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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:
February 28 - April 4, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although the study was quite old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 405.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
not under GLP conditions, study dates 1986
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Slz WX-R
- Analytical purity: 99.93%
- Lot/batch No.: 8623

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd.
- Age at study initiation: not mentioned.
- Weight at study initiation: 2.05-2.47 kg
- Housing: individual metal mesh-bottomed suspenses cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 - 42 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 45 - 75
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1, 24, 48, 72, (96 hours, 1 week): with or without washing after 30 seconds for 1 minute
Observation period (in vivo):
1, 24, 48, 72, (96 hours, 1 week)
Number of animals or in vitro replicates:
3 with washing; 3 without washing
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, in one group
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Criteria of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
non-washed group
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: Score: 10.0, 6.7, 6.7, 1.7, 0 resp. at t = 24, 48, 72, 96 h, 1 week
Irritation parameter:
iris score
Remarks:
non-washed group
Basis:
mean
Time point:
other: 1 h
Score:
1.7
Max. score:
5
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Score: 5.0, 1.7, 1.7, 0, 0 resp. at t= 24, 48, 72, 96 h, 1 week
Irritation parameter:
conjunctivae score
Remarks:
non-washed group
Basis:
mean
Time point:
other: 1 h
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Score: 12.7, 4.0, 0.7, 0, 0 resp. at t = 24, 48, 72, 96 h, 1 week
Irritation parameter:
cornea opacity score
Remarks:
washed group
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h
Irritation parameter:
iris score
Remarks:
washed group
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h
Irritation parameter:
conjunctivae score
Remarks:
washed group
Basis:
mean
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score: 2.7, 0, 0 resp. at t = 24, 48, 72 h
Irritant / corrosive response data:
In the non-washed group (3 animals), all of the cases showed conjunctival redness with a strength level of 1 and conjunctival edema with a strength level of 2 at 1 hour after Slz WX-R application, while 1 case showed iris hyperemia with a strength level of 1. No change in the strength of the conjunctival hyperemia was observed at 24 hours after application, but in all of the cases, the strength of the conjunctival redness increased to a level of 2. Further, 2 cases newly developed iris hyperemia with a strength level of 1, and all of the cases showed corneal opacity with a strength level of 1 and a breadth of 1 to 4 as well as eye discharge with a strength level of 2 to 3. These local reactions gradually lessened, with only 1 case showing corneal opacity with a strength level of 1 and a breadth of 1 at 96 hours after application. After 1 week, all of the local reactions had disappeared. In the washed group (3 animals), all of the cases showed conjunctival redness and conjunctival edema with a strength level of 1 at 1 hour after Slz WX-R application. By 24 hours after application, the conjunctival redness had disappeared in 1 case, and the conjunctival edema also disappeared in 2 cases. However, 1 case newly developed eye discharge with a strength level of 1. All of these local reactions disappeared by 48 hours after application.
Based on the above-noted results, the mean total scores for the local reactions in each tissue were calculated. The maximum value up to 72 hours after application was 27.7 at 24 hours after application in the non-washed group and 4.0 at 1 hour after application in the washed group. These results indicated that Slz WX-R showed moderate irritation of rabbit eyes in the non-washed group, with only extremely mild irritation in the washed group, demonstrating the effects of washing.
Other effects:
none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A study in 3 rabbits revealed that Slz WX-R 6 was moderately irritanting when the eyes were not washed and extremely mild irritating when the eyes were washed after 30 seconds of exposure. The study was not performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions, but was well performed and documented and as such considered reliable with minor restrictions.