1-(aminomethyl)cyclohexaneacetic acid hydrochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

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

Details on test animals or test system and environmental conditions:

The test system is composed of two components, a synthetic macromolecular biobarrier and a Chemical Detection System (CDS); the basis of this test method is that it detects membrane barrier damage caused by corrosive test substances after the application of the test substance to the surface of the artificial membrane barrier, presumably by the same mechanism(s) of corrosion that operates on living skin.
Penetration of the membrane barrier (or breakthrough) is measured by the change in the colour of a pH indicator dye or in some other property of the indicator solution below the barrier.

Test system

Controls:

no

Duration of treatment / exposure:

7 minutes

Number of animals:

no animals

Results and discussion

Any other information on results incl. tables

The potential of the test item GABAPENTIN HCl to be corrosive to the skin was assessed with an in vitro membrane barrier assay using the validated commercial kit CORROSITEX. In a preliminary assay, the test item was demonstrated to be suitable for this test system, since it provoked a colour change in the Chemical Detection System of the kit. The time category for observation/classification was also determined according to manufacturer’s instructions. In the main assay, the test item was assayed in quadruplicate and observed according to the time category, as defined in the preliminary test. Valeroyl chloride (classified as GHS 1B substance) and 10 % (w/v) citric acid solution were concurrently tested as positive and negative controls respectively. The mean penetration time (CORROSITEX Time) for the test item was: 42.545 ± 7.706 minutes. Positive and negative controls results indicate a good functioning of the test system. Positive control was corrosive at 13.33 minutes, in agreement with the historical value. Negative control was not corrosive at 60 minutes. Independently of the main experiment, the pH of a 10% (w/v) solution of the test item in water was measured. The pH was equal to 2.0

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to the OECD guideline for testing of chemicals no. 435, the test item is defined as corrosive to the skin.
The corrosivity sub-category assigned is GSH 1C (Packing Group III).