3-(diethoxymethylsilyl)propylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study meets generally accepted scientific principles, but was not conducted in compliance with GLP. Limited reporting.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The study was conducted to investigate potential for toxicity following high dermal exposures. Appears to be comparable to OECD 402.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(diethoxymethylsilyl)propylamine

EC Number:

221-660-8

EC Name:

3-(diethoxymethylsilyl)propylamine

Cas Number:

3179-76-8

Molecular formula:

C8H21NO2Si

IUPAC Name:

(3-aminopropyl)diethoxymethylsilane

Details on test material:

- Name of test material (as cited in study report): Gamma-aminopropylmethyldiethoxysilane
- Substance type: Cyclic siloxane
- Physical state: Liquid
- Analytical purity: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: 3-5 months
- Weight at study initiation: Average 2.5 kg
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

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

IN-LIFE DATES: No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Trunk
- % coverage: No data
- Type of wrap if used: Vinylite sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.0 and 2.0 ml/kg bw

Duration of exposure:

24 hours

Doses:

2.0 and 4.0 ml/kg bw

No. of animals per sex per dose:

Four males only

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data, but probably day of dosing then on day 14 (weighing).
- Necropsy of survivors performed: yes
- Other examinations performed: Gross pathology

Statistics:

Thompson's method for LD50 calculation.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2.52 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.86 - <= 3.41

Remarks on result:

other: 2293 mg/kg bw based on a relative density of 0.91

Mortality:

All of the animals in the 4.0 ml/kg bw group died within four days of exposure. One animal in the 2.0 ml/kg bw group died on day three after exposure.

Clinical signs:

other: None reported

Gross pathology:

Those that died had lung haemorrhage, liver congestion and pale kidneys.

Other findings:

Rabbits that survived 24 hours had erythema, edema and necrosis of the skin.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study with limited information, but which appeared similar to the now deleted OECD 402 (not GLP; reliability score 2) the LD50 for 3-(diethoxymethylsilyl)propylamine was 2.52 ml/kg bw (2293 mg/kg bw based on a relative density of 0.91). Corrosive effects on the skin were apparent.