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

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:

guideline study

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

Key result

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:

GHS criteria not met

Remarks:

CLP Implementation.

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.

Executive summary:

An acute dermal toxicity study was performed with the test subtance according to OECD guideline 402. According to the results of a preliminary study, a group five rats per sex was given a single dermal application of the test substance at a dose level of 2000 mg/kg bw, the application site (10 %) was covered by a semiocclusive patch for 24 hours. Clinical observations were made at 15 min, 1, 2 and 4 h then daily until day 14 after the removal of the test substance, weights were measured weekly. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. No abnormalities were recorded at the macroscopic examination on Day 15. Based on the results the LD50 for the test substance in rats was determined to be greater than 2000 mg/kg bw.