Hydrocarbons, C12-C16, n-alkanes, isolkanes, alkenes

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

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

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 9 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 17 days

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Results 11

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Results 13

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.