Registration Dossier

Administrative data

Description of key information

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)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Justification for classification or non-classification

Skin irritation

Reference Heppenheimer (2011) is considered as the key study for skin irritation and will be used for classification. The mean relative absorbance (% of the negative control, correlating with mean tissue viability) after 15 minutes incubation in the in vitro human skin model test (EpiSkin, according to OECD TG 439) was 91.1%. The classification criteria according to regulation (EC) 1272/2008 as skin irritant are not met, since the mean tissue viability was above the threshold for skin irritants of 50.0%. No classification required.

Eye irritation

The references Heppenheimer (2011) and Arcelin (2011) are considered as the key studies for severe eye irritation and will be used for classification.

According to Heppenheimer (2011) the mean in vitro score after 240 minutes incubation results of the in vitro bovine corneal opacity and permeability assay (BCOP, according to OECD TG 437) was 7.15. The value was below the threshold for severe eye irritants of 55.1. The classification criteria according to regulation (EC) 1272/2008 as severe eye irritation are not met, hence no classification required.

According to Arcelin (2011) the overall irritation results 24, 48 and 72 hours after application per animal are as follows:

-         Corneal opacity=0.00 for all three animals

-         Iris light reflex=0.00 for all three animals

-         Conjunctival redness=1.67, 1.00, 1.00

-         Conjunctival oedema (chemosis)=0.00 for all three animals

The classification criteria acc. to regulation (EC) 1272/2008 as irritating to eyes are not met, since the values of conjunctival redness were below the threshold of ≥ 2 as well as the effects were fully reversible within 7 days. No classification required.

 

Respiratory irritation

The justification for classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure: inhalation as given in the acute toxicity section.