Carbamic acid, N-[(dimethoxymethylsilyl)methyl]-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Jun - 17 Jul 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No information of analytical purity of the test material is provided.

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:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(1996)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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 N-{[dimethoxy(methyl)silyl]methyl}carbamate

Cas Number:

23432-65-7

Molecular formula:

C6H15NO4Si

IUPAC Name:

methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate

Test material form:

liquid

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
- Weight at study initiation: Step 1: 134 – 158 g (males), Step 2: 126 – 158 g (females), Step 3: 148 – 160 g (males), Step 4: 145 – 150 g (females)
- Fasting period before study: Animals were fasted by withholding food overnight and for a further 3 – 4 h after dosing.
- Housing: Animals were caged in macrolon cages on Altromin saw fiber bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: adequate 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
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: 21K0162

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION: The test substance was freshly mixed prior to application and stirred throughout dose administration to guarantee stability and homogeneity.

CLASS METHOD:
- Rationale for the selection of the starting dose: The starting dose was chosen according to OECD TG 423.

Doses:

200 mg/kg bw
Step 1: 3 males
Step 2: 3 females

2000 mg/kg bw
Step 3: 3 males
Step 4: 3 females

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 weighing: The animals were weighed prior to first application and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination was made twice a day on the day of dosing and once a day thereafter.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality observed throughout the study period.

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period.

Gross pathology:

No special gross pathological changes were found in all animals.

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 this acute toxic class method three fasted Wistar rats of each sex were administered one dose of 200 or 2000 mg/kg bw of the test substance (CAS 23432-65-7) in a stepwise procedure via oral gavage. The animals were observed for 14 days after administration. The acute oral LD50 cut-off value for males/females was calculated to be 5000 mg/kg bw. No signs of clinical toxicity and no mortalities occurred during the observation period. All animals showed the expected body weight gains over the study period. No treatment related gross necropsy findings were observed.