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Administrative data

Description of key information

[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane was found not irritating to rabbit skin or eye in studies conducted according to current OECD guidelines and in compliance with GLP (WIL 2000b,  2000c).

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
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: young adult
- Weight at study initiation: 3475-3602g
- Housing: Individually suspended wire mesh cages
- Diet: ca. 150 g of a commercial feed was offered per day
- Water: ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66.1-66.9
- Humidity (%): 57.7-64.1
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure:backs and flanks
- Type of wrap if used: gauze, gauze binder, secured with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site of administration was wiped with a disposable paper towel moistened with deionized water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
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
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
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:
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:
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:
The test article induced very slight erythema on all animals, which subsided within 48 hours. No edema or other dermal findings were noted during the test period.
Other effects:
There were no deaths during the study, nor remarkable body weight changes.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating to rabbit skin in a study conducted according to an appropriate guideline and in compliance with GLP. The test article induced very slight erythema on all animals, which subsided wihin 48 hours. No edema or other dermal findings were noted during the test period.
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA
- Age at study initiation: 'young adults'
- Weight at study initiation: 3097-3444 g
- Housing: Individual suspended wire mesh cages
- Diet: commercial feed, ca. 150 g / day
- Water: ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66.1-67.4
- Humidity (%): 52.3-57.1
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Single instillation (unwashed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (3m, 1 f)
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: sodium 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:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Minor (grade 1) conjunctival irritation was noted for all animals at the one hour post instillation observation. The eyes of all animals appeared normal by 48-hours post-instillation. There were no corneal or iridial findings.
Other effects:
There were no deaths during the study. No animals vocalized upon instillation of the test article. There were no remarkable body weight changes observed during the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating to rabbit eye in a study which was conducted according to an appropriate OECD guideline and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin irritation found the test material not irritating to rabbit skin in a study conducted according to an appropriate guideline and in compliance with GLP (WIL, 2000b). The test article induced very slight erythema in all animals, which subsided within 48 hours. No edema or other dermal findings were noted during the test period.

The key study for eye irritation found the test material not irritating to rabbit eyes, in a study conducted according to an appropriate OECD guideline and in compliance with GLP (WIL 2001c). Minor (grade 1) conjunctival irritation was noted for all animals at the one hour post instillation observation. The eyes of all animals appeared normal by 48-hours post-instillation. There were no corneal or iridial findings. No animals vocalized upon instillation of the test article. There were no remarkable body weight changes, and there were no deaths during the study.


Justification for classification or non-classification

Bases on available data, no classification is required for skin or eye irritation in accordance with Regulation (EC) No. 1272/2008.

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