Fuels, diesel

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: young adult
- Weight at study initiation: 2 to 4 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week


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: left eye was left untreated

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
- Concentration (if solution): no vehicle
- Lot/batch no. (if required): no vehicle
- Purity: no vehicle

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

24, 48, and 72 hours

Number of animals or in vitro replicates:

4 males and 5 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test eye of three rabbits were flushed with distilled water
- Time after start of exposure: 30 seconds


SCORING SYSTEM: Draize method


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

80

Remarks on result:

other: unrinsed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Remarks on result:

other: unrinsed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

20

Remarks on result:

other: unrinsed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: included within conjunctivae score

Irritant / corrosive response data:

No signs of occular lesions were present. All rabbits scored zero on every point at each observation.

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, exposure of the test material to the eyes of rabbits did not cause any occular lesions. The test material is not classified as irritating to the eye.

Executive summary:

In an eye irritation study, 4 male and 5 female New Zealand White rabbits were exposed to test material diesel fuel (marketplace sample). A dose of 0.1 mL of undiluted test material was placed on the everted lower lid of the right eye of each rabbit within the group. The test eyes of three rabbits, two females and one male, were flushed for one minute with distilled warm water starting 30 seconds after application of the test material. The test eyes of the remaining 6 rabbits were unwashed. The untreated left eye of each rabbit served as a control. Occular lesions were scored at 24, 48, and 72 hours after treatment. Fluorescein dye evaluation was used for the 24 hour reading. Scoring was done in accordance with the Draize technique.

No signs of ocular lesions were present. All rabbits scored zero on every point at each observation. The test material is not classified as irritating to the eye.

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