N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 March 2003 to 10 April 2003

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:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

445-890-5

EC Name:

-

Cas Number:

201290-01-9

Molecular formula:

C14H37NO2Si3

IUPAC Name:

7-ethoxy-2,2,7-trimethyl-3-(trimethylsilyl)-8-oxa-3-aza-2,7-disiladecane

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: dissolved in arachis oil BP


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test material was freshly prepared as a solution at the appropriate concentration in arachis oil BP.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd., UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: +/- 20 % of the mean initial bodyweight of the first treated group
- Fasting period before study: an overnight fast immediately before dosing and three to four hours after dosing
- Housing: housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: free access to Certified Rat and Mouse diet, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15/ hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200, 30 and 30 mg/ml
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg was chosen as the starting dose in the absence of data suggesting the test material was toxic.

Doses:

2000, 300 and 300 mg/kg bw

No. of animals per sex per dose:

3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for deaths or signs of toxicity at 30 min, 1, 2 and 4 hours after dosing and once daily thereafter. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment or death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathological examination of major organs

Statistics:

Not used

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 500 - < 1 000 mg/kg bw

Based on:

test mat.

Mortality:

Two animals treated with 2000 mg/kg bw died one day after dosing. No deaths occurred at a dose level of 300 mg/kg bw.

Clinical signs:

Hunched posture, lethargy, ataxia, decreased respiratory rate and laboured respiration were observed in animals treated with 2000 mg/kg bw. No signs of systemic toxicity were noted in animals treated with 300 mg/kg bw.

Body weight:

All the surviving animals showed the expected body weight gain except for one animal treated at a dose level of 300 mg/kg bw, which showed a body weight loss during the second week of the study.

Gross pathology:

Abnormally red lungs, dark liver and dark kidneys were noted at necropsy in animals that died during the study period. No abnormalities were noted at necropsy in animals that were killed at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In the acute oral toxicity study, conducted according to OECD TG 423 and in compliance with GLP, the estimated LD50 value was in the range of 500 - 1000 mg/kg bw.