Registration Dossier

Administrative data

Description of key information

skin irritation, rabbit: slightly irritating
eye irritation, rabbit: not irritating
respiratory irritation, rat: no significant pulmonary irritation potential

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

An acute skin irritation/corrosion test according to OECD 404 was conducted on 3 rabbits with a commercial product, containing 75 % of the active ingredient. The following effects were recorded after 4 hours exposure under semiocclusive condition to 0.5 mL test substance: An erythema grade 1 was observed in one animal 24 hours up to 6 days after patch removal and in a second animal solely 24 hours after patch removal. All other scores were found to be zero. There were no systemic intolerance reactions.

An eye irritation/corrosion test according to OECD TG 405 was conducted with the same test item (75 % act. ingr.). A single application of 0.1 mL test substance per animal into the conjunctival sac of the right eye did not cause any changes. There were no systemic intolerance reactions.

Regarding respiratory irritation see chapters "Acute Toxicity" and "Repeated dose Toxicity - inhalation".


Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Justification for classification or non-classification

Based on the available studies with a test item containing 75 % of the substance no classification on irritation/corrosion to skin or eye according to Regulation (EC) No 1272/2008, Annex I is concluded.

No classification is warranted for respiratory irritation according to Regulation (EC) No 1272/2008, Annex I as no significant pulmonary irritation potential was found for the substance.