Middle distillate from refinery proces cofeeding vegetable oil

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-04-30 to 1979-05-14

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 exposure duration

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

#2 home heating oil (50% catalytically-cracked)

IUPAC Name:

#2 home heating oil (50% catalytically-cracked)

Details on test material:

- Name of test material: API #78-4, #2 home heating oil (50% cat)
-Substance type: petroleum distillation product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by the sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 50% virgin gas oil and 50% cracked gas oil
- 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 provided by the sponsor
- Storage condition of test material: stored in Elar's test material storage room

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pel-Freeze Farms, Inc.
- Age at study initiation: 4 months
- Weight at study initiation: 2 to 4 kilograms
- Housing: housed individually 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):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

Animals were observed at 24 and 72 hours and 7 and 14 days

Number of animals:

three males and three females

Details on study design:

TEST SITE
- Area of exposure: four test sites located lateral to the midline of the back (two sites on each side)
- % coverage: not reported
- Type of wrap if used: Saran Wrap, Band-Aid, and Conform elastic tape


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


SCORING SYSTEM: scored using the Draize technique

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.5

Max. score:

4

Reversibility:

fully reversible

Remarks:

14 days

Remarks on result:

other: intact skin

Irritant / corrosive response data:

Both erythema and oedema were observed at the 24 hour, 72 hour, and 7 day recording periods. By day 14 no signs of oedema and erythema were observed.

Other effects:

During the 14 day observation period hair did not regrow on the test sites, but grew normally on the surrounding skin.

Any other information on results incl. tables

Table 1: Average dermal irritation scores

	24 hours		72 hours		7 days		14 days
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
Abraded	1.58	0.75	3.08	1.92	2.75	1.50	0	0
Intact	1.58	0.83	3.42	2.17	2.75	1.42	0	0

Primary Irritation Score: 3.83

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 during the 24 to 72 hour observation periods were 2.5 and 1.5, respectively. Based on the conditions of this study, the test substance is considered an irritant.

Executive summary:

In a skin irritation study New Zealand White rabbits (3/sex) were tested with #2 Home Heating Oil (50% cat]) a substance composed of vacuum gas oils/hydrocracked gas oils/distillate fuels. The rabbits were exposed to 0.5 mL of test substance applied to four shaved test area on the back (2 abraded and 2 intact) via a a gauze patch. Gauze patches were secured with Saran wrap and Band-Aids and wrapped with Conform elastic tape. After 24 hours of exposure the covering were removed and the test sites were wiped with gauze sponges to removed excess material. Animals were observed at 24 hours, 72 hours, 7 and 14 days post-administration. Signs of erythema and eodema were scored according to the draize technique.

Signs of erythema and oedema were evident at 24 hours, 72 hours, and 7 days. By day 14 all erythema and oedema had subsided. The mean erythema and oedema scores during the 24 to 72 hour observation periods were 2.5 and 1.5, respectively. Based on the conditions of this study, the test material 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.