Trimethoxyoctadecylsilane

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1983)

Deviations:

yes

Remarks:

No data for analytical purity is available.

Test guideline 2

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

Test material information

Constituent 1

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.