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. The test item did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.2 after 4 hours of treatment.

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

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 is not classified for this endpoint.

 

Serious eye damage/eye irritation:

Not irritating, IVIS =0.2

According to Regulation (EC) No 1272/2008, section 3.3.2.1, this substance is not classified for this endpoint.