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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09.10.1989 to 23.10.1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study meeting generally accepted scientific principles but not conducted in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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): DYNASYLAN 1505 (3-aminopropyl)diethoxymethylsilan
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
rat
Strain:
other: Bor:WISW (SPF Cpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH, Borchen, GERMANY
- Age at study initiation: not stated
- Weight at study initiation: mean 162 g
- Fasting period before study: 16 h
- Housing: 1-5/Makrolon Type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12/h


IN-LIFE DATES: From: 1989-10-09 To: 1989-10-23

[based on translation of report in German.]

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.22 cm3/kg bw
Doses:
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: observed up to 6 h, then daily for 14 days; weighed on days 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination
Statistics:
Mentions Litchfield & Wilcoxon, but none used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One male and one female died between 5 minutes and 48 hours after treatment.
Clinical signs:
Clinical signs included adoption of a prone or squatting position, ruffled fur, altered mobility, diarrhoea or nasal bleeding. All survivors were symptom-free after 48 hours.
Body weight:
No effect on body weight
Gross pathology:
Post mortem revealed hyperaemia of gastric mucosa. It appears full PM was not possible due to cannibalism.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral toxicity study conducted in compliance with the now deleted OECD 401, without GLP status, identified an LD50 value in male and female rats in excess of or 2000 mg/kg bw.