Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 4.3 after 4 hours of treatment. 

Another in vitro eye irritation test was performed with  Reconstructed Human EpiOcularTM Model based on OECD 492, the test item is non-irritant.

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 is not classified for this endpoint.

 

Serious eye damage/eye irritation:

Bovine Corneal Opacity and Permeability test (BCOP test): Irritant, 3<IVIS55.1 (actual 4.3)

EpiOcularTM test: no irritation

According to Regulation (EC) No 1272/2008, section 3.3.2.1, this substance should be classified as Category 2 for this endpoint.