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Description of key information

A skin irritation study in two New Zealand White rabbits using semi-occlusive dressings. Skin irritiation was evaluated using the Draize method.
A skin irritation study in six New Zealand White rabbits using both abraded and non-abraded skin and fully occlusive dressings. Skin irritation was evaluated using the Draize method.
An eye irritation study in six New Zealand White rabbits. Eye irritation was evaluated using the Draize ocular irritation scoring method.

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:
no adverse effect observed (not irritating)

Additional information

Skin Irritation

Key Study

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced no erythema and no edema. Both treated skin sites appeared normal at the 7-Day observation.

Conclusion

The test item produced a primary irritation index of 0.0 and was not classified as irritant to rabbit skin according to the Draize classification scheme and not classified according to EU classification. No corrosive effects were noted.

Supporting Study

A group of six New Zealand white rabbits were clipped over a wide area. One side of the animals' backs was abraded with a lancet needle. A 0.5 ml potion of the test material was applied to an abraded and an intact portion of the skin on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place. The wrapping was removed at the end of 24 hours and the treated areas were examined. Readings were also made after 72 hours. The Draize method of scoring was employed.

The test substance caused an overall primary irritation score of 1.38. The test substance is not classified in accordance with Regulation (EC) No. 1272/2008

Eye Irritation

In a study conducted according to Section 1500.02 Federal Hazardous Substances Act Regulations CFR 16 P.125 the test chemical was placed into the right eye of each of 6 New Zealand White rabbits. The untreated eye acted as a control. The eyes were not washed after instillation. Treated eyes were examined at 1, 2, 3, 4 and 7 days after instillation.

No irritation score greater than zero was recorded for any tissue of any of the six animals at any of the observation time-points..

The test substance is not an irritant to the eye of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Justification for classification or non-classification

In the Key dermal irritation study, treatment with the test item resulted in an overall primary skin irritation score of 0.0, which is not sufficient for the substance to be classified.

In the supporting dermal irritation study, which used fully occlusive dressings, treatment with the test item caused an overall primary skin irritation score of 1.38, which is not sufficient for the substance to be classified.

Treatment with the test item caused an overall primary eye irritation score of 0.0, which is not sufficient for the substance to be classified.

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