1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10/05/1989 - 13/11/1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(now deleted)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine

EC Number:

253-634-7

EC Name:

1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine

Cas Number:

37697-65-7

Molecular formula:

C13H33N3Si

IUPAC Name:

{bis[(butan-2-yl)amino](methyl)silyl}(butan-2-yl)amine

Test material form:

other: colourless liquid

Test animals

Species:

rat

Strain:

other: Ico rat-IFA.SD. (IOPS. Caw)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Credo, France
- Age at study initiation: 5-7 weeks old
- Weight at study initiation: 120-161 g
- Fasting period before study: 17-18 hours of water only regime
- Housing: housed by sex in groups of 5 in type MI polycarbonate cages
- Diet (e.g. ad libitum): complete pelleted rat-mouse maintenance diet, ad libitum
- Water (e.g. ad libitum): softened and filtered mains water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70 % R.H.
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1781 mg/kg

Doses:

1126 mg/kg, 1411 mg/kg, 1781 mg/kg, 1260 mg/kg, 1596 mg/kg

No. of animals per sex per dose:

5 males and 5 females - 1126 mg/kg
5 males and 5 females - 1411 mg/kg
5 males and 5 females - 1781 mg/kg
5 males and 5 females - 1260 mg/kg
5 males and 5 females - 1596 mg/kg

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: deaths and abnormal clinical signs were noted 15 min after the administration of the test article, then at 1, 2 and 4 hours and then daily for the 14-day study period; the animals were weighed the day before the treatment, immediately before the treatment and at day 8 and 15 during the study period, and at the time of death from day 2 onwards.
- Necropsy of survivors performed: The animals that died during the study were necropsied as well as the surviving animals at the end of the 14-day study, which were killed by the means of overdosing with carbon dioxide.
- Other examinations performed: after necropsy the abdominal and thoracic cavities were opened and special attention was paid to the liver, heart, lungs and kidneys.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 292 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Bliss' method

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 280 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Litchfield and Wilcoxon' method

Mortality:

10% of the animals in the group treated with 1126 mg/kg died from day 2 onwards. 60% of the rats treated with 1260 mg/kg died from day 2 onwards. 60 % of the rats treated with 1411 mg/kg died from day 2 onwards. 100 % from the rats treated with 1596 mg/kg and 1781 mg/kg died from 2 onwards.

Clinical signs:

Subdued behaviour or prostration were noted in all the groups of animals at 2 and 4 hours after administration. Lethargy was observed in the animals treated with 1260 mg/kg or 1596 mg/kg. The surviving animals treated with 1126 mg/kg had normal behaviour by day 2 after administration, while the rats treated with 1260mg/kg or 1411mg/kg had normal behaviour by day 6. One of the surviving animals had diarrhorea (day 4 and 5) from the group treated with 1260 mg/kg and an animal treated with 1411 mg/kg showed piloerrection (day 3, 4 and 5).

Body weight:

Males treated with 1781 mg/kg and females treated with 1411mg/kg showed noticeably lower body weight than those in the control group. Males treated with 1411 mg/kg showed statistically lower mean body weight than those in the control group. The rest of the animals did not show any noticeable change in their body weight.

Gross pathology:

Animals that died during the study showed congested areas in the lungs, the stomach and the intestines. The animals examined at the end of the study showed adhesion between the liver, the stomach and the abdominal wall.

Any other information on results incl. tables

LD 50 for males:

Bliss' method: 1309 mg/kg

Litchfield and Wilcoxon's method: 1277 mg/kg

LD 50 for females:

Bliss' method: 1275 mg/kg

Litchfield and Wilcoxon' method: 1299 mg/kg

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In an acute oral toxicity study conducted to the now deleted OECD 401 and to GLP, the LD50 for 1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine was 1292 mg/kg bw (Bliss' method) or 1280 mg/kg bw (Litchfield and Wilcoxon's method) in rats.