Trimethyloxosulphonium iodide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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:

Trimethyloxosulphonium iodide

EC Number:

217-204-2

EC Name:

Trimethyloxosulphonium iodide

Cas Number:

1774-47-6

Molecular formula:

C3H9OS.I

IUPAC Name:

trimethyl(oxo)-λ⁶-sulfanylium iodide

Test material form:

solid: crystalline

Details on test material:

Test item: Trimethylsulfoxonium Iodide (CAS 1774-47-6)
Batch No.: 20130228 (0056D53)
Physical state: solid, crystalline powder
Colour: white or light-yellow
Content (Chemical Titration): 99.66 %
Storage: on cool and dry place, protected from light

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Crl:(WI)Br rats
Source: TOXI COOP ZRT.
Hygienic level at arrival: SPF
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8 weeks old in first and second step
Body weight range at starting (first step): 176 - 177 g
Body weight range at starting (second step): 178 - 179 g
Housing: Group caging (3 animals/cage)
Light: Artificial light, from 6 a.m. to 6 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Helianthi annui oleum raffinatum

Details on oral exposure:

A single oral administration - followed by a fourteen-day observation period - was performed by gavage.
Starting dose was selected on the basis of the available information about the test item. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw (first step, group 1) as the starting dose in three female rats. Thus no animals died the test was continued at 2000 mg/kg bw (second step, group 2) dose level on further three female rats. Only one animal died in the second step at 2000 mg/kg bw dose level, the test was finished

All doses were formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 mg/mL. Formulation was prepared just before the administration and stirred continuously during the treatment.

The day before treatment the animals were fasted. The food but not water was withheld overnight. The food was given back 3 hours after the treatment.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 female / dose

Control animals:

no

Details on study design:

The observation period was 14 days. Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, 5 h and 6 h after the treatment and twice each day for 14 days thereafter.
The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
At the end of the observation period rats were sacrificed and necropsy were performed.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No death occurred in step 1, 2000 mg/kg single oral dose of the test item Trimethylsulfoxonium Iodide (CAS 1774-47-6). All female rats in this group survived until the end of the 14-day observation period. One rat dosed at 2000 mg/kg bw (step 2) died on Day 3. Death seemed to be consequences of systemic toxic effect of the test item. Two animals survived until the end of the 14-day observation period.

Clinical signs:

other: In group 1 treated with 2000 mg/kg bw dose: Clinical sign of reaction comprised of piloerection. This symptom (score +1) occurred in all animals between Day 2 and Day 3. In group 2 treated with 2000 mg/kg bw dose: Piloerection (score +1; +3) was detected

Gross pathology:

One rat treated with 2000 mg/kg bw dose (group 2) of the test item spontaneously died during the study. The other animals survived until the scheduled necropsy on Day 15.
An external necropsy finding as anus contaminated with feces was detected in one animal. An internal necropsy finding as autolysis was observed in one animal. It is normal physiological process after death.
Moderate hydrometra was observed in one female of the group 2 and slight hydrometra was detected in one animal of group 1 and in one animal of group 2. This alteration is physiological finding and connected to the cycle of the animal. Internal necropsy finding as pale kidneys was observed in two animals of group 1 and in one animal of group 2. This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Most likely the observation is a congenital anomaly.

Any other information on results incl. tables

Groups	Treatment		Lethality
	Test item	Dose (mg/kgbw)	Females
1	“trimethylsulfoxonium iodide” Step1	2000	0/3
2	“trimethylsulfoxonium iodide” Step2	2000	1/3

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The method used is not intended to allow the calculation of a precise LD50 value.
The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423.
Hazard Category: Acute Tox. 5

Executive summary:

Dose (mg/kg bw)

Mortality (dead/treated)

LD50 (mg/kg bw)

GHS category

2000

1/6

above 2000

5