N-methyl-3-(trimethoxysilyl)propylamine

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

An acute oral toxicity study is available for the registered substance N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8) which was conducted according to OECD 401 (Hüls AG, 1989a). In this limit test five fasted Bor:WISW rats of each sex were administered a single dose of 2000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. No mortalities occurred during the entire study period. All animals showed clinical signs such as 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. With the exception of one animal the remaining 9/10 animals showed expected gains in body weight during the study period. 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. Thus, the acute oral LD50 value for males/females was calculated to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral toxicity of the registered substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.

No data on acute inhalation or dermal toxicity are available.