N-[3-(triethoxysilyl)propyl]ethylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 Nov - 21 Dec 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Federal Department Of Home Affairs, Bern, Switzerland

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

EC Number:

225-806-1

EC Name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

Cas Number:

5089-72-5

Molecular formula:

C11H28N2O3Si

IUPAC Name:

N-[3-(triethoxysilyl)propyl]ethylenediamine

Test animals

Species:

rat

Strain:

other: HanIbm:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males), 10 weeks (females)
- Weight at study initiation: 193.8 - 211.9 g (males), 167.4 - 186.7 g (females)
- Fasting period before study: overnight fasting prior to application
- Housing: 5 animals per cage (Makrolon type-4)
- Diet: Pelleted standard Kliba 343 (Batch 80/94, 81/94, 82/94), Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 58± 12
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10-15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100, 150, 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:

1000, 1500, 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:
Mortality/Viability/Clinical signs: 4-5 times at test day and daily for surviving animals during days 2-15
Body weights: On test day (before administration), and on day 8 and 15
- Necropsy of survivors performed: yes

Statistics:

LOGIT-Model (COX, Analysis of binary data, 1977): mean lethal dose calculation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed after treatment with 1000 mg/kg bw. After treatment with 1500 mg/kg bw 0/5 males and 2/5 females were found dead. Treatment with 2000 mg/kg bw led to 1/5 death males and females, each. Mortalities occurred on day 1 or 2, respectively.

Clinical signs:

1000 mg/kg bw no clinical signs observed
1500 and 2000 mg/kg bw: sedation, spasms, dyspnea, ruffled fur, and diarrhea (reversible within 1 or 2 days for females and males, respectively)

Body weight:

No effect on body weight gain was observed.

Gross pathology:

No organ abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study conducted according to OECD 401 and in compliance with GLP, a LD50 >2000 mg/kg bw was observed in rats. No mortality was observed after treatment with 1000 mg/kg bw. After treatment with 1500 mg/kg bw 0/5 males and 2/5 females were found dead. Treatment with 2000 mg/kg bw led to 1/5 death males and females, each. Mortalities occurred on day 1 or 2, respectively. Clinical signs of toxicity at 1500 and 2000 mg/kg bw were sedation, spasms, dyspnea, ruffled fur, and diarrhea (reversible within 1 or 2 days for females and males, respectively). No effects on bw gain and no abnormalities after necropsy have been observed.