Middle distillate from refinery proces cofeeding vegetable oil

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-05-28 to 1979-06-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 405.

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

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 (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


IN-LIFE DATES: 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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

80

Remarks on result:

other: unrinsed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

10

Remarks on result:

other: unrinsed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.11

Max. score:

20

Reversibility:

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:

Under the conditions of this study and according to EU regulations, 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. .