N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine

EC Number:

274-092-8

EC Name:

N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine

Cas Number:

69709-01-9

Molecular formula:

C11H27N3O3Si

IUPAC Name:

N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, the Netherlands
- Age at study initiation: no data
- Weight at study initiation: males: 118-142 g; females: 87-147 g
- Fasting period before study: overnight before treatment and 4 hours post-administration
- Housing: house in groups of 5, males and females separated, in stainless steel cages
- Diet: stock diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C
- Humidity (%): 30-70%
- Air changes (per hr): 10/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: 4.30 mL/kg

Doses:

2.07, 2.49, 2.99, 3.58 or 4.30 mL/kg bw equivalent to 2111, 2539, 3049, 3651 and 4386 mg/kg bw based on density of 1.02 gm/cm3.

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for signs of toxicity during the first 4 hours after dosing, thereafter daily during the 14-day study period. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and macroscopic observations at necropsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3.67 mL/kg bw

Based on:

test mat.

95% CL:

> 3.23 - <= 4.17

Remarks on result:

other: equivalent to 3743 mg/kg bw based on density of 1.02 gm/cm3

Mortality:

2, 1 and 4 males out of 5 treated with 2.99, 3.58 and 4.30 ml/kg bw, respectively, died during the 14-day observation period. 4 and 3 females out of 5 treated with 3.58 and 4.30 ml/kg bw, respectively, were also found dead. Deaths occurred between 3 and 21 hours post-administration. The survivors recovered gradually and looked healthy by the end of the study.

Clinical signs:

Sedation, rough coats and signs of unconsciousness during the first 4 hours post-administration.

Body weight:

No changes in body weight gain were noted.

Gross pathology:

No treatment-related macroscopic abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Assuming a density of 1.02 gm/cm3, this is equivalent to 3743 mg/kg bw.

Conclusions:

In the acute oral study, conducted according to a protocol similar to OECD TG 401, but not compliant with GLP, the reported LD50 value for 1,1,3,3-tetramethyl-2-[3-(trimethoxysilyl)propyl]guanidine was 3.67 mL/kg bw, which is equivalent to 3743 mg/kg bw based on density of 1.02 gm/cm3.