Dibutylbis(dodecylthio)stannane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

In-life dates: 24th August to 29th September 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutylbis(dodecylthio)stannane

EC Number:

214-688-7

EC Name:

Dibutylbis(dodecylthio)stannane

Cas Number:

1185-81-5

Molecular formula:

C32H68S2Sn

IUPAC Name:

dibutylbis(dodecylsulfanyl)stannane

Details on test material:

- Name of test material (as cited in study report): Dabco T120 Catalyst
- Analytical purity: 100%
- Lot/batch No.: 817231
- Physical state: clear liquid
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Date recieved: 13/08/2010
- Specific gravity: 1.00

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animals were received from Ace Animals, Boyertown, PA on 08/03/10 & 09/07/10 and from Taconic Farms, Hudson, NY on 08/17/10
- Age at study initiation: The animals were born the weeks of 06/08/10, 06/21/10, 06/28/10 & 07/20/10.
- Weight at study initiation: The pretest body weight range was 208 - 275 grams for males and 212 - 264 grams for females.
- Fasting period before study: 16-20 hours prior to dosing
- Housing: The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; 5/sex/cage prior to dosing and 3/sex/cage following dosing. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity.

Doses:

Initially, a single dose was administered orally by syringe and dosing needle at a dose level of 300 mg/kg to three male and three female rats. Since the animals survived, an additional three male and three female rats were dosed at a dose level of 2000 mg/kg.

No. of animals per sex per dose:

3 males & 3 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were humanely sacrificed using CO2 and were examined for gross pathology following study termination.

Statistics:

no data

Results and discussion

Preliminary study:

n/a

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All six animals survived the single 300 and 2000 mg/kg oral doses.

Clinical signs:

other: In the 300 mg/kg dose animals, chromodacryorrhea was briefly noted in one animal; otherwise no abnormal physical signs were noted. In the 2000 mg/kg dose animals, instances of localized alopecia and soiling of the anogenital area were observed during th

Gross pathology:

In the 300 mg/kg dose animals, necropsy results revealed chromodacryorrhea in one animal and all other animals were normal.

In the 2000 mg/kg dose animals, aside from localized alopecia, the necropsy results were normal.

Any other information on results incl. tables

Table 1. Dose volume and Body weights.

Animal number	Sex	Dose Volume (cc)	Bodyweight (g)
			Day 0	Day 7	Day 14
Dose: 300mg/kg
1	F	0.069	230	283	290
2	F	0.071	235	276	292
3	F	0.079	264	305	328
Mean			243	288	303
S.D.			18.4	15.1	21.4
#			3	3	3
4	M	0.075	250	297	320
5	M	0.08	265	322	345
6	M	0.083	275	304	368
Mean			263	308	344
S.D.			12.6	12.9	24
#			3	3	3
Dose: 2000 mg/kg
7	F	0.49	246	266	278
8	F	0.42	212	237	245
9	F	0.43	216	230	241
Mean			225	244	255
S.D.			18.6	19.1	20.3
#			3	3	3
10	M	0.43	215	262	343
11	M	0.44	222	211	288
12	M	0.42	208	282	343
Mean			215	252	325
S.D.			7	36.6	31.8
#			3	3	3

S.D. = Standard deviation

# = number of animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was determined to be greater than 2000 mg/kg of body weight in rats.

Executive summary:

A study was conducted to determine the potential for oral toxicity using the Acute Toxic Class Determination. This study is designed to comply with the standards set forth in OECD Guidelines for the Testing of Chemicals, Guideline 423 adopted December 17, 2001. Guideline 423 is referred to in OPPTS 870,1000 (December 2002) as an acceptable method to assess lethality within a dose range.

Initially, three healthy male and three healthy female Sprague Dawley rats were dosed orally with the test material at 300 mg/kg. Since the animals survived, an additional three male and three female rats were dosed at a dose level of 2000 mg/kg. The rats were observed 0.5, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. The test article was assigned to a toxic category based on the mortality response noted.

All six animals survived the single 300 mg/kg oral dose. Chromodacryorrhea was briefly noted in one animal; otherwise no abnormal physical signs were noted. Body weight changes were normal, Necropsy results revealed chromodacryorrhea in one animal and all other animals were normal.

All six animals survived the single 2000 mg/kg oral dose. Instances of localized alopecia and soiling of the anogenital area were observed during the observation period. Body weight changes were normal in 5/6 animals; one male lost weight within the first week of observations. Aside from localized alopecia, the necropsy results were normal.

The test material is considered to be in Acute Toxic Category 5 or unclassified. The LD50 is greater than 2000 mg/kg of body weight in rats.