A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)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'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime

EC Number:

458-680-3

EC Name:

A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime

Cas Number:

797751-44-1

Molecular formula:

not applicable, multiconstituent substance

IUPAC Name:

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

Test material form:

liquid

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
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 180 - 199 g
- Fasting period before study: the food was withdrawn the evening before the administration of the test substance
- Housing: single caging in Makrolon cages type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22 ºC
- Humidity (%): average 56.1%
- 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

Details on oral exposure:

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

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:

3 females per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before the test and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

dissolved

Mortality:

No mortality occurred.

Clinical signs:

other: 1/6 animals was affected. The finding, observed only 0.5 hours after the administration, was signs of reduced well-being.

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:

Table1:    

Dose	Step No.	Animal	Number of animals
(mg/kg)		Nos.	exposed	affected	deceased
2000	1	51, 52, 53	3	1	0
2000	2	54, 55, 56	3	0	0

Body weights and body weight gain:

Table2: Individual data, means and standard deviations SD.

Dose	Animal	Body weight (g)				Body weight gain (g)
mg/kg (Step No.)	No.	before administr.	7 days p.a.	14 days p.a.	death	0-7 days p.a.	7-14 days p.a.
2000	51	199	211	230	-	12	19
(1)	52	186	204	223	-	18	19
	53	181	209	224	-	28	15
	mean	188.7	208.0	225.7	-	19.3	17.7
	SD	9.3	3.6	3.8	-	8.1	2.3
2000	54	189	206	229	-	17	23
(2)	55	180	200	218	-	20	18
	56	186	202	212	-	16	10
	mean	185.0	202.7	219.7	-	17.7	17.0
	SD	4.6	3.1	8.6	-	2.1	6.6

Observations in life:

Table3:     A grade of severity was recorded where applicable (low - mid - high)

Findings	Dose (mg/kg), Step No.	No. of the affected animals	Observation time (p.a.) first    last	Maximum grade of severity
signs of reduced well-being	2000, 1	51	0.5 h	-
normal at any time	2000, 1	52, 53	0 h / 14 d	-
	2000, 2	54, 55, 56	0 h / 14 d	-

1/6 animals was affected. The finding, observed only 0.5 h after the administration, was: Signs of reduced well-being.
This term encompasses unspecific alterations, like sedation, apathy, piloerection, hunched posture or closed eyes, in single or multiple occurrence.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The LD50, oral of the test substance is higher than 2000 mg/kg body weight in rats.

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 was treated sequentially with a single oral dose of 2000 mg/kg bodyweight. The test material was administrated orally as an emulsion in corn oil.

Clinical sign and body weight were monitored during the study. All animals were subjected to gross necropsy (no relevant findings at post mortem examination were noted).

The acute oral median lethal dose (LD50) of test substance is higher than 2000 mg/kg body weight in rats.