Lime (Citrus aurantifolia), ext.

Eye irritation

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

Test material information

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

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

Time point:

other: 24, 48, and 72 hours

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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.