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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: USEPA Pesticide Assessment Guidelines (540/9-82-025)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C11-C14, isoalkanes, cyclics <2% aromatics
IUPAC Name:
Hydrocarbons, C11-C14, isoalkanes, cyclics <2% aromatics
Test material form:
other: clear, colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100%
Duration of treatment / exposure:
4 hours
Observation period:
21 days
Number of animals:
6
Details on study design:
The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least eight centimeters by eight centimeters. Care was taken to avoid abrading the skin. Only those animals with exposure areas free from pre-existing skin irritation or defects were selected for testing.

There was one intact skin test site per animal. East test site was treated with 0.5 milliliters of actual undiluted test material by introducing the test material at room temperature beneath a surgical gauze patch measuring 1 inch x 1 inch and two single layers thick. Each patch was secured in place with a strip of a non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent the animals from possibly ingesting any of the test material. To secure the wrappings in place, the edges of the dressing were wrapped with a non-irritating adhesive tape in a manner which would not cdause discomfort to the animals. The animals were then returned to their cages.

Four hours after treatment the wrapping, tape, and gause patches were removed. The backs of the animals were gently washed with room temperature tap water and a wet cloth to remove as much residual test material as possible. The animals were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 0, 24, 48, and 72 hours and on Days 7, 9, 13, 17, and 20 (Day 0 considered day of treatment) after washing.

For each observation time, all of the erythema and edema scores were added, and the sum was divided by the number of animals observed to determine an irritation score. The maximum irritation score was selected from the observation time yielding the highest irritation score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 0 - 4.2
Max. score:
4.2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 9 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 9 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.6
Max. score:
2
Reversibility:
fully reversible within: 9 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 17 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 20 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 9 days
Irritant / corrosive response data:
Erythema was present at each observation time through Day 17. Edema was present at each observation time through Day 7. The maximum irritation score of 4.2 our of a possible 8.0 was obtained at the one hour observation.

Any other information on results incl. tables

Observation Time

ERYTHEMA FORMATION

EDEMA

FORMATION

OTHER OBSERVATIONS

IRRITATION SCORE

Rabbit Number

Rabbit Number

Rabbit Number

1M

2M

3M

4F

5F

6F

1M

2M

3M

4F

5F

6F

1M

2M

3M

4F

5F

6F

0 Hours

2

2

2

2

2

2

2

2

2

2

2

3

0

0

0

0

0

0

4.2

24 Hours

2

1

2

2

2

2

2

1

1

1

1

2

0

0

0

0

0

0

3.2

48 Hours

2

1

1

2

1

1

1

1

1

1

1

1

0

0

0

0

0

0

2.3

72 Hours

2

1

3

1

1

1

1

1

1

1

1

1

0

0

0

0

0

0

2.5

Day 7

1

1

3

1

1

1

0

0

1

0

1

1

0

0

0

0

0

0

1.8

Day 9

0

0

1

0

1

1

0

0

0

0

0

0

S

S

S

S

S

S

0.5

Day 13

0

0

1

0

1

1

0

0

0

0

0

0

S

S

S

S

S

S

0.5

Day 17

0

0

0

0

0

1

0

0

0

0

0

0

0

S

0

0

S

S

0.2

Day 20

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

S

0.0

Maximum Irritation Score = 4.2

M – Male; F – Female

S – Sloughing of skin of various thicknesses

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.
Executive summary:

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least eight centimeters by eight centimeters. Care was taken to avoid abrading the skin. Only those animals with exposure areas free from pre-existing skin irritation or defects were selected for testing.

There was one intact skin test site per animal. East test site was treated with 0.5 milliliters of actual undiluted test material by introducing the test material at room temperature beneath a surgical gauze patch measuring 1 inch x 1 inch and two single layers thick. Each patch was secured in place with a strip of a non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent the animals from possibly ingesting any of the test material. To secure the wrappings in place, the edges of the dressing were wrapped with a non-irritating adhesive tape in a manner which would not cdause discomfort to the animals. The animals were then returned to their cages.

Four hours after treatment the wrapping, tape, and gause patches were removed. The backs of the animals were gently washed with room temperature tap water and a wet cloth to remove as much residual test material as possible. The animals were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 0, 24, 48, and 72 hours and on Days 7, 9, 13, 17, and 20 (Day 0 considered day of treatment) after washing. For each observation time, all of the erythema and edema scores were added, and the sum was divided by the number of animals observed to determine an irritation score.

Erythema was present at each observation time through Day 17. Edema was present at each observation time through Day 7. The maximum irritation score of 4.2 our of a possible 8.0 was obtained at the one hour observation.

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.

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