Peppermint, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

31-Aug-2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Test was conducted according to OECD Test Guideline No. 437, 2009, under GLP Standards, and QA. Due to the read-across purpose it was given a Klimisch 2 rating, in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID. The justification for read across is provided in the attached background material of the chapter summary.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Mentha arvensis, ext.

EC Number:

290-058-5

EC Name:

Mentha arvensis, ext.

Cas Number:

90063-97-1

IUPAC Name:

90063-97-1

Constituent 2

Reference substance name:

Cornmint oil

IUPAC Name:

Cornmint oil

Details on test material:

- Name of test material (as cited in study report): Cornmint oil (mentha arvensis)
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Composition of test material, percentage of components: Confidential
- Lot/batch No.: Confidential
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator (2-8°C) protected from light

Test animals / tissue source

Species:

other: not relevant: in vitro test

Strain:

other: Bovine

Details on test animals or tissues and environmental conditions:

BOVINE EYES:
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse, where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 ul per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 ul of physiological saline per cornea

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 ul per cornea
- Concentration (if solution): 10% (w/v) Benzalkonium Chloride

Duration of treatment / exposure:

Exposure: 10 minutes
Post incubation period: 120 minutes

Observation period (in vivo):

Not applicable

Details on study design:

TEST SITE: Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 3 times
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After the 10 minutes exposure and washing step, the corneas were incubated for 120 +/- 10 minutes at 32 °C. After the completion of the incubation period opacity determination was performed by sodium fluorecein treatment. Incubation 90 min. Optical density of the medium determined at 490 nm.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

TOOL USED TO ASSESS SCORE: opacitymeter and microplate reader.

DATA EVALUATION: A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.

Results and discussion

In vivo

Results

Irritation parameter:

other: In vitro irritancy score (IVIS)

Basis:

mean

Time point:

other: 10 minutes

Score:

ca. 4.3

Reversibility:

other: not applicable

Other effects:

No pH effect of the test substance was observed on the rinsing medium.

Applicant's summary and conclusion

Interpretation of results:

other: not severe irritant or corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In the in vitro Bovine Corneal Opacity and Permeability test, cornmint oil (mentha arvensis) did not induce ocular irritation through both endpoints, opacity and permeability, resulting in a mean in vitro irritancy score of 4.3 after 10 minutes of treatment. It is concluded that this test is valid and that Cornmint oil (mentha arvensis) is not severe irritant or corrosive in the BCOP test under the experimental conditions described in the report.

Executive summary:

This in vitro study was performed according to OECD Guideline 437 (2009) to assess the corneal irritation and damage potential of Cornmint oil (mentha arvensis) by means of the Bovine Corneal Opacity and Permeability Assay (BCOP) using fresh isolated bovine corneae. The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 119 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Cornmint oil (mentha arvensis) did not induce ocular irritation through both endpoints, opacity and permeability, resulting in a mean in vitro irritancy score of 4.3 after 10 minutes of treatment. Finally, it is concluded that this test is valid and that Cornmint oil (mentha arvensis) is not severe irritant or corrosive in the BCOP test under the experimental conditions described in the report.