Tin bis(2-ethylhexanoate)

Endpoint summary

Description of key information

Acute oral LD50: 5870 mg/kg bw
Acute dermal LD50: >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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. No pathological examinations of the test animals were reported.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: The test substance was placed in a syringe and introduced through the esophagus into the stomach with a stainless steel catheter.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: Young adult
- Weight at study initiation: 200-250 grams
- Fasting period before study: Fasted 24 hours prior to dosing.
- Housing: Cages with wire mesh floors elevated above dropings in groups of 5.
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature: 72 deg F
- Humidity: No data
- Air changes: No data
- Photoperiod (hrs dark / hrs light): Light was furnished for eith out of every tewnty-four hour period.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

none

Details on oral exposure:

no vehicle

Doses:

1.6, 3.2, 6.4 and 12.8 g/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Animals were observed for 21 days.

Statistics:

The LD50 was calculated using the Thompson Moving Average Method (Biometrics, September, 1952, Vol. 8, No. 3).

Sex:

male

Dose descriptor:

LD50

Effect level:

5 870 mg/kg bw

95% CL:

>= 3.14 - <= 10.98

Remarks on result:

other: reported in g/kg

Mortality:

1.6 g/kg - 0 mortality
3.2 g/kg - one mortality on day 12 of the test
6.4 g/kg - three mortalities on day 2 of the test
12.8 g/kg - one mortality on day 2 and thee mortalities on day 4 of the test

Clinical signs:

other: The rats which received the two higher doses, 6.4 and 12.8 g/kg were listless following administration of the test material.

Gross pathology:

No data

Other findings:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for tin bis(2 -ethylhexanoate) is 5.87 g/kg with 95% confidence limits of 3.14 g/kg to 10.98 g/kg.

Executive summary:

An approximation of the LD50 was attained by administering the chemical compound to a number of rats on each of several levels. A group of twenty young adult male albino rats of the Sprague-Dawley Strain weighing approximately 200 -250 grams was selected for use in this study. The animals were divided into four subgroups of five animals each and fasted for twenty-four hours prior to dosing. The experimental material was placed in a syringe and introduced through the esophagus into the stomach with a stainless steel catheter. Five rats were dosed at 1.6, 3.2, 6.4 and 12.8 g/kg with the test materail as supplied. Animals on the same dosage level were then placed in a common cage with free access to food and water. The cages employed had wire mesh floors elevated abouve the droppings and were kept in temperature controlled rooms at 72 deg F +/- 2 deg F. Light was furnished for eight out of every twenty-four hour period. The animals were observed for a twenty-one day period and deaths were recorded. The LD50 was calculated using the Thompson Moving Average Method (Biometrics, September, 1952, Vol. 8, No. 3). Rats which received the two higher doses were listless following administration of compound. Fatalities occurred during the first four days on these two levels. One death occurred on the twelfth day at 3.2 g/kg level. The oral LD50 of tin bis(2 -ethylhexanoate) is 5.87 g/kg with 95% confidence limits of 3.14 g/kg to 10.98 g/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 870 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The acute oral toxicity of tin bis(2 -ethylhexanoate) was evaluated in rats. The test material was administered without dilution at concentrations of 1.6, 3.2, 6.4, and 12.8 g/kg, via intragastric intubation, to four groups of 5 male rats. Animals were observed for 21-days post-exposure and mortalities were recorded daily. Animals in the 6.4 and 12.8 g/kg dose groups were observed to be listless following test material administration. Mortalities in these two dose groups occurred within the first four days following test substance administration. The single mortality in the 3.2 g/kg dose group occurred on day 12.

The oral LD50 (+95% confidence limits) of the test substance was reported as 5.87 (3.14-10.98) g/kg. The study was assigned a K-2 rating. [AME Test Report]

 

Groups of 6 male rats were exposed to the test substance at dose levels of 1.0, 1.7, 2.89, 4.91, and 8.35 g/kg bw. The test material was administered in paraffin oil as a single dose by oral gavage. Animals were observed animals for 14 days post-exposure and mortalities were recorded. At the end of the observation period, surviving animals were sacrificed and all animals underwent gross pathological examination. All mortalities occurred within 1 to 2 days after dosing. Clinical signs of toxicity included piloerection, soiled coat, hypokinesis and ataxia. No clinical signs persisted after 11 days post-exposure. Postmortem observations revealed fluid gut contents, pale kidneys, mottled liver, and patchy pink lung. The oral LD50 (+95% confidence limits) of the test substance was reported as 3.4 (2.5-4.8) g/kg bw. The study was assigned a K-2 rating. [Dow Test Report]

 

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 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 (erythema) 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. The study was assigned a K-1 rating. [Dow Test Report]

Justification for classification or non-classification

Based on the available studies, it is concluded that the substance does not need to be classified according to Regulation (EC) No 1272/2008.