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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data was generated according to valid testing guidelines.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: 40 CFR, Section 163.81-4, Federal Register, August 22,m 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guideline of November, 1982
Deviations:
no
GLP compliance:
no
Remarks:
Routine Quality Assurance Unit auditing, to assure laboratory compliance with GLP was ongoing during the period of time when this study was conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Inc. Douglassville PA
- Housing: Stainless Steel caging with elevated wire mesh flooring, 1 rabbit/ cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-23.8.
- Humidity (%):55 +/- 25%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: 10 March 1986 – 24 March 1986

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 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
The eyes were examined and graded for ocular reaction at 1 hour and 1, 2, 3, 4, 7, 14 days following instillation of test material into the eyes.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.
- Time after start of exposure: not applicable.

SCORING SYSTEM: Interpretation of the results was made in accordance with the modified Draize technique for scoring ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: day 2
Remarks on result:
other: 5/6 animals had Dull eyes during the study
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: day 14
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: day 7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the test material produced mild to moderate conjunctival irritation in the albino rabbit eyes. At Day 7, very slight irritation was noted for 2/6 animals and no irritation noted for 4/6 animals. At Day 14 no irritation was noted for 2/6 animals exhibiting irritation at day 7. Corneal involvement was observed in 5/6 animals however it was not evident at day 7. No iritis was noted during the 14 day observation period
Executive summary:

In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the New Zealand White rabbits (6 animals).The test material produced mild to moderate conjunctival irritation in the albino rabbit eyes which fully reversed in all animals by Day 14. Corneal involvement was observed in 5/6 animals however it was not evident at day 7. No iritis was noted during the 14 day observation period.

 

The test substance is not classified as in irritant in accordance with the classification system of GHS.