Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Skin corrosion

An in vitro study was performed to assess the corrosivity potential of the test substance by means of the Human Skin Model Test (OECD 431).The cytotoxic effects of the test item on EpiDerm, a reconstituted three-dimensional human epidermis model, were determined.

The corrosivity potential of the test item. was predicted from the relative mean tissue viabilities obtained after 3 min and 60 min treatment compared to the negative control tissues concurrently treated with Aqua dest (= 100%). According to the Prediction Model: a mean relative tissue viability of ≥ 50% after 3 min exposure and≥ 15% after 60 min exposure conclude to a non-corrosive effect of the test item.

After 3 min treatment, the mean relative tissue viability (% negative control) was 84.4 % (NSMTT-corrected) and hence ≥ 50% (84.4%, NSMTT-corrected). After 60 min treatment, the mean relative tissue viability was 90.1 % (NSMTT-corrected) and thus ≥ 15%. In conclusion, the test item showed no corrosive effects. The test item is hence classified as “non-corrosive“.

Skin irritation

The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum (OECD 439). Irritant potential of the test item was predicted from the relative mean tissue viabilities compared to the corresponding negative control tissues concurrently treated with DPBS. The mean relative tissue viability (% negative control) was 10.5% after 60 min treatment and 42 h post-incubation.

The test item is considered irritant to the skin if the mean relative tissue viability of three individual tissues is reduced ≤ 50% of the negative control. Thus, based on the available data on skin irritation, test item is therefore classified as “irritant” in accordance with the

criteria for classification according to Regulation (EC) 1272/2008 (CLP) and classified "Category 2".

Eye irritation

In function of the determination of the eye irritation potential of the substance the following information was taken into account:

Based on Annex VII, column 2 (section 8.2), no eye irritation study is to be provided when the substance is classified as skin irritant and the available information indicates that it should be classified as eye irritation (Category 2). The substance was evaluated for skin corrosion and irritation potential and concluded to be non-corrosive, but irritant (Category 2) based on the results of the in vitro OECD 439.

Specifically in function of the eye irritation properties of the substance, an in vitro eye irritation study (BCOP) was run. Sadly, this test provided results unsuitable for classification purposes (IVIS = 5.68). Other in vitro studies for eye irritation were considered but due to the fact that for these tests similar mechanisms as the performed skin irritation can be relevant, it is unlikely that these other in vitro tests will be able to provide a clear-cut answer on the classification.

Therefore, the available in vitro data were taken together in a weight of evidence approach (both the positive skin and inconclusive eye irritation study). This results in a positive classification for eye irritation, which is regarded as a conservative approach in absence of additional data.  In conclusion, the substance should be considered as to be an eye irritant "Category 2" according to Regulation No 1272/2008, section 3.3.