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 classification or non-classification

The mean viability of the test substance was evaluated in a Skin Irritation Test using the EpiDerm™ Skin Model. The test substance, positive control, and negative control were exposed to the EpiDerm™ tissues in triplicate for 60 minutes, with a post-exposure time of 42 hours. Irritation potential was determined by measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test substance for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%. The mean viability of the test substance was 102.4%. The test substance was not determined to directly reduce MTT. Based upon the results of this assay, the test substance was not predicted to be a skin irritant.
The Bovine Corneal Opacity and Permeability Assay was used to assess the potential ocular irritancy of the test substance as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas. Based on changes in corneal opacity and permeability (relative to the control corneas), an in vitro score was determined. The in vitro score was 1.7. Following the classification established by Gautheron et al. (1992) (Sina classification system) based on studies with a wide range of test materials, the test substance, would be considered a mild irritant (in vitro score from 0 to 25). Following the modification of the Sina classification system proposed by Vanparys, et al. (1993) based on an evaluation of 50 pharmaceutical and commercially-available industrial compounds, the test substance would be considered a non-irritant (an vitro score from 0 to 3).
Therefore, the substance does not need to be classified for skin or eye irritation according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.