Triethoxy(3-isocyanatopropyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 July 2003 to 21 August 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(3-isocyanatopropyl)silane

EC Number:

246-467-6

EC Name:

Triethoxy(3-isocyanatopropyl)silane

Cas Number:

24801-88-5

Molecular formula:

C10H21NO4Si

IUPAC Name:

triethoxy(3-isocyanatopropyl)silane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: within 20% of the mean of the initial bodyweight of the first treated group
- Fasting period before study: overnight before dosing, and approximately 3 to 4 hours after dosing
- Housing: groups of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From: 15 July 2003 To: 16 July 2003 [report gives this date as "necropsy", although animals in the first and second tested groups (at 300 mg/kg bw) were observed for 14 days prior to necropsy]

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

BP

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/ml or undiluted
- Amount of vehicle (if gavage): 10 or 2 ml/kg bw
- Justification for choice of vehicle: no data available
- Lot/batch no. (if required): no data available
- Purity: no data available

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: "all available information on the toxicity of the test material"

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed 1/2, 1, 2 and 4 hours after dosing, then once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 300 - <= 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Mortality: 0/3 in two 300 mg/kg bw groups; 3/3 in 2000 mg/kg bw group

Mortality:

0/6 animals given 300 mg/kg bw died
3/3 animals given 2000 mg/kg bw died (between 30 minutes and 4 hours after dosing)

Clinical signs:

other: In animals given 300 mg/kg bw, there were no signs of systemic toxicity In animals given 2000 mg/kg bw, hunched posture, ataxia, decreased breathing rate, diarrhoea, diuresis, lethargy and pilo-erection were noted in two animals during the day of dosing

Gross pathology:

In animals given 300 mg/kg bw, no abnormalities were noted at necropsy
In animals given 2000 mg/kg bw, no abnormalities were noted at necropsy for one rat, while abnormally red lungs, dark liver and kidneys, and slight haemorrhage of the gastric mucosa were noted in the other two animals

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In an acute oral toxicity study, performed according to OECD Test Guideline 423 and in compliance with GLP, triethoxy(3-isocyanatopropyl)silane was harmful to rats when given as a single oral gavage administration at up to 2000 mg/kg bw. The LD50 value was estimated to be in the range of 300 to 500 mg/kg bw.

Executive summary:

A GLP acute oral study was carried out in female Sprague-Dawley rats exposed to triethoxy(3-isocyanatopropyl)silane by gavage, according to OECD Test Guideline 423 (acute oral toxicity – acute toxic class method).

A group of three females was given a single oral gavage administration of triethoxy(3-isocyanatopropyl)silane at 300 mg/kg bw (in arachis oil BP) and observed for 14 days. No deaths or clinical signs were observed, and no abnormalities were seen upon gross necropsy. The same results were reported for another group of three females treated in the same way.

A further group was treated at a higher dose level of 2000 mg/kg bw (undiluted). All three of the females treated by gavage at this dose level died within four hours of dosing. Clinical effects (hunched posture, ataxia, decreased breathing rate, diarrhoea, diuresis, lethargy and pilo-erection) were noted in two of these animals. Abnormalities seen at necropsy for these two animals included red lungs, dark liver and kidneys, and slight haemorrhage of the gastric mucosa.

Triethoxy(3-isocyanatopropyl)silane was harmful to rats when given as a single oral gavage administration at up to 2000 mg/kg bw. The LD50 value was estimated to be in the range of 300 to 500 mg/kg bw.