Registration Dossier

Administrative data

Description of key information

skin:
- rabbit (24 h, semiocclusive): not irritating
- rabbit (24 h, occlusive): not irritating (according to Draize; reevaluated according to OECD 404)
eye:
- rabbit: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1984-03-27 to 1984-03-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD guideline, GLP, observation period only 72 h.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period only 72 h
Principles of method if other than guideline:
The study was based on that described in the Journal Officiel de la Republique Francaise, 21 February 1982. Six male New Zealand White rabbits were treated with the undiluted test substance for 24 h under semiocclusive conditions to examine the skin irritating potential of the test substance.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics & Rosemead Rabbits Ltd., Lea Valley, Essex
- Age at study initiation: approximately 12 - 16 weeks
- Weight at study initiation: 2.78 - 3.10 kg
- Housing: individually
- Diet: free access to a standard laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire)
- Water: free access to tapwater
- Acclimation period: a minimum period of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Humidity (%): Humidity was not controlled but remained within a range of 52 - 58% RH recorded daily on a wet and dry bulb hygrometer.
- Air changes (per hr): approximately 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: The test material was introduced under a composite patch which consisted of a 2.5 cm x 2.5 cm square of absorbant lint BPC backed by a 4.0 cm x 4.0 cm square of absorbant lint BPC with a final backing of a 3.0 cm x 3.0 cm square of polythene. The patches were applied to the abraded and intact test sites of each animal and held securely in position by two lengths of Sleek adhesive strapping (Smith & Nephew Limited) in the form of a cross. An elasticated corset was then applied (Seton's Tubigrip) to prevent interference with the patches.

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing with cotton wool soaked in lukewarm water or other suitable solvent.
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize J.H (1959): Association of Food & Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemieals in Foods, Drugs and Cosmetics"
Irritation parameter:
erythema score
Basis:
animal: #1, #4
Time point:
other: 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #3, #6
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #2
Time point:
other: 24/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #5
Time point:
other: 24/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
edema score
Basis:
animal: #1, #3, #6
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #2, #4
Time point:
other: 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
The test material produced slight or well-defined cutaneous irritation in 6/6 rabbits. Very slight to moderate erythema, with or without very slight oedema was observed at the intact and abraded sites of all six rabbits at the 24 hours reading. The reactions had ameliorated completely in one rabbit by the 72 hours observation when very slight to well-defined erythema, with or without very slight oedema persisted at the intact and abraded sites of four rabbits and the abraded site only of the remaining rabbit.
No data is available on reversibility after 72 h. As most of the 72 h scores were lower compared to the 24 h scores, a full reversibility is expected after at least 21 days.
Other effects:
no
Exposition:  24 h
Animal  Reading  Erythema Edema
1 24 h 1 0
2 24 h 2 1
3 24 h 1 0
4 24 h 1 1
5 24 h 2 1
6 24 h 1 0
1 72 h 0 0
2 72 h 1 0
3 72 h 1 0
4 72 h 0 0
5 72 h 2 1
6 72 h 1 0
1 24 - 72 h 0.5 0
2 24 - 72 h 1.5 0.5
3 24 - 72 h 1 0
4 24 - 72 h 0.5 0.5
5 24 - 72 h 2 1
6 24 - 72 h 1 0
mean (animal 1-6) 24 - 72 h 1.1 0.3

The test material produced a Primary Cutaneous Irritation Index of 1.5 and was classified as a slight irritant to the skin.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this primary dermal irritation study in rabbit, Allyl methacrylate was slightly irritating.
Executive summary:

In a primary dermal irritation study similar to OECD 404 6 rabbits were dermally exposed to 0.5 mL of undiluted Allyl methacrylate to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an semi-occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored according to Draize J.H (1959): Association of Food & Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics". In this study, Allyl methacrylate was slightly irritating and is not a dermal irritant.. Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of Association of Food & Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
October 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; No Glp
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA, according Draize; reevaluated according OECD 404
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
24 h
Observation period:
no data
Number of animals:
6
Details on study design:
no data
Irritation parameter:
erythema score
Basis:
animal: #2, #5, #6
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #1, #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
no data
Remarks:
No data in respect to reversibility for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Remarks on result:
positive indication of irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal: #2, #4, #5, #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Remarks:
24 hours exposure
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant
Remarks on result:
no indication of irritation
Remarks:
24 hours exposure
Irritant / corrosive response data:
no data
Other effects:
no data

Reevaluation of the test results according to OECD404/GHS: only records for the shaved skin (not scarified) were considered

