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Administrative data

Description of key information

The test substance was corrosive (cat. 1B) in the EpiDermTM model (OECD 431, in vitro Skin Corrosion: Human Skin Model Test). Therefore, an eye irritation study does not need to be conducted.

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 (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation in vitro

An in vitro skin irritation study according to OECD test guideline 431 and GLP was performed. The test substance (50 µL) was placed atop the human tissue samples. Length of exposition was 3 and 60 minutes. Nine tissues were used for the experiment at each time point, three tissues for the test substance, three for the positive control and three for the negative control.

After rinsing, tissues were incubated with MTT for three hours and extracted overnight subsequently at room temperature without shaking. OD570 of isopropanol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues. In the experimental arrangement the test substance caused a cell viability of 89.5 % and 9.4 % after 3 min and 60 min treatment, respectively and thus, is considered as corrosive to skin. As cell viability was >= 50 % after the 3-min treatment period the substance does not fulfill the criteria for subcategory 1A. A differentiation between subcategory 1B and 1C is not feasible with the assay. Therefore, as a worst case, cat. 1B is assumed. This study is classified as acceptable and satisfies the requirements for Test Guideline OECD 431 for in vitro Human Skin Corrosion data.

 

Eye irritation

Since the test substance is considered as corrosive to skin an eye irritation study is not needed according to REACH Annex VII column 2. In humans the substance is described as a strong irritant to mucous membranes (Hawley, 1977).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin corrosion cat. 1B (H314: Causes severe skin burns and eye damage) under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776. Furthermore, the test substance is included in Annex VI to Regulation (EC) No 1272/2008 with Eye Irrit 2, H319 (Table 3.1) and Xi, R36 (Table 3.2).