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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1-(3-{13-[3-(aminomethyl)phenyl]-6,6,8,8-tetramethoxy-7-oxa-2,12-diaza-6,8-disilatridecan-1-yl}phenyl)methanamine; 1-[3-({[3-(trimethoxysilyl)propyl]amino}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:
other: There were no clinical signs of toxicity.
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.