Registration Dossier

Administrative data

Description of key information

Skin irritation
A certain skin irritation potential of the test item was determined via the two skin irritation studies performed on rabbit skin.
Eye irritaion
A certain eye irritation potential of of the test item was determined via the eye irritation study conducted with 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:
1994-01-17 until 1994-02-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Age at study initiation: young adult
- Weight at study initiation: 3.35 - 3.82 kg
- Housing: single
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, CH
- Water: municipal drinking water, regularly assayed
- Acclimation period: at least 1 week
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): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
15 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm at the back
- Type of wrap if used: Idealbinde, Pfaelzische Verbandsstoff-Fabrik, Kaiserslautern, Germany


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol (=Polyethylenglykol) pure; Lutrol/water 1:1


SCORING SYSTEM: OECD Draize
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: Scaling was observed; see table for details
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
2.44
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: Scaling was observed; see table for details
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 -48 - 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details

Exposition:

4 h

Animal

Reading

Erythema

Edema

Symptoms

1

1 h

2

1

 

2

1 h

1

0

 

3

1 h

2

1

 

1

24 h

3

1

 

2

24 h

2

0

 

3

24 h

2

0

 

1

48 h

3

1

 

2

48 h

2

0

 

3

48 h

2

0

 

1

72 h

3

1

 

2

72 h

2

0

 

3

72 h

3

0

 

1

8 d

1

0

Scaling

2

8 d

1

0

Scaling

3

8 d

1

0

Scaling

1

15 d

0

0

 

2

15 d

0

0

Scaling

3

15 d

0

0

 

mean

24 - 72 h

2.44

0.33

 

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
1994-01-24 until 1994-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult
- Weight at study initiation: 3.67 - 4.37 kg
- Housing: single
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, CH
- Water: municipal drinking water, regularly assayed
- Acclimation period: at least 1 w eek
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:
not washed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: OECD Draize
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: iris remained normal
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: iris remained normal
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: iris remained normal
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see table for details

Animal  Reading  Opacity Iritis Redness Chemosis Symptoms
1 1 h 0 0 2 1 discharge score 3; small retractions of the eye lids
2 1 h 0 0 0 0  
3 1 h 0 0 1 0 discharge score 1
1 24 h 0 0 2 0 small retractions of the eye lids
2 24 h 0 0 0 0  
3 24 h 0 0 2 1 discharge score 1
1 48 h 0 0 2 0 small retractions of the eye lids
2 48 h 0 0 0 0  
3 48 h 0 0 2 0 discharge score 1
1 72 h 0 0 2 0 small retractions of the eye lids
2 72 h 0 0 0 0  
3 72 h 0 0 2 0 discharge score 1
1 8 d 0 0 0 0  
2 8 d 0 0 0 0  
3 8 d 0 0 0 0  
mean 24 - 72 h 0.00 0.00 1.33 0.11  
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

Key study: A GLP conform in vivo study was performed to assess the acute dermal irritation or corrosion potential of the test substance T- butyl methacrylate in White Vienna rabbits according to the OECD guideline 404. An amount of 0.5 mL of the test substance was once topically applied for 4 hours to the intact skin of three rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing.

The average score (24 to 72 hours) for irritation was calculated to be 2.4 for erythema and 0.3 for edema. Signs of skin irritation (such as erythema and edema) were reversible within 15 days after removal of the patches, while scaling was still present in one animal at study termination.

Under the test conditions chosen and considering the described findings (erythema mean scores >= 2 for each animals at the 24, 48 and 72 h observation point) the test item is regarded as irritant to the skin.

Supporting study: A GLP conform in vivo study was performed to assess the acute dermal irritation or corrosion potential of the test substance T- butyl methacrylate in New Zealand White rabbits similar to the OECD guideline 404. An amount of 0.5 mL of the test substance was once topically applied for 24 hours to the intact and abraded skin of six rabbits, using a patch of 2.5 cm x 2.5 cm, covered with occlusive dressing. The site was inspected 24 h and 72 h after the administration.

Erythema accompanied by slight oedema was observed at three of the intact and four of the abraded sites at the 24 hour reading. Very slight erythema with very slight to slight oedema was observed at the remaining three intact and two abraded sites. At the 72 hour reading very slight erythema with or without very slight oedema was observed at four of the intact and four of the abraded sites. Reactions had completely resolved in the remaining two intact and two abraded sites. Based on this supporting study the test item is not regarded as irritant to skin.

 

Eye irritation

To assess the acute eye irritation potential of the test substance t- butyl methacrylate in vivo a GLP conform eye irritation test in White Vienna rabbits was performed according to the method described in OECD guideline 405. An amount of 0.1 mL of the test substance was once applied to one eye of three rabbits. The cornea and the iris scores were 0 for all animals. A chemosis score of 1 was observed in one single animal (animal 3) at the 24 h observation. For two of the three animals a redness score of 2 was observed for the 24, 48 and 72 h observation time point. The findings were reversible in all animals within 8 days after application, thus the study was terminated. Due to the observed redness scores the test item is regarded as irritant to the eye. Under the test conditions chosen and considering the described findings t- butyl methacrylate is regarded as eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Most reliable study

Justification for selection of eye irritation endpoint:
Most reliable study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Based on the available in vivo studies, the test substance is classified as skin irritant (R38) according to the criteria of Directive 67/548/EEC (DSD) and Cat. 2 according to Regulation (EC) No 1272/2008 (CLP).

Based on data available the test substance is classified as eye irritant (R36) according to the criteria of Directive 67/548/EEC (DSD) and Cat. 2

Based on the signs of respiratoy tract irritation observed in the acute inhalation toxicity test with a sructural analoqe substance and based on a harmonised classificaation - Annex VI of Regulation (EC) No 1272/2008 (CLP) (chemical group: monoalkyl or monoaryl or monoalkyaryl esters of methacrylid acid with the exception of those specified elsewhere in this Annex) the test item is classified as STOT SE3 (H335: specific concentration limit C >= 10%) according to Regulation (EC) No 1272/2008 (CLP) and as XI, R37 (specific concentration limit C>= 10% according to regulation Directive 67/548/EEC (DSD).