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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.