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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-10-21 to 1980-10-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified 'reliable without restriction' because it was conducted according to OECD guideline 405.

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation for ocular irritation 1 hour post-exposure was not conducted as recommended by OECD Guideline 405.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Solvent dewaxed light paraffinic oil, CAS No. 64742-56-9
- Molecular weight (if other than submission substance): 322
- Substance type: Other Lubricant base oil (Sufficiently refined, IP 346 <3%)
- Physical state: Liquid
- Analytical purity: Not reported
- Composition of test material, percentage of components: Saturates - 88.3%; Aromatics - 11.3%
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
- Other:
Specific gravity 60/60: 0.8490
Viscosity: 64.2 SUS @ 100°F

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elkhorn Rabbitry (Watsonville, California)
- Age at study initiation: Not reported
- Weight at study initiation: 3.0 - 5.0 Kg
- Fasting period before study: Not reported
- Housing: Individual cage
- Diet (e.g. ad libitum): Purina Rabbit Chow® ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 14 days


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: From: 1980-10-02 To: 1980-10-28

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye of test animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Unwashed - single application with subsequent observation for 72 hours
Washed - single application folllowed by washing with water 30 seconds later and subsequent observation for 72 hours.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
9 (5 males, 4 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (water)
- Time after start of exposure: 30 seconds post exposure to TS


SCORING SYSTEM: Draize scoring method


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
8
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
8
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
See (Table 1) "Remarks on results including tables and figures"

Any other information on results incl. tables

Table 1. Mean Eye Irritation Scores for Male and Female Rabbits

 

24 hours

48 hours

72 hours

Washed eyes

0

0

0

Unwashed eyes

0

0.33

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Rabbits with washed eyes exhibited no irritation through the 72-hour observation period. One male rabbit in the unwashed group exhibited conjunctival chemosis at the 48-hour observation period. The remaining rabbits showed no signs of irritation through the study period.
Executive summary:

In a primary eye irritation study, 6 New Zealand White rabbits (3 male, 3 female) had 0.1 mL of dewaxed light paraffinic oil instilled into the conjunctival sac of their right eye. The left eyes of these rabbits served as treatment controls. Additionally, 3 rabbits (2 male, 1 female) were administered the test material in the right eye and the eyes were rinsed with warm water 30 seconds following exposure.

Ocular lesions were observed for at 24, 48, and 72 hours post-exposure and fluorescein dye evaluations employed for each reading. Grading and scoring of ocular irritation was performed according the method of Draize.

Rabbits with washed eyes exhibited no irritation through the 72-hour observation period. A single male rabbit in the unwashed group exhibited conjunctival chemosis at the 48-hour observation period. The remaining rabbits showed no signs of irritation through the study period.

Solvent dewaxed light paraffinic oil is not considered to be an ocular irritant.

This study is classified 'reliable without restriction' because it was conducted according to OECD guideline 405.