Registration Dossier
Registration Dossier
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EC number: 222-583-2 | CAS number: 3542-36-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- not specified
- GLP compliance:
- no
- Remarks:
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: Average male = 2.95 kg. Average female = 3.80 kg
- Housing: SIngly caged in an experimental room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): available at all times
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 ºC
- Humidity (%): 50 - 70 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 15 hours light from 8:00 - 23:00
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: One abraded and one shaved site
- Vehicle:
- other: 50 % PEG 400 in water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): enough to moisten the test subtance - Duration of treatment / exposure:
- Dressing was removed after 24 hours.
- Observation period:
- 72 hours
- Number of animals:
- 3 male and 3 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square gauze pad
- % coverage: NDA
- Type of wrap if used: Square gauze pad covered in aluminium foil secured with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- other: irritation had deminished considerably after 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.25
- Max. score:
- 2
- Reversibility:
- other: irritation had deminished considerably after 72 hours
- Irritant / corrosive response data:
- A mild to moderate skin reaction was present in all animals at 24 hours which diminished considerably by 72 hours.
- Other effects:
- NDA
Any other information on results incl. tables
Please refer to the attached pdf for the tabulated Primary Skin Irritation Scores.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: US Hadardous Substances Regulations
- Conclusions:
- Compound TK 11339 is midly irritating to the skin of albino rabbits when tested by the method described above.
- Executive summary:
In a primary skin irritation study, 32/73/5.L, 500 mg of Compound TK 11339 (dioctyltin dichloride), moistened with a 50% PEG 400 in water solution, was applied to both shaved and abraided skin of male and female New Zealand White rabbits. The gauze pad keeping the test substance in contact with the skin was removed after 24 hours. Animals then were observed for 72 hours.
Compound TK 11339 is slightly irritating to skin of New Zealand White rabbits when tested according to the method used.
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