[3-(trimethoxysilyl)propyl]urea

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 Feb - 28 June 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

yes

Remarks:

no data on purity available

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[3-(trimethoxysilyl)propyl]urea

EC Number:

245-904-8

EC Name:

[3-(trimethoxysilyl)propyl]urea

Cas Number:

23843-64-3

Molecular formula:

C7H18N2O4Si

IUPAC Name:

[3-(trimethoxysilyl)propyl]urea

Details on test material:

- Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, slightly viscous liquid
- Analytical purity: no data available
- Lot/batch No.: 2131UG060495
- Storage condition of test material: original container at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2739 - 2903 g
- Fasting period before study: no
- Housing: individually housed in wire-mesh cages
- Diet: Purina Certified Rabbit Chow No. 5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.4
- Humidity (%): 34.7-60.2
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

8 days
Reading time points: 1, 24, 48 and 72 h and 4, 5, 6, 7 and 8 days

Number of animals:

6 (2 males, 4 females)

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: test substance was applied under a secured 2-ply gauze patch overwrapped with a gauze binder and secured with Dermiform tape

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the treatment period the sites were wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean of all 6 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

other: mean of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No oedema reactions were observed in any animal at any time point. After 0.5-1 h no erythema reactions were observed. After 24 h 2/6 animals showed erythema (grade 1), which were fully reversible within 7 days. In addition, in the 2 animals with erythema reactions desquamation was observed from Day 3 until Day 7.

Other effects:

No deaths, clinical signs of toxicity or body weight changes were observed throughout the study period.

Any other information on results incl. tables

Table 1: Individual scores from skin irritation study in rabbits.

Rabbit No.	1 (male)		2 (male)		3 (female)		4 (female)		5 (female)		6 (female)
Observation time	Ery.	Oed.	Ery.	Oed.	Ery.	Oed.	Ery.	Oed.	Ery.	Oed.	Ery.	Oed.
1 h	0	0	0	0	0	0	0	0	0	0	0	0
24 h	0	0	1	0	0	0	1	0	0	0	0	0
48 h	0	0	1	0	0	0	1	0	0	0	0	0
72 h	0	0	1d	0	0	0	1d	0	0	0	0	0
4 d	-	-	1d	0	-	-	1d	0	-	-	-	-
7 d	-	-	0	0	-	-	0d	0	-	-	-	-
8 d	-	-	-	-	-	-	0	0	-	-	-	-
Mean value	0	0	1	0	0	0	1	0	0	0	0	0
24 + 48 + 72 h

Ery.: Erythema

Oed.: Oedema

d: Desquamation

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In a skin irritation study according to OECD 404 the test item was found to be not irritating to skin. Treatment of 6 New Zealand White rabbits under semi-occlusive conditions with 0.5 ml undiluted test substance induced no edema in any animal at any time point. Slight erythema (grade 1) were observed in 2/6 animals but were fully reversible within 7 days. Furthermore no signs of systemic toxicity no effects on body weight were observed.