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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
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
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
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.

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