Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion:

Two in vitro studies are available.

One in vitro skin irritation study was performed using a human three dimensional epidermal model based on the most recent OECD 439 guidelines (2015). The test item is non-irritant under the experimental conditions.

Another in vitro skin corrosion test was performed to evaluate test item ability to induce skin corrosion using a human skin model according to OECD 431 (2016). The test item is not corrosive in the in vitro skin corrosion test under the experimental conditions.

 

Eye irritation:

Bovine Corneal Opacity and Permeability test (BCOP test) was performed based on the most recent OECD guideline 437.

In the first experiment, the mean in vitro irritancy score was 54 after 240 minutes of treatment with the test item. Since the individual in vitro irritancy scores were spread over 2 categories (42, 48 and 71), a repeat experiment was performed.

In the second experiment, the mean in vitro irritancy score was 47 after 240 minutes of treatment with the test item. The in vitro irritancy score values were, like in the first experiment spread, over 2 categories (38, 41 and 62).

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irritation/corrosion:

The test item is non-irritant in the in vitro skin irritation test and not corrosive in the in vitro skin corrosion test

According to Regulation (EC) No 1272/2008, section 3.2.2.1, this substance should not be classified for this endpoint.

 

Serious eye damage/eye irritation:

In the first experiment, the mean in vitro irritancy score was 54 after 240 minutes of treatment with the test item. Since the individual in vitro irritancy scores were spread over 2 categories (42, 48 and 71), a repeat experiment was performed.

In the second experiment, the mean in vitro irritancy score was 47 after 240 minutes of treatment with the test item. The in vitro irritancy score values were, like in the first experiment spread, over 2 categories (38, 41 and 62). However, since in both experiments it was observed that the cornea membranes were detached resulting in a clear cornea (and no effect on opacity),

According to Regulation (EC) No 1272/2008, section 3.3.2.1, this substance should be classified as category 1 for this endpoint.