Registration Dossier

Administrative data

Description of key information

The key studies for skin and eye irritation were selected as the only available guideline studies for those endpoints.

In the key skin irritation study, conducted according to OECD test guideline 404 and in compliance with GLP, 3-trimethoxysilylpropyl methacrylate was reported to be not irritating to skin (WIL, 2001).

In the key eye irritation study, conducted according to OECD test guideline 405 and in compliance with GLP, 3-trimethoxysilylpropyl methacrylate was reported to be not irritating to eyes (WIL, 2000).

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:
2000/09/28 - 2000/10/01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc., Denver PA

- Age at study initiation: Young adult

- Weight at study initiation: 2750 to 2981 grams at initiation of dosing

- Housing: Individual suspenpended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research laboratories, Inc., in accordance with standard operating procedures.

- Diet: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 grams per day during the study.

- Water: Municipal water was provided ad libitum

- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-68 (19.4-20 °C)

- Humidity (%): 50-59 %

- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light


Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5ml

- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
2 males, 1 females
Details on study design:
TEST SITE

- Area of exposure: dorsal skin

- Type of wrap if used: A two - ply gauze patch secured in place with tape. The patches were overwrapped with gauze binder and secured with tape.

REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test site was wiped with a disposable paper towel moistened with deionized water.

- Time after start of exposure: 4 hours

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:
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
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:
A primary irritation index of 0.1 was calculated from the results, consistent with a descriptive rating classification of slightly irritating.
Other effects:
No deaths or remarkable body weight changes were observed. Very slight erythema was noted in one animal at the 30-60 minute observation. There was no edema, nor were there any other dermal findings.  
Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study, conducted according to OECD TG 404 and in compliance with GLP, the test substance 3-trimethoxysilylpropyl methacrylate, was reported to not be irritating to skin.
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:
2000/10/02-2000/10/12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
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: 2501 to 2936 grams

- Housing: Individual suspended wire mesh cages. The animals were maintained by the animals husbandry staff of WIL Research laboratories, Inc. in accordance with standard operating procedures.

- Diet: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 grams per day.

- Water: Municipal water, ad libitum

- Acclimation period: minimum of 7 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-69 (19.4-20.6 °C)

- Humidity (%): 40-61 %

- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye.
Amount / concentration applied:
TEST MATERIAL

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

- Concentration (if solution): undiluted

Duration of treatment / exposure:
Single instillation, not rinsed.
Observation period (in vivo):
The eyes were examined for ocular reactions as approximately 24, 48 and 72 hours after dosing.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing: not rinsed


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein and UV lamp
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:
0.66
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Minor conjunctival irritation (grade 1) was observed in the treated eye of all animals which completely subsided by 72 hours. There were no corneal or iridial findings.
Other effects:
There were no deaths or test article - related body weight changes during the study period.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

       1/1/1

1/0/1 

24 h

 0/0/0 

 0/0/0 

1/1/1 

0/0/0

48 h

0/0/0

0/0/0

1/0/1 

 0/0/0 

72 h

0/0/0

0/0/0

 0/0/0  

 0/0/0 

Average 24h, 48h, 72h

 0

 0

 0.55

 0

Reversibility*)

 -

-

c

Average time (unit) for reversion

 -

 By 72 hours

 -

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study, conducted according to OECD TG 405 and in compliance with GLP, 3-trimethoxysilylpropyl methacrylate was reported to not be irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No in vitro skin irritation or eye irritation toxicity study are available for the registered substance. However, in vivo studies are available. 

In the key skin irritation toxicity study, conducted according to OECD Test Guideline 404 and in compliance with GLP, 3-Trimethoxysilylpropyl methacrylate was determined to not be irritating to rabbit skin. No deaths or remarkable body weight changes were observed. Very slight erythema was noted in one animal at the 30-60 minute observation. No oedema or other dermal findings were observed (WIL, 2001).

In a supporting in vivo skin irritation, not conducted according to any guideline and pre-GLP, the primary irritation index was calculated to be 1.19. The observed skin reactions do not meet the criteria for classification as a skin irritant (Consultox Labs, 1976).

In the key irritation toxicity study, conducted according to OECD test guideline 405 and in compliance with GLP,

3-trimethoxysilylpropyl methacrylate was not irritating to the eyes of rabbit. Minor reversible conjunctival redness was observed in the eye irritation test. No deaths or body weight changes were observed in any animals (WIL, 2000).

In an eye irritation test, not according to any guideline and pre-GLP, the test material was found to be slightly irritating. However, the observed effects do not meet the criteria for classification as an eye irritant (Consultox Labs, 1976).

Justification for classification or non-classification

Based on the available irritation data for 3-trimethoxysilylpropyl methacrylate, no classification for irritation is required according to Regulation (EC) No 1272/2008.