Allyltrimethylsilane

Endpoint summary

Description of key information

Oral (OECD 420), rat: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

Deviations:

no

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

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.

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

Preliminary study:

A preliminary study was not conducted.

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:

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

This study was conducted according to an appropriate OECD test guideline and in compliance with GLP.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No data on acute inhalation or dermal toxicity is available for allyltrimethylsilane. Only an acute oral toxicity study is available. In this study, an LD50 value of greater than 2000 mg/kg bw in rats is reported in a key study conducted according to OECD 420 and in compliance with GLP (Dony, 2019). No mortality occured. There were no signs of systemic toxicity noted in any of the animals and all animals showed expected gains in body weight. 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. Based on these results, the acute median lethal oral dose (LD50) to rats of allyltrimethylsilane was demonstrated to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

The available data on acute oral toxicity indicates that allyltrimethylsilane does not meet the criteria for classification according to Regulation (EC) No 1272/2008, and is therefore conclusive but not sufficient for classification.