Registration Dossier

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:
1990-08-28 to 1992-04-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out according to EPA OTS 798.4500.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: F-133 (thermocracked kerosine), CAS No. 68333-23-3
- Substance type:
- Physical state: liquid
- Analytical purity: 100% petroleum hydrocarbons
- Storage condition of test material: stored at temperature no greater than 27 degrees celsius
- Specific gravity: approximately 0.74
- Flash point: approximately -43 degrees celsius, extremely flammable
- pH: 5
- Density: 0.8965 g/ml

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: J. Leslie Furs, American Fork, Utah
- Age at study initiation: young adult
- Weight at study initiation: 2.0 to 4.0 kilograms
- Housing: housed separately in stainless steel, wire meshed bottomed cages
- Diet: fresh certified Agway rabbit feed was provided ad libitum
- Water: fresh potable water was provided ad libitum
- Acclimation period: seven days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21 degrees celsius, within protocol limits
- Humidity (%): 40 to 60%, within protocol limits
- Air changes: no less than ten air changes per hour
- Photoperiod: 12 hours light/ 12 hours dark


IN-LIFE DATES:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye on each animal served as untreated control
Amount / concentration applied:
0.1 mL of undiluted liquid test article
Duration of treatment / exposure:
single treatment, eyelids held together for approximately 1 second post dosing.
Observation period (in vivo):
observations were made at pre-screening, 1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no data provided on washing



SCORING SYSTEM: Eye irritation scores were generated using the Draize system. Scores were collected at the 24 and 72 hour intervals and were used to determine the Primary Eye Irritation Index.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
20
Remarks on result:
other: all 3 animals had conjunctivae scores of 8 at 1 hour which fully resolved by 24 hours
Irritant / corrosive response data:
At pre-screening all animals were free of ocular lesions. There was no evidence of damage to the cornea or iris for all animals at all scoring periods. Mild conjunctivae indicators such as redness, chemosis, and discharge were evident at the one hour scoring interval, and at no other scoring interval. Fluorescein staining scores were zero for all study animals over all scoring periods.
Other effects:
No ocular lesions were seen in the untreated control eyes during the study period.

Any other information on results incl. tables

All three rabbits had an ocular reaction 1 hour after instillation of the test material; the score for each animal was 8.0. No irritation was observed thereafter.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the mean cornea, iris, and conjunctivae scores of 0.0 calculated for all three test animals using the 24, 48, and 72 hour readings, thermocracked kerosine is considered not irritating according to EU criteria.
Executive summary:

In a primary eye irritation study, 0.1 mL/eye of undiluted thermocracked kerosine was instilled into the conjunctival sac of the right eye of three female young adult New Zealand White rabbits, and their eyelids held together for one minute after instillation. Observations were made at pre-screening, 1, 24, 48, and 72 hours. Irritation was scored according to the Draize method.

At pre-screening all animals were free of ocular lesions. There was no evidence of damage to the cornea or iris for all animals over all scoring periods. Mild conjunctivae indicators such as redness, chemosis, and discharge were evident at the one hour scoring interval, and at no other scoring interval. Fluorescein staining scores were zero for all study animals over all scoring periods. The mean cornea, iris, and conjunctivae scores (24, 48, and 72 hours) were all 0.0. Thermocracked kerosine is not irritating to the eye according to EU criteria.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was carried out according to EPA OTS 798.4500.