N,N',N''-tricyclohexyl-1-methylsilanetriamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

N,N',N''-tricyclohexyl-1-methylsilanetriamine

EC Number:

240-040-8

EC Name:

N,N',N''-tricyclohexyl-1-methylsilanetriamine

Cas Number:

15901-40-3

Molecular formula:

C19H39N3Si

IUPAC Name:

N,N',N''-tricyclohexyl-1-methylsilanetriamine

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

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

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffra-Credo, France
- Age at study initiation: between 5 and 7 weeks old
- Weight at study initiation: from 125 g to 165 g
- Fasting period before study: 16-17 hours of water only regime
- Housing: housed by sex and in groups of 5 in type MI polycarbonate cages (interior dementions 365 x 225 x 180)
- Diet: complete pelled rat-mouse maintenance diet ad libitum
- Water: softened and filtered mains drinking water ad libitum
- Acclimatisation period: 9 days before the start of the treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 27
- Humidity (%): 40 to 70% R.H.
- Air changes (per hr): at least 10 per hour
- 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: 893 mg/kg

Doses:

Four groups (2 to 5) of 5 males and 5 non-pregnant females. Group 2 treated with 566 mg/kg, group 3 treated with 710 mg/kg, group 4 treated with 893 mg/kg and group 5 treated with 634 mg/kg.

No. of animals per sex per dose:

5 males and 5 non-pregnant females.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: any deaths and abnormal clinical signs were notes 15 minutes after the administration, then at 1, 2 and 4 hours and then daily for the 14 day study period; the animals were wighed the day before the treatment, immediately before administration of the test article, at days 8 and 15 as well as at the time of death.
- Necropsy of survivors performed: on the last day of the study (day 15) all surviving rats were killed by means of overdosing with carbon dioxide. The abdominal and thoracic cavities were opened and particular attention was pain to the liver, heart, kindneys and lungs.
- Other examinations performed: the daily observations performed included changes in the skin and fur, the eyes, mucous membranes, respiratory system, circulatory system, autonomic and central nervous system as well as somato-motor activity and behaviour. Shivering, convultions, salivation, diarrhoea, lethargy, sleeping and coma were noted with particular attention.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

642 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:

637 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Lichfield and Wilcoxon' method

Mortality:

By day 15 of the study, 30% from the group of males and females treated with 566 mg/kg were dead, first death recorded 4 hours after administration. The same effect was observed in the group of males and females treated with 634 mg/kg. 80% of males and females treated with 710 mg/kg were
dead and 100% mortality was observed for the group (males and females) treated with 893 mg/kg of the tested article.

Clinical signs:

Subdued behaviour or prostration were noted in animals treated with 566 mg/kg, 634 mg/kg and 710 mg/kg and 893 mg/kg. A female, treated with 566 mg/kg, was showing prostration until day 5 and at day 6 was found dead.Convulsions or tremors were observed in rats treated with 710 mg/kg
or 893 mg/kg. All surviving animals (from each group) recovered normal behaviour by day 3. 4 and 6 respectively.

Body weight:

Males of groups 2 and 5 had noticeably lower body weight than those in the control group, while no such observation could be noted in the female
groups 2 and 5.

Gross pathology:

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

Any other information on results incl. tables

LD 50 for males:

Bliss' method: 640 mg/kg

Lichfield and Wilcoxon' method: 636 mg/kg

LD 50 for females:

Bliss' method: 643 mg/kg

Lichfield and Wilcoxon' method: 639 mg/kg

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 was reported to be 642/637 mg/kg bw in a reliable study, conducted according to OECD test guideline 401 (now deleted) and in compliance with GLP.