2-Propenoic acid, tris(1-methylethyl)silyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 October 2004 to 20 December 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triisopropylsilyl acrylate

Cas Number:

157859-20-6

Molecular formula:

C12H24O2Si

IUPAC Name:

Triisopropylsilyl acrylate

Test animals

Species:

rat

Strain:

other: HanBrl:Wist

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: 12 weeks
- Weight at study initiation: 184.2-190.7 g
- Fasting period before study: Approximately 18 hours
- Housing: In groups of 3 in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum
- Water: Community tap water ad libitum
- Acclimation period: 6-7 days under laboratory conditions, after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01-Oct-2004 To: 27-Oct-2004

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

300

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: chosen after a non-GLP solubilty trial which was performed before the study initiation date
- Lot/batch no. (if required): 1078164 12004034
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

DOSAGE PREPARATION (if unusual): Shortly before each dosing occasion, test item weighed into a tared glass beaker and the vehicle added (weight:volume) and homogeneity maintained during administration using a magnetic stirrer.

CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: limit dose

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females (test repeated - total number of animals 6)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and viability assessed approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during test days 2-15; animals weighed on test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: macroscopic examination

Statistics:

No statistical analysis used

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at 2000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Slight to moderate ataxia at 2-hour observation and up to test day 2 in one animal and slight ataxia in four further animals at 5-hours.

Gross pathology:

No macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study (limit test) in female rats, conducted according to OECD test guideline 423 and to GLP, the LD50 was >2000 mg/kg bw, the only dose tested.

Executive summary:

Tri(isopropyl)silyl acrylate was tested in an acute oral toxicity study, conducted to OECD test guideline 423 and to GLP.

Animals were treated by oral gavage with a dose of 2000 mg/kg bw in PEG 300 and observed for 14 days.

All of the animals survived until the end of the study but clinical signs of toxicity were noted between the 2-hour and 2-day time points in one animal and at the 5-hour time point in four further animals.

The oral LD₅₀ for tri(isopropyl)silyl acrylate in female rats was >2000 mg/kg bw under the conditions of the study.