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

Endpoint summary

Description of key information

The key skin irritation study is an OECD Test Guideline 404 rabbit study which concluded the substance was not irritating to the skin (Hüls, 1997c, reliability 1).

The key eye irritation study is an OECD Test Guideline 405 rabbit study which concluded the substance was not irritating to the eye (Hüls, 1997d, reliability 1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10th March 1997 to 14th March 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: small white Russian Mol:Russian / Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding/Research Centre Ltd., Tornbjergvej 40, Ejby DK-4623 LI. Skensved, Denmark
- Age at study initiation: no information
- Weight at study initiation: 2.3, 2.3 and 2.4 kg
- Housing: conventional, single animal per stainless steel cage.
- Diet: Ssniff K4 complete diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Four hours

Observation period:

30-60 minutes, 24, 48 and 72 hours, and 6 days after removal of the patch.

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze covered with a non-irritating bandage and then a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: four hours

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

<= 1

Max. score:

4

Remarks on result:

other: very slight edema was observed at 48 and 72 hours after patch removal

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

[2-(perfluorohexyl)ethyl]triethoxysilane has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP. Very slight erythema was observed after 30-60 minutes, and 2, 48 and 72 hours, in two of the three small white Russian rabbits exposed to the undiluted test substance for four hours. One animal showed very slight edema 48 and 72 hours after the removal of the bandage. All signs of irritation had reversed by 6 days after application. One animal showed no signs of skin irritation during the entire observation period. It is concluded that the test substance is not irritating to the skin.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-03-10 to 1997-03-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: small white Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding/Research Centre, Ltd., Tombjergvej 40, Ejby, DK-4623 LI. Skensved, Denmark
- Age at study initiation: adult
- Weight at study initiation: 2.0-2.6 kg
- Housing: single animal per stainless steel cage
- Diet (e.g. ad libitum): Ssniff K 4, complete diet for rabbits, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30-70% (deviations of short duration are caused by cleaning of the animal room)
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): artificial light 12/12

IN-LIFE DATES: From: 10th March 1997 to 14th March 1997

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 cm³

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Evaluation of the eyes was performed 1, 24, 48 and 72 hours after application of test substance

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline solution
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein test

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Within one hour of application, distinct hyperaemia of several blood vessels occurred in all animals. On one animal, the redness of the connective tissue was accompanied by a slight swelling, including the nictitating membrane. The cornea and iris showed no changes. Only one animal showed a slight redness of the connective tissue in the form of distinct hyperaemia of the blood vessels 24 hours after treatment. Further changes in the eye and conjunctiva were not observed. After 48 and 72 hours the eyes of all three animals were normal.

Other effects:

None reported.

Interpretation of results:

GHS criteria not met

Conclusions:

In an eye irritation study conducted according to OECD 405 and to GLP, [2-(perfluorohexyl)ethyl]triethoxysilane was only very slightly and transiently irritating to the eyes of small white Russian rabbits and therefore was not classified as an eye irritant.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

2-(Perfluorohexyl)ethyl]triethoxysilane has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP (Hüls, 1997c, reliability 1). Very slight erythema was observed after 30-60 minutes, and 2, 48 and 72 hours, in two of the three small white Russian rabbits exposed to the undiluted test substance for four hours. One animal showed very slight edema 48 and 72 hours after the removal of the bandage. All signs of irritation had reversed by 6 days after application. One animal showed no signs of skin irritation during the entire observation period. It is concluded that the test substance is not classifiable for irritation to the skin.

In an eye irritation study conducted according to OECD TG 405 and in compliance with GLP, [2-(perfluorohexyl)ethyl]triethoxysilane was only very slightly and transiently irritating to the eyes of small white Russian rabbits and therefore was not classified as an eye irritant (Hüls, 1997d, reliability 1).

Justification for classification or non-classification

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