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:

Three groups, each of 5 female mice were treated with 25μl of the test item suspended in acetone/olive oil carrier (3:1) at concentrations 25, 12.5 and 6.25% w/v. A fourth group received only the carrier. The item was applied topically on the entire dorsal surface of each ear on Day 1, 2 and 3. On Day 6 mice were dosed with 20μCi3H-methyl thymidine and 5 h later they were sacrificed. The thymidine incorporation in the excised and pooled (per group) lymph nodes was measured. The mean stimulation index (SI) (pooled radioactive incorporation in group/pooled radioactive incorporation control) of each group was calculated. A historical positive group (phenylenediamine) was included. Details of housing and feeding conditions are given. Body weights were recorded individually and were within normal fluctuations. All the animals survived throughout the test without clinical signs. None of the three concentrations reached an SI >3, consequently aluminium dross is not expected to have sensitizing effects.

Migrated from Short description of key information:
The stimulation index of aluminium dross from a local lymph node assay to female mice at concentrations of 25, 12.5 and 6.25% w/v aluminium dross in acetone/olive oil was in every case below 3. As a result the substance is not expected to exhibit sensitizing properties

Justification for classification or non-classification

According to OECD 429 and the criteria given in Annex I of Regulation (EC) 1272/2008, the test item ALUFLUX or Aluminium dross or gray Aluminium dross, as described in this report is expected to have no sensitising properties and therefore, should not be regarded as a dermal sensitiser.