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Administrative data

Description of key information

- Skin corrosion: Non corrosive based on OECD TG 431


- Skin irritation: Skin irritant based on OECD TG 439


- Eye irritation: not irritant based on OECD TG 438


- The substance is expected not to be a respiratory irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin corrosion


The substance was tested in duplicate in an in vitro skin corrosion test according to OECD TG 431 test guideline and GLP principles. Tissues were exposed to the substance, a negative control (deionised water) and a positive control (8.0 N KOH) for 3 minutes and 1 hour. The test item did not induce color interference but it did interact with MTT. An additional test was performed with freeze-killed tissues treated with test item and one freeze-killed negative control treated tissues were for the cytotoxicity evaluation with MTT at each time point. The ODs of the test item treated viable tissues were corrected using he OD of the freeze-killed tissues Acceptability criteria for the negative control, positive control and variability between measurements were met. The cell viability of the tissues exposed to the substance were 113% and 125% for 3 minutes and 60 minutes exposure, respectively. Both values were not below the threshold for corrosivity (50% after 3 minutes exposure and 15% after 60 minutes exposure), therefore the substance is considered not to be corrosive.


Skin irritation


In an in vitro skin irritation test performed in accordance with OECD guideline 439 and GLP, the test substance was applied undiluted (10 μL) on a human three dimensional epidermal model (EPISKIN Standard model) for 15 minutes. As a negative control, phosphate buffered saline was used and as a positive control, a 5% aqueous solution of sodium dodecyl sulphate. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissue. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The positive control had a mean cell viability of 5% after 15 minutes exposure. The relative mean tissue viability obtained after 15 minutes treatment with the test substance was 5%. Since the mean relative tissue viability was below 50% after 15 minutes treatment the substance was considered to be an irritant.


Eye irritation


In an Isolated Chicken Eye (ICE) test, performed according to OECD Guideline 438 and according to GLP, isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application amount of 30 μL. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells. In addition an irritation index was given (Irritation Index = maximum mean corneal swelling (%) + maximum mean opacity (x 20) + mean fluorescein (x 20)). The maximum possible Irritation Index is circa 200. The negative control eye, treated with physiological saline, showed no corneal effects. The positive control, treated with a 5% aqueous solution of benzalkonium chloride, caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 145. The test substance caused very slight corneal swelling, slight corneal opacity and very slight fluorescein retention. The calculated Irritation Index was 32. In conclusion, based on the results obtained in the ICE test and according to its classification schemes, the test substance was considered to be not irritating to eyes.


Respiratory irritation


For respiratory irritation mostly human data are used for the assessment because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (REACH guidance R.7.2.3, 2008). There are no human data such as indicated in R7.2.3 of the ECHA guidance that indicate respiratory reactions of the substance e.g. from consumer experience or occupational exposure. In addition, despite the skin irritation potential, the substance is not corrosive or severely irritating which further minimizes the respiratory irritation hazard (REACH guidance: 7.2.1.2, 2008).

Justification for classification or non-classification

Based on the positive results in the skin irritation test, the substance needs to be classified as skin irritant (category 2): H315 according to EU CLP (EC No. 1272/2008 and its amendments).


Based on the available data and in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for eye and respiratory irritation.