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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/06/1999 to 15/07/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
439-510-7
EC Name:
-
Cas Number:
149048-48-6
Molecular formula:
Constituent 1: C14H26N2O3Si Constituent 2: C13H22N2O2Si
IUPAC Name:
Reaction Mass of N-[3-(trimethoxysilyl)propyl]-1,3-benzenedimethanamine and {3-[(2,2-dimethoxy-1,2-azasilolidin-1-yl)methyl]phenyl}methanamine
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK.
- Age at study initiation: 8-12 weeks old.
- Weight at study initiation: Males: 207-236 g; females: 210-230 g.
- Fasting period before study: Overnight.
- Housing: Groups of five by sex in solid floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): Ad libitum, except during fasting period and 3-4 hours after dosing.
- Water (e.g. ad libitum): Ad libitum, except during fasting period and 3-4 hours after dosing.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): Approximately 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.86 ml/kg
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: Animals were observed for death or overt toxicity 0.5, 1, 2 and 4 hours after dosing and then once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded prior to dosing on Day 0 and on Days 7 and 14.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths or adverse effects.
Mortality:
No deaths occurred.
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
All animals showed an expected gain in body weight.
Gross pathology:
No abnormal findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on an acute oral study in rats conducted to the now deleted OECD TG 401 (reliability score 1) and in compliance with GLP there were no deaths at a dose of 2000 mg/kg bw. The authors concluded the LD50 to be >2000 mg/kg bw. There were no adverse clinical signs, effects on body weight gain or abnormal findings during necropsy examinations.