Methyl [3-(trimethoxysilyl)propyl]carbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 June - 23 July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

adopted 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 2001

Deviations:

yes

Remarks:

200 mg/kg bw instead of 300 mg/kg bw was used as starting dose.

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl [3-(trimethoxysilyl)propyl]carbamate

EC Number:

245-659-7

EC Name:

Methyl [3-(trimethoxysilyl)propyl]carbamate

Cas Number:

23432-62-4

Molecular formula:

C8H19NO5Si

IUPAC Name:

methyl N-[3-(trimethoxysilyl)propyl]carbamate

Details on test material:

- Name of test material (as cited in study report): Silan 449003 VP (SLM 449003)
- Physical state: colourless-yellowish liquid

- Storage condition of test material: room temperature, protected from light

Test animals

Species:

rat

Strain:

other: HsdBrlHan:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data available
- Weight at study initiation: 143 - 154 g (step 1), 142 - 152 g (step 2), 151 - 160 g (step 3), 143 - 162 g (step 4)
- Housing: animals were kept in Macrolon cages on Altromin saw fiber bedding
- Fasting period before study: yes (overnight before dosing and 3-4 h after dosing)
- Diet: Altromin 1324 maintenance diet for rats and mice (totally-pathogen-free), ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes, adequate acclimatisation period

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
- Amount of vehicle (if gavage): 5 ml/kg bw (step 1-4)

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw (step 1-4)

Doses:

200, 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a careful clinical observation was made twice a day on the day of dosing and once a day thereafter, body weights were determined prior to substance application and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination included changes in the skin/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.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

Beside 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.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

In an acute oral toxicity study according to OECD guideline 423 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed up to 2000 mg/kg bw. In conclusion, a LD50 cut-off value of 5000 mg/kg bw was derived.