[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is taken from a secondary source

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study in rats

GLP compliance:

not specified

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:

(2-Aminoethyl)(3-(trimethoxysilyl)propyl)amine

Specific details on test material used for the study:

Not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Lesser Ketones Manufacturing Association Leesburg, VA
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data available
- Rationale for use of males (if applicable) No data available
- Age at study initiation:e No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing:No data available
- Historical data:No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum):No data available
- Acclimation period:No data available
- Microbiological status when knownNo data available
- Method of randomisation in assigning animals to test and control groups No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Doses per time period: One
Post dose observation period: 72 hours

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

0.84, 1.04, 1.35, 1.75, 2.28, 2.96, 3.85 ml/kg bw

No. of animals per sex per dose:

5animal /sex/dose

Control animals:

no

Details on study design:

Not specified

Statistics:

Not specified

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

1.68 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.52 - <= 1.86

Remarks on result:

other: limited time to observe

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2.25 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.91 - <= 2.66

Remarks on result:

other: limited time to observe

Mortality:

In females LD 50 value found at 1.68ml/kg bw while in males the LD50 value was found to be 2.25ml/kg bw

Clinical signs:

other:

Body weight:

other body weight observations

Gross pathology:

Necropsy findings, including quantities, severity, and the number of animals affected, were as follows: It was noted that red-colored sores and apoplexy occurred in the gastric glandular, and the intestine wall began to discolor. Values [LD50 or LC50] with confidence limits when calculated: Males received 2.25 ml/kg body weight with 95% confidence limits and females received 1.68 ml/kg body weight with 95% confidence limits.

Applicant's summary and conclusion

Interpretation of results:

other: Not Classified

Conclusions:

The oral LD50 values were identified as 2.25 ml/kg bw in males and 1.68 ml/kg bw in females according to a relatively limited citation of a study without guidelines or good laboratory practices compliance and observation apparently only for 72 hours.

Executive summary:

In accordance with guideline 401, a test of acute oral toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3) was conducted using Rat of Wistar species at various dose levels 0.84, 1.04, 1.35, 1.75, 2.28, 2.96, 3.85 ml/kg bw.

The test sample was administered to all animals in five species/sex/doses. Clinical findings reviles sedation, diarrhea, and watery eyes were observed within the 2.96 and 3.85 ml/kg groups.

Necropsy findings, including quantities, severity, and therefore the number of animals affected, were as follows: It was noted that red-colored sores and apoplexy occurred within the gastric glandular, and therefore the intestine wall began to discolor. Values [LD50 or LC50] confidently limits when calculated: Males received 2.25 ml/kg weight with 95% confidence limits and females received 1.68 ml/kg weight with 95% confidence limits. No mortality was observed. 

The LD50 value of the test sample was 2.25 ml/kg bw for males and 1.68 ml/kg bw for females. Hence the test chemical cannot be classified according to CLP Criteria for classification.