Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-05-13 to 1997-05-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[2-(Perfluorohexyl)ethyl]triethoxysilane

IUPAC Name:

[2-(Perfluorohexyl)ethyl]triethoxysilane

Constituent 2

Reference substance name:

Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane

EC Number:

257-473-3

EC Name:

Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane

Cas Number:

51851-37-7

Molecular formula:

C14H19F13O3Si

IUPAC Name:

triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, 33176 Borchen, Germany
- Age at study initiation: no information
- Weight at study initiation: 200-300 g
- Fasting period before study: no
- Housing: Makrolon type III cages, one animal per cage, soft wood bedding
- Diet: Ssniff R 10 diet in pellet form ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 =/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: To: 27.05.1997

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 x 50 mm
- % coverage: no information.
- Type of wrap if used: semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure the treated area of skin was cleansed with corn oil and absorbent paper.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Undiluted test substance was applied to skin prepared by clipping approximately 24 hours before exposure.
- Amount(s) applied (volume or weight with unit): 1.50 cm²/kg bw.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

five males and five females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for clinical signs approximately 30 minutes after dosing and at hourly intervals for the remainder of day one, then daily. The rats were checked at least twice daily for any mortalities. The dermal response was observed daily for irritation and lesions. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs; body weight; macroscopic appearance of tissues in abdominal and thoracic cavities.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: There were no mortalities

Mortality:

There were no mortalities in any of the five male and five female rats treated dermally with 2000 mg/kg bw of test substance.

Clinical signs:

other: There were no signs of systemic reaction to treatment. No local dermal irritations at the treatment site were observed following removal of the dressings.

Gross pathology:

No abnormalities were observed on examination at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

[2-(perfluorohexyl)ethyl]triethoxysilane has been tested for acute dermal toxicity to rats in a study conducted according to OECD TG 402 and in compliance with GLP. No mortalities or clinical signs were observed in any of the five male and five female animals exposed for 24 hours to 2000 mg/kg bw of undiluted test substance, either during exposure or in the following 14 day observation period. It is concluded that the LD50 is ˃2000 mg/kg bw.