Registration Dossier
Registration Dossier
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EC number: 807-674-2 | CAS number: 109884-54-0
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:
Skin sensitisation
CAS 109884-54-0
The skin sensitising properties of isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester (CAS 109884-54-0) were tested in a study according to OECD TG 429 and in compliance with GLP using the local lymph node assay (LLNA) (Latour, 2014d). In this study groups of five female CBA mice were treated with the test item at concentrations of 25, 50 and 100% (w/w) (highest concentration tested in a preliminary study) in acetone/olive oil 4:1 (v/v). Topical application of 25 µL of the appropriate test substance concentrations was performed daily at the dorsal surface of each ear for three consecutive days. Five days following the first topical application of the test item or vehicle all mice were injected via the tail vein with 250 µL PBS containing 3H-methylthymidine (20 µCi per mouse). Five hours after injection lymph nodes were prepared of each animal, followed by determination of 3HTdR incorporation. Positive and negative controls were included in the study and gave the expected results. The calculated stimulation indices (SI) of the test substance were 1.1, 1.0 and 1.6 for the substance concentrations 25, 50 and 100%, respectively. Thus, under the conditions of the test, the test substance revealed no skin sensitising properties.
Conclusion for skin and eye irritation
In conclusion, a reliable skin sensitisation study is available for the target substance indicating that isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester is considered not to be a skin sensitiser.
Migrated from Short description of key information:
Skin, mouse (OECD 429): not sensitising
Justification for selection of skin sensitisation endpoint:
The reliable GLP compliant OECD Guideline study was choosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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