[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin irritation (OECDTG439): not irritant

Skin corrosion (OECDTG431: not corrosive

Eye irritation (OECDTG437): not irritant

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

Skin irritation:

The substance was tested in triplicate in an in vitro skin irritation test according to OECD TG 439 test guideline and GLP principles. Tissues were exposed to the substance, a negative control (PBS) and a positive control (5% SDS) for 15 minutes. The substance was tested for direct MTT reduction and colour interference.

The solutions did not turn blue / purple, nor a blue / purple precipitate was observed. The OD for the test item solution was >0.08, it was concluded that the test item did interfere with the MTT endpoint. In addition to the normal procedure, three tissues were treated with test item. Instead of MTT solution these tissues were incubated with assay medium. The non-specific color by the test item was 4.66% of the negative control tissues. The OD of the tissues incubated with assay medium was subtracted from the ODs of the test item treated tissues incubated with MTT medium.

Acceptability criteria for the negative control, positive control and variability between measurements were met.
The cell viability of the tissues exposed to the substance was 96% for 15 minutes exposure. Since the mean relative tissue viability for the substance was above 50%, the substance is considered to be not irritant.

 

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 (Milli-Q water) and a positive control (8.0 N KOH) for 3 minutes and 60 minutes. The substance was tested for direct MTT reduction and colour interference, the test item induced colour interference. 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 99% and 85% for 3 minutes and 60 minutes exposure, respectively. Both values did not exceed thereshold for corrosivity (50% after 3 minutes exposure and 15% after 60 minutes exposure), therefore the substance is considered not to be corrosive.

 

Eye irritation:

A Bovine Corneal Opacity and Permeability test (BCOP) was performed with the substance according to OECD guideline 437 and GLP principles. The substance was tested as it is. The mean in vitro irritancy

score of the positive control ( 20% (w/v) Imidazole) was 115, and the mean in vitro irritancy score of the negative control (physiological saline) was 0.8. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.9 after 240 minutes of treatment.

Since the substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.

Justification for classification or non-classification

Based on the available study results, the substance does not have to be classified and has no obligatory labelling requirement for skin and eye irritation according to Regulation (EC) No 1272/2008 and its amendments.