Lithium neodecanoate

Endpoint summary

Description of key information

No sensitisation studies with lithium neodecanoate are available, thus the sensitising potential will be addressed with existing data on the dissociation products lithium and neodecanoic acid. Neodecanoic acid have not shown any skin sensitisation potential in experimental testing.

Read-across from other lithium carbonate indicates no requirement for classification of lithium for skin sensitisation. Lithium neodecanoate is not expected to show signs of dermal sensitisation, since both individual moieties are considered to have no skin sensitising potential.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No sensitisation studies with lithium neodecanoate are available, thus the sensitising potential will be addressed with existing data on the dissociation products lithium and neodecanoic acid.

 

Lithium

Skin sensitisation

A skin sensitisation test in Hartley guinea pigs was performed according to OECD 406 and EU method B.6 (Buehler test). Lithium carbonate Pharmaceutical Grade (0.30 g) was applied undiluted topically to the left shoulders (previously clipped free of hair) of 10 male and 10 female Hartley guinea pigs. The test material was left in contact with the skin for approximately six hours. The animals received three induction treatments one week apart. A concurrent positive control group of 10 animals was treated in a similar manner with DNCB (0.15 % weight/volume). 14 days after the third induction treatment, the animals were challenged with the test material at a virgin skin site. An additional 5 male and 5 female naive animals received 0.30 g of the undiluted test material (challenge control group). The positive control group was challenged with DNCB. Observations for skin reactions were recorded at initiation and termination. All animals remained healthy and gained weight during the study. No skin reactions were noted on any of the test or challenge control animals at any time during the study. Animals in the positive control group had slight erythema and edema following the initial induction application and all but one had well defined to moderate erythema and slight to mild edema following challenge. Under the conditions of this study, the test material is non-sensitizing when topically applied to Hartley guinea pigs.

 

Neodecanoic acid

Skin sensitisation

Neodecanoic acid has been examined for skin sensitization potential in the guinea pig maximization procedure of Magnusson and Kligman. Groups of ten male and ten female guinea pigs were used for the test and a further five males and five females as controls. Induction was accomplished in two stages. 1) Intradermal injection: Two rows of three injections were made, one on each side of the midline in the shorn skin of the shoulder region. 2) Topical application: One week after the intradermal injections, the same area was clipped free from hair. A 4x4 cm patch of filter paper was soaked in a solution of the test material and placed over the injection sites and covered with an occlusive dressing. The dressing was left in place for 48 hours. The challenge procedure was carried out two weeks after topical induction. Challenge was accomplished by topical application of the test material to the flank of animals via an occluded patch. The challenge lasted 24 hours. Immediately after the challenge, and then again at 24 and 48 hours later, each animal was examined for signs of skin sensitization. At no point was there any evidence of skin sensitization produced by neodecanoic acid.   

 

Lithium neodecanoate

Lithium neodecanoate is not expected to have a skin sensitising activity, since the two moieties lithium and neodecanoic acid have not shown any skin sensitisation potential. Thus, lithium neodecanoate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Further testing is not required. For further information on the toxicity of the individual assessment entities, please refer to the relevant sections in the IUCLID and CSR.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Lithium neodecanoate is not expected to show signs of dermal sensitisation, since the two moieties lithium and neodecanoic acid are not considered to have skin sensitisation potential. Thus, lithium neodecanoate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.