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Toxicological information

Skin irritation / corrosion

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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:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.