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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 27, 2010 - July 27, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to OECD Test Guideline No. 437, 2009, under GLP Standards, and QA.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: INVITTOX (UK) protocol no. 98 "The Bovine Corneal Opacity and Permeability Assay", February 1994
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Nutmeg Oil - Myristica fragrance oil
IUPAC Name:
Nutmeg Oil - Myristica fragrance oil
Details on test material:
- Name of test material (as cited in study report): Nutmeg Oil - Myristica fragrance oil
- Analytical purity: Confidential
- Lot/batch No.: Confidential
- Expiration date of the lot/batch: Confidential
- Stability in Solvent: Not relevant
- Storage condition of test material: At room temperature

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: Odenwaldschlachthof Brensbach, 64395 Brensbach, Germany

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Yes, Saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml

POSITIVE CONTROL: 2-Ethoxyethanol - 0.75 ml

NEGATIVE CONTROL: 0.9% (w/v) NaCl in deionised water (Saline) - 0.75 ml
Duration of treatment / exposure:
130 minutes (10+120)
Observation period (in vivo):
Not applicable
Number of animals or in vitro replicates:
9 freshly isolated bovine cornea: negative control, positive control and test item: 3 cornea each.
Details on study design:
EXPOSURE OF THE CORNEA: in cornea holder.

REMOVAL OF TEST SUBSTANCE:
- Washing (if done): The test item or control items, respectively, were rinsed off from the application side by changing cMEM (complete Minimum Essential Medium)
- Time after start of exposure: at 10 minutes and again at 2 hours after incubation.

SCORING SYSTEM: (See also: Other information on materials and methods)
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490 value).
The following formula was used to determine the in vitro score of the positive control and the test item:
In vitro Score = (opacity value - opacity value mean negative control) + (15 x corrected OD490 value).
The in vitro Score was calculated for each individual treatment and positive control cornea. The mean in vitro Score value of each treated group was calculated from the individual in vitro Score values.

TOOL USED TO ASSESS SCORE:
Cornea opacity value: opacitometer (OP_KiT opacitometer (Electro Design, 63-Riom France).
Permeability (optical density value) at 490 nm (OD490): fluorescein; spectrophotometer.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Mean in vitro Score Negative control
Basis:
other: Cornea 1, 2, and 3
Score:
ca. 0.39
Reversibility:
other: not applicable
Remarks on result:
other: Non eye irritant
Irritation parameter:
other: Mean in vitro Score Positive control
Basis:
other: Cornea 1, 2, and 3
Score:
ca. 85.07
Reversibility:
other: not applicable
Remarks on result:
other: Very severe eye irritant
Irritation parameter:
other: Mean in vitro Score Test substance
Basis:
other: Cornea 1, 2, and 3
Score:
ca. 2.72
Reversibility:
other: not applicable
Remarks on result:
other: Non eye irritant
Irritant / corrosive response data:
The test item, Nutmeg Oil - Myristica fragrance oil, did not cause any opacity or permeability of the corneae compared with the results of the negative control.

Any other information on results incl. tables

Negative and positive controls were within historical ranges.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item Nutmeg Oil - Myristica fragrance oil did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro Score was 2.72 and therefore, the test item was classified as non eye irritant. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nutmeg Oil - Myristica fragrance oil is not considered to be an eye irritant.
Executive summary:

This in vitro study was performed according to OECD Guideline 437 to assess the corneal irritation and damage potential of Nutmeg Oil - Myristica fragrance oil by means of the Bovine Corneal Opacity and Permeability Assay (BCOP) using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item Nutmeg Oil - Myristica fragrance oil, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t10). Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a third time (t130). After the opacity measurements permeability of the corneae was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 1 °C in a horizontal position. The liquid coming out was measured spectrophotometrically. With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro Score was calculated as 0.39. The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant. The mean in vitro Score was calculated as 85.07. The test item Nutmeg Oil - Myristica fragrance oil did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro Score was 2.72 and therefore, the test item was classified as non eye irritant. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nutmeg Oil - Myristica fragrance oil is not considered to be an eye irritant.