Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.