Gas oils, paraffinic

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-10-28 to 1982-08-04

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:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Eyes were flushed 30 seconds after treatment. OECD TG 405 suggests flushing to occur after 24 hours of treatment.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrodesulfurised middle distillate (CAS# 64742-80-9)

IUPAC Name:

Hydrodesulfurised middle distillate (CAS# 64742-80-9)

Details on test material:

- Name of test material (as cited in study report): API 81-09 (CAS# 64742-80-9)
- Physical state: Clear liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: Approximately 2.5 to 3.5 kg
- Housing: individual screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 degrees Celsius
- Humidity (%): 40% to 58% relative humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye was used as the untreated control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the liquid test material was placed in the eye.


VEHICLE - no vehicle was used.

Duration of treatment / exposure:

Group II animals had the treated eye flushed for one minute with lukewarm water starting 30 seconds after compound instillation. The eyes of rabbits in Group I remained unflushed.

Observation period (in vivo):

Ocular lesions in the treated eyes were observed 1, 48, 72 hours and at 7 days after treatment. Sodium fluorescein and ultraviolet light were used to reveal possible corneal injury at 72 hours and 7 days after treatment.

Number of animals or in vitro replicates:

Nine male and female rabbits.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rabbits in Group II had eye flushed with lukewarm water for one minute after exposure. Treated eyes in Group I remained unflushed.
- Time after start of exposure: 30 seconds


SCORING SYSTEM: Draize method


TOOL USED TO ASSESS SCORE: sodium fluorescein and ultraviolet light

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

unwashed

Time point:

other: 24 hours

Score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Individual animal data were not provided.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean overall eye irritation score for unwashed animals was reported as 2.0 at 24 hours. Irritation was reversible at 48 hours post exposure. Hydrodesulfurised middle distillate was not classified as irritating because individual animal irritation data was not provided.

Executive summary:

In a primary eye irritation study, 0.1 mL of test material (Hydrodesulfurised middle distillate) was instilled into the conjunctival sac of the left eye of young adult New Zealand White rabbits (4 male/5 female). The right eye of the animals were used as the control. Rabbits in Group II had the treated eye washed for one minute after 30 seconds of treatment. Rabbits treated in Group I remained unwashed for the entire observation period. Animals were observed for seven days. Irritation was scored by the method of Draize.

The maximum primary irritation score for Group I (unwashed) was 2.7 at 1 hour and 2.0 at 24 hours. Irritation was reversed at 48 hours. The primary irritation score for Group II (washed) was 2.7 at 1 hour. Irritation was reversible at 24 hours. Hydrodesulfurised middle distillate is considered non-irritating to the rabbit eye because of the low irritation score and reversibility, and is not classified as irritating because individual animal irritation data was not provided.

This study received a Klimisch score of two and is classified as reliable with restriction because it is an acceptable and a well-documented study report.