Cyclohexapentylose

Endpoint summary

Description of key information

Under the conditions of a repeated insult occlusive patch test the read-across substance .beta.-cyclodextrin did not induce irritation or allergic contact dermatitis in human subjects.

Additional information

.Alpha.-, .beta.- and .gamma.-cyclodextrin are composed of six, seven and eight identical α-D-glucopyranoside units, respectively. The water solubility is between 18 and 232 g/L at 25°C with .beta.-cyclodextrin being the least soluble within this group. The potential for skin irritancy and skin sensitisation can be considered similar and the results from a 9 Repeated Insult (occlusive) Patch Test (9 RIPT) with .beta.-cyclodextrin can be considered as valid and reliable also for the evaluation of .alpha.- and .gamma.-cyclodextrin.

The amount of test material applied to each test patch was approximately 0.2 g. The test material was placed onto Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.

The subjects removed the patch 24 hours after application. Twenty-four hour rest peri-ods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine (9) applications of the test material had been made. Procedurally, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction Phase or, at the discretion of the Study Director, if the skin response warrants a change in site, the patch would be applied to a previously unpatched adjacent site for the next application. If a 2-level reaction (or greater) occurs on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenged with the test material. After a rest period of 15 to 19 days (no further application of the test material, the challenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading. A total of 55 subjects completed the test, 3 subjects discontinued for personal reasons unrelated to the conduct of the study. Scattered, transient, barely perceptible to mild (1 -level) non-specific patch test responses were observed on 3/55 test panelists (subject nos.6, 39, 41) during the induction or challenge phase of the study. None of the non-specific response was irritant or allergic in nature. Under the conditions of a repeated insult occlusive patch test the read-across substance .beta.-cyclodextrin did not induce irritation or allergic contact dermatitis in human subjects.