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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:
1985-08-20 to 1986-02-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it closely follows 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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
This study had satellite group where the treated eye was washed 20 to 30 seconds after instillation. Corrosive effects were not observed in this study; the negative response was not confirmed by conducting the experiment again with two animals.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: oily liquid
Details on test material:
- Name of test material (as cited in study report): API 84-01
- Substance type: Unrefined paraffinic oil

Light paraffinic distillate, API 84-01, CAS No. 64741-50-0

- Molecular weight (if other than submission substance): 296
- Physical state: Liquid (light amber)
- CAS number: 64741-50-0
- Viscosity, cSt: 2.67 at 100°C
- API Gravity: 31.5
- Flash Point: (°F) 372
- Sulfur, Wt %: 0.2
- Nitrogen ppm: 256
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- Composition of test material, Wt. %:
Olefins: 39.7
Naphthenes 21.7
- PONA % by MS:37.0

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: 14 weeks
- Weight at study initiation: 2559 to 3166 grams
- Housing: Individually 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): 20 to 24 degrees Celsius
- Humidity (%): 64% to 70%
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitres
Duration of treatment / exposure:
Group II animals had treated and control eye flushed for 1 minute with water starting 20 to 30 seconds after the test material instillation. Group I animal eyes were left unflushed.
Observation period (in vivo):
The animals were observed for 1 hour, 24 hours, 48 hours, 72 hours and 7 days after instillation.
Number of animals or in vitro replicates:
Nine animals were tested in total. Six animals were treated with unwashed eyes, three animals had eyes washed after 20 to 30 seconds of instillation.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Three animal's eyes were washed, six animals remained unwashed.
- Time after start of exposure: 20 to 30 seconds

SCORING SYSTEM: Draize; the primary eye irritation score is the total eye irritation score (includes cornea, iris, and conjuctivae irritation score) for all animals divided by the number of animals in each group at each observation period.

TOOL USED TO ASSESS SCORE: Sodium fluorescein

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: unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
other: unwashed eyes
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: unwashed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: unwashed eyes

Any other information on results incl. tables

Primary eye irritation scores were as follows:    

1 hr

24hr

48hr

72hr

7days

Group I

(unwashed)

3.0

1.7

0.0

0.0

0.0

Group II

(washed)

4.0

0.0

0.0

0.0

0.0

The test substance produced slight irritation which was essentially completely resolved within 48 hours.


Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The material was not significantly irritating to the eye of the rabbit.
Executive summary:

In a primary eye irritation study, 0.1 millilitre of API 84 -01 was instilled on to the corneal surface above the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The nine animals treated were 14 week, young adult, New Zealand White rabbits. Three of the nine rabbits had eyes washed 20 to 30 seconds after instillation. Six of the nine rabbits eyes remained unwashed. Animals were observed for 7 days total. Irritation was scored by the method of Draize.

One animal died on day 7, but this was not considered to be treatment related. The test material did not cause an initial pain response or corneal or iridial irritation. The mild eye irritation that occurred had cleared by 48 hours. The test material was not considered irritating by EU classification.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely follows OECD Guideline 405.