Registration Dossier

Administrative data

Description of key information

Three reliable studies are available for determining the irritation/corrosion to skin, and one for the eye irritation endpoint:
Skin irritation/corrosion:
Liggett & Parcell, 1984, was conducted according to the OECD 404 guideline and was allocated a reliability score of 2 according to the criteria of Klimisch et al, 1997. The study was conducted upon rabbits in vivo using a substance containing the registered substance at 30-31.2w/w in oil (applied unchanged). Mean erythema scores of 2 (max 2) were reported at 24 and 48 hours and 1.7 (max 2) at 72 hours (fully reversible within 10 days). Mean oedema scores of 1 (max 1) were reported at 24, 48 and 72 hours (fully reversible within 9 days) based upon these results no classification was appropriate.
Warren, 2010, evaluated the irritation potential in vitro, using the EpiSkin TM reconstituted human epidermal model for which a specific OECD guideline (439) was adopted on 22 July 2010, under GLP. The results of this study indicate that the substance is irritating to the skin and requires labelling with R38.
Whittingham, 2010, evaluated the corrosion potential in vitro, using the EpiSkin TM reconstituted human epidermal model, according to OECD guideline 431 and under GLP. The substance resulted to be non-corrosive to the skin.
Eye irritation:
Liggett & Parcell, 1984, was performed according to the OECD 405 guideline and was conducted upon rabbits in vivo. The study was allocated a reliability score of 2 according to the Klimisch et al, 1997, criteria. The study reported increasingly severe scores for the cornea and chemosis (24 hours mean: 2, max: 2), (48 and 72 hours mean: 2.3 max: 3 for both examinations). However with the exception of the cornea in 1 animal, all results were fully reversible within 21 days. Based upon these results, the substance was considered irritating to eye, requiring labelling as R41, Risk of serious damage to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The available data were adequate for the regulatory purpose required and for a basis for classification. Although in vivo data did not trigger for classification for skin irritation, the study was performed with a substance containing only ca. 30% of the registered substance. In the in vitro study evaluating irritation potential to the skin, the 97% pure registered substance was used and therefore this study was considered more appropriate for classification purposes.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based upon the above information the registered substance meets the classification set out in 67/548/EEC and EC Regulation 1272/2008 and should therefore be classified as follows:

R38 - irritating to skin;

R41 - Risk of serious damage to eyes

 

Skin Irritation/Corrosion category 2, H315 Causes skin irritation;

Eye irritation category 1, H318 Causes serious eye damage