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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
26 Jun 1978 to 3 Jul 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
exposure duration of 24 hours instead of 4 hours/ occlusive coverage/ dilutions of the substance tested
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
Name cited in study report: PGA-X
Lot No: 80524
Appearance: colorless high viscous liquid

Test animals

Species:
rabbit
Strain:
other: albino rabbits of Japanese native strain
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ichikawaya Limited
- Weight at study initiation: 2.6 to 3 kg
- Housing: The animals were housed individually in a conventional aluminum rabbit cage
- Diet: The animals were allowed free access to complete pelleted rabbit diet (Diet RC-4, Oriental Yeast Co.)
- Water: The animals were allowed free access to automatic watering.
- Acclimation period: 7 day observation period. During this period, all animals were inspected for sigins of disease and skin condition

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 24
- Humidity (%): 50 to 60

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: acetone
Controls:
yes, concurrent vehicle
Amount / concentration applied:
- 0.15 mL of each concentration (and vehicle control) was individually applied.
- concentrations: 0.1, 0.4, 1.6, 6.4, and 25.6% v/v
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
six males
Details on study design:
TEST SITE
- Preparation of test site: Twenty-four hours before the intended application, the fur were clipped from the dorsal and blank regions of all animals by electric clippers.
- Type of wrap: Application was done on the intact skin of the rabbits with test-plaster (Bayer-Dorf) as a patch. 0.15 mL of five test solutions and acetone which was the vehicle control were applied individually. The patches were secured in place by 1.2 x 4 cm adhesive tape (Eratex). The entire trunk of the animal was wrapped with an impervious polystyrene film and covered with cloth for the 24-hours of exposure. The cloth material aids to maintain the test patches in position.
REMOVAL OF TEST SUBSTANCE
After 24 hours of exposure, the patches were removed and applied areas were rinsed with 200 mL tepid water. The plastic collar was fitted on the neck of the rabbit to prevent for the rabbit to access by mouth and to maintain the applied area during the observation period.

OBSERVATION TIME POINTS
Three hours after exposure, the first readings for the resulted reactions were made and assigned to the 24 hour data points. The second reading was done 74 hours after application. Score were additionally determined at 48 hours and 7 days.

SCORING SYSTEM:
- Erythema and eschar formation, edema formation on applied areas were evaluated by the procedure described by Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 0.1% concentration
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 0.1% concentration
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 0.4% concentration
Irritation parameter:
erythema score
Basis:
animal: #3 and #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: 0.4% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 0.4% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 48 and 72h
Score:
0
Max. score:
4
Remarks on result:
other: 0.4% concentration
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 0.4% concentration
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 1.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #3 , #4 and #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1.6% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1.6% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1.6% concentration
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4 and #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 1.6% concentration
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1.6% concentration
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 48 and 72h
Score:
0
Max. score:
4
Remarks on result:
other: 1.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #1, #4 and #5
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 and 72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #4, #5 and #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 6.4% concentration
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 6.4% concentration
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: 6.4% concentration
Irritation parameter:
edema score
Basis:
animal: #3, #4, #5 and #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 6.4% concentration
Irritation parameter:
edema score
Basis:
animal: #1, #3 and #4
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 6.4% concentration
Irritation parameter:
edema score
Basis:
animal: #2, #5 and #6
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: 6.4% concentration
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: 6.4% concentration
Irritation parameter:
erythema score
Basis:
animal: #1, #3 and #4
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #2, #5 and #6
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 26.5% concentration
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
erythema score
Basis:
animal: #2, #5 and #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal: #1, #2, #4, #5 and #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal: #1 and #4
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal: #2, #5 and #6
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal: #1 and #4
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: 25.6% concentration
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 25.6% concentration
Irritant / corrosive response data:
No irritation was observed for the regions treated with the vehicle control.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Since the diluted substance (at 25.6%) resulted in significant skin irritation, the test item was considered to be irritating to the skin.
Executive summary:

In a study, comparable to OECD404, 0.15 mL of five different test substance dilutions were applied on distinct regions of the intact skin of six male albino rabbits of Japanese native strain under occlusive conditions. The applied concentrations were 0.1, 0.4, 1.6, 6.4 and 25.6% dissolved in acetone. A vehicle control was taken along. Animals were exposed for 24 hours after which the substance was removed with 200 mL tepid water. Application of the vehicle was included as control. Erythema and edema were scored according to the Draize scoring system 24, 48, 72 hours and 7 days after exposure. Irritating effects were observed mostly at the sites treated with 6.4 and 25.6% test substance. Erythema scores of 1 to 3 were obtained in in the 6.4% dose group after 24 hours, but the effects were reversible within 7 days, except for one animal. Edema was scored between 0 to 2 after 24 hours and was fully reversible. After application of 25.6% the erythema score was 2 to 3 after 24 and 48 hours and 1 or 2 after 72 hours. The effects were fully reversible within 7 days in half of the animals. The edema scores were 0 or 1 and fully reversible in the 7 day observation period. For one animal an edema score of 2 was obtained at the 24 and 48 timepoints, these effects were reversible as well. Based on the effects observed on the intact skin, the diluted substance at 25.6% has to be considered as irritating to the skin.