Registration Dossier

Administrative data

Description of key information

Skin and eye irritation studies have been conducted on MV31.  The results of the studies are: 
Eye Irritation: Non-irritating when tested according to OECD 405.
Skin Irritation: Non-irritating when tested according to OECD 404.

Key value for chemical safety assessment

Additional information

The eye irritation potential of the test material was determined in New Zealand White rabbits (3, female). The study was conducted according to OECD GLP (1999). The test method was based on OECD 405 (1987), EEC Method B.5 (1992), and US EPA OPPTS 870.2400 (1998). 0.1 mL of the test material was instilled in the conjunctival sac of the left eye of each animal. The right eye of each animal was left untreated to serve as a control. 24 hours after administration the treated eyes were washed thoroughly with isotonic saline. The eyes were examined at 1, 24, 48, and 72 hours. At 24 and 72 hours, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. The cornea (0-4), Iris (0-2), and Conjunctivae (Redness: 0-3, Chemosis: 0-4, and Discharge; 0-3) were examined and scored appropriately at each of the observation period. A conjunctivae redness score of 1 was observed in a single animal at the 24 hour observation period and had resolved by the 48 hour observation. No other scores were noted at any other animals at any other point during the study. Based on the results of the study, the test material is not an eye irritant.

 

The dermal irritation potential of the test article was evaluated in New Zealand White rabbits (3 female). The study was conducted according to OECD GLP (1999). The test method was based on OECD 404 (1992), EEC Method B.4. (1992) and US EPA OPPTS 870.2500 (1998).  Prior to exposure (24 hours) the hair on the left flank of each animal (25 mm2) was clipped. Each animal was treated with 0.5 mL of the test article dosed on a 2.5 cm2 cellulose patch, placed on a piece of surgical plaster and covered with a semi-occlusive bandage. The patch was left in place for 4 hours, after which the remaining test article was removed from the exposure site with warm water. The skin was examined for erythema and edema at 1, 24, 48, and 72 hours. Animals were observed daily for clinical signs and mortality. No abnormal clinical signs were observed in any animals during the study period. No erythema or edema was observed in any animal at any time period during the study. Based on the results of the study, the test article is not irritating to skin.

Justification for classification or non-classification

Criteria for classifying as a skin or eye irritant are not met.