acrylic acid, 3-(trimethoxysilyl)propyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7th April 1994 - 28th July 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

-

EC Number:

419-560-6

EC Name:

-

Cas Number:

4369-14-6

Molecular formula:

C9H18O5Si

IUPAC Name:

3-(trimethoxysilyl)propyl prop-2-enoate

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Inc.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 5 weeks old
- Weight at study initiation: Males 104-113.7 g; females: 93.9 - 101.9 g
- Fasting period before study: Yes, overnight
- Housing: Individually
- Diet (e.g. ad libitum): MF pelleted diet, ad libitum
- Water (e.g. ad libitum): Municipal water, ad libitum
- Acclimation period: Yes, but duration not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE:
- Concentration in vehicle: 0, 10 and 20 w/v % in olive oil
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Not specified

DOSAGE PREPARATION (if unusual): The test substance was weighed and dissolved in olive oil. The dose formulations were prepared daily before dosing. Stability of the test substance in dose formulations were confirmed for 3 days before dosing. Test concentrations were confirmed.

Doses:

0, 1000 and 2000 mg/kg bw

No. of animals per sex per dose:

5M, 5F

Control animals:

yes

Remarks:

vehicle (olive oil) control

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for general condition were carried out continuously up to 6 hours post-dosing, and once a day until 14 days post-dosing. Body weights were recorded at days 1, 3, 7, 10 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: In each animal surface, orifices, organs in skull, thoracic cavity and abdominal cavity were examined macroscopically.

Statistics:

Mean values and standard deviations for body weights in each group were calculated.

Results and discussion

Preliminary study:

Doses: 0, 20, 100, 500, and 2000 mg/kg bw
Mortality data: No animals died at any of the tested dose levels.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No males died during the study.

One female at 2000 mg/kg bw died 1 day after dosing. Decreased spontaneous locomotion, respiratory rate, ptosis and salivation, mucous stool, and soft stool were observed from 30 minutes after dosing in this female.

Clinical signs:

other: Males: Decreased spontaneous locomotion, respiratory rate, ptosis and salivation were observed from 15 minutes after dosing at 2000 and 1000 mg/kg bw. These effects resolved by day 1 post-dosing. Mucous stool was seen in males at 0, 1000, and 2000 mg/kg b

Gross pathology:

Dead female at 2000 mg/kg bw: Reddish spots in the mucosa of the glandular stomach were observed.

Surviving females: No abnormalities were seen at any dose.

Males (all survived): Adhesion to the diaphragm and liver (1/5) in the forestomach was seen at 2000 mg/kg bw, with no abnormalities noted at 1000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study with 3-(trimethoxysilyl)propyl acrylate in olive oil, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, the LD50 value was >=2000 mg/kg bw in male and female rats.