 Erythema/ 24h   

 Erythema/72h

 Oedema/24h

 Oedema/72h

 animal 1

 1

 0

 1

 0

 animal 2

 0

 0

 0

 0

 animal 3

 1

 0

 1

 0

 animal 4

 1

 0

 1

 0

 animal 5

 1

 0

 1

 0

 animal 6

 1

 0

 1

 0

 average (single scores: animal 1-6)

 0.833

0

 0.833

0

 Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores

 0.416

 Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores

 0.416

 

 Overall average PDII out of 8 scores; For evaluation according to GHS classification system:

 0.833

 

 

 

 

 

Remarks concerning the study result: The study for acute skin irritation/ 
corrosion was performed before OECD 404 came into force. For this reason the 
test values were reevaluated according to OECD criteria and test scores 
(erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

 

Classification criteria according to the different classification systems:
 
EU-GHS:
 
Category 1:Corrosive subcategories
 
Corrosive in >= 1 of 3 animals
(applies to authorities not using subcategories): Corrosive
(only applies to some authorities)
 
Subcategory   Exposure                      Observation
------------------------------------------------------------
1A            <= 3 minutes                  <= 1 hour
1B            > 3 minutes to <= 1 hour      <= 14 days
1C            > 1 hour to <= 4 hours        <= 14 days

 

 

A: Single harmonized corrosion category, using the results of animal testing.
A: Corrosive is a test substance that produces destruction of skin tissue, namely,
visible necrosis through the epidermis and into the dermis, in at least 1 of 3
tested animals after exposure up to 4 hours duration. Corrosive reactions are
typified by ulcers, bleeding, bloody scrabs and, by the end of observation at 14
days, by discoloration due to bleaching of the skin, complete areas of alopecia
and scars. Histopathologic determinations should be consided evaluate questionable
lesions.
 
Substances and/or mixtures are considered corrosive (Skin categorry 1) if it has
a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid
reserve suggests the substance or prepatration may not be corrosive despite the
low or high pH value, then further testing needs to be carried out to confirm
this, preferably by use of an appropriate validated in vitro test.
 
Category 2:
 
(1) Mean value of >= 2.3 to < 4.0 for erythem/eschar or for oedema in at least 2
    of 3 animals from gradings at 24, 48 and 72 hours after patch removal or, if
    reactions are delayed, from grades on 3 consecutive days after the onset of
    skin reactions, or
(2) Inflammation that persits to the end of the observation period normally 14
   days in at least 2 animals, particularly taking into account alopecia
    (limited area), hyperkeratosis, hyperplasia, and scalling, or
(3) In some cases where there is pronounced variability of response amoung
    animals, with very definite positive effects related to chemical exposure
   in a single animal but less than the criteria above.
 
UN-GHS (additional category 3):
 
Category 3:Mild irritant (Applies to only some authorities for e.g. UN-GHS)
 
Mean value of >= 1.5 to < 2.3 for erythem/eschar or for oedema from gradings
in at least 2 of 3 tested animals from grades at 24, 48 and 72 hours or, if
reactions are delayed, from grades on 3 consecutive days after the onset of
skin reactions (when not included in the irritant category above).
 
According to the results of this dermal irritation study n-Decylmethacrylate
has to be classified as follows:
 
According to GefStoffV:slightly below the irritancy threshold (non-irritant,
                        but 24 hour exposition, no wash off the test substance)
According to EU-GHS (CLP):Hazard category: None(effects < 2.3 both erythem
                        and oedema)
According to UN-GHS:Hazard category: 3(Erythem > 1.5 but < 2.3, 24 hour
                        exposition, no wash off the test substance)
 
 
 

 

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this primary dermal irritation study in rabbit, Allyl methacrylate was slightly irritating.
Executive summary:

In a primary dermal irritation study similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of undiluted Allyl methacrylate to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored similar to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404. No dermal irritation response was observed, neither at the intact nor at the abraded application sites. In this study, Allyl methacrylate was slightly irritating and is not a dermal irritant.. Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1984-04-09 to 1984-04-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD guideline, GLP
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
The study was based on the method described in the Journal Officiel de la Republique Francaise 21 April 1971 and 5 June 1973. The eyes of six New Zealand White rabbits were treated with the undiluted test substance to examine the eye irritating potential of the test substance.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington,Leics, and Rosemead Rabbits Ltd., Lea Valley, Essex
- Age at study initiation: approximately 12-16 weeks
- Weight at study initiation: 2.47 - 2.71 kg
- Housing: individually
- Diet: standard laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire) ad libitum
- Water: free access to tap water
- Acclimation period: for a minimum period of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 25
- Humidity (%):Humidity was not controlled but remained within a range of 55-65 % RH recorded daily on a wet and dry bulb hygrometer.
- Air changes (per hr): approximately 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

