Lemon, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Very concise report, but the study seems reliable. No data on environmental conditions. No Guideline followed and study not performed under GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

An Acute Dermal Toxicity Limit test was performed as a standard acute method. Six male/female rabbits were prepared by clipping their trunks free from hair. Two areas on the back of each rabbit were selected: one area of skin was abraded; the remaining area was left intact. A dose of 5 ml/kg of liquid Lemon oil was applied to the skin of each of a group of rabbits. Liquid test material was delivered under a rubber sleeve by using a hypodermic syringe; then the sleeve was covered with Webril padding. The rabbits were fitted with a collar to prevent the removal of the wrappings. 24 hours later, the binders were removed, and the local dermal reactions were scored according to the method of Draize. Toxic effects, dermal reactions, and mortality were recorded daily for 14 days. A necropsy was performed on animals that died during the course of the study and on those animals which were killed (by air embolism) at termination.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lemon, ext.

EC Number:

284-515-8

EC Name:

Lemon, ext.

Cas Number:

84929-31-7

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).

IUPAC Name:

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

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
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: Individually
- Diet (e.g. ad libitum): Commercial diet
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS: No data

IN-LIFE DATES: No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg

Duration of treatment / exposure:

24 hours

Observation period:

24 hours and 14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Not defined
- % coverage: 10% (240 cm2)
- Type of wrap if used: Rubber sleeve with Webril padding

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours the binders were removed

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Time point:

other: 24 hours

Score:

>= 2 - <= 4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: 6/6 animals

Results 2

Irritation parameter:

edema score

Time point:

other: 24 hours

Score:

>= 1 - <= 3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: 4/6 animals

Irritant / corrosive response data:

Skin irritation:
- Erythema score: between 2-4 in all animals
- Edema score: between 1-3 in 4 animals
- Discoloration: noted in 1 animal
- Scaling: noted in 5 animals
- Eschar formation: noted in 5 animals

Other effects:

1 out of 6 animals died during study.

Any other information on results incl. tables

Classification of skin irritation is based on acute dermal toxicity test. No tissue damage observed at termination.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

An Acute Dermal Toxicity Limit test was performed as a standard acute method. As no detailed scoring data is available, it is not possible to classify lemon oil according to the EU classification criteria outlined in 67/548/EEC and 1272/2008. However, the available scores at 24 hrs indicate lemon oil should be considered irritating to the skin.

Executive summary:

Skin irritation potential of lemon oil was determined in an acute dermal toxicity limit test, which was performed as a standard acute method. Six male/female rabbits were prepared by clipping their trunks free from hair. Two areas on the back of each rabbit were selected: one area of skin was abraded; the remaining area was left intact. A dose of 5 ml/kg of liquid Lemon oil was applied to the skin of each of a group of rabbits. The test material was delivered under a rubber sleeve by using a hypodermic syringe; then the sleeve was covered with Webril padding. The rabbits were fitted with a collar to prevent the removal of the wrappings. The binders were removed 24 hours later, and the local dermal reactions were scored according to the method of Draize. Toxic effects, dermal reactions, and mortality were recorded daily for 14 days. A necropsy was performed on animals that died during the course of the study and on those animals which were killed (by air embolism) at termination.

Observed skin irritation was as follows: erythema score: between 2-4 in all animals; edema score: between 1-3 in 4 animals; Discoloration: noted in 1 animal; Scaling: noted in 5 animals; Eschar formation: noted in 5 animals. 1 out of 6 animals died during study. As no detailed scoring data is available, it is not possible to classify lemon oil according to the EU classification criteria outlined in 67/548/EEC and 1272/2008. However, the available scores at 24 hrs indicate lemon oil should be considered irritating to the skin.