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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Body weights not reported
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Test material name: Naugalube 438L CN 5294300
Supplier: Uniroyal Inc.
Description: Brown viscous liquid
storage at ambient temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino, not further specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nicholas Helf
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1 August 1983 To: 4 August 1983

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
3 ays
Number of animals or in vitro replicates:
6
Details on study design:
The test article was placed by syringe or syringe-type applicator into the conjunctival sac which was formed by gently pulling the lower eye1 i d away frorn the
eye. After instilllation, the lids were held together briefly to insure adequate distribution of the test article, One eye of each rabbit was dosed. The contralateral
eye served as a control. No washing step was included.

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:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None of the six treated animals showed any sign of ocular irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met