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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
In vivo done previously
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between March 09th, 1987 and March 30th, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well-documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 40CFR158 Series 81-4, EPA Pesticide Assessment Guidelines-Subdivision F-Hazard Evaluation – Human & Domestic Animals, November 1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid at room temperature
- Analytical purity: not provided.
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
The treated eye was not washed out.
Observation period (in vivo):
Treated eyes were examined after 1 hour and 1, 2, 3, 4 and 7 days following treatment. Eyes exhibiting ocular irritation at 7 days were also examined at 14 days. If ocular irritation persisted at 14 days, eyes were re-examined at 21 days.
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
ca. 12.5
Max. score:
110
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 9.3
Max. score:
110
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 21 d
Score:
ca. 1.3
Max. score:
110
Reversibility:
not fully reversible within: 21 d
Other effects:
None.

Any other information on results incl. tables

Conjunctival irritation was noted in 6/6 animals on day 1, 5/6 animals on day 3, 3/6 animals on day 7, the remining 3/6 animals exhibited conjunctival irritation through day 21.

Corneal opacity was noted for 3/6 animals on day 2, and in 1/6 animals after day 3 and day 7.  0/6 animals showed corneal opacity on days 14 and 21.

Iritis was noted for 1/6 animals at 24 and 48 hours and 0/6 animals on day 3.

Table 1: Average Ocular Irritation Scores

Time

1 h

 1 d

2 d

 3 d

4 d

7 d

14 d

21 d

Ocular Irritation Scores

14.3

12.5

17.2

9.3

8.0

5.0

1.3

1.3

Table 2:  Mean Scores (24,48,72 hours)

Corneal Opacity

Iris

Conjunctival Erythema

Conjunctival Edema

0.28

0.11

1.22

1.83

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test substance is an eye irritant.
Executive summary:

An eye irritation study was performed using male New Zealand White rabbits according to the definition of the 40 CFR158 Series 81-4, EPA Pesticide Assessment Guidelines-Subdivision F-Hazard Evaluation. 6 rabbits were administered with a single dose of 0.1 ml test material to one eye of each animal, and eyes were examined and graded for ocular reaction following dose administration using the Draize method.

Conjunctival irritation was noted in 6/6 animals on day 1, 5/6 animals on day 3, 3/6 animals on day 7, the remining 3/6 animals exhibited conjunctival irritation through day 21. Corneal opacity was noted for 3/6 animals on day 2, and in 1/6 animals after day 3 and day 7. 0/6 animals showed corneal opacity on days 14 and 21. Iritis was noted for 1/6 animals at 24 and 48 hours and 0/6 animals on day 3. Based on these scores, the test substance is classified as an eye irritant.