Registration Dossier

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

Constituent 1
Chemical structure
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-[diethoxy(methyl)silyl]propan-1-amine
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:
None reported
Body weight:
Animals that died gained very little weight or lost weight by Day 14.
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.