hydrolysis products of 3-(triethoxysilyl)propan-1-amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 - 20 Jan 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany

Test material

Test material information

Constituent 1

Reference substance name:

hydrolysis products of 3-(triethoxysilyl)propan-1-amine

EC Number:

939-125-9

Molecular formula:

not applicable for UVCB substance

IUPAC Name:

hydrolysis products of 3-(triethoxysilyl)propan-1-amine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.5-2.8 kg
- Housing: before and after the 4-hour exposure period, the animals were kept singly in cages measuring 380 mm x 425 mm x 600 mm (Dipl. Ing. W. EHRET GmbH, Schönwalde, Germany). During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head, but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine.
- Diet: sniff® K-H V2333 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 Jan 2012 To: 20 Jan 2012

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

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:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm² on the dorsal area of the trunk
- Type of wrap if used: the test item was applied to the test site and then covered with a gauze patch. The patch was held in place with non-irritating tape for the duration of the exposure period.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

In the initial test with one animal, no severe irritancy or corrosion was product by the test substance at any reading time point. In the confirmatory test with 2 further animals, no erythema or edema were observed 1, 24, 48 and 72 h after exposure.

Other effects:

No further local or systemic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified