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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and well-documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA Guidelines in FR Vol. 44, No. 145, pgs. 44054-44093
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
Test substance:Kerosine/heating oil (F-76-01)
- Lot/batch No.: 2070
- Storage condition of test material: vented and continuously monitored for temperature. The test material was stored at 60-100°F
- Physical description: clear liquid
- Density: 0.8170 g/mL
- Purity: 100% hydrocarbons

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Alpine Rabbitry, Sandy, Utah
- Age at study initiation: 8-14 weeks old
- Weight at study initiation: 1.8-2.3 kg
- Housing: caged individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66-74 degrees F
- Humidity (%): 29-53%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period:
24 and 72 hours and 4,5,6,7,8,9,10 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1" square
- Type of wrap if used: covered with 1" square gauze pads stabilized with a strip of hypoallergenic tape after which a dental dam was applied to the test sites and secured with 3" wide tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize (1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
3.13
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: erythema scores ranging from 2-4 in all except one animal who scored 1 at 24 hours
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
2.42
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: scores ranged mostly from 2-4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
1.92
Max. score:
4
Reversibility:
not fully reversible within: 10 days

Any other information on results incl. tables

Observation for irritation was extended to 10 days. Although the degree of edema declined throughout the observation period, the degree of erythema and eschar did not decline so markedly. Scores for the range of erythema and edema as well as the average irritation scores and their ranges are summarised in the following table.

Obs. period

Range of scores

Irritation index

 

Erythema

Edema

Mean

Range

24 hr

1-4

0-4

5.6

1.0-7.5

72 hr

2-4

1-3

5.4

3.8-6.2

4 day

3-4

1-3

5.4

4.5-6.0

5 day

2-4

0-2

4.9

4.0-6.0

6 day

1-4

0-1

4.3

3.5-4.8

7 day

1-4

0-1

4.0

3.2-4.8

8 day

1-3

0-2

3.3

2.0-4.2

9 day

1-3

0-1

3.2

2.2-4.0

10 day

0-4

0-1

3.7

2.2-4.0



On the basis of these findings, the test material was described as a
 moderate dermal irritant.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema and edema scores over 72 hours (i.e., average of 24 and 72 hour readings) were 3.46 and 2.33 for intact skin for each endpoint respectively. The test material was classified as irritating according to EU criteria.
Executive summary:

In a primary dermal irritation study, 6 female New Zealand White rabbits were dermally exposed to undiluted Kerosine/heating oil (0.5mL per test site). Two of the test sites on each rabbit were intact skin. After exposure, the test site was covered with a gauze pad and the trunk of the rabbit was wrapped in an impervious covering. Twenty-four hours later the patches were removed and any residual material was wiped from the skin. Each of the test sites was evaluated for skin responses within 60 minutes of patch removal (24 hour reading), and again at 72 hours, then daily until 9 days post-application. The responses were scored using the Draize scale.

The mean erythema and edema scores over 72 hours (i.e., average of 24 and 72 hour readings) were 3.46 and 2.33 for intact skin for each endpoint respectively. The test material was classified as irritating according to EU criteria.  

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well-documented study report.