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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:
The test was commenced on 13 June 1988 and completed on 17 June 1988.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted to internationally recognised guidelines but not to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
see "Principles of method if other than guideline"
Principles of method if other than guideline:
The study report claims compliance with US EPA Pesticide Assessment Guidelines Subdivision F, 81-4.
A review of the study report revealed minor deviations from OECD Test Guideline 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002).

The following minor deviations from OECD Test Guideline 405 (adopted 24 April 2002) were noted:
- The test report does not provide a rational for in vivo testing,
- Test material purity is not available,
- The following information on test animals was not provided: age of animals at the start of the study; individual animal weights at the start and conclusion of test.

These deviations are not considered to have influenced the outcome or the integrity of the study.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Analytical purity: Not reported
- Lot/batch No.: 88/3/1
- Stability under test conditions: Not reported
- Storage condition of test material: Dark under ambient conditions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Supplied by Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire, UK.
- Age at study initiation: Young adult
- Weight at study initiation: Not reported
- Housing: Animals housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Rabbit Diet, supplied by Special Diet Services (1 Stepfield, Witham, Essex, UK, CM8 3AB). Allowed ad libitum.
- Water: Tap water allowed ad libitum.
- Acclimation period: 7 days before test commencement

ENVIRONMENTAL CONDITIONS
- Temperature: Mean maximum and minimum temperatures were 20°C and 17°C.
- Humidity: Mean relative humidity was 58%.
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation (light hours 0700-1900h)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
The test material was placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 seconds.
Observation period (in vivo):
The eyes were examined for irritation, using a 420/5.5x Panoramic Loupe (Keeler, U.K.) and pen torch (Pifco) and ocular reactions were recorded 1, 24, 48 and 72 h after installation, using the scoring system as detailed in section "Any other information on materials and methods incl. tables".
Number of animals or in vitro replicates:
6 animals - 3 male and 3 female (nulliparous and non-pregnant)
Details on study design:
- Removal of test substance: Eyes were apparently not rinsed.

SCORING SYSTEM: Refer to section "Any other information on materials and methods incl. tables" below.

TOOL USED TO ASSESS SCORE: 420/5.5x Panoramic Loupe (Keeler, U.K.) and pen torch (Pifco)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: 6 animals (3M, 3F)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: No irritation was seen in this study.
Remarks on result:
other: Score of 0 for all animals at all timepoints
Irritation parameter:
iris score
Basis:
other: 6 animals (3M, 3F)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: No irritation was seen in this study.
Remarks on result:
other: Score of 0 for all animals at all timepoints
Irritation parameter:
chemosis score
Basis:
other: 6 animals (3M, 3F)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: No irritation was seen in this study.
Remarks on result:
other: Score of 0 for all animals at all timepoints
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: 6 animals (3M, 3F)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: No irritation was seen in this study.
Remarks on result:
other: Score of 0 for all animals at all timepoints
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
other: 6 animals (3M, 3F)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: No irritation was seen in this study.
Remarks on result:
other: Score of 0 for all animals at all timepoints
Irritant / corrosive response data:
Details of reaction scores are given in the tables in section "Any other information on materials and methods incl. tables".
No irritant responses were noted at any time during the test.

Any other information on results incl. tables

Cuprous Thiocyanate:

Primary Eye Irritation in Rabbits

Reaction Scores

 

                1 h

                24 h

 Rabbit/Sex  7♂  8♀  9♂  10♀  11♂  12♀  7♂  8♀  9♂  10♀  11♂  12♀
 Cornea  0  0  0  0  0  0  0  0  0  0  0  0
 Iris  0  0  0  0  0  0  0  0  0  0  0  0
 Conjunctivae:                        
 redness  0  0  0  0  0  0  0  0  0  0  0  0
 chemosis  0  0  0  0  0  0  0  0  0  0  0  0
 discharge  0  0  0  0  0  0  0  0  0  0  0  0

 

                48 h

                72 h

 Rabbit/Sex  7♂  8♀  9♂  10♀  11♂  12♀  7♂  8♀  9♂  10♀  11♂  12♀
 Cornea  0  0  0  0  0  0  0  0  0  0  0  0
 Iris  0  0  0  0  0  0  0  0  0  0  0  0
 Conjunctivae:                        
 redness  0  0  0  0  0  0  0  0  0  0  0  0
 chemosis  0  0  0  0  0  0  0  0  0  0  0  0
 discharge  0  0  0  0  0  0  0  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Cuprous thiocyanate is non-irritant to rabbit eyes.
Executive summary:

The execution of this type of short-term study is not individually inspected by the Quality Assurance Department. The processes involved are inspected at intervals according to a pre-determined schedule.

The report has been audited by IRI Quality Assurance Personnel according to the appropriate Standard Operating Procedures and is considered to describe the methods and procedure used in the study. The reported results accurately reflect the original data of the study.

The conclusion of this study is that cuprous thiocyanate is non-irritant to rabbit eyes.