Registration Dossier
Registration Dossier
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EC number: 211-560-2 | CAS number: 665-66-7
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion (OECD 431): corrosive (BASF 2012)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Additional information
There are valid in vitro 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. The skin was treated with the undiluted test substance 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 mean tissue viability in the corrosion test was 85% and 13% (positive control: 18% and 10%) after treatment for 3 min and 1 h, respectively. Thus, the substance is considered corrosive (BASF 61V0506/11A475, 2012).
The study is suitable and reliable for assessment of skin corrosion as it was performed according to OECD test guideline.
Conclusion: The undiluted test item was corrosive in an in vitro human epidermis model.
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 causes 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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