Triethoxyhexadecylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 April 2002 to 16 May 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 2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit und Soziales

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyltrimethoxysilane

EC Number:

240-464-3

EC Name:

Hexadecyltrimethoxysilane

Cas Number:

16415-12-6

Molecular formula:

C19H42O3Si

IUPAC Name:

hexadecyl(trimethoxy)silane

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, GERMANY
- Age at study initiation: 41 days (m); 49 days (f)
- Weight at study initiation: 210-211 g (m); 185-199 g (f)
- Fasting period before study: 16 h
- Housing: 2-3/Makrolon cage (type III)
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.25 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: none identified within report, but follows guideline which recommends a starting dose of 2000 mg/kg bw.

Doses:

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: observations 5, 15, 30, 60 mins; 3, 6, 24 h; then daily for 14 days. Weighings weekly.
- Necropsy of survivors performed: yes

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:

No mortality was observed throughout the study period.

Clinical signs:

other: No clinical signs were observed in the animals during the study.

Gross pathology:

No significant findings.

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:

A reliable study conducted according to the standard guideline for the Acute Toxic Class method and in compliance with GLP found the LD50 in rats to be in excess of 2000 mg/kg bw. There were no clinical signs of toxicity, effects on body weight or macroscopic findings.