Registration Dossier

Administrative data

Description of key information

Based on the results of an OECD 404 study, the test item is not considered to be irritating to skin.

Based on the results of an OECD 405 study, the test item is not considered to be irritating to eyes.

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 study available

Additional information

Skin irritation:

A study was designed to assess the skin irritation potential of the test item following a single dermal application to rabbits. The study was conducted according to OECD guideline 404 and EU Methode B.4. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal irritation was observed following a single semi-occlusive application of the test item to intact rabbit skin for four hours.

Eye irritation:

A study was designed to assess the eye irritation potential of the test item following a single instillation into the eye of the rabbit. The study was conducted in compliance with OECD guideline 405 and EU Method B.5. Three rabbits were each administered a single ocular dose of a volume of 0.1 mL of the test substance (mean weight 61 mg) and observed for three days after instillation. A single instillation of the tets item into the eye of the rabbit elicited an ocular response confined to transient very slight to well-defined conjunctival. The mean scores (24/48/72 h) were: corneal opacity: 0, iris lesions: 0, conjunctival redness: 0.33 and conjunctival chemosis: 0.11. Responses had resolved by three days after treatment.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. No skin and eye irritation was observed. As a result the substance is not considered to be classified for skin irritation or eye damage under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.