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:

In the key dermal sensitisation study (Harlan CCR, 2010) with DCDPS in dimethylformamide, 4 female mice/dose level were tested at concentrations of 0, 5, 10, or 25 % (w/v) by means of the local lymph node assay (LLNA). During the course of the study, no signs of local irritation were noted. Low and mid dose group animals (5 and 10 %) showed no signs of systemic toxicity. In the high dose group (25 %), one animal died. The remaining animals at this dose level showed no symptoms of systemic toxicity. There was no effect of treatment on the body weights. The stimulation indices were 1.62, 0.83 and 1.00 at 5, 10 and 25 %, respectively. No EC3 value was established. Hexyl cinnamic aldehyde was used as positive control item and induced the appropriate response over background. Using the same dose levels as in the main assay, the EC3 value for the positive control item was 12.9 %. In this study, DCDPS was not a dermal sensitiser.

 

In the supporting dermal sensitisation study (ICI Ltd, 1970), using the technique of Stephens (1967), application of a 10 % solution of DCDPS to the ears of three albino guinea pigs for 3 days did not result in erythema when challenged with doses of 10, 1, and 0.1% four days later. It was concluded that the substance was not a dermal sensitiser.


Migrated from Short description of key information:
DCDPS was no dermal sensitiser in the key local lymph node assay (LLNA) performed according to test guideline OECD 429. In the supporting dermal sensitisation study performed in guinea pigs (abstract, reliability category 4) similarly no sensitising potential of DCDPS was noted.

Justification for classification or non-classification

Based on the key study result, 4,4'dichlorodiphenyl sulfone (DCDPS) is not subject to classification for sensitisation according to Directive 67/548/EEC and Regulation 1272/2008/EC.