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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 May 2001 - 29 May 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

vehicle for control group was not specified

GLP compliance:

yes

Test type:

standard acute 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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: at least 12 weeks old (adult)
- Weight at study initiation: 2.01 - 2.42 kg
- Housing: individual housing in suspended stainless steel cages with hardwood chips (Prochip, Harlan Teklad, Madison, WA) bedding
- Diet: TEK 8630 Rabbit Diet, Harlan Teklad, Madison, WI, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2.8
- Humidity (%): 30 - 70
- Air changes (per hr): 10 to 15

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: 10 %
- Type of wrap if used: gauze patches (two layers thick) were applied directly to the clipped skin. Patches were secured in place by wrapping the entire trunk with an impervious bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, skin was whiped gently
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.35 to 4.03 mL/animal
- Concentration (if solution): 1.2 g/mL
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for clinical signs, weighing 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 occured during study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy and histopathological examination 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 dermal application of 2000 mg/kg bw of the test item for 24 hours, 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 dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.