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Administrative data

Description of key information

In vivo eye irritation and skin irritation studies were conducted on PPVE-2. The results of the studies were:

 

Eye Irritation: Not irritating when tested according to OECD 405 (1987).

 

Skin Irritation: Not corrosive when tested according to OECD 404 (1992).

 

Key value for chemical safety assessment

Additional information

Eye Irritation:

 

The primary eye irritation/corrosion potential of the test article was evaluated in New Zealand White Rabbits. This study was performed in accordance with OECD GLP (1999). The study design was based on OECD 405 (1987) and Directive 92/69/EEC guideline B.5 (1992). Approximately 24 hours prior to the study the eyes of all animals were examined using a fluorescein solution. Animals without ocular abnormalities were selected for this study. The test material (0.1 mL) was administered as received to the conjunctival sac of the left eye of three rabbits. The contralateral eye served as the control. The treated eyes were washed with 37 C saline at 24 hours post-dose. The eyes were examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours post-dose using the Draize technique. Sodium fluorescein dye procedures were used at 24 and 72 hours after dosing to improve the evaluation of the cornea. One hour after dosing, the conjunctivae of one animal showed definitely injected blood vessels (score: 1). At 24 hours after dosing, all animals were normal. Based on the results of this study, the test article is not an ocular irritant.

 

Skin Irritation:

 The primary skin irritation potential of the test article was evaluated in New Zealand albino rabbits. This study was performed in accordance with OECD GLP (1999). The study design was based on OECD 404 (1992) and Directive 92/69/EEC guideline B.4 (1992). The hair was clipped from the dorsal skin of three rabbits exposing an area of approximately 25 square centimeters. The test material (0.5 mL) was applied over the surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was affixed to the prepared area on the intact rabbit skin and covered with a semi-occlusive bandage. At the end of the 4-hour exposure all wrappings were removed and the skin was cleaned of residual test substance using tap water. Observations for skin irritation (erythema and edema) were recorded at approximately 30-60 minutes and 24, 48 and 72 hours after unwrapping. There were no abnormal clinical signs, erythema or edema throughout the study. Based on the results of this study, the test article is not a dermal irritant.

Justification for classification or non-classification

Based on the results of the studies, the test article not classified for eye or skin irritation according to GHS.