Chloromethyltrimethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chloromethyltrimethylsilane

EC Number:

219-058-5

EC Name:

Chloromethyltrimethylsilane

Cas Number:

2344-80-1

Molecular formula:

C4H11ClSi

IUPAC Name:

(chloromethyl)trimethylsilane

Test material form:

other: colourless liquid

Details on test material:

Purity 99.8%

Test animals

Species:

rat

Strain:

other: HsdRccHan : WIST rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

HsdRccHan : WIST rats (Full-Barrier), Sex: females, non-pregnant, nulliparous.
Step 1: Body weight at the commencement of the study: 166 - 169 g;
Step 2: Body weight at the commencement of the study: 166 - 172 g;
Three female animals were used for each step.
The animals were derived from a controlled full barrier maintained breeding
system (SPF).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the
animals were bred for experimental purposes.
The animals were barrier maintained (semi-barrier) in an air conditioned
room
Temperature: 22 ± 3 QC
ReI. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Feeding ad libitum, ssniff RIM-H, 10 mm V1534-000 complete diet for
rats/mice - maintenance, totally-pathogen-free (TPF)
Free access to tap water (drinking water, municipal residue control,
microbiol. controlled periodically)
The animals were kept in Macrolon cages on Lignocel bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period (at least 5 days).
The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all
animals.
Prior to administration food was withheld from the test animals overnight.
Following the period of fasting the animals were weighed and the test item
was administered. Then the food cwas withheld for a further 3-4 hours.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Aqua ad inj., B. Braun Melsungen AG, Lot 6153A195

Details on oral exposure:

In the first and second steps 2 gof the test item was dissolved with the
vehicle ad 10 mL to gain a concentration of 2000 mg/kg body weight.
The test substance was freshly mixed prior to administration and stirred
throughout dose administration to guarantee stability and homogeneity. The
vehicle was chosen due to its non-toxic characteristics.
The test item was administered in a single dose by gavage uSIng an
intubation cannula.
The test item was administered at a volume of 10 mL/kg body weight.

Doses:

The starting dose (step 1) was selected to be 2000 mg/kg body weight. As
three of three animals survived, the second step was performed with the
same dose. According to the acute toxic class method regime no further
testing was required since no compound-related mortality was found in any
animals of step 2.

No. of animals per sex per dose:

3 male and 3 female animals, dose 2000 mg/kg bw

Control animals:

not specified

Details on study design:

The animals were observed for 14 days after dosing.
The animals were weighed prior to the administration and once a week A careful clinical examination was made several times on the day of dosing.
Part of this were at least three observations within the first four hours postdose.
The animals were weighed prior to the administration and once a week thereafter.
A careful clinical examination was made several times on the day of dosing.
Part of this were at least three observations within the first four hours postdose.
Animals were observed once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and
mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were
examined. Particular attention was directed to observations of tremor,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
At the end of the observation period the animals were sacrificed by an
overdosage ofpentobarbital.
All animals were subjected to gross necropsy. All gross pathological changes
were recorded.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: No treatment related effects were observed in any animals.

Gross pathology:

No special gross pathological changes were found in any animals.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test
item Chloromethyltrimethylsilane showed no oral toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test
item Chloromethyltrimethylsilane was classified into Category 5 (LDso cutoff:
unclassified).

Executive summary:

The acute toxic class method was performed with the test item Chloromethyltrimethylsilane. A careful clinical examination was made several times on the day of dosing. Part of this were at least three observations within the first four hours postdose. Animals were observed once a day thereafter. In the first step the test item was given at a dose of 2000 mg/kg body weight to a group of 3 female rats (HsdRccHan : WIST) in a single exposure via oral gavage. No treatment related effects were observed in any animals of step 1. Therefore, the second step was performed with the same dosage in the same manner to a further group of 3 female rats (HsdRccHan : WIST). No treatment related effects were observed in any animals of step 2. At the end of the observation period the animals were sacrificed. Necropsy was carried out to record gross pathological changes. No treatment related effects were observed in any animals of steps 1 and 2. Beside acute injection ofblood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animals of steps 1 and 2. Throughout the 14-days observation period no weight loss was recorded in any animals (table 1). The weight gain was within the expected range. Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test itenl is provided. Conclusions Considering the reported data of this toxicity test it can be stated that the test item Chloromethyltrimethylsilane showed no oral toxic characteristics. According to GHS (Globally Harmonized Classification System) the test item Chloromethyltrimethylsilane was classified into Category 5 (LDso cutoff: unclassified).