Foots oil (petroleum)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1984-09-25 to 1984-10-02

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 OECD guideline 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrotreated light naphthenic distillate, insufficiently refined, IP 346 ≥ 3% (CAS # 64742-53-6)

IUPAC Name:

Hydrotreated light naphthenic distillate, insufficiently refined, IP 346 ≥ 3% (CAS # 64742-53-6)

Details on test material:

Read Across to Lubricant Base Oils
- Test substance: API 83-12 (CAS No. 64742-53-6)
- Name of test material (as cited in study report): API 83-12
- Substance Type: Lubricant Base Oils (IP 346 ≥ 3%)
- Molecular weight (if other than submission substance): 148.3
- Physical state: clear, colorless liquid
- Composition of test material, percentage of components: 61.6% saturates, 36.1% aromatics, 2.3% polar compounds
- Viscosity: 53.5 SSU at 100°F, 33.3 SSU at 210°F
- Sulphur, Wt%: 0.019
- Gravity API: 26.2
- Flash Point 255°F
- Distillation at 10% 533, at 95% 713 °F
- Initial Boiling Point: 464°F
- End Point 796 °F
- Pour Point 60°F
- Colour 0.5
- Aniline 148.3 °F

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults (approximately 14 weeks old)
- Weight at study initiation: range of 2,440 to 2,871
- Housing: individually housed in screen-bottom cages
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: fourteen days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24°C)
- Humidity (%): 60 to 68%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-09-05 To: 1984-09-25

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

one second

Observation period (in vivo):

Observations of ocular lesions in the treated eyes were recorded in both groups at 1, 24, 48, and 72 hours and at 7 days after treatment.

Number of animals or in vitro replicates:

9 (six in group 1 and three in group 2)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated and control eye of group II animals were flushed with 1 minute with lukewarm water, 20 to 30 seconds after test material instillation. The eyes of group I rabbits were not flushed.
- Time after start of exposure: 20 to 30 seconds.


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: sodium 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

Reversibility:

not specified

Remarks on result:

other: unrinsed eye

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Reversibility:

not specified

Remarks on result:

other: unrinsed eye

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

12

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unrinsed eye

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

not specified

Remarks on result:

other: unrinsed eye

Irritant / corrosive response data:

No pain responses or corneal or iridal irritation was seen during the study. All irritation had cleared by the 48 hour observation period. No signs of ill health was observed during the study

Any other information on results incl. tables

There was no pain response during instillation of the test material and no corneal or iridial irritation was seen during the study. Any irritation that occurred had cleared by 48 hours. The primary eye irritation scores for the first 48 hours of the study were as follows:

Period	Unwashed eyes	Washed eyes
1 hour	2.7	2.0
24 hours	0.3	0
48 hours	0	0
72 hours	0	0
7 days	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Scoring of irritation was performed using the method of Draize. The test material was classified as not irritating.

Executive summary:

Read across justification

The physical and chemical properties of foots oils are comparable to the other lubricant base oil intermediate streams from which they are derived. Hence their health effects are also similar to those of other lubricant base oils, and the conclusions of the hazard assessment for other lubricant base oils also apply to foots oils.

In a eye irritation study, nine New Zealand White rabbits were exposed to 0.1 mL of hydrotreated light naphthenic distillate in one eye. The other eye served as the no-treatment control. After instillation of the test material the upper and lower lids of the test animals were held together for one second. Twenty to thirty seconds following instillation the eyes of three of the six test animals were flushed for one minute with lukewarm water. The eyes of the remaining test animals were unflushed. Observation for ocular lesions were made in all animals at 1, 24, 48, and 72 hours and 7 days after treatment. Body weights were recorded immediately prior to application and upon study termination. Scoring of irritation was performed using the Draize technique. At study termination all animals were euthanized.

There was no pain response during instillation of the test material and no corneal or iridial irritation was seen during the study. Any irritation that occurred had cleared by 48 hours. In this study the study material was considered not irritating to the eye.

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