1H-Imidazolium, 3-ethyl-1-methyl-, methanesulfonate (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Non guideline study conducted according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Principles of method if other than guideline:

The study follows the testing strategy for determination of eye irritation/corrosion as given in the following OECD guideline:
- OECD Guideline for Testing of Chemicals No. 405, April 24, 2002 (“Acute Eye Irritation/Corrosion”)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-ethyl-3-methyl-1H-imidazol-3-ium methanesulfonate

EC Number:

604-453-0

Cas Number:

145022-45-3

Molecular formula:

C6 H11 N2. C H3 O3 S

IUPAC Name:

1-ethyl-3-methyl-1H-imidazol-3-ium methanesulfonate

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct
composed of normal human derived epidermal keratinozytes used to model the human
corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially
prepared cell culture inserts (MILLICELLs®, 10 mm ∅) and are commercially available as kits
(EpiOcular™ 200), containing 24 tissues on shipping agarose. (Harbell J.W. et al., 2009)

Test system

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

After application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed.

Observation period (in vivo):

After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution
and the tissues were incubated in the incubator for 3 hours.
After incubation, the tissues were washed with PBS to stop the MTT-incubation.
The formazan that was metabolically produced by the tissues was extracted by incubation of
the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate
shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was
determined spectrophotometrically. Blank values were established of 4 microtiter wells filled
with isopropanol for each microtiter plate.

Results and discussion

Any other information on results incl. tables

viability (% of negative control) = 71

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

EMIM Methansulfonat does not show an eye irritation potential in the EpiOcular™ eye irritation test.

Executive summary:

The potential of EMIM Methansulfonat 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 (EpiOcular™). 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 testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 71%. Based on the observed results and applying the evaluation criteria it was concluded, that EMIM Methansulfonat does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.