Hexadecyltrimethoxysilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxyoctadecylsilane

EC Number:

221-339-2

EC Name:

Trimethoxyoctadecylsilane

Cas Number:

3069-42-9

Molecular formula:

C21H46O3Si

IUPAC Name:

Ttrimethoxy(octadecyl)silane

Constituent 2

Reference substance name:

Octadecyltrimethoxysilane

IUPAC Name:

Octadecyltrimethoxysilane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Si 118
- Substance type: Alkoxysilane
- Physical state: liquid
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

other: Weisse Russen (Albino)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 3-4 months (males), 4 months (females)
- Weight at study initiation: 2.14 - 2.31 kg (males), 2.06 - 2.26 kg (females)
- Fasting period before study: at the day of treatment
- Housing: single housing
- Diet: standardized laboratory animal diet, ssniff (k) rabbit diet, ssniff GmbH, Soest, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- Humidity (%): 45 - 55
- Air changes (per hr): no data
- 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: shoulder
- % coverage: no data
- Type of wrap if used: patch + bandage ( no further details)

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw (2.247 ml/kg bw)
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were observed 6-8 h after treatment and once daily afterwards. Weighing was performed shortly before application of test substance and on days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: No clinical signs were observed throughout the study period.

Gross pathology:

No treatment-related findings were observed.

Other findings:

Directly after treatment erythema were observed at the site of treatment. Within 3 - 7 days desquamation was observed. The effects were fully reversible within 13 days.

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 acute dermal toxicity according to the OECD TG 402 and in compliance with GLP. The LD 50 was found to be > 2000 mg/kg bw for both males and femals. Hence, classification for actue dermal oxicity according to EC/1272/2008 is not warranted.