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Administrative data

Description of key information

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

In a primary dermal irritation study performed according to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) guideline in compliance with GLP, three New Zealand White female rabbits were dermally exposed to 0.5 g of DMBA (moistened with 0.5 mL distilled water) for 4 hours under a semi-occlusive dressing. After removal of the residual test item, irritation was scored according to Draize method at 1, 24, 48 and 72 hours after removal of dressings.

There were no signs of toxicity or ill health in any rabbit during the observation period. Transient very slight erythema with or without very slight oedema was observed in all animals, resolving in all instances by Day 2 or Day 4. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 0.7 for erythema and 0.0, 0.0, 0.0 for edema score, respectively. In this study, DMBA is not a skin irritant on rabbits.

Eye

In an eye irritation study conducted according to EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) guideline and in compliance with GLP, 3 New Zealand White female rabbits were exposed to 60 mg of DMBA in one eye while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined and the changes were observed at 1, 24, 48 and 72 hours and 4, 7 and up to 14 and 21 days after treatment and graded according to the Draize method.

A single instillation of DMBA elicited corneal opacification and well defined to moderate conjunctival irritation in one rabbit, these effects persisted (without reduction, in the case of corneal opacity) until study termination, 21 days after treatment. However the other two rabbits showed markedly less reaction; no corneal effects were seen, and all conjunctival changes had resolved seven days after treatment. There were no signs of toxicity or ill health in any rabbit during the observation period. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2.0, 0.0, 0.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 2.7, 2.0, 2.0 for conjunctivae score and 2.3, 1.7, 1.7 for chemosis score. In this study, DMBA is an eye irritant on rabbits.


Effects on eye irritation: irritating

Justification for classification or non-classification

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