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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21st to 23rd September 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. No data on purity or GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
EC Number:
239-594-3
EC Name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Cas Number:
15546-11-9
Molecular formula:
C18H28O8Sn
IUPAC Name:
methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Details on test material:
- Name of test material (as cited in study report): TK 11.637
- Physical state: liquid
- Lot/batch No.: 250-252

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: raised on site
- Age at study initiation: no data
- Weight at study initiation: 2-3 kg
- Housing: The animals were housed individually in metal cages, numbered by ear tags
- Diet (e.g. ad libitum): The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours per day

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
Duration of treatment / exposure:
The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently, closed for a few seconds.
Observation period (in vivo):
24 & 48 hours
Number of animals or in vitro replicates:
3 rinsed, 3 unrinsed
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline
- Time after start of exposure: 30 seconds

SCORING SYSTEM:

CORNEA

A Opacity and degree of density (most dense area scored)
No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

A x B x 5 Maximum possible score = 80


IRIS

A Values
Normal 0
Folds above normal, congestion, swelling, circumcornea injection
(any or all of these or combination of any thereof)
iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

A x 5 Maximum possible score = 10


CONJUNCTIVAE

A Redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3

(A + B + C) x 2 Maximum possible score = 20



TOOL USED TO ASSESS SCORE:
The eye irritation was appraised with a slit-lamp on day 1 and 2 and was scored for each individual rabbit

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
other: study was terminated after 48 hours for humane reasons
Remarks on result:
other: Only 1 animal could be scored (unrinsed eyes) as the opacity was not visible due to the conjunctival chemosis in the others
Irritation parameter:
cornea opacity score
Remarks:
area involved
Basis:
animal #3
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
other: study was terminated after 48 hours for humane reasons
Remarks on result:
other: Only 1 animal could be scored (unrinsed eyes) as the opacity was not visible due to the conjunctival chemosis in the others
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Time point:
other: 48 hours
Score:
2
Max. score:
4
Reversibility:
other: study was terminated after 48 hours for humane reasons
Remarks on result:
other: Only 1 animal could be scored (unrinsed eyes) as the opacity was not visible due to the conjunctival chemosis in the others
Irritation parameter:
cornea opacity score
Remarks:
area involved
Basis:
animal #3
Time point:
other: 48 hours
Score:
3
Max. score:
4
Reversibility:
other: study was terminated after 48 hours for humane reasons
Remarks on result:
other: Only 1 animal could be scored (unrinsed eyes) as the opacity was not visible due to the conjunctival chemosis in the others
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 & 48 hours
Score:
2
Max. score:
2
Reversibility:
other: study was terminated after 48 hours for humane reasons
Remarks on result:
other: Only 1 animal could be scored (unrinsed eyes) as the opacity was not visible due to the conjunctival chemosis in the others
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24 & 48 Hours
Score:
3
Max. score:
3
Reversibility:
other: study was terminated after 48 hours for humane reasons
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 & 48 hours
Score:
4
Max. score:
4
Reversibility:
other: study was terminated after 48 hours for humane reasons
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24 & 48 hours
Score:
3
Max. score:
3
Reversibility:
other: study was terminated after 48 hours for humane reasons
Irritant / corrosive response data:
The test material was found to cause an extreme irritation when applied to the rabbit eye mucosa.

Any other information on results incl. tables

The test material was found to cause an extreme irritation when applied to the rabbit eye mucosa.

The conjunctival damage was maximum in all animals at both readings.

Corneal and iris damage could be estimated only in less than half of the eyes due to the extreme chemosis.

The test was ended after 48 hours for humane reasons.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this experiment the test material was found to cause an extreme irritation when applied to the rabbit eye mucosa.
Executive summary:

Under the conditions of this experiment the test material was found to cause an extreme irritation when applied to the rabbit eye mucosa.

This assessment is based on the fact that conjunctival irritation was maximal at both readings in all animals and that in more than half the cases corneal damage could not be observed due to the extreme chemosis.

The test was ended after the second reading for humane reasons.

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