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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance is slightly irritating to skin and eyes of rabbits. In vitro tests using an artificial 3D-Skin model revealed neither corrosive nor irritating properties of the test substance. 
    
    
    
    
    

tests using an artificial 3D-Skin model revealed neither corrosive (OECD TG 431) nor irritating (EU Method B.46) properties of the test substance in vitro (Wingenroth, 2011a,b).

tests using an artificial 3D-Skin model revealed neither corrosive (OECD TG 431) nor irritating (EU Method B.46) properties of the test substance in vitro (Wingenroth, 2011a,b).

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

The substance was slightly irritating to the skin of rabbits according to OECD TG 404 (Gmelin, 2010a). All signs were fully reversible within one week. No relevant systemic intolerance reactions were observed. In addition, tests using an artificial 3D-Skin model revealed neither corrosive (OECD TG 431) nor irritating (EU Method B.46) properties of the test substance in vitro (Wingenroth, 2011a,b).

According to GHS classification criteria the substance is not an irritant to the skin.

 

 

Eye irritation

The substance was slightly irritating to the eyes of rabbits according to OECD TG 405 (Gmelin, 2010b). In all animals redness of conjunctivae were fully reversible within 3 days. No systemic intolerance reactions were observed. In addition, the test substance was identified as "non-irritant" to the chorioallantoic membrane (irritation score (IS) = 0) in the in vitro HET-CAM test according to a protocol recommended by ICCVAM, Nov. 2006 (Wingenroth, 2011c).

According to classification criteria the substance is not an irritant to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
Only one key study available

Justification for selection of eye irritation endpoint:
Only one key study available

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No.1272/2008 (CLP) is not required.