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Administrative data

Description of key information

Skin Irritation: corrosive, rat, Corrosion in vitro, method equivalent to OECD 430, Pooles 2004
Eye Irritation: corrosive based on results of skin corrosion test
Respirarory Irritation: no data

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin:

Only a single in-vitro Transcutaneous Electrical Resistance (TER) study, conducted with a method equivalent to guideline OECD 430 (not explicitly mentioned), without GLP, is available. The study is considered to be relevant, reliable (Klimisch 2) and adequate for the purposes of risk assessment, classification and labelling.

The test material caused an inherent TER of 2.6 kOhm, i.e. less than the OECD 430 threshold value of 5 kOhm.

This was confirmed by a sulforhodamine B dye binding value of 44.70 microgram/disk, which is higher than the binding caused by the positive control (40.53 microgram/disc).

The dye binding of the control discs (12.64 microgram/disc) was below the values requested by OECD 430, which proves the integrity of the pelt.

According to OECD 430, the test substance is considered to be corrosive to skin.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The available study is considered to be relevant, reliable (with restriction) but adequate for the purposes of classification and labelling.

The substance met the criteria for classification as "corrosive" and it is classified as R34 Causes burns, according to Directive 2001/59/EC, Annex VI, 3.2.5.

Further classification with R41 Risk of serious damage to eyes is not applied, as it is implicit in the R34 classification (Annex VI, 3.2.6.2).

The substance is classified as Skin Corrosion Category 1A (H314: Causes severe skin burns and eye damage), according to Regulation (EC) 1272/2008, Annex I, Part 3, 3.2.2.

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