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Toxicological information

Eye irritation

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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
Study period:
1984-05-09 to 1984-05-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and well documented study report based on sound scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
test material was washed less than 24 hours after instillation
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
Substance as identified in the study report: API 83-07 (CAS# 64741-59-9)
Physical Description: light brown liquid
Initial Boiling Point (°F): 464
Final Boiling Point (°F): 701
Gravity API degrees: 14.1

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
- Weight at study initiation: 2.1 to 2.5 kg
- Housing: individually housed in screen-bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 25°C
- Humidity (%): 58 to 64%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-05-09 To: 1984-05-16

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye of each animal served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single instillation, eye lids held together for one second
Observation period (in vivo):
7 days; readings of ocular lesions taken at 1, 24, 28, and 72 hours and at 7 days after instillation of test material
Number of animals or in vitro replicates:
6 animals in no-rinse group, 3 animals in rinse group
Details on study design:
Rabbits were divided into two groups: Group 1 animals' eyes remained unflushed, and Group 2 animals had eyes flushed for 1 minute at 20 to 30 seconds after test material instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
other: washed and unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
other: washed and unwashed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: unwashed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: included in conjunctivae scores above
Irritant / corrosive response data:
No pain response/vocalisation was observed upon instillation of test substance. No corneal or iridal irritation was observed. Blanching of conjunctivae was exhibited by one Group 1 animal at the 1-hour timepoint. Irritation resolved by 72 hours, and no systemic toxicity was observed throughout the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test material caused a mildly-irritating, reversible response when instilled in eyes of rabbits with or without rinse. Based on calculated irritation scores (0/80 for corneal, 0/10 for iridial, and 0.44/20 for conjunctival for both washed and unwashed eyes), the test material is classified as not irritating to rabbit eyes.
Executive summary:

A sample of light catalytically cracked distillate was tested for eye irritation potential in groups of nine male New Zealand White rabbits. Treated and control eyes from three rabbits were flushed with lukewarm water for one minute starting 20 to 30 seconds after instillation while the treated eyes of 6 rabbits remained unrinsed. Eye irritation was quantified according to the method of Draize at 1, 24, 48, and 72 hours and 7 days, and results presented as the primary eye irritation score (total irritation score for all animals divided by the number of animals in the group).

 

No pain response (vocalisation) was elicited from any animal following instillation of the test material. No corneal or iridal irritation was observed. Blanching of conjunctivae was exhibited by one Group 1 animal at the 1-hour timepoint. Irritation resolved by 72 hours, and no systemic toxicity was observed throughout the study period. Based on calculated irritation scores (0/80 for corneal, 0/10 for iridial, and 0.44/20 for conjunctival for both washed and unwashed eyes), the test material is classified as not irritating to rabbit eyes.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and a well documented study report.