Registration Dossier

Administrative data

Description of key information

Not skin corrosive, not eye corrosive

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

According to the interpretation of results and prediction model given in the OECD 431, a substance shall be considered as Non corrosive if the Mean cell viability is ≥ 50 % after 3 min exposure AND ≥ 15 % after 60 min exposure

 

The percentage of mean cell viability for treated cells resulted to be ≥ 50 % both after 3 minutes and after 60 minutes of exposure ( 105.1% and 122.5 % respectively), therefore the target substance shall be considered as non corrosive for skin.

 

Eye irritation

According to the classification scale for irritant effect of ICCVAM-Recommended Test Method Protocol, a substance shall be classified as Irritant if the Irritation Grade (N) is greater than 9, if 5 ≤ N < 9, the substance is considered as mildly irritant.

The Irritation Grade of the tested parent substance #1 is 6.8, therefore the substance is Mildly Irritant.

Based on the test results, the substance does not requires classification for serious eye damage. According to the ECHA Guidance R7.a, the HET-CAM test method were not sufficiently accurate for regulatory use especially for Category 2 chemicals, to make a final conclusion on their validity. Considering the test results, the variable evaluation of irritant categories, the false positive rate of the HET-CAM test and the chemical nature of the substance no conclusion on the eye irritation classification is reachable.