4H-3,1-benzoxazine-2,4(1H)-dione

Endpoint summary

Additional information

There are reliable data from animal studies available to assess the skin and eye irritation potential of the substance.

skin

In a study following a standardized test protocol (BASF test), clipped skin areas of two Vienna White rabbits received a 50% aqueous solution of the test substance (purity unknown). The skin areas were treated for 1, 5 or 15 min or for 20 h under occlusive conditions. No erythema and no edema were observed in the 1, 5 and 15 min treatments, respectively (score 0 according to the OECD/Draize scheme). In the 20 h treatment, questionable erythema (mean score 1.0) were observed in both animals in the 24 and 48 h reading (the 72 h reading was not performed); slight edema was observed in only one animal at the 24 h reading leading to a mean edema score of 0.33 considering the relevant reading period of 24 to 48 h; the effects were reversible at least within 8 days. The observation period was finished after the 8 day reading. The test substance was considered as not irritant to the skin (BASF 1971).

Additionally, the application of 50 mg of the unchanged test substance (technical grade) to the auricular skin of two rabbits for 24 hours under semiocclusive conditions did not produce any sign of irritation in a test following a standardized protocol (BAYER 1970).

Data from a standardized test with eight volunteers provided comparable, negative results. Here, 50 mg of the test substance (technical grade) was applied to the subjects for 24 h under semiocclusive conditions. During the observation period of further 7 days no signs of irritation were observed (BAYER 1970).

eye

In a study following a standardized test protocol (BASF test), 50 µL of the unchanged test substance (purity unknown) was administered to the eyes of two Vienna White rabbits; the eyes were not rinsed. The relevant reading period was 24-48 h since the 72 h reading was not performed. Completely reversible effects were slight corneal opacity (mean OECD/Draize score 0.75, reversible within 5 days) and slight to moderate chemosis (mean score 0.75; reversible within 48 hours). A slight to moderate conjunctivae redness (mean score 1.25) was not completely reversible within the observation period of 8 days (score 1 in one animal). Hemorrhage was observed in both animals in the 24 and 48 h reading. According to the conditions of the test, the test substance does not fullfil the criteria for classification following 67/548/EEC and GHS requirements, respectively. However, in comparison with the actual OECD guideline only half of the recommended amount was applied here. Stronger irritation effects are assumed if an eye irritation study would be performed according to OECD 405 (BASF 1971).

In another study, instillation of 50 mg of the unchanged test substance (technical grade) into the eye of two rabbit in a standardized test produced no signs of irritation (BAYER 1970). Also here, the applied amount of test substance is lower than recommended in the actual guideline.

Justification for classification or non-classification

Following the available test results, the test substance has not to be classified as skin irriating according to 67/548/EEC and GHS requirements, respectively.

The test substance is classified as irriating to the eye (R36) following Annex I of 67/548/EEC. The respective GHS category would be 2A. However, the available experimental data does not support this classification directly. In addition, the test substance is listed in Annex VI to Regulation (EC) No. 1272/2008 and classified as irritating to skin (Cat.2 according to GHS criteria).