Lime (Citrus aurantifolia), ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

this is an in vivo study, already performed in 1971

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Documentation acceptable as basic data. No Guideline followed and study not performed under GLP.

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:

Six rabbits (weighing 2.5 to 3.4 kg) 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. 0.5 ml of the test material, Lime oil, was applied to each area. The areas of application were immediately covered with two single layers of gauze approximately one-inch square. The gauze was secured in place with adhesive tape, and the entire trunk wrapped with a nonabsorbent binder. The binder was removed after 24 hours, and the effects (erythema and edema) scored by the Draize method. Scoring was repeated at 72 hours.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lime Oil

IUPAC Name:

Lime Oil

Details on test material:

- Name of test material (as cited in study report): Lime Oil
- Physical state: No data
- Lot/batch No.: confidential

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 to 3.4 kg.

ENVIRONMENTAL CONDITIONS: No data

IN-LIFE DATES: No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: The areas of application were immediately covered with two single layers of gauze approximately one-inch square. The gauze was secured in place with adhesive tape, and the entire trunk wrapped with a nonabsorbent binder.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: the binder was removed after 24 hours

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Time point:

other: 24 and 72 hours

Score:

ca. 1

Reversibility:

no data

Remarks on result:

other: 6 rabbits

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

subtotal

Time point:

other: 24 and 72 hours

Score:

ca. 4

Reversibility:

no data

Remarks on result:

other: 6 rabbits

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

subtotal

Time point:

other: 24 and 72 hours

Score:

ca. 0

Reversibility:

no data

Remarks on result:

other: 6 rabbits

Irritant / corrosive response data:

Mildly irritating

Other effects:

No data

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: not specified

Conclusions:

The individual Primary Irritation Index score obtained at 24 and 72 hours was 1.0. Erythema score was 4.0 and edema score was 0. Lime oil appeared to be mildly irritating to rabbit skin. As the report is very concise, the documentation is insufficient for an assessment, and interpretation of results remain inconclusive.

Executive summary:

A primary skin irritation study was carried out to define irritational responses to Lime oil. No guideline has been followed. Six rabbits (weighing 2.5 to 3.4 kg) 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. 0.5 ml of the test material, Lime oil, was applied to each area. The areas of application were immediately covered with two single layers of gauze approximately one-inch square. The gauze was secured in place with adhesive tape, and the entire trunk wrapped with a nonabsorbent binder. The binder was removed after 24 hours, and the effects (erythema and edema) scored by the Draize method. Scoring was repeated at 72 hours. The individual Primary Irritation Index score obtained at 24 and 72 hours was 1.0. Erythema score was 4.0 and edema score was 0. Lime oil appeared to be mildly irritating to rabbit skin. As the report is very concise, the documentation is insufficient for an assessment, and interpretation of results remain inconclusive.