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Administrative data

Description of key information

An in vivo eye irritation and in vivo skin irritation study were conducted on PPVE. The results of the studies were:

 

Eye Irritation: Severely irritating when tested according to OECD 405 (1987).

 

Skin Irritation: Non-irritating when tested according to OECD 404 (1992).

Key value for chemical safety assessment

Additional information

Eye Irritation:

 

The primary eye irritation potential of the test article (liquid, batch 10B1001) 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 and 7 and 14 days post-dose using the Draize technique. Sodium fluorescein dye procedures were used at 24 and 72 hours and at 7 and 14 days after dosing to improve the evaluation of the cornea. Mean values (over 24, 48 and 72 hours) for each animal: corneal opacity (0.0, 1.0, 1.0); iritis (0.0, 0.67, 0.67); conjunctival redness (0.33, 2.67, 2.67); and conjunctival chemosis (0.0, 1.67, 1.67). Conjunctival redness persisted through Day 7. The animals were normal at 14 days after dosing. Based on the results of this study, the test article is a severe ocular irritant.

 

Skin Irritation:

 

The primary dermal irritation potential of the test article was determined in New Zealand White rabbits. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD 404 (1992). The test article (0.5 mL) was administered unchanged to clipped skin on a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster on the dorsal region of each rabbit. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The test article was left on the skin for a 4 hour exposure. After the exposure period, all remnants of the test article were carefully removed from the skin by washing with warm tap water. Examinations of the skin took place after 30 -60 minutes as well as 24, 48, and 72 hours after patch removal. Erythema, eschar formation and edema were evaluated and scored according to the Draize scale. No signs of irritation were observed during the study. All erythema and edema scores were 0 at 24, 48 and 72 hours in all animals. Based on the results of the study, the test article is not irritating to skin.

Justification for classification or non-classification

Based on the results of the studies, PPVE is not classified for dermal irritation and is a Category 2A severe ocular irritant according to GHS.