Registration Dossier

Administrative data

Description of key information

Based on skin irritation and eye corrosion studies, performed in vitro, it can be concluded that the test substance is not corrosive or irritating to the skin and does not cause irreversible damage to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

In a GLP-compliant, OECD 431 guideline study the potential of the test substance to cause dermal corrosion/irritation was assessed by a single topical application of 25μL bulk volume (about 19 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™) (BASF 2009). Two (corrosion test) or three (irritation test) EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour (corrosion test) or 1 hour with about 42 hours post-incubation (irritation test). Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 103%, and it was 102% after an exposure period of 1 hour. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 99%. Based on the observed results it was concluded, that the test substance does not show a skin irritation potential in the EpiDerm skin corrosion / irritation test under the test conditions chosen.

Eye irritation

In a GLP-compliant study, the potential of the test substance to cause serious damage to the eyes/mucous membranes was assessed by a single topical application of 25μL bulk volume (about 19 mg) of the undiluted test substance to the chorionallantoic membrane (CAM) of fertilized and incubated hen eggs (BASF 2009). Three eggs were observed for 100 seconds and then the test substance was removed by washing. The occurrence of vascular injury or intravascular coagulation in response to the test substance was recorded. The chorionallantoic membrane of the eggs did not show any irritation effects. Based on the results of this study it is concluded, that the test substance does not produce changes indicative for serious eye damage in the HET-CAM Test under the test conditions chosen.


Justification for selection of skin irritation / corrosion endpoint:
One in vitro skin irritation/corrosion study is available. This study is adequate for covering this endpoint.

Justification for selection of eye irritation endpoint:
One study is available, which studied the potential to cause eye damage in vitro. This study is adequate for covering a conclusion about eye damage, but not for eye irritation.

Justification for classification or non-classification

Based on the fact that the EpiDerm™ study showed no irritating/corrosive effects after application, classification for skin irritation/corrosion is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Based on the findings in the eye corrosion study in vitro the test substance is considered to be not corrosive. However, no information is available on the irritating properties of the test substance. As a worst case assumption the substance was classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 as eye irritant Category 2: H319 Causes serious eye irritation and Xi: R36 Irritating to eyes according to the Directive 67/548/EEC (DSD).