Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Sensitisation

Guinea pigs received three topical applications with 0.4 ml of 10 or 25 % glycidyl methacrylate in dipropylene glycol monomethyl ether during the three-week induction phase. The single challenge application induced slight erythema in these animals (7/10). (The Dow Chemical Company: 1992)

Ou-Yang et al. (1988) reported on delayed and rapid allergy reaction tests in guinea pigs. In delayed allergy reaction test, localized smear applications or intradermal injection with 0.1 ml of 1 % glycidyl methacrylate in acetone induced hyperemia, edema, scleroma and necrosis. Those changes belong to the strong allergenic category. As for rapid allergic reaction test, two tests by active and passive stimulation were conducted. In the active stimulation, 0.5 % glycidyl methacrylate with homologous serum albumin was injected intradermally and the challenge was conducted intravenously. Breathing difficulties, wheezing, increased mouth and nose secretions, spasms and death were observed, belonging to the strong allergic category. In the passive stimulation, firstly, the diluted serum given from the sensitized guinea pig was injected subcutaneously to other animals and one hour later, 0.5 ml of 0.1 % glycidyl methacrylate with homologous serum albumin was injected intravenously to the same animals. Blue circles or spots observed belonged to the strong allergic category. Both the delayed and rapid allergy test results showed that glycidyl methacrylate was a strong sensitizer. The author reported that this might be the reason that the epoxy radical of glycidyl methacrylate easily combined with protein.

There were two data on human patch test.

Three cases of allergic contact hypersensitivity to glycidyl methacrylate used in adhesive sealant manufacturing were reported. Both closed and open patch testing with 1 % glycidyl methacrylate solution in petrolatum was positive in all 3 cases. Symptoms included erythema, edema, and vesiculation and a strong 2+ reaction as scored according to the International Contact Dermatitis Research Group classification. (Dempsey: 1982)

Patch test was conducted for a 31-year-old non-atopic woman, who had worked as a chemist and mixed emulsions used to impregnate paper and textile materials to make them oil and water resistant. In this work, she had been in contact with acrylate derivatives (glycidyl methacrylate, ethoxyethyl acrylate, etc.). In relation to this work, she had a history of recurrent acute vesiculopapular hand dermatitis with severe itching and burning mainly on the fingertips, palmar and dorsal aspects of the fingers, and both palms. As a result of patch test, she reacted only to nickel, glycidyl methacrylate (0.01 and 0.05 % acet.) and ethoxyethyl acrylate among the European standard series and (meth) acrylate series. This reaction to nickel was relevant to her jewely intolerance. (Matura et al.: 1995)

In the European DSD labelling and classification, this chemical is classified as R43, may cause sensitisation by skin contact

Based on these data glycidyl methacrylate is considered to be a skin sensitizer.

Justification for classification or non-classification

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

Skin sensitisation Category 1A (H317)