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Description of key information

An in vitro eye irritation study was conducted on C4 methacrylate and anin vivoskin irritation study was conducted on C4 acrylate (structural analogue). The results of the studies were:

 

Eye Irritation: Not irritating (not classified) when tested according to OECD 437.

 

Skin Irritation: Not irritating when tested according to OECD 404 (2002).

Key value for chemical safety assessment

Additional information

Eye Irritation:

The ocular irritation potential of the test article was evaluated in the Bovine Corneal Opacity and Permeability Test (BCOP). The study was conducted according to OECD 437 and was conducted in compliance with OECD GLP regulations. The test article (off-white powder) was dissolved in 0.9% saline to yield a 20% concentration (200 mg/mL). A volume of 0.75 ml of the 20% (w/v) test article formulation in saline, 20% (w/v) imidazole formulation in saline, MEM solution or 0.9% saline was applied to the epithelium of each of the three test article corneas, three positive control corneas, three negative control corneas and three vehicle control corneas in a manner which ensured that the entire cornea was covered. The test article corneas were dosed via the open-chamber method. The negative, positive, and vehicle controls were dosed via the closed-chamber method. All holders and corneas were placed in a horizontal position (anterior side up) in the 32 C incubator for four hours. Following the exposure, all tissues were washed with MEM solution containing phenol red. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were then refilled with fresh MEM solution. Opacity measurements were made following the four-hour exposure and MEM solution refill. Immediately following the four-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 mL of 0.5% sodium fluorescein solution in Dulbecco's phosphate-buffered saline (PBS). Each holder was then returned to the 32 C incubator in a horizontal position (anterior side up) ensuring contact with the fluorescein and the cornea. After 90 minutes, the fluid from the posterior chamber was removed and the amount of dye that passed through the cornea (permeability) was measured as the optical density at 490 nm by a spectrophotometer. Negative, vehicle and positive controls performed as expected, indicating a valid test system. A 4 hour exposure to the test article resulted in a mean In Vitro Irritancy Score (IVIS) of -2.97, corrected mean opacity score of -3.00 and corrected mean optical density of 0.002. Based on the results of the study, the test article is not irritating to the eye.

 

Skin Irritation:

Skin irritation results for C4 sulfonamido acrylate (CAS 67584-55-8) are reported for read across to C4 sulfonamido methacrylate (CAS 67584-59 -2). The primary skin irritation/corrosion potential of T-7600 was assessed in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines described in EC Commission Directive 92/69/EEC, B.4 and OECD No. 404. Three male rabbits were exposed to 0.5 grams of the test article, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No mortality, systemic toxicity, corrosive effects or skin irritation was caused by 4 hours exposure to the test article. Based on the results of this study and according to the EC criteria for classification and labelling requirements, the test substance does not have to be classified and has no obligatory labeling requirement for skin irritation.

 

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, data gaps for mammalian toxicity can be addressed by read across. The read across is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.

Justification for classification or non-classification

Based on the results of the studies, C4 methacrylate is not classified for ocular or dermal irritation according to GHS.

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