Ethyl 2-methyl-1,3-dioxolane-2-acetate

Endpoint summary

Description of key information

- Sensitisation data (humans)

The substance, when dermally administered to humans in a diluted state, is concluded to be non-sensitising (Epstein (1978 & 1979)).

Additional information

The skin sensitisation potential of the test material is considered in a weight of evidence approach by evaluating two studies in which the test material was administered as a diluted mixture in vehicle.

 

Epstein reported on two Maximisation Tests which were conducted to determine the skin sensitisation potential of the test material in line with the method described in the Journal of Investigative Dermatology, Volume 47, No. 5; 1966 p 393-409. The methodology and results were reported in very limited detail in the reports. It was not possible to assess the quality of the reported results from the data presented. From the limited information available, the studies appear to have been conducted in compliance with good scientific principles. They were assigned a reliability score of 4 according to the criteria of Klimisch (1997).

During the studies, the test material was applied under occlusion to sites on the volar aspects of the forearms of subjects, for five 48 hour periods administered on alternate days. The patch sites were pre-tested for 24 hours with aqueous sodium lauryl sulfate under occlusion. Following a 10-14 day rest period, challenge patches of the test material were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications aqueous sodium lauryl sulphate under occlusion without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right. The challenge sites were read at 48 and 72 hours. Questionable reactions were biopsied and followed by retests, whereby the test material was applied at new sites one week later; they were examined in the same manner.

Before the Maximisation Test was conducted, the test material was pre-tested on all subjects in order to determine whether sodium lauryl sulphate pre-treatment was required. A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-tested with sodium lauryl sulphate.

Under the conditions of both studies there were no instances of contact sensitisation from the test material. It is therefore considered unlikely that the test material is a skin sensitiser.

 

In conclusion, the studies were conducted on a diluted mixture of the registered substance, however, since the test material is marketed and used at lower concentrations, the results of these studies are regarded as being conservative for human exposure. Although there are a number of reporting deficiencies, overall the studies were performed to sound scientific principles. Bearing these points in mind, when considered together, the studies are deemed adequate for assessment as an accurate reflection of the substance.

The available data are considered to be complete and the conclusion that the test material is not a skin sensitiser to humans, was taken forward for risk assessment.