Registration Dossier
Registration Dossier
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EC number: 206-108-6 | CAS number: 301-10-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Very brief description of methods and results. Characterization of test material was not reported.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
- Reference Type:
- publication
- Title:
- Final Submittal: Tin bis(2-Ethylhexanoate) CAS Number 301-10-0
- Author:
- The Metal Carboxylates Coalition
- Year:
- 2 007
- Bibliographic source:
- U.S. High Production Volume (HPV) Chemical Challenge Program
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize skin irritation technique
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Tin bis(2-ethylhexanoate)
- EC Number:
- 206-108-6
- EC Name:
- Tin bis(2-ethylhexanoate)
- Cas Number:
- 301-10-0
- Molecular formula:
- C16H30O4Sn
- IUPAC Name:
- tin bis(2-ethylhexanoate)
- Details on test material:
- - Name of test material: Stannous Octoate
- Physical state: Liquid
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Storage condition of test material: No data
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino rabbits
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 hours after application of the test material
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: The fur was clipped from about the sixth thorasic vertebrae to the sacral region and about 4 inches from the vertebral colum on each side using an electric clipper. Two areas, approximately 10 cm apart, on the back of each rabbit were selected as application sites.
- % coverage: no data
- Type of wrap if used: Two layers of light gauze cut into squares were secured to the selected areas by strips of 1-inch wide adhesive tape.
The trunk of each rabbit was then wrapped in polyethylene sheeting and taped at both ends.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize, Woodward and Calv ery as described on page 48 of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published by the Food and Drug Officials of the United States.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.54
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
Any other information on results incl. tables
Mean (n=6) skin reaction scores for intact skin:
Erythema/Eschar Formation (24-h): 1.50
Edema Formation (24-h): 1.33
Erythema/Eschar Formation (72-h): 0.17
Edema Formation (72-h): 0
Mean (n=6) skin reaction scores for abraded skin:
Erythema/Eschar Formation (24-h): 1.33
Edema Formation (24-h): 1.50
Erythema/Eschar Formation (72-h): 0.17
Edema Formation (72-h): 0.17
The Primary Irritation Score was calculated to be 1.54, indicating the test material is mildly irritating.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Utilizing a method for evaluating the skin irritation potential of an experimental material, it was found that M &T Chemicals, Inc., tin bis(2-ethylhexanoate) is a mild irritant to intact and abraded skin of the albino rabbit.
- Executive summary:
A group of six (three males and three females) healthy albino rabbits was employed in this project to study the experimental material. The fur was clipped from about the sixth thorasic vertebrae to the saral region and about 4 inches from the vertebral column on each side using an electric clipper. Two areas, approximately 10 cm apart, on the back of each rabbit were selected as application sites. One site was abraded by making four epidermal incisions in a cross hatch pattern on this site. Then 0.5 ml of the experimental material was applied to each site and patches consisting of two layers of light gauze cut into squares were secured to the selected areas by stripps of 1 inch wide adhesive tape. The trunk of each rabbit was then wrapped in polyethylene sheeting and taped at both ends. The experimental material was left in contact with the skin for 24 hours after which the trunk bands were removed and the sites examined and evaluated. The sites were again examined seventy-two hours after application. The scoring method used was Draize, Woodard and Clavary. It was found that M &T Chemicals, Inc., tin bis(2 -ethylhexanoate) is a mild irritant to intact and abraded skin of the albino rabbit.
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