Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating based on an OECD TG 404
Eye irritation: non irritating based on an OECD TG 405

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

Skin irritation:


This study was performed to assess the skin irritation potential of Salicynalva to the rabbit according to EU Method B.4 and OECD TG 404. Three rabbits were each administered a single dermal dose of 0. 5 ml of the test substance and observed for a maximum of six days. A single semi-occlusive application of Salicynalva to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. The erythema scores were 2, 1.67, and 0 and the edema scores were 1, 0.67, and 0, respectively. The reactions had resolved within 6 days. In conclusion, the test substance is not irritating to the skin in accordance with EU CLP (EC no 1272/2008 and its amendments).


Eye irritation:


A study was performed to assess the eye irritation potential of Salicynalva to the rabbit according to EU Method B.5 and OECD TG 405. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation. A single instillation of Salicynalva into the eye of the rabbit elicited transient dulling effect on the cornea of 2/3 animals after 1 hour. No effects were observed at the other time points. In conclusion, the test substance is not irritating to the skin in accordance with EU CLP (EC no 1272/2008 and its amendments).

Justification for classification or non-classification

The substance does not have to be classified for Skin irritation according to EU CLP (EC No. 1272/2008 and its amendments).


The substance does not have to be classified for Eye irritation according to EU CLP (EC No. 1272/2008 and its amendments).