Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Stannous octoate S-26
- Physical state: liquid
- Lot/batch No.: 0003496636
- Expiration date of the lot/batch: 2010-05-05
- Stability under test conditions: stable
- Storage condition of test material: room temperature under nitrogen pad

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Received from Harlan, Indianapolis, Indiana or Charles River Laboratories, Stoneridge, New York, USA
- Age at study initiation: 9-11 weeks
- Weight at study initiation: males: 178-195 g; females: 132-145 g
- Fasting period before study: no data
- Housing: singly housed in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Certified Rodent Diet (PMI #5002)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 deg C
- Humidity (%): 20-61%
- Air changes (per hr): 14 or 17
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark

IN-LIFE DATES: From: 2010-03-01 or 09 To: 2010-03-23

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- % coverage: 10
- Type of wrap if used: gauze pad with Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed with ethanol followed by tap water and a clean paper towel
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage side observations: first several hours after application and at least once daily thereafter for 14 days.Body weights: prior to test substance application (initial) and again on Days 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived exposure to the test substance
Clinical signs:
All animals appeared active and healthy during the study.
Dermal irritation (erythema) noted at the dose site of three female rats between Days 1 and 2, and for two male rats on Day 1
Body weight:
All animals gained weight durng the study
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the single dose acute dermal LD50 of tin bis(2 -ethylhexanoate) was greater than 2,000 mg of body weight in male and female rats.
Executive summary:

An acute dermal toxicity test was conducted with Fischer 344 rats to determine the potential for tin bis(2 -ethylhexanoate) to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the test substance was greater than 2,000 mg/kg of body weight in male and female rats. Two thousand milligrams of the test substance per kilogram of body weight was applied to the skin of ten healthy rats for 24 hours. The test substance was initially applied to the skin of the 5 female rats. Due to the absence of mortality of these animals, the test substance was applied to the skin of the 5 remaining male rats. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice. All animals survived exposure to the test substance, gained body weight, and appeared active and healthy during the study. Apart from dermal irritation (etythema) noted at the dose site of three female rats between Days 1 and 2, and for two male rats on Day 1, there were no other clinical findings recorded for any animal over the course of the study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.