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Diss Factsheets

Administrative data

Description of key information

Skin irritation: irritating to the skin (Draize Test, equivalent or similar to OECD TG 404, BASF AG, 80/204, 1981)
Eye irritation: causing severe effects in the eye (Draize test, equivalent or similar to OECD TG 405, BASF AG, 80/204, 1981)

Key value for chemical safety assessment

Additional information

Skin irritation:

In a skin irritation study conducted according to the Draize test white rabbits (4 males and 2 females) were dermal exposed to 0.5 mL of test substance for 24 hours to 6.25 cm² body surface area on intact and abraded skin, under occlusive conditions. Animals then were observed for 8 days. Irritation was scored by means of the Draize scoring system. For experiments with substance applied on intact skin following results were observed: In all animals erythema grade 3 and edema grade 1 to 3 were seen after 24 hrs. Both effects were not reversible within 8 days. Furthermore, at the end of the study (after 8 days) scale formation occurred. In this study, the test substance was a dermal irritant. The mean values of edema and erythema scores were 2.06 and 2.72.


Eye irritation:

(-)-Phenylacetylcarbinol was tested for eye irritation according to the Draize method in 6 rabbits (BASF AG, 1981, 80/204). The eyes were treated with unchanged test item without washing and were examined for reaction during a period of 8 days. The reading time points were 24, 48 and 72 hours, and day 8. Eye reaction was scored according to the Draize scoring system.

All 6 animals displayed slight to severe findings:

- Corneal opacity graded 1 affected all animals, and at test ending, corneal opacity still was evident in 5/6 cases, and reached a score of 2 in one of these 5 animals.

- Effects in the iris graded 1 concerned 4/6 animals at reading time point 24 hour; at 48 and 72 hour, 2 animals still displayed such effects, and in one of these 2 animals, the effect lasted until day 8.

- Obvious conjunctival redness graded 2 was seen in all animals at all relevant reading time points (24, 48 and 72 h); no reversibility was noticed since redness (grade 1 in 5 cases, and grade 2 in one case) still was evident in all animals at day 8.

- Chemosis almost graded 2 was seen at reading time point 24 h in all animals and lasted up to 72 h in 3 cases, with a score of 1; at day 8 no more chemosis was evident.

- Secretion above normal and graded 1 to 2 was reported for all animals and 24 hr and lasted in all animals until 72 hr. In one case, secretion above normals still was observed at day 8.

Moreover, 2 cases of myosis were reported for time point 24 h, and scarring of the eyelid was reported for 3/6 animals at 48 h, and for 5/6 animals at day 8.

All findings are indicative of severe eye irritation due to the test item. Because of corneal opacity that still was seen in 5/6 animals at test ending and because of the scarring of the eyelid that also was reported in 5/6 animals at day 8, the test item is to be designated as causing serioud damages to the eye.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under EU Directive 67/548/EEC. As a result the substance is considered to be classified R38 for skin and R41 for the eye

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under CLP Regulation 1272/2008. As a result the substance is considered to be classified in Category 2 for skin and in Category 1 for the eye.