A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 28, 2004 to October 13, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

According to OECD 423 Guideline , with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (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:

A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

EC Number:

460-110-3

EC Name:

A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

Cas Number:

797751-43-0

Molecular formula:

not applicable, multiconstituent substance

IUPAC Name:

2,5,8-trimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene; 3-methoxy-3,6-dimethyl-2,4-dioxa-5-aza-3-silahept-5-ene; 5-methoxy-2,5,8-trimethyl-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene

Details on test material:

- Name of test material (as cited in study report): Wasox-MMAC2
- Physical state: Clear liquid.
- Lot/batch No.: 1000024854.
- Expiration date of the lot/batch: December 2005.
- Storage condition of test material: Storage under a nitrogen atmosphere at ambient temperature
- Other: Handling precautions: Exothermic reaction with water or humidity from the air.

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 0-97633 Sulzfeld
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 182 - 194 g
- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: Single caging in Makroion cages type 111(39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Bedding material: aspen wood chips.
- Diet (e.g. ad libitum): ad libitum (altromin 1324 forte)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22 ºC (continuous control and recording)
- Humidity (%): average 56.1% (continuous control and recording)
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

(Mazola, approx. 0.02% H2O)

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: the test substance was not soluble in water. Corn oil is a common vehicle for acute oral toxicity testing
- Dose volume: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: From comparable chemical substances, a minor acute toxicity is known; therefore it seemed appropriate to perform the limit test with the dose 2000 mg per kg body weight.

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

6 females per dose (3 per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations: within the periods 0 - 0.5,0.5 - 1, 1 - 2,2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks.
Body weights: before administration, 7 and 14 days after administration.
- Necropsy of survivors performed: yes.
- Other examinations performed:
Clinical signs: skin, fur, eyes, occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Body weight: body weight gain for each week of the study (0-7 days, 7-14 days).
Gross pathology.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: All animals were normal during the entire observation period.

Gross pathology:

Effects on organs: No relevant findings at post mortem examination were noted.

Any other information on results incl. tables

Synopsis of the results.

Dose	Step No.	Animal	Number of animals
(mg/kg)		Nos.	exposed	affected	deceased
2000	1	21, 22, 23	3	0	0
2000	2	24, 25, 26	3	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

The oral LD50 of the test article Wasox-MMAC2 in rats was higher than 2000 mg/kg bw.

Executive summary:

The Acute Toxic Class Method assay (Limit Test) for the test substance was performed in rats according to OECD 423 Guideline. Two groups of three fasted female rats was treated sequentially with a single oral dose of 2000 mg/kg body weight. The test material was administrated orally (by gavage) as an emulsion in corn oil. Clinical signs and body weights were monitored for 14 days after administration and all animals were subjected to gross necropsy. All animals survived until the scheduled termination. All animals gained weight in both weeks after administration and all were normal during the entire observation period. All animals were normal at the necropsy.

The oral LD50 of the test article Wasox-MMAC2 in rats was higher than 2000 mg/kg bw.