Hydrocarbons, C9-16, hydrotreated, dearomatized

Skin irritation / corrosion

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

Guideline:

other: EPA Guidelines in FR Vol. 44, No. 145, pgs. 44054-44093

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

8008-20-6

Cas Number:

8008-20-6

IUPAC Name:

8008-20-6

Constituent 2

Reference substance name:

Kerosine/heating oil

IUPAC Name:

Kerosine/heating oil

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 or test system 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

Results

Results 1

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

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 3

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

Results 4

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

Results 5

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

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.