Butylhydroxyoxostannane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Young albino rabbits of the New Zealand strain were used to evaluate the eye irritating properties of the test material. The test method was patterned after that of Draize, et al.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Butylhydroxyoxostannane

EC Number:

218-880-1

EC Name:

Butylhydroxyoxostannane

Cas Number:

2273-43-0

Molecular formula:

C4H10O2Sn

IUPAC Name:

butyl(oxo)stannanol

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: young

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL (40 mg) test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of the animal served as a control.

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days.

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing

SCORING SYSTEM:
- At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.
- The maximum possible score was 110 points, which indicated maximal irritation and damage to all 3 ocular tissues. Zero score indicated no irritation.
- In this scoring system, special emphasis was placed upon irritation or damage to the cornea, while less emphasis was placed upon damage to the iris and conjunctiva.
- The criteria used for assignment of the classification was the frequency, the extent and the persistence of irritation or damage which occurred to the 3 ocular tissues. The classification was obtained by selecting the maximum mean irritation score at 1, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury did not meet the requirements defined for the classification appropriate for a particular numerical score, the classification was raised by 1 or more levels.

CORNEA
- Opacity (D) Degree of density (area which is most dense is taken for reading):
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
- Area of cornea involved (A):
One quarter (or less) but not 0 = 1
Greater than one quarter but less than one half = 2
Greater than one half but less than three quarters = 3
Greater than three quarters to whole area = 4
Score equals D x A x 5
Total maximum = 30

IRIS
- Values:
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or a combination of any thereof), iris still reacting to light (sluggish reaction is positive) = 1
No reaction to light, haemorrhage, gross destruction (any or all of these) =2
Score equals value x 5
Total maximum = 10

CONJUNCTIVAE
- Redness (R) (refers to palpebral conjunctiva only):
Vessels definitely injected above normal = 1
More diffuse, deeper crimson red; individual vessels not easily discernible = 2
Diffuse, beefy red = 3
- Chemosis (S):
Any swelling above normal (includes nictitating membrane) = 1
Obvious swelling with partial eversion of the lids = 2
Swelling with lids about half-closed = 3
Swelling with lids about half-closed to completely closed = 4
- Discharge (D):
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) = 1
Discharge with moistening of the lids and hairs just adjacent to the lids = 2
Discharge with moistening of the lids and hairs and considerable area around the eye = 3
Score (R + S + D) x 2
Total maximum = 20

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1.1

Max. score:

5

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: redness, chemosis and discharge combined to give conjunctivae score

Any other information on results incl. tables

Table 1: Summary of Results

Tissue	Rabbit Number	1 Hour	24 Hours	48 Hours	72 Hours	7 Days
Cornea (D-A)	1	0	0	0	0	0
Iris		0	5	0	0	0
Conjunctivae (R-S-D)		4 (2-0-0)	4 (2-0-0)	2 (1-0-0)	0	0
Total		4	9	2	0	0
Cornea (D-A)	2	5(1-1)	0	0	0	0
Iris		0	5	0	0	0
Conjunctivae (R-S-D)		4 (2-0-0)	4 (2-0-0)	0	0	0
Total		9	9	0	0	0
Cornea (D-A)	3	0	0	0	0	0
Iris		0	0	0	0	0
Conjunctivae (R-S-D)		4 (1-1-0)	2 (1-0-0)	0	0	0
Total		4	2	0	0	0
Cornea	Average	1.7	0.0	0.0	0.0	0.0
Iris		0.0	3.3	0.0	0.0	0.0
Conjunctivae		4.0	3.3	0.7	0.0	0.0
Total		5.7	6.6	0.7	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU Criteria

Conclusions:

Under the conditions of this study the test material was not irritating to the eyes.

Executive summary:

The eye irritation potential of the test material was investigated using New Zealand white rabbits.

The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.

Under the conditions of this study the test material was not irritating to the eyes.