Morpholine, 4-[(diethoxymethylsilyl)methyl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-05-09 until 2005-06-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

not applicable

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:

-

EC Number:

480-370-1

EC Name:

-

Cas Number:

21743-27-1

Molecular formula:

Hill formula: C11H25NO4Si CAS formula: C11H25NO4Si

IUPAC Name:

4-((Triethoxysilyl)methyl)morpholine

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: female: step 1: 174 - 186 g, female: step 2: 153 g all animals
- Fasting period before study: yes
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/10 ml vehicle
- Justification for choice of vehicle: non-toxic characteristics

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Assuming substance is non-toxic

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (step 1), 3 (step 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: three times in first four hours postdose. Animals were observed once a day thereafter. Weighting on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: none

Mortality:

No mortality has been observed.

Clinical signs:

other: No clinical signs have been observed.

Gross pathology:

No changes were found in any animal.

Other findings:

- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was determined to be > 2000 mg/kg bw.

Executive summary:

An acute toxicity test according the acute toxic class method (OECD 423) was performed. In the first step the test item was given at a dose of 2000 mg/kg bw to a group of 3 female rats (HsdBrlHan:WIST) in a single exposure via oral gavage. In the second step the test item was given at the same dose to a further group of 3 female rats (HsdBrlHan:WIST) in a single exposure via oral gavage. No mortality occured during the study. General signs of toxicity were not observed. The body weight gain of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. Therefore, the LD50 (oral, rat) was determined to be > 2000 mg/kg bw.