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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
November, 1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Very concise report. Chemical identity of substance not reported. No data on environmental conditions, housing and diet. No Guideline followed and study not performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline
Principles of method if other than guideline:
Three normal, healthy, albino rabbits were used in this experiment. The method of procedure is that suggested by Dr. Draize and described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", published by the Association of Food and Drug Officials of the. United States. Each animal had 0.1 ml of the test sample instilled into the right eye with no further treatment. The untreated left eye of each animal served as its own control. Both the treated and control eyes were examined every 24 hours for 4 days and then again on the 7th day. The scorings recorded were made according to the Draize scale for scoring ocular lesions.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Lemon, ext.
IUPAC Name:
Lemon, ext.
Constituent 2
Reference substance name:
Lemon oil
IUPAC Name:
Lemon oil
Details on test material:
- Name of test material (as cited in study report): Lemon oil, California C.P.
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Both the treated and control eyes were examined every 24 hours for 4 days and then again on the 7th day.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize method

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
Time point:
other: 24, 48, and 72 hours
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
ca. 2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
ca. 1.6
Max. score:
3
Reversibility:
fully reversible within: 7 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: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
ca. 1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Instillation of Lemon oil as described did not produce any corneal opacity or iris congestion. An intense conjunctival irritation did occur involving chemosis and discharge. On the 7th day of observation the treated eyes were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Instillation of Lemon oil as described (5%) did not produce any corneal opacity or iris congestion. An intense conjunctival irritation did occur involving chemosis and discharge. On the 7th day of observation the treated eyes were normal. Based on the irritation scores and according to the EU classification criteria outlined in 1272/2008, Lemon oil does not have to be classified as irritating to eye.
Executive summary:

To determine if lemon oil (5%) produces any irritation when instilled into rabbits eyes, 3 normal, healthy, albino rabbits were used in this experiment. The method of procedure is that suggested by Dr. Draize and described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", published by the Association of Food and Drug Officials of the.United States. Each animal had 0.1 ml of the test sample instilled into the right eye with no further treatment. The untreated left eye of each animal served as its own control. Both the treated and control eyes were examined every 24 hours for 4 days and then again on the 7thday. The scorings were made according to the Draize scale for scoring ocular lesions.

Instillation of Lemon oil as described did not produce any corneal opacity or iris congestion. An intense conjunctival irritation did occur involving chemosis and discharge. On the 7thday of observation the treated eyes were normal. Based on irritation scores and according to the EU classification criteria outlined in 1272/2008, Lemon oil (5%) does not have to be classified as irritating to eye.