Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: corrosive
Eye irritation/corrosion: corrosive

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 irritation/corrosion:

An in vitro study was performed to assess the corrosive potential of the test substance by means of the In Vitro Membrane Barrier Test for Skin Corrosion using the Corrositex™ test kit (Heppenheimer, 2010).

The test item passed the qualify test and was considered as suitable for testing with the Corrositex™ test kit.

The test item induced a colour change in the category B vial, but not in the Category A vial after 1 minute incubation. Therefore, the test item was classified according to category I.

500μL of the test item were applied on quadruplicate bio-barriers for the classification test. The bio-barriers were placed atop vials containing the CDS reagent. The time needed to corrode the bio-barrier and induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.

500μL of the negative control (10% citric acid) or 500 µL the positive control (Sulfuric acid 95-98%) was placed atop one bio-barrier and the colour change of the CDS reagent was monitored up to 240 minutes. The negative control did not induce a change in the colour of the CDS reagent after 240 minutes. The positive control showed a distinct change in the colour of the CDS reagent after 1minute 7 seconds incubation. These results ensured the validity of the test.

 

The mean time needed to change the colour of the CDS reagent after treatment of the bio-barriers with the test item was 77 minutes 41 seconds. According to the classification criteria the test item was classified as corrosive and placed in packing group III (R34, GHS 1C).

This study is considered as acceptable as it satisfied the criteria of OECD guideline.

Eye irritation/corrosion:

In accordance with column 2 of REACH Annex VIII, the in vivo eye irritation study (required in section 8.2.1) does not need to be conducted as the substance is classified as corrosive to the skin based on the results of the in vitro membrane barrier test for skin corrosion (Heppenheimer, 2010).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to the results of the key study, the substance is classified for irritation/corrosion as:

- Skin Corr. 1C (H314, Cause severe skin burns and eye damage) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP)

- Corrosive (C; R34) according to the criteria of the Council Directive 67/548/EC and its subsequent adaptations.