Dimethyl sulphide-borane

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl sulphide-borane

EC Number:

236-313-6

EC Name:

Dimethyl sulphide-borane

Cas Number:

13292-87-0

Molecular formula:

C2 H9 B S

IUPAC Name:

Dimethylsulfide -- borane

Details on test material:

- Name of the test substance used in the study report: Dimethylsulfide borane
- Purity: 93.7%
- Test substance No.: 05/0010-1
- Batch No.: 101169913
- Homogeneity: The test substance was homogeneous by visual inspection

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: Approximately 8 - 12 weeks
- Weight at study initiation: 180 gram
- Fasting period before study: At least 16 hours before administration, but water was available ad libitum.
- Housing: One rat per cage was housed in fully air-conditioned rooms in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG).
- Diet: Kliba-Labordiät (Maus 1 Ratte Haltung "GLP"), Provimi Kuba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h /12 h (6.00 a.m. - 6.00 p.m. /6.00 p.m. - 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Administration volume: 0.63 ml/kg

Doses:

500 mg/kg bw

No. of animals per sex per dose:

1

Control animals:

no

Details on study design:

- Duration of observation period following administration: At least 14 days
- Frequency of observations and weighing: Individual body weight determination shortly before administration (day 0). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Pathology: Necropsy of the animal that died was perfored as early as possible after death.

Based on the physical and chemical characteristics of the test substance and its composition, a starting dose of 500 mg/kg body weight has been chosen in the first step with 3 female animals. As the first animal dosed showed severe ballooning of the abdomen immediately after application and died directly thereafter, the remaining two animals of the administration group were not treated and the study was terminated.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

< 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No LD50 could be determined due to the instantaneous decomposition of the test substance in the aqueous milieu of the gastro intestinal tract accompanied by heavy gas production.

Mortality:

The animal died immediately after application.

Clinical signs:

other: The animal showed severe ballooning of the abdomen immediately after application.

Gross pathology:

During necropsy the animal showed accumulation of gas in the abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:

other: toxic