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

Endpoint summary

Description of key information

[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested in an acute oral toxicity study conducted according to OECD Test Guideline 423 and in compliance with GLP. The LD50 was determined to be >2000 mg/kg bw (Hüls, 1997a, reliability 1).

The key study for acute dermal toxicity reported an LD₅₀ value of > 2000 mg/kg bw [2-(perfluorohexyl)ethyl]triethoxysilane, determined in a reliable study conducted according to GLP and current OECD TG 403 (Hüls, 1997b, reliability 1).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1992

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Additional information

[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested in an acute oral toxicity study conducted according to OECD TG 423 and in compliance with GLP (Hüls, 1997a, reliability 1). 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.

[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 (Hüls, 1997b, reliability 1). 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.

Justification for classification or non-classification

Based on the available studies on acute toxicity, [2-(perfluorohexyl)ethyl]triethoxysilane does not require classification for acute toxicity according to Regulation (EC) 1272/2008.