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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Feb 1999 - 19 Feb 1999
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 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
no
GLP compliance:
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:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: less than 3.5 kg
- Housing: single housing
- Diet: standard laboratory rabbit diet (LKK-20, Hope Farms Woerden, The Netherlands), ad libitum. In addition hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water: tap water diluted with decalcified 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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping with electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent areas of the untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted test substance
Duration of treatment / exposure:
4 h
Observation period:
72 h (the test was probably completed after 72 h due to negative results at the 72 h reading)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 cm x 3 cm
- % coverage: no data
- Type of wrap if used: the test area was covered with a Metalline patch which was mounted on Micropore tape and was wrapped around the abdomen and secured with coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with water was performed.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring scheme

OBSERVATIONS:
The animals were observed twice daily for mortality/viability and at least once daily for toxicity. Body weights were recorded once before treatment. Skin reactions were recorded 1, 24, 48, and 72 h after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
After 1 hour an erythema (grade 1) was observed in all 3 animals, which was fully reversible within 24 hours.

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:
A skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), found ureidopropyltrialkoxysilane, mixed methoxy and ethoxy not to be irritating to the skin of rabbits. The report describes the material as non-irritant according to CLP criteria.