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Description of key information

A Primary Skin Irritation study (key), in vitro skin irritation study (supporting) and Primary Eye Irritation study have been conducted on Isooctyl Acrylate (IOA) (CASRN 29590-42-9).  Based on the results of the studies, IOA should not be classified as a skin or eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin Irritation

Key study:

Undiluted test material (0.5 ml) was applied to intact and abraded skin of 6 albino rabbits. Gauze patches and impervious dressing were placed over the test sites for 24 hours. Skin was examined at 24 and 72 hours to determine irritation scores. The Draize method of scoring was used. Scores of 1 were obtained for all animals at 24 and 72 hours for erythema and eschar formation for both intact and abraded skin. Scores of 0 were obtained for all animals at 24 and 72 hours for edema formation for both intact and abraded skin. The primary irritation score was calculated to be 1.0/8.0. The test material was not a primary dermal irritant based on the test conditions.

Supporting study:

The skin irritation potential of two samples (MTDID 7819CE, MTDID 7819LS) of the test article (CASRN 29590 -42 -9) was evaluated in the reconstructed human epidermal tissue model, EpiDerm. The study was not conducted under GLP conditions but was well documented. The study method was based on OECD Guideline 439. Tissues were exposed to the test article, positive control (5% SDS), or negative control (DPBS) in triplicate. After a 60 -minute exposure period, the tissues were washed with DPBS and incubated for 42 hours. Following incubation, tissue viability was quantified by MTT assay. Tissue viability values were normalized to the negative control group tissue viability mean. Test article-treated tissues with viability greater than 50% are considered not irritating. The viability of MTDID 7819CE was 94% and the viability of MTDID 7819LS was 96%. Based on the results of the study, both lots of the test article are considered not irritating to the skin.

Eye Irritation

 

Undiluted test material (0.1 ml) was instilled into the right eyes of six young adult albino rabbits. The test material was not washed from the eyes. Contralateral eyes were used as controls. Eyes were examined at 1, 24, 48, 72 hours and 5 and 7 days and scored (Draize method). The mean primary irritation scores at examinations: 1-hour (1.0/8.0); 24 hours (0.0/8.0); 48 hours (0.0/8.0); 72 hours (0.0/8.0); 5 days (0.0/8.0); and 7 days (0.0/8.0). At 1-hour, all animals exhibited a slight discharge and four of the animals had slight chemosis. No evidence of irritation was noted at any other examination time. The test material was concluded not to be a primary ocular irritant.

Justification for classification or non-classification

This substance has a harmonized classification of irritating to the eyes, skin, and respiratory tract (Annex I to Directive 67/548/EEC, now Table 3.2 of Annex VI to Regulation (EC) No 1272/2008; Table 3.1 of Annex VI to Regulation (EC) No 1272/2008).

Self-classifications of this substance based on the CLP or GHS criteria do not result in an eye, skin, or respiratory tract irritation classification.

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