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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
1979-05-28 to 1979-06-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restriction because it was conducted according to or similar to guideline study OECD 405, but was conducted 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 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 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 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 sponsor
- Storage condition of test material: stored in Elars' test material storage room

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Pel-freeze Farms, Inc.
- Age at study initiation: young adult
- Weight at study initiation: 2 to 3 kg
- Housing: housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: two 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
four females and five males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the right eye of one male and two females were flushed for one minute with distilled warm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize technique

TOOL USED TO ASSESS SCORE: fluorescein dye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
80
Remarks on result:
other: unrinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0
Max. score:
10
Remarks on result:
other: unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48,72 hours
Score:
0.11
Max. score:
20
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: unrinsed
Irritant / corrosive response data:
One rabbit, in the unrinsed group, exhibited minor conjunctival erythema at the 24 and 48 hour reading. All other animals were normal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study, male and female rabbits were administered 0.1 mL of undiluted #2 home heating oil, read-across substance similar to the registering substance. Under the conditions of this study, the test material is not irritating to eyes.
Executive summary:

In an eye irritation study, four females and five males were administered 0.1 mL of undiluted #2 home heating oil. The test material was applied to the everted lower lid of the right eye of each of the nine rabbits. The left eye served as the untreated control. In one male and one female, the test eye was flushed for one minute with distilled warm water 30 seconds after application. Ocular lesions were scored at 24, 48, and 72 hours after treatment. Fluorescein dye evaluation was used for the 24 hour scoring. Scoring was based on the Draize technique.

Only one rabbit, in the unrinsed group, exhibited minor conjunctival erythema at the 24 and 48 hour reading. All other animals were normal. Under the conditions of this study and according to EU regulations, the test material is not irritating to eyes.

This study received a Klimisch score of 1. It is classified as reliable without restrictions because it was conducted similar to guideline study OECD 405. .