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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The key study for skin irritation found the substance not irritating to rabbit skin (WIL, 1995).

The key study for eye irritation found the substance not irritating to rabbit eye (WIL, 1995).

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:
May 1995 - October 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: U.S. EPA FIFRA/TSCA and Japanese MAFF guidelines
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products Inc.
- Age at study initiation: Young adult
- Weight at study initiation: 2kg or more
- Housing: individual housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67
- Humidity (%): >30
- 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:
3M/3F
Details on study design:
TEST SITE
- Area of exposure: the back

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:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
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
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test material induced very slight erythema on two of six rabbits. There was no edema or other dermal findings. All erythema completely subsided by 24 hours post-dosing.
Other effects:
There were no deaths during the study. There were no remarkable body weight changes during the study period.
Interpretation of results:
GHS criteria not met
Conclusions:
All scores for all animals at 24, 48 and 72 hours were zero, and the substance was therefore concluded to not be irritating to rabbit skin. The study was conducted according to current guideline and in compliance with GLP.
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:
May 1995 - October 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: U.S. EPA FIFRA/TSCA and Japanese MAFF guidelines
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton research Products, Inc.
- Age at study initiation: Young adult
- Weight at study initiation: 3421 to 3813 grams
- Housing: individual suspended mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67.6 - 68.2
- Humidity (%): 42-67
- 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 M, 3 F
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / UV light / 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:
cornea opacity score
Basis:
animal #4
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 #5
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 #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
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:
other: 24/48/72h
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:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
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:
3
Remarks on result:
no indication of irritation
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no irritant effects, except slight conjunctival redness in one animal.
Other effects:
There were no deaths. None of the rabbits vocalized upon instillation of the test material.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating to the eyes of rabbits in a study conducted according to current 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 reports all scores for all animals at 24, 48 and 72 hours to be zero, with the conclusion that the substance is not irritating to rabbit skin (WIL, 1995). The study was conducted according to current guideline and in compliance with GLP. There were no deaths during the study. There were no remarkable body weight changes during the study period.

Supporting skin irritation studies from the read-across substances, 3-(trimethoxysilyl)methyl methacrylate (CAS 54586-78-6) and 3-(trimethoxysilyl)propyl methacrylate (CAS 2530-85-0), were also available and supported the findings of the key study (WIL, 2001 and Bioservice, 2003). Both studies were conducted according to an appropriate OECD test guideline, and in compliance with GLP.

The key study for eye irritation reports all scores for chemosis, corneal opacity and the iris to be zero in all animals at 24, 48 and 72 hours, with the conclusion that the substance is not irritating to rabbit eyes (WIL, 1995). The study was conducted according to current guideline and in compliance with GLP. There were no deaths during the study. None of the rabbits vocalized upon instillation of the test material.

Supporting eye irritation studies from the read-across substances, 3-(trimethoxysilyl)methyl methacrylate (CAS 54586-78-6) and 3-(trimethoxysilyl)propyl methacrylate (CAS 2530-85-0), were also available and supported the findings of the key study (WIL, 2000 and Bioservice, 2003). Both of the studies were conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Skin and eye irritation studies with the analogous substances, 3-(trimethoxysilyl)propyl methacrylate (CAS 2530-85-0) and 3-(trimethoxysilyl)methyl methacrylate (CAS 54586-78-6) have been included in the data set for completeness (WIL, 2001; Bioservice, 2003; Bioservice, 2003), to demonstrate the similar irritation/corrosion potential of the registered substance and the read across substances and support the read across approach for sensitisation.


Justification for classification or non-classification

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