1,2-Ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14.09.1998 to 09.02.2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-(trimethoxysilyl)propyl)ethylenediamine

EC Number:

217-164-6

EC Name:

N-(3-(trimethoxysilyl)propyl)ethylenediamine

Cas Number:

1760-24-3

Molecular formula:

C8H22N2O3Si

IUPAC Name:

N-(2-Aminoethyl)-3-aminopropyltrimethoxysilane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: 7-12 weeks
- Weight at study initiation: 202-286 g
- Fasting period before study: Yes, overnight
- Housing: Individually, in suspended metal cages with mesh floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): Minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24.09.1998 To: 25.11.1998

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 4.954 mL/kg

Doses:

500, 1200 (initially only two males and two females were treated on humane grounds to ensure the dose level selected did not result in greater than 50% mortality), 1200, 3000 and 5000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed daily for mortality and morbidity. The bodyweight of each rat was recorded on Days 1 (prior to dosing, 8 and 15 (or at death). Clinical signs were observed immediately after dosing and at approximately hourly intervals for the remainder of Day 1. On subsequent days animals were observed twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination

Statistics:

The acute median lethal dose was calculated using the method of Finney.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 295 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 539 - <= 3 423

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 897 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 077 - <= 3 343

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

2 574 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 931 - <= 3 431

Mortality:

Four males and all five females treated with 3000 mg/kg bw and all of those at 5000 mg/kg bw died during the study. Deaths occurred between 2 hours and Day 2. There were no deaths in the other groups.

Clinical signs:

other: Piloerection (all doses), hunched posture, waddling/unsteady gait, pallid extremities, eyes dulled, increased salivation, abnormal respiration, ungroomed appearance, fecal disturbances, increased sensitivity and increased lacrimation (among rats at 1200,

Gross pathology:

All animals that died had congestive changes in the majority of organs and tissues. There were no changes in animals that survived to the end of the observation period.

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 conducted to EPA OPPTS 870.1100 (Acute Oral Toxicity) and to GLP (reliability score 1) the LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine was 2295 mg/kg bw in rats. Piloerection (all doses), hunched posture, waddling/unsteady gait, pallid extremities, eyes dulled, increased salivation, abnormal respiration, ungroomed appearance, fecal disturbances, increased sensitivity and increased lacrimation (among rats at 1200, 3000 and/or 5000 mg/kg bw), walking on toes, blue/cold extremities, lethargy, partially closed eyelids and body tremors (3000 and 5000 mg/kg bw) and prostration (5000 mg/kg bw). These clinical signs had resolved by Day 6. All animals that died had congestive changes in the majority of organs and tissues. There were no changes in animals that survived to the end of the observation period.