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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
449-160-7
EC Name:
-
Cas Number:
116912-64-2
Molecular formula:
C7H18N2O4Si C8H20N2O4Si C9H22N2O4Si C10H24N2O4Si
IUPAC Name:
[3-(ethoxydimethoxysilyl)propyl]urea; [3-(trimethoxysilyl)propyl]urea; {3-[diethoxy(methoxy)silyl]propyl}urea

Test animals

Species:
rat
Strain:
other: CRL:(WI) BR (outbred, SPF quality)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: Females (153 ± 2 g); Males (206 ± 10 g)
- Fasting period before study: overnight
- Housing: 3 animals per sex per cage
- Diet: standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (Fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 50 (Fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
2.17 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: no data.
Doses:
2457 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality/viability twice daily. Body weights were determined at day 1 (pre-administration), 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were determined at periodic intervals at day 1 and once daily until day 15.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 457 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: Uncoordinated movements were noted in all females on the day of treatment (day 1). No clinical signs of toxicity were noted in the males.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In an acute oral limit test, conducted according OECD 423 and in accordance with GLP (reliability score 1), there was no mortality or marked systemic effect in rats at 2457 mg/kg bw.