2,2-bis(methylthio)propane

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan. This minor deviation was not considered to have compromised the validity or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

478-900-1

EC Name:

-

Cas Number:

6156-18-9

Molecular formula:

C5 H12 S2

IUPAC Name:

2,2-bis(methylthio)propane

Details on test material:

- Name of test material (as cited in study report): BISMETHYLTHIOPROPANE
- Synonym: BMTP
- Chemical name: 2,2-bis-methylthiopropane
- Batch number: 2KS149
- Description: colorless liquid
- Storage conditions: at room temperature and protected from light
- Purity: 97.76%
- Date of analysis: 8 November 2006
- Expiry date: November 2007.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation:c approximately 8 weeks old
- Weight at study initiation: 198 ± 9 g
- Fasting period before study: yes
- Housing: polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm).
- Diet : free access to SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water : Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 21 December 2006 - 18 January 2007

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: solubility

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 or 6

Control animals:

no

Details on study design:

CLINICAL EXAMINATIONS
The single administration was performed in the morning of day 1; it was followed by a 14-day observation period.

- Clinical signs and mortality
The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Type, time of onset and duration of clinical signs were recorded for each animal individually.

- Body weight
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.

PATHOLOGY
- Sacrifice
On day 15, all animals were killed by carbon dioxide asphyxiation.

- Macroscopic necropsy examination
All study animals were subjected to a macroscopic examination as soon as possible after death.
After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.

- Preservation of tissues
No organ samples were taken.

Statistics:

Not appropriate

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Remarks on result:

other: no mortality was observed

Mortality:

No mortality was observed

Clinical signs:

other: At the dose-level of 300 mg/kg, no mortality and no clinical signs were observed. At the dose-level of 2000 mg/kg, no deaths occurred. On day 1, hypoactivity or sedation, lateral decubitus, piloerection and/or dyspnea, were observed in 5/6 females.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD0 of BISMETHYLTHIOPROPANE was higher than 2000 mg/kg in rats.

Executive summary:

The acute oral toxicity of BISMETHYLTHIOPROPANE (BMTP) was evaluated in rats according to OECD guideline 423. BMTP was prepared in corn oil and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three or six fasted female Sprague-Dawley rats at dose levels of 300 and 2000 mg/kg bw, respectively. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.At the dose-level of 300 mg/kg, no mortality and no clinical signs were observed. At the dose-level of 2000 mg/kg, no deaths occurred. On day 1, hypoactivity or sedation, lateral decubitus, piloerection and/or dyspnea, were observed in 5/6 females. Decubitus without any response to the external stimuli was noted in 2/6 animals. No other clinical signs were observed thereafter. The body weight gain of the treated animals was similar to that of laboratory historical control animals. At necropsy, no apparent abnormalities were observed in any animal. The oral LD₀ of BISMETHYLTHIOPROPANE was higher than 2000 mg/kg in rats.