Lithium isooctadecanoate

Endpoint summary

Description of key information

In vitro studies on dermal irritation have been conducted on lithium isooctadecanoate. No irritant responses leading to classification were observed.

 

In vitro studies on ocular irritation are currently ongoing on lithium isooctadecanoate.In vitro and in vivo studies on ocular irritation have been read across from fatty acids C18 (unsaturated) lithium salts in which no classifiable irritant responses were observed.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro skin corrosion and skin irritation studies have been conducted on lithium isooctadecanoate. The studies are GLP-compliant and follow OECD guidelines 431 and 439 respectively. The skin corrosion study showed the relative mean viability of the test material treated tissues was 104.3% after 3 minutes exposure and 104.0% after 60 minutes exposure. Therefore, lithium isooctadecanoate was considered to be non-corrosive to the skin. The skin irritation study showed a relative mean viability of the test material treated tissues of 93.1% after 15 minutes of exposure and so lithium isooctadecanoate was considered to be non-irritant. These results are supported by data on the structural analogue, fatty acids C18 (unsaturated) lithium salts, which was also shown to be non-corrosive and non-irritant to skin.

  

There are no data available on eye corrosion or eye irritation for lithium isooctadecanoate but in vitro studies on ocular irritation are currently ongoing. On the basis of the data read across from fatty acids C18 (unsaturated) lithium salts, lithium isooctadecanoate is considered to be non-irritant to eyes.

 

Eye irritation studies on fatty acids C18 (unsaturated) lithium salts have been read across to lithium isooctadecanoate on the basis that the substances have common structures of lithium salts of C18 fatty acids, varying only by the presence of a methyl group or unsaturated carbon-carbon double bonds. See IUCLID section 13 for read across justification.

 

The study on fatty acids C18 (unsaturated) lithium salts is GLP-compliant and follows a reliable alternative method to the in vivo rabbit Draize eye irritation test. The study used human derived keratinocytes to form a corneal epithelial tissue reconstruct and this method is recommended by ECVAM for inclusion in a formal international validation study. The eye irritation study showed the relative mean viability of the test material treated tissues to be 86.5% after 10 minutes of exposure, so fatty acids C18 (unsaturated) lithium salts is considered to be non-irritant.

 

An in vivo eye irritation study on fatty acids C18 (unsaturated) lithium salts has been read across to lithium isooctadecanoate. The study is GLP-compliant and follows OECD guideline 405. A single application of fatty acids C18 (unsaturated) lithium salts to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. One treated eye appeared normal at the 72 hour observation and the other treated eye appeared normal at the 14 day observation. Fatty acids C18 (unsaturated) lithium salts produced a maximum group mean score of 12.0 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. Fatty acids C18 (unsaturated) lithium salts did not meet the criteria for classification under EU CLP.

Justification for classification or non-classification

Skin irritation: Not classified. Study was negative.

 

Eye irritation: Not classified. Data read across from fatty acids C18 (unsaturated) lithium salts (not classified - studies were negative).