Fuel oil, no. 4

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-06-05 to 1976-06-20

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 a well-documented study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 hour occluded exposure duration

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

68334-30-5

Cas Number:

68334-30-5

IUPAC Name:

68334-30-5

Constituent 2

Reference substance name:

Diesel fuel -marketplace sample

IUPAC Name:

Diesel fuel -marketplace sample

Test material form:

other: low viscosity hydrocarbon liquid

Details on test material:

- Name of test material (as cited in study report): API #79-6, disel fuel (marketplace sample)
- Substance type: petroleum distillate product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components wt percent: 41.7% paraffins, 30.9% cycloparaffins (monocycloparaffins 18.8% dicycloparaffins 9.3%, tricycloparaffins 2.8%) 27.4% aromatics (alkylbenzenes 8.4%, indans and tetralins 5.3%, dinaphthenobenzenes 1.1%, C11+ naphthalenes 7.6%, biphenylenes 2.5% fluorenes etc 1.1% tricyclic aromatics 1.4%)
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported by sponsor
- Storage condition of test material: stored in Elars' test material storage room
- Flash Point: 142 °F
- Sulfur 0.19%
- Viscosity at 100°F: 2.17 cSt
- Bromine number 1.42
- benzene 80 ppm v/v
- acid number 0.0
- Distillation range (ASTM D-86) 5-95%: 412-648 °F
- Initial BP: 367 °F
- Final Boiling Point: 675°F

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: not reported
- Weight at study initiation: 2 to 3 kg
- Housing: individually housed in stainless steel cages with grated bottoms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

other: on each animal, 2 sites were abraded and 2 sites were intact skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not reported


VEHICLE
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): not reported
- Lot/batch no. (if required): not reported
- Purity: not reported

Duration of treatment / exposure:

24 hours

Observation period:

Observations were recorded at 24 and 72 hours, and 7 and 14 days following test material administration.

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: four test sites located lateral to the midline of the back (2 sites on each side)
- % coverage: not reported
- Type of wrap if used: bandaged strips and elastic tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess test material was removed by wiping the skin with gauze sponges
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

4

Max. score:

4

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

3.83

Max. score:

4

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Remarks on result:

other: intact skin

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

2.92

Max. score:

4

Remarks on result:

other: intact skin

Irritant / corrosive response data:

At 24 hours the test sites were very irritated. Blisters formed, some open and with skin peeled back. At 72 hours, the sites remained very irritated, two rabbits had open sores. By day 7 most of the sites had formed scabs. By the 14th day, the skin was healing, but still dry and flaky with no hair growth on the test sites.

Any other information on results incl. tables

	24 hours		72 hours		7 days		14 days
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
Abraded	4.00	3.00	3.83	2.67	3.50	1.58	0.17	0
Intact	4.00	3.00	3.83	2.92	3.75	1.67	0.17	0

Primary dermal irritation score: 6.81

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean erythema and oedema scores for 24 and 72 hours are 3.9 and 2.96, respectively. Diesel fuel (market place sample) is classified as an irritant.

Executive summary:

In an skin irritation study, 3 male and 3 female New Zealand White rabbits were exposed to diesel fuel (market place sample). Before test material application, each animals was clipped of hair in an area from the shoulders to the hips and halfway down either side of the thorax. There were four exposure sites per animals (2 on each side of the midline). On the day of the study, the left posterior and right anterior site on each animal was abraded. Incisions penetrated the stratum corneum, but not the dermis. The remaining test sites were left in tact. 0.5 mL of test material was applied to gauze patches backed by plastic wrap. The patches were applied to the four test sites and were secured in place with bandage strips and elastic tape. After 24 hours, the wrapping and patches were removed. Excess test material was removed by wiping the skin with gauze sponges. Observations for erythema and oedema were recorded at 24 and 72 hours, and 7 and 14 days post-application. Erythema and oedema were scored using the Draize method.

At 24 hours the test sites were very irritated. Blisters formed, some open and with skin peeled back. At 72 hours, the sites remained very irritated, two rabbits had open sores. By day 7 most of the sites had formed scabs. By the 14th day, the skin was healing, but still dry and flaky with no hair growth on the test sites. The mean erythema and oedema scores for 24 and 72 hours are 3.9 and 2.96, respectively. Diesel fuel is classified as an irritant.

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