Butanedioic acid, 1-[2-[(1-oxo-2-propen-1-yl)oxy]ethyl] ester

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

A study was perfonned to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:

- OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)

- Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC.

The test material was considered to be a sensitiser under the conditions of the test.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

MAES contains Succinic Anhydride at concentrations up to a maximum of about 1 %. Cyclic acid anhydrides are irritants to skin and mucous membranes of the eyes and respiratory system. In humans, they can cause irritation and sensitization after direct contact with the skin and the mucous membranes or after exposure by inhalation. The irritative symptoms (itching, lacrimation, sneezing, rhinorrhoea, cough, and dyspnoea) begin immediately following exposure to high concentrations of dusts or vapours.

The most common allergic diseases are rhinoconjunctivitis and asthma, both immediate-type IgE-mediated allergies. Also, late-type respiratory symptoms with specific IgG antibodies have been described. Less frequent consequences are the severe disease called pulmonary disease–anaemia syndrome, contact eczema, contact urticaria, allergic laryngitis, and allergic alveolitis.

Allergic reactions of the skin and conjunctiva and allergic respiratory manifestations are well known effects of occupational exposure to cyclic acid anhydrides. Respiratory diseases include occupational allergic rhinoconjunctivitis and occupational asthma. Urticaria and allergic rhinoconjunctivitis often precede asthma. Cases of haemorrhagic alveolitis, haemorrhagic anaemia, allergic alveolitis, and allergic laryngitis have also been reported in association with exposure to anhydrides. These manifestations of allergic respiratory sensitisation necessitate a self classification of succinic anhydride as a respiratory sensitizer cat. 1 with hazard phrase H334: may cause allergy or asthma symptoms or breathing difficulties if inhaled.

Justification for classification or non-classification

Based on the test results, 2-(acryloyloxy)ethyl hydrogen succinate should be classified as Skin Sens. cat. 1. It contains Succinic Anhydride at concentrations up to a maximum of about 1 %. Cyclic acid anhydrides can cause irritation and sensitization after direct contact with the skin and the mucous membranes or after exposure by inhalation. As a consequence, 2-(acryloyloxy)ethyl hydrogen succinate also has to be classified as cat. 1 for Respiratory Sensitization.