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EC number: 222-583-2 | CAS number: 3542-36-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Hadardous Substances Regulations under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- Deviations:
- yes
- Remarks:
- slight modifications
- GLP compliance:
- no
- Remarks:
- Study Pre-dates GLP
Test material
- Reference substance name:
- Dichlorodioctylstannane
- EC Number:
- 222-583-2
- EC Name:
- Dichlorodioctylstannane
- Cas Number:
- 3542-36-7
- Molecular formula:
- C16H34Cl2Sn
- IUPAC Name:
- dichlorodioctylstannane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred on the premises maintained under a semi-barrier system.
- Age at study initiation: 2 - 4 months
- Weight at study initiation: Average male = 2.95 kg. Average female = 3.80 kg.
- Housing: Caged singly in an experimental room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): available at all times
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 ºC
- Humidity (%): 50 - 70 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 15 hours light daily from 08:00 - 23:00
Test system
- Vehicle:
- not specified
- Controls:
- other: Right eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 80 mg test compound
VEHICLE: NDA - Duration of treatment / exposure:
- Test compound injected into left conjunctiva and then the eye was held shut for 1 second. Test compound was left on the eye for 30 seconds before swashing.
- Observation period (in vivo):
- Rabbits were examined after 1, 6, 24, 48 and 72 hours.
- Number of animals or in vitro replicates:
- 3 male, 3 female.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was flushed with 30 ml of warm water.
- Time after start of exposure: 30 seconds
SCORING SYSTEM:
0: Non irritant
1 - 10: Minimally irritating
11 - 25: Slightly irritating
26 - 55: Moderately irritating
57 - 84: Markedly irritating
> 84: Extremely Irritating
TOOL USED TO ASSESS SCORE: NDA
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 day, 2 days and 3 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Compound was visible in the eyes up to 24 hours after application, although washing tended to remove some of it.
The eye irritation was generally of a mild nature. A small area of superficial ulceration was seen in one of the rabbits at 24 hours, but this had resolved by 48 hours. - Other effects:
- NDA
Any other information on results incl. tables
Table 1: Raw Eye Irritation data for rabbits 11 - 16
1 hour |
6 hours |
1 day |
2 days |
3 days |
||||||||||||||||||||||||||
Rabbit Number |
11 |
13 |
15 |
12 |
14 |
16 |
11 |
13 |
15 |
12 |
14 |
16 |
11 |
13 |
15 |
12 |
14 |
16 |
11 |
13 |
15 |
12 |
14 |
16 |
11 |
13 |
15 |
12 |
14 |
16 |
I. Cornea |
||||||||||||||||||||||||||||||
A Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B Area Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
a = A x B x 5 (max. 80) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
||||||||||||||||||||||||||||||
b = Score x 5 (max. 10) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
||||||||||||||||||||||||||||||
A Redness |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
2 |
2 |
2 |
2 |
1 |
2 |
1 |
2 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
B Chemosis |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C Discharge |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
3 |
2 |
2 |
2 |
3 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
c = (A + B + C) x 2 (max. 20) |
6 |
6 |
2 |
4 |
4 |
4 |
10 |
16 |
8 |
8 |
10 |
16 |
8 |
8 |
4 |
6 |
4 |
10 |
2 |
0 |
0 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Total = a + b+ c (max. 110) |
6 |
6 |
2 |
4 |
4 |
4 |
10 |
16 |
8 |
8 |
10 |
16 |
8 |
8 |
4 |
6 |
4 |
15 |
2 |
0 |
0 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Compound TK 11339 is slightly irritating to the eyes of New Zealand White rats when tested according to the method used.
- Executive summary:
In a primary eye irritation study, 34/73/5.L, 80 mg of Compound TK 11339 (dioctyltin dichloride) was instilled into the conjunctival sac of the left eye of male and female New Zealand White rabbits and left for 30 seconds before washing. Animals then were observed for 72 hours. Total eye irritation out of 110 was determined.
Compound TK 11339 is slightly irritating to the eyes of New Zealand White rabbits when tested according to the method used.
According to the EU classification system the test material will not be considered irritating to the eye.
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