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Skin irritation

Hopf (1968) investigated the skin irritation potential of the test material by subjecting 100 people to a concentrated form in a closed epicutaneous lobule test, conducted according to the Bloch and Jadassohn method. Twenty eight of the subjects were skin sensitive and allergic. Patches were applied on the back and inside of the upper arm. Dermal readings were taken after 24 hours and then after 48 and 72 hours. During the course of the study no case of skin irritation was noted in any of the subjects. Since the specimens were tested in concentrated form, under extreme test conditions (covering in humid chamber), it was concluded that toxic effects on human skin can be excluded.

Skin sensitisation

Kligman (1973) studied the skin sensitisation potential of the test material. A maximisation test was conducting 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 with a group of healthy inmate volunteers. During the test, the test material was applied under occlusion to sites on the volar forearms of 25 healthy male volunteers, for five 48 hour periods administered on alternate days. The patch sites were pre-tested for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a 10 day rest period, challenge patches of the test material were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one hour applications of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.

Before the maximisation test was conducted, the test material was pre-tested on 5 subjects in order to determine whether sodium lauryl sulfate pre-treatment was required. A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from the test material and it was decided to use sodium lauryl sulfate as a pre-treatment in the test.

Under the conditions of the study there were no instances of contact sensitisation from the test material during the maximisation test. It is therefore considered unlikely that the test material is a skin sensitizer.

The methodology and results in both studies were reported in very limited detail. It was not possible to assess the quality of the reported results from the data presented. From the limited information available, the study appears to have been conducted in compliance with good scientific principles. Both studies were therefore assigned a reliability score of 4 in accordance with the principles for assessing data quality as described in Klimisch (1997).

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