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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

The skin sensitization potential of the test article was evaluated in mice. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No. 429 (2002); EC Directive 67/548/EEC, An. V, B.42 (2004); OPPTS 870.2600 (2003) Test substance concentrations for the main study were based on the results of a preliminary study. The test article was combined with a vehicle (Acetone/Olive oil (4:1v/v)) for dosing. In the main study, 3 groups of 5 experimental animals were epidermally exposed to 25%, 50%, or 100% concentrations of the test substance (liquid) in vehicle on 3 consecutive days. 5 vehicle control animals were similarly treated with vehicle alone. 3 days after the last exposure, all animals were injected with 3H-methyl thymidine and after 5 hours the draining auricular lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed and expressed as DPM and a stimulation index was calculated for each group. The majority of nodes were considered normal in size, except for one node of one animal treated at 50% that was reduced in size. No macroscopic abnormalities of the surrounding area were noted. Mean DPM values for the 25%, 50% and 100% were 172, 220, and 179 respectively. The mean DPM/animal value for the vehicle control group was 447. 2 animals treated at 50% were found dead on day 6 after injection of 3H-methyl thymidine. Macroscopic examination did not reveal any abnormalities. No symptoms of systemic toxicity were observed in the surviving animals of the main study. The SI values for the 25, 50 and 100% concentrations were 0.4, 0.5, and 0.4 respectively. There was no indication that the test substance could elicit an SI >3 when tested up to 100%. Based on the results of the study, the test article is not considered a sensitizer.

Migrated from Short description of key information:
A Local Lymph Node Assay (LLNA) has been conducted on HFE-7300. The result of the study is:

Non-sensitizing in a Local Lymph Node Assay according to OECD 429.

Justification for classification or non-classification

Criteria for classifying as a dermal sensitizer are not met.