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Diss Factsheets

Administrative data

Description of key information

In vitro tests on skin and eye irritation (EpiDerm and EpiOcular) are available for the substance. Both assays showed negative results.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For the substance itself in vitro tests are available for both skin and eye irritation. Summaries of these studies are provided below.

Skin irritation in vitro

An in vitro EpiSKIN skin irritation test was performed in accordance with OECD Guideline 439 and EU method B.46. Disks of epidermal units (three units / chemical) were treated with the test item and were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator. Exposure of the test material was terminated by rinsing the epidermal units with PBS 1x solution. Epidermis units were then incubated at 37 °C for 42 hours. The viability of each disk was subsequently assessed by incubating the tissues for 3 hours with MTT solution at 37 °C. The resulting formazan crystals were extracted with acidified isopropanol and quantified with the optical densities (OD) recorded spectrophotometrically. SDS (5 % aq.) and PBS treated epidermis units were used as positive and negative controls, respectively. For each treated tissue viability was expressed as a percentage relative to negative control. In this in vitro test, the substance did not show significantly reduced cell viability in comparison to the negative control. All obtained test item viability results were above 50 % when compared to the viability values obtained from the negative control, therefore the test item was considered to be non-irritant to skin. Positive and negative controls showed the expected cell viability values within acceptable limits (BASF 2012).

Eye irritation in vitro:

In a GLP compliant in vitro EpiOcular™ test, the potential of the substance to cause ocular irritation was assessed by a single topical application of 50 μL of the test substance to a reconstructed three dimensional human cornea model. Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 105%. Based on the observed results and applying the evaluation criteria, it was concluded, that the substance does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen (BASF 2012).

Justification for classification or non-classification

Based on the observed results, classification for skin and eye irritation is not warranted in accordance with with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.