Registration Dossier
Registration Dossier
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EC number: 946-056-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
skin sensitisation (OECD 429, RL1): not sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters (CAS 92969-90-9). was assessed in a local lymph node assay (LLNA) performed according to OECD TG 429 and under GLP conditions (key, 2017). A pre-screen test was performed to determine the concentrations to be used in the main study. The undiluted test substance caused mild clinical signs (piloerection, hunched posture) and mild skin irritation in 2/2 mice, and the highest concentration selected for the main study was therefore a 50% dilution. Mice were exposed daily for 3 consecutive days, to 10, 25 and 50% (w/w) test substance in dimethylformamide or to the vehicle alone, on the dorsum of both ears. On Day 6, mice were injected intravenously with [³H]-thymidine, and 5 hours later the draining auricular lymph node of each ear was excised into PBS and pooled per group. The proliferation activity was measured as a function of isotope incorporation in the lymph nodes. The Stimulation index calculated for the test substance concentrations 10, 25 and 50% were 0.9, 1.1 and 1.4, respectively. All EC values were therefore <3. Reliability checks were performed by the testing laboratory with 5, 10 and 25% hexyl cinnamic aldehyde at least every 6 months to demonstrate the adequacy and reproducibility of the study.
Based on the results of the conducted study, Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters (CAS 92969-90-9) is considered to be not skin sensitising.
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 criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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