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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1979-04-30 to 1979-05-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restrictions because it is an acceptable and a well-documented study report, but is done for the read-across substance. Read-across justification: Based on the chemical composition, the renewable hydrocarbons produced from raw materials such as fatty acid rich oil like Crude Tall Oil (CTO) or triglyserides, using a hydrotreatment process have similar hydrocarbon fractions and they contain the same critical constituents than fossil diesel fuels. According to the identified hydrocarbon blocks, the typical carbon number ranges and the physicochemical properties, the renewable hydrocarbons with diesel type fractions can be considered as having structural similarities and similar behaviour in contact with water and in the physiological processes than the analogue source substances (fossil diesel fuels). Their irritation properties, skin sensitisation property as well as acute and long-term adverse effects to human health is similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from the analogue fossil diesel fuels is used to evaluate skin and eye irritation, the genetic toxicity, carcinogenicity, developmental toxicity and short term and/or long-term toxicological effects of the target substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hours exposure
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 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

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

Resultsopen allclose all
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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 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:
New Zealand White rabbits were exposed to the read-across substance, similar to renewable hydrocarbons of wood origin (diesel type fraction), for 24 hours in occlusive conditions. 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 skin irritant.
Executive summary:

This skin irritation study was conducted for the read-across substance, #2 Home Heating Oil (50% cat]), similar to the registering substance.

In this study New Zealand White rabbits (3/sex) 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, but is conducted for the read-across substance.