusson and Kligman maximisation test have been considered. In all cases the results were negative. A published sensitisation study using a lithium complex grease containing 8.8% lithium 12 -hydroxystearate according to the Buehler method also showed no evidence of sensitisation.

On the basis of the category justification and the preamble to this endpoint, it is justifiable to read across the negative result from the fatty acids C18 (unsaturated) lithium salts study to the other members of the category, and together with the results from sensitisation studies on lithium 12-hydroxystearate support the lack of sensitisation potential of the lithium salts of fatty acids in the C14 – C22 category.


Short description of key information:
Local Lymph Node Assay: Stimulation Index <3 at the highest concentration tested.

Justification for selection of skin sensitisation endpoint:
The data are representative of the lithium salts of C14 - C22 fatty acid substances and can be read across to other category members.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification required. Stimulation Index <3 in a LLNA.