Registration Dossier

Administrative data

Description of key information

The test article showed only none to slight signs of irritation on skin and eye of New Zealand White rabbits. The observed scores are not sufficient for classification. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

.Beta.-Cyclodextrin was evaluated in an acute skin irritation study on three adult New Zealand White Rabbits according to a guideline equivalent to OECD 404. An amount of 0.5g of the test article moistened with 0.5 ml of physiological saline was applied to the back of each rabbit. Following application, the test site was occluded with a one-inch square gauze patch. The trunk of each animal was then wrapped with an occlusive binder.

A scaling system 0-4 is used. A total for erythema and eschar formation was added to a total for edema then divided by 4 to yield the individual aniumal score. The mean of the three scores was calculated and this score represents the mean primary irritation score.

24 hours post application, the occlusive binders and patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-abraded test article as possible. Half an hour after unwrapping the exposure sites were examined and scored separately for both erythema and and edema. The exposure sites were again examined and scored at 72 hours post-application. The mean primary irritation score of 0.5 was caused by barely perceptible erythema in the three rabbits at the 24 h interval. No eschar or edema was observed at any interval. All treated sites were completely normal be 24 hours post-application. The substance caused minimal irritation which was not sufficient for classification. 

In another skin irrtation assay with beta-Cyclodextrin (purity 100%) according to OECD Guideline 404 on 6 albino rabbits 0.5 g of the substance was administered to the clipped and shaved skin. The substance was left under occlusive conditions for 23 h. The skin was then observed after 1, 24 and 48 hr, showing an edema score of 0 and also an erythema score of 0 for all animals at all observation times. Only one animal exhibited a erythema score of 0.5 at the 24 h observation interval. The erythema score of this animal returned to 0 after 48 hr and showed full reversibility. Under the conditions used beta Cyclodextrin has to be clssified as not irritant to the skin of rabbits.

 

.Beta.-Cyclodextrin was evaluated in an acute eye irritation study on three adult New Zealand White Rabbits according to a guideline equivalent to OECD 405. 0.1 g of the test article was be instilled into one eye of each animal; the other eye served as the untreated control. The test article was instilled into the eye by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. Observation was performed after 24, 48 and 72 hours, the eyes were examined with fluorescein. Eye irritation was graded and recorded according to the numerical scoring system of Draize 1959. The maximum total score was the sum of all scores obtained from the cornea (opacity and area of cornea involved), iris, and conjunctivae (redness, chemosis and discharge). Total maximum possible score = 110. Only minimal effects were seen on cornea and iris score whereas the conjunctivae score showed a mild irritation at 24 hours. The overall mean irritation score for each time period was 18.7 +/- 8.1 at 24 hours, 5.7 +/- 5.5 at 48 hours and 0 at 72 hours. Therefore all effects were reversible within 72 hours. The substance caused slight irritation which was not sufficient for classification.

In another eye irrtation assay with beta-Cyclodextrin (purity 100%) according to OECD Guideline 405 on 6 albino rabbits received 0.1 ml of the substance. The substance was administered to the conjonctival sac of the right eye of each rabbit. the left eye serving as a control; the instillation was unique. The substance was left in the sack and reading was performed after 1 h and 1, 2, 3, 4 and 7 days after administration. The scoring scheme used was that given by kay and Calanora. Only slight effects were seen in the conjunctiva score (especially chemosis, lachrynation and enanthena) which were fully reversible within 2 days. Under the conditions used beta Cyclodextrin is only slightly irritant to the eyes of rabbits, not relevant for classification according to European legislation.

 

 


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The substance caused none or only slight irritation which was not sufficient for classification.