N-methyl-3-(trimethoxysilyl)propylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 - 23 Oct 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study conducted according to the appropriate OECD test guideline

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:

(1981)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-methyl-3-(trimethoxysilyl)propylamine

EC Number:

221-334-5

EC Name:

N-methyl-3-(trimethoxysilyl)propylamine

Cas Number:

3069-25-8

Molecular formula:

C7H19NO3Si

IUPAC Name:

N-methyl-3-(trimethoxysilyl)propylamine

Test animals

Species:

rat

Strain:

other: Bor: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: approx. 162 g
- Fasting period before study: Animals were fasted overnight (16 h) prior to dosing.
- Housing: Animals were housed in groups of 1 - 5 in Makrolon cages (type III).
- Diet: R10 diet for rats (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- 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: 2.11 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed prior to dosing and 1, 7 and 14 days thereafter. Furthermore, animals were observed for clinical signs of toxicity up to 6 h after administration of the test material and daily thereafter.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

All animals showed staggering movements, piloerection, hunched posture, bloody noses (partially), mild sedation and ataxia as well as dyspnea five to ten minutes after test material administration. All clinical signs were reversible within 48 h post-administration of the test material.

Body weight:

With the exception of one animal the remaining 9/10 animals showed expected gains in body weight during the study period.

Gross pathology:

Necropsy revealed partially hyperaemia of the mucous membrane of the small intestine in 2/5 females. Additionally, partially peritoneal hyperaemia and a narrowed spleen was observed in 1/5 males. All other animals did not show any abnormalities at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In an acute oral toxicity study according to OECD guideline 401, no mortality and no signs of systemic toxicity were observed at 2000 mg/kg bw. In conclusion, a LD50 >2000 mg/kg bw was derived.