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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
20 January 2003 - 30 January 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study is perfomed according to OECD Guideline 405, 1987, and under GLP. 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.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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
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
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 VI of 67/548/EEC and 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 VI of 67/548/EEC and 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