Dimethoxymethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Feb - 01 Mar 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2001)

Deviations:

yes

Remarks:

rational for starting dose not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

(2002)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt fuer Arbeitsschutz, Arbeitsmedizin und sicherheitstechnik, Munich, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diethoxy(methyl)silane

EC Number:

217-982-3

EC Name:

Diethoxy(methyl)silane

Cas Number:

2031-62-1

Molecular formula:

C5H14O2Si

IUPAC Name:

Diethoxy(methyl)silane

Details on test material:

- Name of test material (as cited in study report): Diethoxymethylsilane, SEMICOSIL M2E, Silane, diethoxymethyl-
- Physical state: colourless liquid
- Lot/batch No.: LC 11/05 Pos.2
- Expiration date of the lot/batch: January 12, 2008
- Storage condition of test material: at room temperature, protected from light

Test animals

Species:

rat

Strain:

other: HsdRccHan : WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Weight at study initiation: step 1: 175-181 g, step 2: 185-196g
- Fasting period before study: fasting over night, and 3-4 hours post application
- Housing: in Macrolon cages on altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF), ad libitum
- Water: drinking water (municipal residue control, microbiol. controlled periodically), ad libitum
- Acclimation period: adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle: Since the test substance is sensitive to hydrolysis, care was taken to avoid contact to water, as vehicle cottonseed oil was used
- Lot/batch no.: 125K0087

CLASS METHOD
- Rationale for the selection of the starting dose: not specified

Doses:

2000 mg/kg bw in step 1 and 2

No. of animals per sex per dose:

3 females per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing was done before application and once a week thereafter, observations were made several times on day of dosing and once a day thereafter
- Necropsy of survivors performed: yes (gross pathology only, no histopathology)
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities or clinical signs of toxicity observed

Mortality:

No mortalities were observed during the study.

Clinical signs:

other: No clinical sings were observed during the study.

Body weight:

other body weight observations

Remarks:

Throughout the 14-day observation period, no weight loss was recorded in any animal. The weight gain was within the expected range.

Gross pathology:

Besides acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animal of any step.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In conclusion, under the conditions of the present study, according to OECD 423 and GLP, at the limit concentration of 2000 mg/kg bw no mortalities or clinical signs of toxicity were observed. The test substance does not need to be classified for oral toxicity.