Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 Nov - 26 Nov 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butan-2-one O,O',O''-(methylsilylidyne)trioxime

EC Number:

245-366-4

EC Name:

Butan-2-one O,O',O''-(methylsilylidyne)trioxime

Cas Number:

22984-54-9

Molecular formula:

C13H27N3O3Si

IUPAC Name:

butan-2-one O,O',O''-(methylsilanetriyl)oxime

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): SILANE 196 - Méthyltris (méthyléthylcétiminoxy) silane
- Substance type: Ketoxime
- Physical state: Liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: 5-7 wk
- Weight at study initiation: 188-201 g (m); 167-177 g (f)
- Housing: single housing in suspended stainless steel cage
- Diet : standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: apparently from: 1986-11-05 To: 1986-11-20

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10%
- % coverage: 10%
- Type of wrap if used: bandage (adhesive perforated tape)

REMOVAL OF TEST SUBSTANCE
- Washing: wiped with gauze
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw (2.02 ml/kg bw)
- Concentration: neat

Duration of exposure:

24 h

Doses:

Definitive study: 2000 mg/kg bw
Preliminary study: 1000, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 15 min; 1, 2 and 4 h; then daily till day 14. Weights weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Bliss; Litchfield & Wilcoxon mentioned. None required.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred up to 2000 mg/kg bw.

Mortality:

None

Clinical signs:

other: No clinical, behavioural or local (dermal) effects.

Gross pathology:

No treatment related effect.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

A reliable limit study conducted in compliance with a standard guideline and in accordance with GLP, identified an LD50 of > 2000 mg/kg bw in male and female rats. No local effects were reported.