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Diss Factsheets

Administrative data

Description of key information

skin: Not irritating (Arcelin, 2002)
eye: Risk of serious damage to eyes (Arcelin, 2002)

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:
adverse effect observed (irritating)

Additional information

Skin

The primary skin irritation potential of UAX-1179 was investigated by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits under GLP according to OECD TG 404 (Arcelin, 2002). The test item did not elicit any skin reactions at the application site of any animal at the 24-, 48- and 72-hour readings (all scores 0). Thus, UAX-1179 is considered to be “not irritating” to rabbit skin.

Eye

The primary eye irritation potential of UAX-1179 was investigated by instillation of 0.1 mL into the left eye of one young adult New Zealand White rabbit in a GLP-Guideline study (Arcelin, 2002). The eye reactions (mean values from 24 to 72 hours) consisted of grade 3.00 corneal opacity, grade 1.00 iris lesions, grade 2.00 redness of the conjunctivae and grade 2.00 chemosis of the conjunctivae.

The instillation of UAX-1179 into the eye of a single male rabbit resulted in moderate to severe ocular changes. The animal vocalized immediately after treatment and a marked opacity, affecting up to the whole area of the cornea was present at the 1-hour reading. The corneal opacity accompanied by reddening of the conjunctivae and sclera, swelling and discharge were evident throughout the 72 hour observation period. Blood was also present around the eye at the 1-hour reading and ruptured blood vessels were evident during the observation period. There was no indication of reversibility of the effects at the 72-hour reading and the animal displayed signs of distress and pain during the examination. Based on these results the animal was prematurely sacrified and no further animals were treated. Based upon the classification criteria of EEC Commission Directive 93/21/EEC of April 27, 1993, UAX-1179 is considered to be “R41- Risk of serious damage to eyes”.

Respiratory tract

There is no data for Irritation to respiratory tract by UAX-1179. Exposure of humans by inhalation is not likely because of the low vapour pressure of UAX-1179. The formation of aerosol can be excluded by uses (see 3.5).


Effects on eye irritation: highly irritating

Justification for classification or non-classification

DSD: Xi; R41, risk of serious eye damage

CLP: Eye damage cat 1; H318, Causes serious eye damage, with signal word: danger