3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 June 1988 to 12 July 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate

EC Number:

241-165-0

EC Name:

3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate

Cas Number:

17096-07-0

Molecular formula:

C16H38O5Si4

IUPAC Name:

3-{2,2,6,6-tetramethyl-4-[(trimethylsilyl)oxy]-3,5-dioxa-2,4,6-trisilaheptan-4-yl}propyl 2-methylprop-2-enoate

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals, Germany
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males 118 to 136 g and females 106 to 118 g
- Fasting period before study: overnight before dosing
- Housing: Housed in group of five in stainless steel cages with wire-screen bottom and front.
- Diet (e.g. ad libitum): cereal based, open formula diet for rats and mice, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10.0 mL. This dose was considered to be the maximum tolerable amount of a non-aqueous liquid for single oral administration.

DOSAGE PREPARATION (if unusual): The test material was administered undiluted.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable

Doses:

10.0 mL

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication, during the first 4 hours after treatment and thereafter, at least once daily for 14 days. The individual body weights of the rats were recorded on day 0, 3, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic changes.

Statistics:

Not used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 10 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 9250 mg/kg bw based on density of 0.925 g/cm3

Mortality:

No deaths occurred and all rats looked healthy throughout the 14-day observation period.

Clinical signs:

other: None of the rats showed any clinical signs of intoxication.

Gross pathology:

Macroscopic examination of the rats at the termination of the study, did not reveal any treatment-related gross alteration.

Other findings:

No other findings reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study, conducted to the now deleted OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 10.0 mL/kg bw (equivalent to 9250 mg/kg bw).