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:

One key study in guinea pigs was identified to evaluate the skin sensitising potential of di-tert-nonyl polysulfide.

 

In a key skin sensitization test (Manciaux, 2002; Klimisch score = 2), male and female Hartley guinea pigs (10/sex) were exposed to di-tert-nonyl polysulfide (TPS 37 LS; CAS # 68425-16-1). On day 1 of the induction phase, all animals in the treatment group were administered the following 3 pairs of intradermal injections in the intrascapular region: (1) Freund’s complete adjuvant (FCA) 50% v/v in 0.9% NaCl; (2) TPS 37 LS (25% w/w in corn oil; and (3) TPS 37 LS (25% w/w in corn oil) in a 50% v/v mixture of FCA and 0.9% NaCl. Animals in the control group were administered corn oil using a dosing regimen identical to the one described above. On day 8 of the induction phase, animals in the treatment group were topically administered TPS 37 LS (at the same site) at a concentration of 50% (w/w) in acetone while animals in the control group were topically administered the vehicle control acetone. The application sites were subsequently covered with occlusive dressing for a period of 48 hours. On day 22, all animals of the test and control group were challenged by a cutaneous application of TPS 37 LS (1% w/w in acetone) to the right flank. The left flank served as control and received the vehicle only. Subsequently, the test material and vehicle control were maintained under an occlusive dressing for a period of 24 hours and skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.

No mortality or signs of adverse clinical toxicity were observed at challenge or through the study period. No positive reactions were noted for any of the test (0/20) or control animals (0/10) at 24 and 48 hours. Based on these results, TPS 37 LS was not found to be sensitising in the guinea pig maximisation test.


Migrated from Short description of key information:
One key study in guinea pigs was identified to evaluate the skin sensitising potential of di-tert-nonyl polysulfide. In a maximisation test, di-tert-nonyl polysulfide was not observed to be sensitising to guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

This data is not available


Migrated from Short description of key information:
This data is not available

Justification for classification or non-classification

In a dermal sensitisation study, di-tert-nonyl polysulfide was not observed to be a skin sensitiser in guinea pigs. Therefore, di-tert-nonyl polysulfide does not meet the criteria for classification as a dermal sensitiser under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.