Distillates (petroleum), full-range straight-run middle

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-06-11 to 1985-12-02

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 TG 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

group II had eyes washed.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64741-44-2

Cas Number:

64741-44-2

IUPAC Name:

64741-44-2

Constituent 2

Reference substance name:

Straight-run middle distillate

IUPAC Name:

Straight-run middle distillate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): API 83-11
- Molecular formula (if other than submission substance): Straight run middle distillate
- Molecular weight (if other than submission substance): Clear, pale-yellow liquid
- CAS number: 64741-44-2
- Gravity API: 36.2
- Sulfur wt %:0.30
- Nitrogen ppm: 80
- Boiling range (ASTM D-86 equiv) 10%: 488 °F
- Initial Boiling Point 366 °F
- End Boiling Point 735 °F
- Viscosity at 40°C cSt: 4.16
- Aniline Point °F: 171
- Composition % by MS:
olefins 2.0
aromatics 21.0
saturates 77.0

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: Approximately 14 weeks
- Housing: Individual in screen-bottomed cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
- Temperature (°C): 21 to 25
- Humidity (%): 58% t o 64%: relative humidity

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitre

Duration of treatment / exposure:

Animals in Group I were dosed in with API 83-11. The eyes remained unflushed.
Animals in Group II: Eyes were flushed for one minute, 20 to 30 minutes aftre instillation.

Observation period (in vivo):

Readings of occular lesions in the treated eyes of both groups were made at 1, 24, 48, and 72 hours and at 7 days after treatment.

Number of animals or in vitro replicates:

Six animals were dosed in Group I and 3 animals were dosed in Group II.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Animals in Group II had eyes flushed with warm water for 1 minute, 20 to 30 minutes after treatment. Group I eyes were not flushed.
- Time after start of exposure: 20 to 30 minutes after instillation.

SCORING SYSTEM: Draize Technique

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

20

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Slight irritation noted at 24 hours; mean averages to 0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: included within conjunctivae scoring

Irritant / corrosive response data:

No sign of systemic toxicity was observed during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No pain response (vocalization) was elicited from any animal following instillation of the test material. No corneal irritation was seen during the study. All irritation had cleared by the 48-hour observation. No sign of systemic toxicity was observed during the study.

Executive summary:

In a primary eye irritation study, 0.1 millilitre of a straight run middle distillate was instilled into the conjunctival sac of one eye of nine young adult New Zealand White rabbits. The eyes of three rabbits were washed, twenty to thirty minutes after instillation. The remaining six rabbits were not washed. Animals were observed 1, 24, 48, and 72 hours and at 7 days after treatment. The mean conjunctivae, iridial and corneal scores at 24, 48 and 72 hours post-exposure were 0. The test material was not found to be irritating to rabbit eyes. Irritation was scored by the method of Draize.

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