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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Nov - 25 Nov 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1983)
Deviations:
yes
Remarks:
No data for analytical purity is available.
Qualifier:
according to guideline
Guideline:
other: EEC (84/449/EWG) (1984)
Deviations:
yes
Remarks:
No data for analytical purity is available.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxyoctadecylsilane
EC Number:
221-339-2
EC Name:
Trimethoxyoctadecylsilane
Cas Number:
3069-42-9
Molecular formula:
C21H46O3Si
IUPAC Name:
trimethoxyoctadecylsilane

Test animals

Species:
rat
Strain:
other: Wistar Bor: WISW (SPFTNO)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., Borchen, Germany
- Age at study initiation: 49 days (males), 63 days (females)
- Weight at study initiation: 138 – 148 g (males), 132 – 137 g (females)
- Housing: animals were caged individually in Macrolon cages (type II)
- Bedding: softwood granulate type I, coarse I (Bogner GmbH, Solingen, Germany)
- Diet: standard diet, ssniff (R) Special diet for rats (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Fasting period before study: 16 h before treatment
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 – 22.5
- Humidity (%): 45 - 60
- 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: 5.62 ml/kg bw

Doses:
5002 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 6 – 8 h after dosing and subsequently once daily thereafter
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: External appearance, body orifices, body cavities (thoracic and abdominal) and their contents were examined macroscopically.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 002 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed throughout the study period.
Clinical signs:
The test substance did not produce systemic toxic effects.
Body weight:
All animals showed the expected body weight gains over the study period.
Gross pathology:
No abnormalities were detected at necropsy at the end of the 14-day observation period.

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:
The test material was investigated for acute oral toxicity according to the OECD TG 401, and in compliance with GLP. The test material was administered once via oral gavage to 5 Wistar rats per sex at a limit dose of 5002 mg/kg bw. No mortality and no clinical signs occurred throughout the study period. Based on these findings, classification for acute oral toxicity according to Regulation (EC) No 1272/2008 is not warranted.