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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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to standard methods under GLP as a final step of skin irritation testing. The study is reliable, relevant, and adequate for classifcation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.8 - 3.3 kg
- Fasting period before study: Not provided
- Housing: Individually in suspended cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled
- Humidity (%): Not provided
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 mL


Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 6cm2 (2 x 3 cm gauze patch)
- Type of wrap if used: porous dressing (semi-occlusive) and porous, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washing with distilled water at the end of the exposure period
- Time after start of exposure: 4 hours

SCORING SYSTEM: Erythema and edema were scored according to the numerical Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.55
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 h
Score:
0.55
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Table 2. Dermal and Systemic observations

Time after patch removal

Rabbit H4909

male

Rabbit H4933

male

Rabbit H4936

male

Mean Scores

 1 Hour

Erythema

1

1

0

 

 

Edema

0

0

0

Systemic Observations

A

A

A

 

 

 

 

 

24 Hour

Erythema

1s

1

1

1.00

 

Edema

0

0

0

0.00

Systemic Observations

A

A

A

 

 

 

 

 

 

48 Hour

Erythema

1s

0

0f

0.33

 

Edema

0

0

0

0.00

Systemic Observations

A

A

A

 

 

 

 

 

 

72 Hour

Erythema

1

0

0f

0.33

 

Edema

0

0

0

0.00

Systemic Observations

A

A

A

 

 

 

 

 

 

Day 7

Erythema

0

0

0

 

 

Edema

0

0

0

Systemic Observations

A

A

A

 

 

Sum of Mean Scores =

1.66

Modified Primary Irritation Index (PII)

 =   Sum of Mean Scores/3 =

0.55

 

 

 

A=appeared normal

f= flaking skin

s= shiny areas

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Modified Primary irritation Index is 0.55. Tin disulfide is a dermal irritant.
Executive summary:

Three healthy New Zealand White rabbits (males) were dosed dermally with Tin disulfide. The test article (0.56 g) was applied dermally to one intact site per rabbit and wrapped with a piece of porous dressing (semi-occlusive) large enough to cover all dose sites with at least 5 cm square to spare on all sides of the gauze patch. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Erythema and edema were scored at 1, 24, 48 and 72 hours and on Day 7 following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights were recorded pretest, at 72 hours and at termination. At 1 hour post exposure, erythema was absent to very slight and edema was absent. At 24 hours erythema was very slight, edema was absent and shiny areas were observed on one animal. By 48 hours, erythema was absent to very slight and edema was absent with shiny areas and flaking skin observed. Erythema remained absent to very slight, edema was absent and flaking skin persisted at 72 hours. Both erythema and edema were absent by Day 7. No abnormal physical signs were observed. Two animals had net body weight gain by study termination, although one of the animals lost weight between 72 hours and Day 7. The remaining animal lost weight by study termination. The Modified Primary Irritation Index was 0.55. Tin disulfide (CAS 1315-01-1; EINECS: 215- 252-9), Tin disulphide; Trade name: Tribotecc® - SNS2 Grade A, Batch# E 10320 is not a Category 2 irritant according to Regulation (EC) No. 1272/2008, Section 3.2.2.7.