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:
single treatment (no washing out conducted)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: according to Draize J.H. 1959, Assoc. of Food and Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of a standard ophthalmoscope (Keeler). Observation of corneal opacity may be carried out under ultra-violet illumination (Mineralight UVSL-58) preceded by the instillation into the eye of 0.05 mL of fluorescein.
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #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, #2, #3, #4, #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:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3, #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4.0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #5, #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
The test material produced slight ocular irritation in 6/6 rabbits. A dulling of the normal lustre of the cornea was observed in two rabbits on Day 1 only. Iritis was observed in one rabbit on Day 1 only. Mild inflammation or a diffuse crimson-red colouration of the conjunctivae, with or without slight swelling was observed in all six rabbits on Day 1. The reactions had ameliorated in one rabbit by Day 2, in three further rabbits by Day 3 and in the two remaining rabbits by Day 4.
Cornea Iris Conjunctiva
Animal  Reading  Opacity Area involved Redness Chemosis Discharge
1 24 hrs 0 0 0 1 1 0
2 24 hrs 0 0 0 1 1 1
3 24 hrs D 1 0 1 1 0
4 24 hrs 0 0 0 1 0 0
5 24 hrs 0 0 0 2 1 1
6 24 hrs D 1 1 1 1 1
1 48 hrs 0 0 0 1 0 0
2 48 hrs 0 0 0 1 0 1
3 48 hrs 0 0 0 1 0 0
4 48 hrs 0 0 0 0 0 0
5 48 hrs 0 0 0 1 0 0
6 48 hrs 0 0 0 1 0 0
1 72 hrs 0 0 0 1 0 0
2 72 hrs 0 0 0 0 0 0
3 72 hrs 0 0 0 0 0 0
4 72 hrs 0 0 0 0 0 0
5 72 hrs 0 0 0 1 0 0
6 72 hrs 0 0 0 0 0 0
1 4 days 0 0 0 0 0 0
2 4 days 0 0 0 0 0 0
3 4 days 0 0 0 0 0 0
4 4 days 0 0 0 0 0 0
5 4 days 0 0 0 0 0 0
6 4 days 0 0 0 0 0 0
1 7 days 0 0 0 0 0 0
2 7 days 0 0 0 0 0 0
3 7 days 0 0 0 0 0 0
4 7 days 0 0 0 0 0 0
5 7 days 0 0 0 0 0 0
6 7 days 0 0 0 0 0 0
1 24/48/72 hrs 0   0 1 0.3  
2 24/48/72 hrs 0   0 0.7 0.3  
3 24/48/72 hrs 0   0 0.7 0.3  
4 24/48/72 hrs 0   0 0.3 0  
5 24/48/72 hrs 0   0 1.3 0.3  
6 24/48/72 hrs 0   0.3 0.7 0.3  
mean animal 1-3 24/48/72 hrs 0.0   0.1 0.8 0.3  
D = Dulling of the cornea

The test material produced a Maximum Mean Score of 5.8

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Allymethacrylate was not irritating according to EU-criteria in this eye irritation study.
Executive summary:

Allymethacrylate was not irritating according to EU-criteria in this eye irritation study.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, No GLP
Qualifier:
according to
Guideline:
other: Appraisal of the safety of chemicals in food, drugs and cosmetics, FDA, according Draize
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
other: the untreated right eye conducted as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single treatment (no washing out conducted)
Observation period (in vivo):
1, 2, 3, 4, 5, 6 and 7 days after instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: observation time: 7 days
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: observation time: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #4, #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: observation time: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: observation time: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 4 days
Remarks on result:
other: observation time: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: observation time: 7 days
Irritant / corrosive response data:
not irritating

 

Classification of eye irritation studies according GHS-criteria

 

Substance:Allyl methacrylate                            AMA                        CAS:96-05-9

 

Internal No.:UNTER 78-014

 

Date/Expert:06-12-15/Am

 

Animal No.

Corneal opacity/Hornhauttrübung[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

0

0

0

0

0

 

 

4

0

0

0

0

0

 

 

5

0

0

0

0

0

 

 

6

0

0

0

0

0

 

 

 

 

 

 

 

 

 

none

 

 

 

 

 

 

 

 

Animal No.

Iritis/Regenbogenhautentzündung[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

0

0

0

0

0

 

 

4

0

0

0

0

0

 

 

5

0

0

0

0

0

 

 

6

0

0

0

0

0

 

 

 

 

 

 

 

 

 

none

 

 

 

 

 

 

 

 

Animal No.

