N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11.06.1985 to 27.08.1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EG-Richtlinie 84/449 (Amtsblatt der Europäischen Gemeinschaften 27, 1984, L251, 96) durchgeführt

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No information on test substance purity

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine

EC Number:

231-701-1

EC Name:

N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine

Cas Number:

7691-02-3

Molecular formula:

C8H19NSi2

IUPAC Name:

bis(ethenyldimethylsilyl)amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: Males: 9 weeks; Females: 14 weeks
- Weight at study initiation: Males: average 176 g; Females: average 172 g
- Fasting period before study: yes, 16 hours before and 4 hours after administration.
- Housing: Makrolon Type III cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 2
- Humidity (%): 50± 10
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11.06.1985 To: 27.08.1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.0 ml/kg

Doses:

0.1, 0.31, 0.5, 0.63, 0.73, 0.8, 1.0 ml/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily for clinical signs of toxicity. Animals were weighed prior to the application, after one week and at the end of the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: Pathological examination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.57 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Equivalent to 469 mg/kg bw based on a density of 0.882 g/cm³

Mortality:

See Table 1

Clinical signs:

other: Reduction of general health, anaesthesia, and abdominal/lateral position

Gross pathology:

No abnormal findings in animals that survived at doses of 0.1 to 0.8 ml/kg bw. Animals that died in the 0.31 to 1.0 ml/kg bw groups had slightly reddened gastric mucosa, and in the 0.73 to 1.0 ml/kg bw groups the livers had red to black discolouration.

Any other information on results incl. tables

Table 1 Summary of mortality data

Dose group (ml/kg bw)	Mortality		Time point of death	% Mortality
	Males	Females
0.1	0/5	0/5	NA	0
0.31	0/5	1/5	8 hours	10
0.5	2/5	2/5	1 hour-3 days	40
0.63	2/5	2/5	8-24 hours	40
0.73	3/5	3/5	2 -8 hours	60
0.8	4/5	5/5	2 hours-5 days	90
1.0	5/5	5/5	1 hour-3 days	100

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In the acute oral toxicity study, conducted according to a guideline similar to the now-deleted OECD Test Guideline 401, but without information on GLP compliance the LD50 for N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine was concluded to be 0.57 ml/kg bw (equivalent to 469 mg/kg bw based on a density of 0.882 g/cm³).