Tin bis(2-ethylhexanoate)

Acute Toxicity: dermal

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:

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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 (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 or test system 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:

other: 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

Gross pathology:

No gross abnormalities were noted for any of the animals when necropsied

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the single dose acute dermal LD50 of tin bis(2 -ethylhexanoate) was greater than 2,000 mg/kg 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. 2,000 mg/kg bw 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.