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EC number: 247-666-0 | CAS number: 26401-97-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
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- Irritation / corrosion
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- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Draize
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Methods of the Food and Drug Administration
- GLP compliance:
- no
- Remarks:
- This study pre-dates the inception of GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg - Type of coverage:
- not specified
- Preparation of test site:
- other: abraded and non-abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE
- The backs of six rabbits were shaved 24 hours prior to the start of the experiment. A small cross-hatched abrasion was made on the right side of the animal. 0.5 mL of the test material was applied to the abraded area and an equal amount was placed on a non-abraded area.
- Type of wrap if used: the treatment area was covered with a gauze bandage and the animal restrained for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours the patches were removed and the treated areas were washed with water.
OBSERVATION TIME POINTS
- Readings were made according to the Draize method scale at 24 and 72 hours. - Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- (intact skin)
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- 1.6
- Reversibility:
- not specified
- Irritant / corrosive response data:
- - At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1.
- At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6; the combined average was 2.05, supporting data are given in Table 1. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.
- Executive summary:
The skin irritation potential of the test material was investigated in a study broadly similar to OECD 404 using New Zealand White rabbits.
Animals were treated with 0.5 mL of test material on an abraded and non-abraded section of skin on their backs. The application was kept on the animals for 24 hours before removal and washing with water. The readings of erythema and oedema were made according to the Draize scale at 24 and 72 hours.
At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1. At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6.
Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.
Table 1: Results of Skin Irritation Study on the test material.
Time of reading |
Animal number |
Abraded skin |
Intact skin |
||
Oedema |
Erythema |
Oedema |
Erythema |
||
24 hours |
B36 |
0 |
1 |
0 |
0 |
B37 |
0 |
1 |
0 |
1 |
|
B38 |
0 |
1 |
0 |
1 |
|
B39 |
1 |
1 |
0 |
1 |
|
B40 |
1 |
1 |
0 |
1 |
|
B41 |
1 |
1 |
1 |
1 |
|
72 hours |
B36 |
0 |
1 |
0 |
0 |
B37 |
2 |
2 |
1 |
2 |
|
B38 |
1 |
3 |
1 |
2 |
|
B39 |
1 |
3 |
1 |
3 |
|
B40 |
2 |
2 |
1 |
1 |
|
B41 |
2 |
2 |
1 |
1 |
|
Average scores |
2.5 |
1.6 |
|||
Combined average: 2.05 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- This study pre-dates the inception of GLP.
Test material
- Reference substance name:
- Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate
- EC Number:
- 247-666-0
- EC Name:
- Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate
- Cas Number:
- 26401-97-8
- Molecular formula:
- C36-H72-O4-S2-Sn
- IUPAC Name:
- 6-methylheptyl 14-methyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannapentadecan-1-oate
- Test material form:
- liquid
- Details on test material:
- - Appearance: yellowish liquid with viscosity resembling that of light corn oil
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- The eye was held closed for 10 seconds
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- SCORING SYSTEM: Readings were made according to the Draize method at 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. At 48 hours ne animal had a slight redness.
- 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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. At 48 hours ne animal had a slight redness.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2.
- At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3.
- At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0 Supporting data are given in Table 1.
Any other information on results incl. tables
Table 1: Results of eye irritation study on the test material
Time of reading |
Animal number |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Discharge |
Chemosis |
|||
24 hours |
B62 |
0 |
0 |
0 |
2 |
1 |
0 |
B63 |
0 |
0 |
0 |
1 |
0 |
0 |
|
B64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B65 |
0 |
0 |
0 |
1 |
0 |
0 |
|
B66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B67 |
0 |
0 |
0 |
1 |
0 |
0 |
|
24 h average score |
2 |
||||||
48 hours |
B62 |
0 |
0 |
0 |
1 |
0 |
0 |
B63 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B65 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B67 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 h average score |
0.33 |
||||||
72 hours |
B62 |
0 |
0 |
0 |
0 |
0 |
0 |
B63 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B65 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B67 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h average score |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study the test material was concluded not to be an eye irritant.
- Executive summary:
The eye irritation potential of the test material was investigated in a study broadly similar to OECD 405 using New Zealand White rabbits.
Animals were treated with 0.1 mL of test material placed into their right eye, the eye was held closed for ten seconds and then the animal was returned to its cage. The readings were made according to the Draize scale at 24, 48 and 72 hours.
At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2. At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3. At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0.
Under the conditions of the study the test material was concluded not to be an eye irritant.
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