Registration Dossier
Registration Dossier
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EC number: 700-868-7 | CAS number: 54889-63-3
Endpoint summary
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:
The test item Cyclohexane, 1,4-bis(ethoxymethyl)- was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA) according to OECD 429 in mice (BASF SE, 2013, 58V0766/12X375). Test item solution at concentrations of 25, 50 and 100% was prepared in the vehicle acetone:olive oil (4+1, v/v). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation (as determined by a pre-experiment).
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On day 2 and day 3, all animals treated with the test item concentrations of 25, 50, and 100% burrowed themselves into the bedding immediately after the application of the test item. On day 4 and day 5 the animals treated with 100% of the test item showed an erythema of the ear skin (Score 1). In all test groups a statistically significant increase in ear weights (p < 0.05) was observed in comparison to the values of the vehicle control group. For BALB/c mice, a cut-off value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation. All of the indices determined for the test item treated groups reached or slightly exceeded this threshold, thus indicating a slightly irritant property of the test item. In this study Stimulation Indices (S.I.) of 1.38, 1.97, and 2.28 were determined with the test item at concentrations of 25, 50, and 100% (w/w) in acetone:olive oil (4+1, v/v), respectively. Therefore, no EC3 value could be calculated.
The test item Cyclohexane, 1,4-bis(ethoxymethyl)- was thus not a skin sensitiser under the test conditions of this study.
Migrated from Short description of key information:
Skin sensitisation:
- OECD 429: negative
Justification for classification or non-classification
The present data on dermal sensitization do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted.
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