Allyltrimethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 April 2019 to 30 April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Allyltrimethylsilane

EC Number:

212-104-5

EC Name:

Allyltrimethylsilane

Cas Number:

762-72-1

Molecular formula:

C6H14Si

IUPAC Name:

allyltrimethylsilane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS B.V., Inc, Postbus 6174, 5960 AD Horst / The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6 - 9 weeks
- Weight at study initiation: ranging from 129.1 to 178 g
- Fasting period before study: overnight fasting prior to dosing
- Housing: groups of one to five rats housed in Makrolon Type IV, with wire mesh top
- Diet: 2018C Teklad Global 18% protein rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2
- Humidity (%): 45-65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): artificial light 6.00 a.m. - 6.00 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test item was formulated at a concentration of 300 and 2000 mg/mL in the vehicle.

MAXIMUM DOSE VOLUME APPLIED: Administered at a constant dose volume of 10 mL/kg body weight

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

300 mg/kg bw and 2000 mg/kg bw in one female rat per dose group, a further group of four fasted females was given a single oral dose of the test material as a solution in corn oil at a dose level of 2000 mg/kg body weight

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and inspections for morbidity / mortality were performed at least three times within the first six hours after application (i.e., 30 minutes and 1 hour, 2 hours and 4 hours after dosing), thereafter at least once daily for 14 days. Body weights were recorded on Day 0 (prior to dosing), Day 7, and 14, or (if applicable) at death (unscheduled).
- Necropsy of survivors performed: yes

Statistics:

Not reported

Results and discussion

Preliminary study:

A preliminary study was not conducted.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity noted in any of the animals.

Body weight:

All animals showed expected gains in body weight.

Gross pathology:

Only animals dosed with 2000 mg/kg bw showed gross pathological effects. Animal 5 showed secretion of Harderian glands. Animals 2 amd 5 showed enlarged spleens with rough surface and small white dots in the cross section. Parts of the small intestines of animals 2 and 3 were reddened. The wall of the small intestine of animal 2 appeared to be thickened. The uterus of animal 4 was filled with pale liquid.

Other findings:

No other significant findings were reported.

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 OECD and GLP compliant acute oral toxicity study, the acute median lethal oral dose (LD50) to rats administered allyltrimethylsilane was greater than 2000 mg/kg body weight.