Silanediol, 1-methyl-1-(1-methylethoxy)-, 1,1-diacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 May 2001 - 12 June 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-070-9

EC Name:

-

Cas Number:

329039-38-5

Molecular formula:

Hill formula: C8 H16 O5 Si CAS formula: C8 H16 O5 Si

IUPAC Name:

(acetyloxy)(methyl)(propan-2-yloxy)silyl acetate

Details on test material:

- Name of test material (as cited in study report): Methyldiacetoxyisopropoxy silane
- Physical state: Clear, colorless liquid
- Analytical purity: 85.8 %
- Impurities (identity and concentrations): 12.9 % Acetoxydiisopropoxymethtylsilane, 1.3 % hydrolisis product (siloxane)
- Purity test date: 04.10.2001
- Batch No.: AA001 (04.10.01)
- Storage condition of test material: Below 30 °C in an airtight container under nitrogen under the hood

Test animals

Species:

rat

Strain:

other: Outbread Albino Rats (Rattus norwegicus)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Indianapolis, IN
- Age at study initiation: 8 weeks
- Weight at study initiation:205.1 - 229.6 g
- Fasting period before study: Night prior dosing
- Housing: Group housing, maximum of 3 per cage of the same sex, Poycarbonate cages with hardwood chip bedding
- Diet: TEK 712 Rodent Diet, Harlan Teklad, Maddison WI, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70 %
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12 full spectrum fluorescent lights

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs twice on the day of dosing and daily, bodyweight on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Piloerection in all animals for the first 5 days, after 8 days no signs were left and no clinical observations occur until the end of the study

Gross pathology:

Necropsy revealed no substance related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

After single oral application of 2000 mg/kg bw of the test item, no deaths occurred during the GLP-Guideline study. No mortality and no clinical signs of toxicity were observed up to the end of the 14-day observation period in all animals. The median lethal dose of methyldiacetoxyisopropoxy silane after a single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.