Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: not corrosive and not irritating (OECD 431 and 439, GLP)

Eye irritation: not corrosive and not irritating (OECD 437, GLP)

Respiratory irritation: no study available

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

In vitro skin corrosion

The corrosive properties of of the test item to human skin was assessed in an experiment with an artificial three-dimensional model of human skin according to OECD Guideline 431 and under GLP conditions. The EpiDermmodel was employed.

In  comparison to the negative control, the mean viability of cells exposed to the test item was 103.5% after a 3-minute exposure  period  and  92.9%  after a 1-hour exposure.  The 3-minute exposure  and  the  1-hour  exposure  values  were  above  the  cut-off  percentage  cell  viability values  distinguishing  corrosive  from  non-corrosive  test  items  of    50%  and    15%, respectively. Therefore, the test item was non-corrosive in this skin  model and  is  predicted to be non-corrosive to human skin.

In vitro skin irritation

The substance was assessed for cytotoxic properties to skin cells, which might lead to irritation of human skin, by using an artificial threedimensional model of human skin in accordance with OECD Guideline 439 and GLP. The EpiDerm™ model was employed.

The mean viability of cells exposed to TA-2 was 102.9% of the negative control and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%. TA-2 was considered to be non-cytotoxic and predicted to be non-irritant to skin.

In vitro vivo eye corrosion/irritation

The possible potency of the substance of being 'ocular corrosive and severe irritant' was determined employing an in vitro system (Bovine Corneal Opacity and Permeability Assay (BCOP)) according to OECD Guideline 437 and under GLP conditions.

Following  treatment  with  TA-2  a  mean  opacity  of  0.570  ±  0.641  and  a  mean permeability value of -0.016  ± 0.008 compared to the negative control were determined. The calculated IVIS of 0.330 ± 0.622 is below the cut-off value of 3 (UN GHS  no  category). Hence,  the  test  item  did  not  show  severely  irritant  or  corrosive properties and consequently it is not classified as a severe irritant and is not corrosive according to UN GHS classification.

Justification for classification or non-classification

The available data indicate that the substance does not meet the classification criteria for skin corrosion/ irritation or eye corrosion/irritation in accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

There is no information available on respiratory irritation.