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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(adopted 2002)
Deviations:
no
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

Constituent 1
Chemical structure
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:
No clinical signs were observed in the animals during the study.
Body weight:
No treatment-related effect on body weight.
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.