White mineral oil (petroleum)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

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 TG 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

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:

8042-47-5

Cas Number:

8042-47-5

IUPAC Name:

8042-47-5

Constituent 2

Reference substance name:

Highly refined base oil

IUPAC Name:

Highly refined base oil

Test material form:

other: Oily liquid

Details on test material:

- Name of test material (as cited in study report): white mineral oil [F-52-01; ARCOprime 70]
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): see Fig. N/A
- Substance type: petroleum hydrocarbons
- Physical state: transparent colourless liquid
- Analytical purity: 100% petroleum hydrocarbons
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 769
- Expiration date of the lot/batch: September 1989
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: approximately 5 years
- Storage condition of test material: stored in temperature-monitored room (10 to 27 degrees Celsius)
- Density 0.8433 g/ml
- Flash Point °F: 355

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Alpine Rabbitry
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.3 to 3.7 kilograms
- Housing: housed individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 and 23 degrees Celsius
- Humidity (%): 28 and 56%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark


IN-LIFE DATES: From: 1984-10-24 To: 1984-11-15

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated control- left eye

Amount / concentration applied:

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


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

Duration of treatment / exposure:

Eyelids were held closed for 1 to 2 seconds. Test eyes of animals in the washed group were exposed to the test material for 20 to 30 seconds before washing. Test eyes of animals in the unwashed group were never flushed.

Observation period (in vivo):

Observations of ocular lesions were made at 24, 48, 72 hours, day 4, day 5, and day 7 after dosing.

Number of animals or in vitro replicates:

12 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test eyes of 6 of the test animals were washed with lukewarm water for 1 minute. The remaining animals were not.
- Time after start of exposure: 20 to 30 seconds


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

Remarks:

unwashed

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

Remarks:

unwashed

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

Remarks:

unwashed

Time point:

24/48/72 h

Score:

0.22

Max. score:

12

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: All animals scored 0 except: 1 animal scored a 2 at 24 hours, another animal scored a 2 at 48 hours

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:

A very mild irritation occurred in one rabbit in the rinsed at 24 hours, but was completely reversible by 48 hours. A very mild irritation occurred in a different rabbit in the rinsed group at 48 hours, but was completely reversible by 4 days.

A very mild irritation occurred in one rabbit in the unrinsed group at 24 hours, but was completely reversible by 48 hours. A second rabbit in the unwashed group exhibited a very mild irritation at 48 hours, but was completely reversible by 72 hours.

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, the mean unwashed cornea and iris scores (24-72 hours) were both 0.0. The mean unwashed conjunctivae score (24-72 hours) was 0.22. The test material is considered not irritating to the eye.

Executive summary:

In a primary eye irritation study [Klimisch score = 1], the right eye of 12 male New Zealand White rabbits was dose with 0.1 mL of undiluted highly refined base oil. In 6 of the animals, the treated eye was flushed with water after 20 to 30 seconds of treatment. In the remaining 6 animals, the treated eye was not flushed. The left eye of each animal served as the untreated control. Observations of ocular lesions were made at 24, 48, 72 hours, day 4, day 5, and day 7 after dosing. The eyes were examined and scored according to the Draize system. Flourescein examination of all eyes was made on day 4.

A very mild irritation occurred in one rabbit in the rinsed at 24 hours, but was completely reversible by 48 hours. A very mild irritation occurred in a different rabbit in the rinsed group at 48 hours, but was completely reversible by 4 days. A very mild irritation occurred in one rabbit in the unrinsed group at 24 hours, but was completely reversible by 48 hours. A second rabbit in the unwashed group exhibited a very mild irritation at 48 hours, but was completely reversible by 72 hours. Under the conditions of this study, the mean unwashed cornea and iris scores (24-72 hours) were both 0.0. The mean unwashed conjunctivae score (24-72 hours) was 0.22. The test material is considered not irritating to the eye.

This study received a Klimisch score of 1 because it was carried out according to guideline study OECD TG 405.