Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
17 December 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Version / remarks:
30 May 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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.