[3-(2,3-epoxypropoxy)propyl]triethoxysilane

Endpoint summary

Description of key information

In a skin irritation study conducted according to OECD 404 and in compliance with GLP (LPT Laboratory of Pharmacology and Toxicology KG, 2002a) [3-(2,3-epoxypropoxy)propyl]triethoxysilane was not irritating to the skin of rabbits.

In an eye irritation study conducted according to OECD 405 and in compliance with GLP (LPT Laboratory of Pharmacology and Toxicology KG, 2002b) [3-2,3-epoxypropoxy)propyl]triethoxysilane was not irritating to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.06.2002 to 06.09.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Wankendorf
- Age at study initiation: 3.5 months
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: Individually in cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.06.2002 To: 13.07. 2002

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 ml

Duration of treatment / exposure:

Four hours

Observation period:

72 hours

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of trunk
- % coverage: No data
- Type of wrap if used: Non-irritating semi-occlusive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not required as there was no residual test substance

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin reactions were observed in any of the animals at any timepoint.

Other effects:

None

Interpretation of results:

not irritating

Conclusions:

In a skin irritation study conducted to OECD 404 and in compliance with GLP (reliability score 1) [3-(2,3-epoxypropoxy)propyl]triethoxysilane was not irritating to the skin of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.06.2002 to 23.09.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: Approx. 4 months
- Weight at study initiation: 2-2.3 kg
- Housing: Individually in cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.06.2002 To: 19.07.2002

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

N/A

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Remarks:

Conjuctival redness Grade 1 at 1 h but not subsequently.

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Remarks:

Conjuctival redness Grade 1 at 1 h but not subsequently.

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Remarks:

Conjuctival redness Grade 1 at 1 h but not subsequently.

Irritant / corrosive response data:

Grade 1 conjunctival redness one hour after instillation in all animals. This redness had disappeared by the 24 hour reading.

Other effects:

None

Interpretation of results:

not irritating

Conclusions:

In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) [3-2,3-epoxypropoxy)propyl]triethoxysilane was not irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is one study for each of the skin and eye irritation endpoints. There are no supporting studies.

The key in vivo study for skin irritation found the registered substance [3-(2,3-epoxypropoxy)propyl]triethoxysilane not irritating to the skin of rabbits in a 4-hour semi occlusive study, conducted according to current OECD Test Guideline 404 and in compliance with GLP (LPT Laboratory of Pharmacology and Toxicology KG, 2002a). No erythema or oedema were observed in any of the test animals at any of the scoring intervals (24, 48 and 72 hours) following a 4-hour exposure to the test substance.

The key in vivo study for eye irritation found the registered substance [3-(2,3-epoxypropoxy)propyl]triethoxysilane not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD Test Guideline 405 and in compliance with GLP (LPT Laboratory of Pharmacology and Toxicology KG, 2002b). Instillation of the test material into one eye of each animal resulted in irritation of the conjunctivae, which consisted of redness one hour after in all three animals. The redness had completely disappeared by the 24 hours reading.

Justification for selection of skin irritation / corrosion endpoint:
The selected study is the only skin irritation study available for the registered substance. It was conducted according to current OECD Test Guideline 404 and in compliance with GLP.

Justification for selection of eye irritation endpoint:
The selected study is the only eye irritation study available for the registered substance. It was conducted according to current OECD Test Guideline 405 and in compliance with GLP.

Justification for classification or non-classification

Based on the available in vivo data [3-(2,3-epoxypropoxy)propyl]triethoxysilane is not classified for skin or eye irritation according to the criteria of Regulation (EC) No1272/2008.