2,3-epoxypropyl methacrylate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Irritation

Skin irritation

Glycidyl methacrylate induced high irritation to the skin of rabbits (Ou-Yang et al.: 1988). The 0.1 ml applied area showed red, swelled and blistered after one or two days, subdermal bleeding and ulcers after three days, and hard, thicker, cracked, pigmentation after five days. The pathological changes were degeneration and necrosis of surface skin cells, disappearance of cellular boundaries, displaying pink staining material, bleeding in the corium cells and lymph cell infiltration with accompanying formation of abscesses.

There were other data on skin irritation of glycidyl methacrylate. A single covered topical application to the skin of albino rabbits for four hours induced moderate to severe skin irritation including necrosis with slight to moderate edema (Olson: 1960). A 10% solution (aqueous) produced slight redness and edema after 1 application (for 4 hours) and a moderate burn after 2 applications (Olson: 1960). In DOT standard test (equivalent to OECD Test Guideline 404), corrosiveness occurred by 4 hours exposure but not 1-hour exposure (Lockwood: 1991).

Eye irritation

Direct instillation of undiluted glycidyl methacrylate to the eye of albino rabbits induced moderate to severe irritation and corneal damage. Corneal damage did not heal within 7 days post-dosing. This ocular damage was prevented by washing with water within 30 seconds. (Olson: 1960, Smyth: 1969)

In inhalation study using rats, eye irritation was also induced. Acute exposure for 4 hours induced eye irritation at 1,563 mg/m3 and 2,394 mg/m3. Corneal opacity was also observed slightly at 610 mg/m3, and moderately at 1,563 mg/m3 and 2,394 mg/m3. These changes did not heal within 14 days post-exposure. (Nitschke et al.: 1990) In subacute study, rats were exposed at 58.2, 223 and 931 mg/m3, 6 hours/day, 5 days/week for 2 weeks. As a result, eye irritation and corneal clouding were observed at 931 mg/m3. (Landry et al.: 1991)

Respiratory irritation

Labored breathing was induced in rat by acute inhalation exposure for 4 hours at 1,563 mg/m3 and 2,394 mg/m3 (Nitschke et al.: 1990). In another acute inhalation study, changes in lungs, thorax, respiration, etc. were observed in rats, rabbits, guinea pigs and dogs. In this study, exposure was conducted at 1,400 mg/m3 for 6 hours (Haag: 1953). These changes may be resulted from respiratory irritation of this chemical.

In inhalation repeated dose toxicity studies, there were also many changes in respiratory tract, such as noisy and difficult respiration (mouth breathing), and hyperplasia, necrosis and inflammation in nasal tissues. In one subacute toxicity study, rabbits were exposed at 2.9, 12, 29 or 60 mg/m3 6 hours/day, daily for 13 consecutive days. Treatment-related degeneration of the nasal olfactory epithelium was observed at 12 mg/m3. At 29 and 60 mg/m3, there were olfactory epithelial degeneration, and the hyperplasia, erosions, ulcers and inflammation of the nasal epithelium. After 4-week recovery period, there was complete reversibility of these changes except for olfactory epithelial degeneration observed at 29 and 60 mg/m3, which showed only partial reversibility. At 12 mg/m3, nasal tissue was indistinguishable from controls at one month post-exposure. (Cieszlak et al., 1996).

In another subacute inhalation toxicity study rats were exposed to glycidyl methacrylate at concentrations of 58.2, 233 or 931 mg/m3 for 2 weeks (6 hours/day, 5 days/week) (Landry et al.: 1991). These three concentrations were calculated as 7.09, 28.4 or 113 mg/kg/day. Decrease in body weight was observed at 233 and 931 mg/m3. At 931 mg/m3, general debilitation with noisy and difficult respiration (mouth breathing), eye irritation, corneal clouding and distended abdomen (day 4) were observed. The animals at 931 mg/m3 were terminated early on day 4 because of the severity of the respiratory and ocular effects. Microscopically, there was severe multifocal necrosis and inflammation of the olfactory epithelium in the nasal cavity. At 233 mg/m3, there were slight to moderate multifocal necrosis, and inflammation of the respiratory and olfactory nasal epithelium. At 58.2 mg/m3, microscopically there was very slight multifocal necrosis of individual respiratory epithelial cells in 3 of 5 males and in 2 of 5 females. These changes in respiratory tract were considered due to irritation of glycidyl methacrylate. There were no histopathological changes in any other tissues. Therefore, 58.2 mg/m3 (7.09 mg/kg/day) was considered to be LOAEL because of tissue damages in respiratory tract.

In the European DSD labelling and classification, this chemical is listed as R36/38, irritating to eyes and skin.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

According to the available studies glycidyl methacrylate must be classified according to REACH and CLP as:

Eye irritant Category 1 (H314)

Skin corrosive Category 1C (H314)

STOT SE Category 3 (May cause respiratory irritation) (H335)

STOT RE Category 1 (Causes damage to the respiratory tract through prolonged or repeated inhalation) (H372)