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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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; restriction due to testing not performed under GLP but data are of sufficient quality

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Section 1500.42-Hazardous Substance and Articles, Administration and Enforcement Regulations, Federal Register, Vol 38, No. 187, P 27019, 27 September 1973.
Deviations:
no
GLP compliance:
no

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: Ace Animals, Inc. Boyertown PA
- Housing: Stainless steel with elevated wire mesh flooring 1 rabbit/cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 – 23.9
- Humidity (%):40-45%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

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
- Concentration (if solution): undiluted.
Duration of treatment / exposure:
Test material was instilled into the conjunctival sac of 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, 2, 3, 4, 7, 14 and 21 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 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 72 hours
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Effects did not clear in 4/6 animals at 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.17
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Effects were not clear in 2/6 animals at 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2.05
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Effects did not clear in 5/6 animals at 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
3.1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Effects did not clear in 6/6 animals at 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test material caused ocular irritation that persisted through Day 21.
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 substance produced ocular irritation up to 21 days.