Reaction mass of [3-(trimethoxysilyl) propyl]urea, [3-(dimethoxyethoxysilyl) propyl]urea, [3-(methoxydiethoxysilyl) propyl]urea and [3-(triethoxysilyl) propyl]urea.

Acute Toxicity: oral

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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 457 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Effect levels 2

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.