Triethoxy(vinyl)silane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 May 1998 to 3 June 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

Triethoxy(vinyl)silane

EC Number:

201-081-7

EC Name:

Triethoxy(vinyl)silane

Cas Number:

78-08-0

Molecular formula:

C8H18O3Si

IUPAC Name:

triethoxy(vinyl)silane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Labs Inc., Portage, MI, USA
- Age at study initiation: young adults
- Weight at study initiation: 211-308 g
- Housing: 1/suspended mesh-bottomed cage
- Diet: standard diet. ad libitum
- Water: drinking water. ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9-22.3
- Humidity (%): 41.3-61.0
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1998-05-21 To: 1998-06-03

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 16-20
- Type of wrap if used: gauze bandage held with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: removed with damp paper towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.22 ml/kg bw (0.90 g/ml)
- Concentration: neat (100%)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for mortality at 1, 3 and 4 h then twice daily for 14 d; clinical observations at 1, 3, and 4 h then once daily for 14 days; dermal observations at 30-60 mins then daily for 13 days; body weights on days 0 (before treatment), 7 and 14.
- Necropsy of survivors performed: yes, the major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Statistics:

None given - limit test.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths.

Mortality:

None.

Clinical signs:

other: Yellow deposits on urogenital area of 4 female rats on dosing day but not thereafter. [Said in the report to be typical of "bandage/collar application procedures".] No other potentially treatment-related effects.

Gross pathology:

No evidence of treatment-related effects.

Other findings:

- Other observations:
Very slight erythema (redness) in 3 females - days 4-6.
Focal eschar (scabbing or sloughing) in 3 females - days 5-10.
Desquamation (shedding of skin) in 3 males and 5 females - from day 4 and still evident in 1 female on day 14.

Any other information on results incl. tables

Table 1: Number of animals dead [and with evident toxicity]

Dose (mg/kg bw)	Mortality (# dead/total)			Number with evident toxicity (#/total)
	Male	Female	Combined	Male	Female	Combined
2000	0/5	0/5	0/10	No toxicity only local effects reported

 

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 an acute dermal toxicity study conducted in compliance with OECD 402 and in accordance with GLP (reliability score 1), no mortality or systemic effects were seen at 2000 mg/kg bw. Although there were some signs of local irritation, there were no adverse systemic effects.