1-(aminomethyl)cyclohexaneacetic acid hydrochloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 437

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(aminomethyl)cyclohexaneacetic acid hydrochloride

EC Number:

262-075-8

EC Name:

1-(aminomethyl)cyclohexaneacetic acid hydrochloride

Cas Number:

60142-95-2

Molecular formula:

C9H17NO2.ClH

IUPAC Name:

2-[1-(aminomethyl)cyclohexyl]acetic acid hydrochloride

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

bovine corneas

Test system

Vehicle:

physiological saline

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

no data

Number of animals or in vitro replicates:

no data

Results and discussion

Any other information on results incl. tables

The test item was dissolved/suspended at the final concentration of 20% in physiological saline (NaCl 0.9%), being a non surfactant solid. The test item was tested on the epythelial surface of three idoneous bovine corneas for an exposure period of 4 hours. Positive and negative controls [a 20% (w/v) imidazole solution in physiological saline and physiological saline alone, respectively] were concurrently tested in the same number of replicates. The mean opacity detected at the end of the test item exposure period was 131.0. After the determination of opacity the epythelial surface was treated with a 0.5% solution of sodium fluorescein in EMEM for 90 minutes to investigate alteration in cornea permeability. Mean OD490 value was 0.0653 (less than negative control). Positive and negative controls gave the expected results, indicating the good functioning of the test system. These results indicate that the test item induces change in cornea opacity but not in cornea permeability. The calculated in vitro irritancy score (IVIS) for the test item is 131.0. According to the OECD guideline for this test, the test item is defined as corrosive or severely irritant to the eye.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

These results indicate that the test item induces change in cornea opacity but not in cornea permeability. The calculated in vitro irritancy score (IVIS) for the test item is 131.0. According to the OECD guideline for this test, the test item is defined as corrosive or severely irritant to the eye.