Ethoxytrimethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 Nov - 21 Dec 1995

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethoxytrimethylsilane

EC Number:

217-370-6

EC Name:

Ethoxytrimethylsilane

Cas Number:

1825-62-3

Molecular formula:

C5H14OSi

IUPAC Name:

ethoxytrimethylsilane

Details on test material:

- Name of test material (as cited in study report): Silan M3-Ethoxy
- Physical state: colourless liquid
- Storage condition of test material: cool, dark, dry

Test animals

Species:

rat

Strain:

Crj: CD(SD)

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: 45 days (males), 56 days (females)
- Weight at study initiation: 191 - 200 g (males), 189 - 192 g (females)
- Fasting period before study: 16 h prior to application
- Housing: 2-3 animals per cage (Makrolon type III)
- Diet: ssniff R/M-H V 1530 (ssniff Spezialitäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55± 15
- 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: 2.67 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: no data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

First step: 3 males
Second step: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days (once daily). Body weight was determined before administartion and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Changes of skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were observed at least once daily untl all symptoms subsided (afterwards each working day).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed after treatment with 2000 mg/kg bw.

Clinical signs:

other: No clinical signs of systemic toxicity were noted.

Gross pathology:

No organ abnormalities were observed at necropsy.

Any other information on results incl. tables

Table 1: Body weight and relative body weight gain of the animals in the acute oral toxicity study.

Dose group [mg/kg bw]		Bodyweight [g]			Bodyweight gain [%]
		start	after 7 d	after 14 d	day 1-7	day 1-14
2000	male	196.7	262.3	323.3	33.4	64.4
2000	female	190.3	216.0	234.3	13.5	23.1

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:

In an acute oral toxicity study with ethoxy(trimethyl)silane (according to OECD 423, GLP compliant) a LD50 >2000 mg/kg bw was derived. Treatment of 3 male and 3 female Crj:CD(SD) rats with the limit dose of 2000 mg/kg bw provoked no mortality or clinical signs of toxicity. No effect on body weight gain was observed and no findings were reported at necropsy.