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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute 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. 8 weeks
- Weight at study initiation: Males (307 ± 29 g), Females (215 ± 7 g)
- Fasting period before study: no data
- Housing: single housing in polycarbonate cages
- Diet: standard pelleted laboratory animal diet (from Carfil Quality BVBA, Out-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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 18 cm² for females, 25 cm² for males
- % coverage: 10%
- Type of wrap if used: surgical gauze patch covered with aluminium foil and Coban flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing: removal of the test substance and cleaning of residues with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.17 mL/kg bw (equivalent to 2457 mg/kg bw, calculated with a density of 1.13 g/cm³)
- Concentration: undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2457 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: The animals were observed twice daily for mortality/viability. The body weights were determined at day 1 (pre-administration), day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were determined at periodoc intervals at the day of dosing (day 1), and once daily thereafter until day 15.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 457 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: Red staining of the snout, head or neck was observed among several animals on days 1 and 2. These findings were not considered to be substance-related as they are typically noted in association with the bandage application procedures. Focal erythema was s

Gross pathology:

No abnormalities were observed.

Any other information on results incl. tables

Table 1: Results of the acute dermal toxicity study.

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males
2457	0/1/5	4 h - day 2	---	0
Females
2457	0/4/5	4 h - day 10	---	0
LD50 = > 2457 mg/kg bw
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used

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 dermal toxicity study conducted in compliance with OECD 402 and in accordance with GLP (reliability score 1), there were no mortality or other adverse effects observed at 2457 mg/kg bw. (24 hour exposure) (LD0 and LD50 > 2457 mg/kg bw).