Registration Dossier

Administrative data

Description of key information

7.3.1 Skin irritation: 
KS - rabbit. Zorbas, 1994. KL.1 - non irritating;
7.3.2 Eye irritation:
KS - rabbit. Zorbasa, 1994. KL.1 - minimally irritating

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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

ACZ is not a skin irritant. From the eye irritation study ACZ was minimally irritating to the eyes of rabbits, but this had resolved within 72 hours of treatment. Regarding respiratory irritation, currently there are no guideline approved studies which have the objective to address respiratory irritation adequately. Clinical signs of toxicity reported in the acute inhalation study (Warren and Berry, 1985) indicated possible signs of irritation to mucosal membrane in the form of increased lacrimation and nasal / oral staining. However due to the nature of exposure (animals restrained, with snout exposure only) these clinical signs reported are also indicative of the exposure method used. With no human data or repeat dose inhalation studies available there is insufficient evidence to state that ACZ is a respiratory irritant.

Justification for classification or non-classification

No classification required