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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize, J.H. Dermal Toxicity. Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics. 46-59; 1959
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ruscus aculeatus, ext.
EC Number:
281-682-9
EC Name:
Ruscus aculeatus, ext.
Cas Number:
84012-38-4
Molecular formula:
not applicable
IUPAC Name:
Ruscus aculeatus, ext.
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
200, 2000, 5000 mg/kg
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
2 males and 2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
7 d
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
7 d
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
7 d
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 7/10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 7/10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 7/10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 7/10/14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Method.

Upon receipt, the six rabbits of each sex were assigned to the following groups by computerized randomization process. The rabbits were acclimated to laboratory conditions for approximately two weeks prior to initiation of tretment.

Group1: 2 males and 2 females Dosage levels 200 mg/kg

Group2: 2 males and 2 females Dosage levels 2000 mg/kg

Group3: 2 males and 2 females Dosage levels 5000 mg/kg

Compound Administration.

Prior to initiation, the hair was closely clipped from the abdomen of each rabbit (area approximately 10% of the total body surface). Just prior to compound application, the skin of one-half of the animals in each group was abraded with minor incision which were sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma or to produce bleeding. The skin of the remaining rabbits was left intact. The skin was premoistened with physiological saline, and the appropriate amount of the test material was applied to the skin of each rabbit. The test material was held in contact with the skin for 24 hours by means of a nonabsorbent binder composed of polyethylene tubing and Coban elastic bandage. 24 hours following application, the binders were removed, the residual amount of the test material was estimated, and the exposure sites were wiped with gauze to preclude further exposure of the animals to the test material. The test material was administered dermally because potential human exposure is by dermal route.

Observations and records.

All of the rabbits were observed twice daily for mortality and signs of toxic and pharmacologic effects for 14 days.

Dermal responses were graded and scored on days 1, 3, 7, and 14 according to the system of Draize ( 1959).

Individual body weights were recorded prior to treatment, on day 7 and at termination.

Sacrifice and gross pathology.

At termination (Day 14) all surviving rabbits were sacrificed with T- Euthanasia Solution (Taylor Pharmacal Company, Decatur, Illinois) and necropsied; observations were recorded.

Applicant's summary and conclusion

Interpretation of results:
other: No classified
Conclusions:
Most of the test material applied to the exposure sites of each animal was found in situ at 24 hours postapplication. Very slight to well defined erythema was noted in all animals on Days 1, 3 and 7, while very slight edema was noted in all animals on Days 1 and 3. Compound adhering to the skin was observed on all animals on Days 1 and 3; blanching was noted in one male dosed at 5000 mg/kg on Days 1 and 3, and male dosed at 200 mg/kg on Day 3. Thickening of the skin was seen in one male dosed at 2000 mg/kg on Day 3. All animals in Days 7, one male and two females dosed at 2000 mg/kg and one animal of each sex dosed at 5000 mg/kg on Day 10, two females dosed at 2000 mg/kg and one animal of each sex dosed at 5000 mg/kg on Day 14 were noted to have epidermal scaling.
No gross pathology was observed in any of the test animals.