Registration Dossier

Administrative data

Description of key information

Tin disulfide had no sensitising effect in the murine local lymph node assay according to OECD guideline 429. This was confirmed by a study on the read-across substance tin sulfide.

Key value for chemical safety assessment

Skin sensitisation

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

A key Local Lymph Node Assay (LLNA) with Tin disulfide was conducted to study potential contact sensitisation by measuring lymphocyte proliferative response from auricular lymph nodes following topical application of the test item to the female CBA/Ca mouse ear (Sulaiman, 2012). After a screening phase,  five female mice/group received the vehicle (DMSO) or 30% α-hexylcinnamaldehyde (HCA: positive control in DMSO) or 5, 10, 15, 30 and 50% w/v of Tin disulfide in DMSO on days 1 to 3. On day 6, a volume of 250 µL (20 µCi) of 3H-TdR in PBS was administered to each mouse via the lateral tail vein, and uptake into the auricular lymph nodes draining the site of test item application was measured five hours post administration. Proper conduct of the LLNA was confirmed via a positive response using 30% HCA, which elicited proliferation with a Stimulation Index (SI) value of 6.10, in comparison to vehicle-treated mice.The test item did not elicit erythema, no clinical signs and no effect on body weight gain at the tested concentrations. The test item at dose concentrations of 5, 10, 15, 30 and 50% w/v elicited proliferative response with SI of 0.42, 0.41, 1.98, 2.35 and 2.87, respectively in comparison with the vehicle-treated mice. Tin disulfide therefore did not demonstrate dermal sensitization potential in the mouse LLNA, as the lymph nodes draining the area of topical application did not elicit a proliferative response greater than the 3X threshold.

A supporting Local Lymph Node Assay (LLNA) with Tin sulfide as read across substance (Prochazkova, 2010) was also negative for skin sensitisation. Tin disulfide and Tin sulfide showed a comparable toxicological profile for this endpoint.

 

Short description of key information: Both a key Local Lymph Node Assay (LLNA) with Tin disulfide and a supporting LLNA with Tin sulfide were negative, indicating absence of potential for skin sensitisation. 

Justification for selection of skin sensitisation endpoint: Key in vivo study with reference substance confirming absence of sensitisation.

Justification for classification or non-classification

No classification and labelling is needed for skin sensitisation for Tin disulfide according to EU labelling regulations Commission Directive 93/21/EEC and CLP regulation (No. 1272/2008 of 16 December 2008).