Conjunctiva redness (erythem) /Bindehautrötung[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

2

1

0

1

0

 

 

4

0

0

0

0

0

 

 

5

2

1

1

1,33

0

 

 

6

0

0

0

0

0

 

 

 

 

 

 

 

 

 

none


 

Animal No.

Conjunctiva chemosis /Bindehautödem[Scores]

 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

0

0

0

0

0

 

 

4

0

0

0

0

0

 

 

5

0

0

0

0

0

 

 

6

0

0

0

0

0

 

 

 

 

 

 

 

 

 

none

 

 

Classification:

Hazard Category

 

none




n.d. = no data

 

Classification Criteria for serious Eye Damage/Eye Irritation

 

Category 1

 

  • Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
  • Mean Draize score in 2 of 3 animals:

     corneal opacity≥ 3

     iritis ≥ 1,5

 

 

Category 2

 

  • Reversible adverse effects on cornea, iris, conjunctiva
  • Mean Draize score in 2 of 3 animals:

corneal opacity1

iritis1

redness2

chemosis2

 

 

Subcategory 2A

 

  • Reversible in 21 days

 

Subcategory 2B

 

  • Reversible in 7 days

 

 

 

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this primary eye irritation study Allyl methacrylate is not an eye irritant.
Executive summary:

In a primary eye irritation study similar to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405),

0.1 mL of Allyl methacrylate (typical purity: 99 %) was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

Transient conjunctival irritating effects were seen for two respectively three days after application in 2/6 animals. All effects were completely reversible at day 4. From day 4 onward all scores were zero.

In this study, Allyl methacrylate is not an eye irritant.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

In the study of Safepharm (1984) six male New Zealand White rabbits were treated with the undiluted test substance for 24 h under semiocclusive conditions to examine the skin irritating potential of the test substance. The study was based on that described in the Journal Officiel de la Republique Francaise, 21 February 1982 equivalent or similar to OECD guidelines and was conducted in compliance with GLP conditions.

Allyl methacrylate produced slight or well-defined cutaneous irritation in 6/6 rabbits. Very slight to moderate erythema, with or without very slight edema was observed at the intact and abraded sites of all six rabbits at the 24 hours reading. The reactions had ameliorated completely in one rabbit by the 72 hours observation when very slight to well-defined erythema, with or without very slight edema persisted at the intact and abraded sites of four rabbits and the abraded site only of the remaining rabbit. The mean scores of the six animals (24 and 72 h values) for erythema and edema were 1.1 and 0.3, respectively. No data is available on reversibility after 72 h. As most of the 72 h scores were lower compared to the 24 h scores, a full reversibility is expected after at least 21 days.

In the second study from Evonik Industries similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of undiluted Allyl methacrylate to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored similar to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404. No dermal irritation response was observed, neither at the intact nor at the abraded application sites. In this study, Allyl methacrylate was slightly irritating and is not a dermal irritant.. Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines.

Eye:

In the study of Safepharm (1984) the eyes of six male New Zealand White rabbits were treated with the undiluted test substance to examine the eye irritating potential of the test substance. The study was based on that described in the Journal Officiel de la Republique Francaise, 21 February 1982 , equivalent or similar to OECD guideline and was conducted in compliance with GLP conditions. The eyes were not rinsed and the observation period was 7 days. Allyl methacrylate produced slight ocular irritation in 6/6 rabbits. A dulling of the normal lustre of the cornea was observed in two rabbits on Day 1 only. Iritis was observed in one rabbit on Day 1 only. Mild inflammation or a diffuse crimson-red colouration of the conjunctivae, with or without slight swelling was observed in all six rabbits on Day 1. The reactions had ameliorated in one rabbit by Day 2, in three further rabbits by Day 3 and in the two remaining rabbits by Day 4. The mean scores of the six animals (24, 48 and 72 h values) for corneal opacity, iritis, conjunctival redness and chemosis were 0, 0.1, 0.8, and 0.3, respectively.

In the second study IBR, International Bioresearch, Inc. (1978) . 0.1 mL of allyl methacrylate were instilled into rabbits’ eyes (6 animals). The eyes were not rinsed and the observation period was 7 days. The study was conducted according to Draize but before GLP was established. Slight erythema was observed in 2/6 animals which was reversible within 7 days.

Justification for classification or non-classification

Due to the results of the studies no classification concerning skin or eye irritation according to Regulation (EC) no 1272/2008 (GHS) criteria is required.