Registration Dossier

Administrative data

Description of key information

Skin irritation- corrosive
Eye irritation- severely irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The test material was evaluated for its potential to produce dermal irritation in New Zealand White rabbits.  In the study, 0.5 ml of the undiluted test material was held under a patch covered with an impervious cuff in continuous 4-hour contact with the skin of six rabbits from which the hair had been closely clipped. Readings for irritation (erythema and edema) were made after patch removal and through either 48 hours or 14 days post application using the method of Draize, et al., 1944. Results indicate that the test material is corrosive to skin.

The test material was evaluated for its potential to produce irritation in the eyes of New Zealand White rabbits.  In the study, one-tenth ml of the undiluted test material was placed into the eye of each rabbit. The ocular reactions were graded at 24 hr intervals after dosing through 7 or 21 days. In the study, satellite groups of 2 animals each received a four or 30 second wash with either distilled water or 0.85% saline solution. Irritation evaluations were made following the method of Draize et al., 1944.  The test material produced severe eye irritation.

The potential of the test material to irritate skin as well as eyes and gastrointestinal mucosa upon contact indicates that this material is also likely to be irritating to the mucosa of the upper respiratory tract. Repeat-dose inhalation exposure results in irritation of the upper respiratory tract as discussed in 5.6.1.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The test material is classified as corrosive based on the skin irritation/corrosion results. Severe erythema with eschar (in all rabbits) and eschar sloughing off with hair growth beneath it (in 5 of the 6 rabbits) was observed. Desiccation was also observed. Three rabbits had hair growth over entire site with a small area that was hard to the touch. The other rabbits had possible scar formation. The one remaining rabbit's skin site appeared normal. One rabbit had a white linear striation on the application site and possible scar formation. Four of the six rabbits had a small area that was hard to the touch and hair growth covering the entire application site.