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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Non sensitising (OECD TG 406, Buehler test, non-GLP)

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a skin sensitisation study, performed similar to OECD guideline 406, twenty guinea pigs were dosed with 0.5 mL neat material in an Elastoplaster on the left site of the animal for six hours. The treatment was repeated twice a week for three weeks. No positive control group was included in the study. Fourteen days after topical induction, challenge dosing for detection of sensitisation was performed on both left and right sides of the animals. For challenge test substance was used. The redness of the skin was measured with a refractometer and was assessed according to the Draize score. There were no deaths or clinical findings. Draize scores from 0 to 1 were observed for all 20 animals. A hair removal reaction was noted. There were no sensitisation differences between left and right side of the animals detected. No contact hypersensitivity was observed in this study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The respiratory sensitization potential of Zenolide is assessed using the integrated evaluation strategy for respiratory sensitization data in the ECHA guidance (R7A, Fig. 7.3-4, 2017).
1) The substance does not have skin sensitizing properties;

2) Then the substance is not considered a respiratory sensitiser.
Therefore, Zenolide is not considered a respiratory sensitiser.

Justification for classification or non-classification

Based on the information presented the substance does not need to be classified for skin and respiratory sensitisation according to EU CLP (EC 1272/2008 and its amendments).