Registration Dossier

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HanBrl:Wist
Sex:
female
Details on test animals 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:
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.
Body weight:
Body weights were within the range commonly recorded for this strain and age.
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.