Registration Dossier
Registration Dossier
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EC number: 204-594-4 | CAS number: 123-04-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The key study was performed according to OECD guideline 429 in compliance with GLP (BASF SE, 2012). In this study the test item 2-Ethylhexylchloride was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA) in CBA/CaCrl mice. Test item solutions at 25, 50, and 100% (w/w) were prepared in the vehicle acetone:olive oil (4+1 v/v). The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.
Stimulation Indices (S.I.) of 2.12, 4.54, and 6.98 were determined with the test item at concentrations of 25, 50, and 100% (w/w) in acetone:olive oil (4+1 v/v), respectively, and an EC3 value of 34.1% (w/w) was calculated. The DPM values showed a statistically significant and biologically relevant increase in all dose groups in comparison to the vehicle control group and furthermore, a clear dose dependent increase in DPM value was observed. This finding was confirmed by the lymph node weight and lymph node cell count, where a statistically significant (p<0.05) and biologically relevant increase was observed in all dose groups in comparison to the vehicle control group. A dose response was also present. The cutoff-value of 1.55 for the lymph node cell count index reported for BALB/c mice for a positive response was exceeded in all test item treated groups.
Conclusion: The test item 2-Ethylhexylchloride was found to be a skin sensitiser under the test conditions of this study.
Migrated from Short description of key information:
Mouse local lymph node assay (LLNA): sensitising
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No data available.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC):
The available experimental test data concerning skin sensitisation are reliable and suitable for the purpose of classification under Directive 67/548/EEC. According to these data the substance is classified as sensitising to the skin (Xi; R43). No classification is warranted concerning respiratory sensitisation due to lacking data.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:
The available experimental test data concerning skin sensitisation are reliable and suitable for the purpose of classification under Regulation (EC) No. 1272/2008. As a result the substance is classified to be sensitising to the skin (Skin sens. Cat. 1B; H317). No classification is warranted concerning respiratory sensitisation due to lacking data.
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