Orange, sweet, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

an in vivo study was performed with rabbits

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 January 2003 - 30 January 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Remarks:

Statement of Compliance

Test material

Test material information

Constituent 1

Reference substance name:

Orange, sweet, ext.

EC Number:

232-433-8

EC Name:

Orange, sweet, ext.

Cas Number:

8028-48-6

Molecular formula:

This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.

IUPAC Name:

Essential oil of orange obtained from the peel of Citrus sinensis (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities

Constituent 2

Reference substance name:

Cold Pressed Orange oil

IUPAC Name:

Cold Pressed Orange oil

Details on test material:

- Name of test material (as cited in study report): Cold Pressed Orange oil- Physical state: liquid- Analytical purity: no data- Lot/batch No.: no data- Stability under test conditions: no data- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste- F40260 Linxe, France
- Age at study initiation: no data
- Weight at study initiation: 2.18, 2.49 and 2.59 kg
- Housing: in individual boxes
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: 8 to 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 26 -51
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% (undiltued)

Duration of treatment / exposure:

at least 24 hours

Observation period (in vivo):

1 hour after installation, and 24, 48 and 72 hours after, and thereafter daily for 9 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: no data

SCORING SYSTEM: The numerical scorings recorded were made in compliance with OECD guideline 405, 1987, scoring ocular lesions (corneal, iridic and conjunctival irritation). Ocular examinations were performed on both right and left eyes 1 hour after instillation and 24, 48 and 72 hours later.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

Animal # 1, 2, and 3

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

Animal # 1, 2, and 3

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

Animal #1, 2, and 3

Time point:

other: 24, 48, and 72 hours

Score:

ca. 1

Max. score:

3

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

Animal #1

Time point:

other: 24, 48, and 72 hours

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

Animal #2

Time point:

other: 24, 48, and 72 hours

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

Animal # 3

Time point:

other: 24, 48, and 72 hours

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The ocular reactions observed during the study remained slight to moderate and only recorded at the conjunctivae level: slight redness in the 3 animals 1 hour after the test product administration and totally reversible between the 8th and the 9th day of the test, associated with a moderate chemosis 1 hour after the test product administration and totally reversible between the 7th and the 8th day of the test.

Other effects:

The body weight of the animals was within the range commonly recorded for this strain.

Any other information on results incl. tables

The authors conclude that according to the classification established in the Journal Officiel de la République Française, dated July 10th, 1992, the results obtained, in these experimental conditions, enabled to conclude that the test product, Cold Pressed Orange Oil, according to the scales of interpretation retained, is slightly irritant for the eye (Maximum Ocular Irritation Index (Max. O.I.=14.0).

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

not irritating, CLP criteria not met

Conclusions:

In an eye irritation study performed according to OECD405, orange oil did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), Cold Pressed Orange Oil does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.

Executive summary:

The primary eye irritation potential of Cold Pressed Orange Oil was investigated according to OECD test guideline no. 405, 1987. The test item was applied by instillation of 0.1 ml into one eye of each of 3 male New Zealand White rabbits.

The ocular reactions observed during the study remained slight to moderate and only recorded at the conjunctivae level. The mean score was calculated across the 3 scoring times for each animal for corneal opacity, iris lesion, redness and chemosis of the conjunctivae, separately, and was 0.0 for all three animals for corneal opacity and iris lesions, and 1.0 for reddening of the conjunctivae for all three animals. It is concluded that orange oil did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS), Cold Pressed Orange Oil does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits