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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-05-12 to 1997-05-30

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

[2-(Perfluorohexyl)ethyl]triethoxysilane

IUPAC Name:

[2-(Perfluorohexyl)ethyl]triethoxysilane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wistar rats (HsdCpb:WU / SPF) from Harlan Winkelmann GmbH, Gartenstraβe 27, 33176 Borchen.
- Age at study initiation: young adult animals
- Weight at study initiation: weight variation did not exceed ±20% of the mean body weight
- Fasting period before study: about 16 hours
- Housing: groups of max. five rats in Makrolon type III cages, sexes separated
- Diet (e.g. ad libitum): Ssniff R diet in pellet form (laboratory standard rat diet) ad libitum; ad libitum 3 hours after application
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no information in report
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

In the first instance 3 male rats were given a single oral application of the test substance at a dose level of 2000 mg/kg bw. Since no mortalities occurred within 24 hours p.a., 3 female rats were treated in the same way
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed soon after dosing and at frequent intervals for the remainder of day 0 (a period of approximately 6 hours). On subsequent days animals were observed once a day. That nature and severity of the clinical signs were recorded at each observation. Individual body weights were recorded on days 0 (prior to dosing), 7 & 14
- Necropsy of survivors performed: animals were killed on day 14 by CO2 inhalation and subjected to a macroscopic examination after opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded for each animal
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No rats died following a single oral application at 2000 mg/kg bw.

Clinical signs:

other: There were no deaths and no signs of systemic reaction to treatment.

Gross pathology:

No abnormalities.

Other findings:

Macroscopic examination: No macroscopic findings.

Any other information on results incl. tables

Acute oral toxicity study: body weights

Dose		Body weight (g) on day			Body weight gains (g)		Body weight (g) on day			Body weight gains (g)
Animal Number	Substance mg/kg bw	0	7	14	Week 1	Week 2	0	7	14	Week 1	Week 2
		males					females
1	2000	148	210	248	62	38	134	160	169	26	9
2	2000	155	214	252	59	38	144	175	192	31	17
3	2000	152	204	246	52	42	136	161	161	25	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested in an acute oral toxicity study conducted according to OECD 423 and in compliance with GLP. The undiluted test substance was administered by gavage to a group of 3 male and 3 female rats. The rats were dosed at 2000 mg/kg bw. There were no deaths and no signs of systemic reaction to treatment. All animals achieved satisfactory bodyweight gains throughout the study. The LD50 was determined to be >2000 mg/kg bw.