Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion (OECD 431): corrosive (BASF 2010)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Additional information

There are valid in data available for the assessment of the skin irritation/corrosion potential of the test item.

Skin Irritation

In the key study, an in vitro study, performed according to OECD test guidelines 431 (GLP conditions) for assessment of in vitro skin corrosion, a three dimensional human epidermis model (EpiDermTM) was used, which consists of human-derived epidermal keratinocytes cultured to form a multi layered, highly differentiated model of the human epidermis (BASF 61H0433/072306, 2012).

The skin was treated with the undiluted test item for 3 min and 1 h (skin corrosion test). The skin corrosion potential is evaluated by a colourimetric assay (MTT-assay) for measuring the induced cytotoxicity. The test is considered positive if the mean tissue viability is less than 50% after 3 min or less than 15% after 1 h treatment in the corrosion test. The study was repeated, since the value for inter-tissue variability of the test substance for the exposure period of 3 minutes was out of the acceptable range. The mean tissue viability in the corrosion test was 65% and 8% in the first assay and 89% and 15% in the second test (positive control: 22/19% and 13/11%) after treatment for 3 min and 1 h, respectively. Thus, the substance is considered corrosive.

The study is suitable and reliable for assessment of skin corrosion as it was performed according to OECD test guideline.

 

Conclusion: The undiluted read across substance (CAS 665 -66 -7) was corrosive in an in vitro human epidermis model. Therefore, the test item itself was considered to be corrosive, too.

Eye Irritation

Since the substance is classified as corrosive to the skin, an eye irritation study is scientifically unjustified and the test item is classified for causing severe skin burns and eye damage.

Conclusion: The undiluted test item is considered tocause severe skin burns and eye damage

   


Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Dangerous substance Directive (67/548/EEC)

The available experimental test data for skin irritation/corrosion are reliable and suitable for the purpose of classification under Directive 67/548/EEC. As a result the substance is considered to be classified for skin irritation (C, R35, Causes severe burns) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data for skin irritation/corrosion are reliable and suitable for the purpose of classification under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. As a result the substance is considered to be classified for skin irritation/Corrosion (Cat 1A, H314: Causes severe skin burns and eye damage) under Regulation (EC) No.1272/2008, as amended for the 2nd time in Directive EC 286/2011.