Registration Dossier

Diss Factsheets

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 10 minutes 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.