(chloromethyl)triethoxysilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 August 2011 to 14 August 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B (2008)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayrisches Landesamt für Gesundheit ud Lebensmittelsicherheit, Munich, Germany

Test material

Test material information

Constituent 1

Reference substance name:

(chloromethyl)triethoxysilane

EC Number:

239-311-3

EC Name:

(chloromethyl)triethoxysilane

Cas Number:

15267-95-5

Molecular formula:

C7H17ClO3Si

IUPAC Name:

(chloromethyl)triethoxysilane

Details on test material:

Name: (Chloromethyl)triethoxysilane
Physical State at RT: liquid
Colour: Colourless
Batch No.: KH09561
Density: 1.03 g/cm³ at 20°C and 1013 hPa
Expiry Date: 29 April 2013
Stability: stable when protected from moisture
Storage Conditions: at room temperature, protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Crl: KBL (NZW)
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany (The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.)
- Age at study initiation: approximately 15 – 16 weeks
- Weight at study initiation: > 2kg
- Housing: in ABS - plastic rabbit cages, floor 4200 cm² (Semi barrier in an air-conditioned room)
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1415), rich in crude fibre, ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3 (recommendations of TVT [10], GV-SOLAS [11])
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: the residual test material was removed with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No irritant or corrosive effects were observed on the intact skin of the three female rabbits after a contact time of 4 hours.

Other effects:

Neither mortalities nor significant clinical signs of toxicity were observed. The body weight was not affected by the test item application.

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:

The test item was tested for its skin irritating properties according to the OECD TG 404 and in compliance with GLP. No irritant effects were noted during the 72 h observation period following 4 h of exposure. No deaths occured, no signs of systemic toxicity were reported, and the body weight was not affected by the treatment. Hence, classificaion for skin irritation according to EC/1272/2008 is not warranted.