Registration Dossier

Administrative data

Description of key information

skin irritation (in vitro): corrosive  (BASF, 2013)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 400 mg to the Corrositex® Biobarrier Membrane (Corrositex® assay).

The Corrositex® Biobarrier Membrane is the test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). In addition to the test substance a positive and a negative control were assessed.

The Corrositex® assay showed the following results:

The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore the membrane barrier test method was determined to be suitable for the evaluation of the corrosive potential of the test substance.

A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 1 (having a high acid/alkaline reserve).

In the main test four Corrositex® Biobarrier Membranes were treated with the test substance. The mean break through time of the test substance, determined in the actual Corrositex® assay, was 3 minutes and 32 seconds. Based on the observed results and applying the evaluation criteria it was concluded, that the test substance shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen.

Due to the corrosive character of the test substance no test on eye irritation was conducted because of animal welfare. This is justified according to column 2 of REACH Regulation 1904/2006, Annex VII, part 8.2.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance needs to be classified and labelled as C, R34 "Causes burns." under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.

 

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as skin damage cat. 1B, H314 "Causes severe skin burns and eye damage" under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014.