Registration Dossier

Administrative data

Description of key information

Based on the available data, EGDMA is not irritating to the skin and eyes. According to annex VI of the CLP regulation (1272/2008/EC, harmonized classification) EGDMA is classified as a respiratory irritant (STOT SE cat. 3). The scientific basis for that classification is unknown.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Pre-guideline study but comparable to guideline study. Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
Qualifier:
according to
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Principles of method if other than guideline:
Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials".
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
Amount / concentration applied:
undiluted 0.5 mL
Duration of treatment / exposure:
24 hour(s)
Observation period:
24h and 72h post application
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.42
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.42
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Overall primary irritation score (PDII): 0.42 of 8 scores FDA (Draize), 1959,  

re-evaluated according to OECD 404

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  0  0
 animal 2  0  0  0  0
 animal 3  1  0  0  0
 animal 4  1  0  0  0
 animal 5  1  0  0  0
 animal 6  1  0  0  0
 average (single scores: animal 1-6)  0,8333  0  0  0
 Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  0,42  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  0  
 Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  0,42    

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.
Interpretation of results:
GHS criteria not met
Conclusions:
Ethylene glycol dimethacrylate was not irritating in a primary skin irritation study with in rabbits (24/72-hour occlusive application, no wash of the test substance, re-evaluated according to OECD 404).
Executive summary:

In a primary pre-guideline dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to 0.5 mL undiluted Ethyleneglycol dimethacrylate for 72 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.

The mean erythema score (average value of  the single scores (animals 1-6; erythema; intact skin, 24h and 72h)  was determined to be 0.42 out of 4 and the mean edema score 0 out of 4. Therefore Ethylene glycol dimethacrylate is

not a dermal irritant .

Therefore the test substance has not to be classified - according to GHS classification criteria and according to Draize-criteria - as non irritant for skin (GHS-hazard category: none).

Remarks concerning the study result: The study for 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.

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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Pre-guideline study but comparable to guideline study. Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
Qualifier:
according to
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Principles of method if other than guideline:
Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials".
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data.
Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
Amount / concentration applied:
undiluted 0.5 mL
Duration of treatment / exposure:
24 hour(s)
Observation period:
24h and 72h post application
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.583
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.25
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Overall primary irritation score (PDII): 0.583 of 8 scores FDA (Draize), 1959,  

re-evaluated according to OECD 404

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  0  0  0  0
 animal 2  1  1  0  1
 animal 3  0  0  0  0
 animal 4  0  1  0  1
 animal 5  0  0  0  0
 animal 6  0  1  0  1
 average (single scores: animal 1-6)  0,1667  0,5  0  0,5
 Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  0,33  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  0,25  
 Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  0,583    

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.
Interpretation of results:
GHS criteria not met
Conclusions:
Ethylene glycol dimethacrylate was not irritating in a primary skin irritation study with in rabbits (24/72-hour occlusive application, no wash of the test substance, re-evaluated according to OECD 404).
Executive summary:

In a primary pre-guideline dermal irritation study rabbits were dermally exposed (intact and scarified skin) to 0.5 mL undiluted Ethyleneglycol dimethacrylate for 72 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.

The mean erythema score (average value of  the single scores (animals 1-6; erythema; intact skin, 24h and 72h)  was determined to be 0.33 out of 4 and the mean edema score 0.25 out of 4. Therefore Ethylene glycol dimethacrylate

is not a dermal irritant .

Therefore the test substance has not to be classified - according to GHS classification criteria and according to Draize-criteria - as non irritant for skin (EU-GHS-hazard category: none).

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. 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)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-guideline study but comparable to guideline study. Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
according to
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
Principles of method if other than guideline:
Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of each treated animal
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hours, unrinsed
Observation period (in vivo):
7 days after treatment
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not rinsed
Irritation parameter:
other: index of primary eye irritation
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
13
Reversibility:
fully reversible
Remarks on result:
other: re-evaluated according to OECD405

Index of primary eye irritation: 0.0 of 13 (re-evaluated according to OECD 405)

An initial slight irritation of the conjunctiva within the first 8 hours

(irritation scores 0-1) disappeared entirely within the first 24 h; non-irritating

Classification of eye irritation studies according OECD-GHS-criteria

Substance: Ethylene glycol dimethacrylate                                                     CAS: 97 -90 -5

Internal No.: UNTER78 -007

Date/Expert: 15 -12 -2011/RG

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, 2

0 0

0 0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 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, 2

0  0

0  0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 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, 2

0 0

0 0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 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, 2

0 0

0 0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 0

0 0

0 0

-

             

 none

Classification:

Hazard Category

none

Classification Criteria for serious Eye Damage/Eye

Category 1

- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal

- Mean Draize score in 2 of 3 canimals:

corneal opacity 3

iritis ≥ 1,5

Category 2

- Reversible adverse effects on cornea, iris, conjunctiva

- Mean Draize score in 2 of 3 animals:

corneal opacity >= 1

iritis >= 1

redness >= 2

chemosis >= 2

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: EU
Conclusions:
Classification: not irritating
Executive summary:

In a primary pre-guideline eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)) 0.1 mL undiluted Ethyleneglycol dimethacrylate was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.

In this study Ethyleneglycol dimethacrylat is not irritating to eyes.

OECD GHS Category: none

EU GHS Category: none

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

Based on the available test data EGDMA induces slight and reversible irritation. These effects are clearly below the threshold for classification; hence, EGDMA is not regarded as irritating to skin according to the criteria of EU Directive 67/548/EEC and the CLP Regulation (1272/2008/EC) nor according to UN-GHS.

 

Eye

Based on the available test data EGDMA is not irritating. Hence, EGDMA is not regarded as irritating to the eye according to the criteria of EU Directive 67/548/EEC and the CLP Regulation (1272/2008/EC)

nor according to UN-GHS.

 

Respiratory Tract

EGDMA has a low vapour pressure and the only available data by the inhalation route is a repeated exposure screening study in rat in which aerosol production cannot be excluded. In this study, after two week exposure, slight thickening of the alveolar walls was observed which is consistent with weak irritant potential. On the other hand, acute (6hr) inhalation studies in rats with methyl and ethyl methacrylate, but not butyl methacrylate and larger esters, produces lesions in the olfactory region of the nasal cavity at 200ppm (948 mg/m³) (Jones, 2002). Based on molecular weight and vapour pressure, the saturated vapour density of EGDMA can be estimated to be approx. 10 ppm. This concentration is far lower than the irritating concentrations of the lower alkyl methacrylates. Hence, acute exposure to EGDMA is not expected to be irritating to the respiratory tract. Nevertheless, in the entry for EGDMA in Annex VI of the CLP Regulation (1272/2008/EC) in the harmonised classification for this chemical, is classified as a respiratory irritant (STOT SE, cat. 3). The exact reason for this classification – and the predecessor in Annex I of EU Directive 67/548/EEC – is unknown. For the time being, the existing classification will be carried forward.

Compliance to REACh requirements

The requirements are covered with reliable in vivo data, performed with the substance itself and before in vitro testing became current priority.

 

Reference:

Jones O (2002) Using physiologically based pharmacokinetic modelling to predict the pharmacokinetics and toxicity of methacrylate esters. A Thesis submitted to the U. of Manchester for the degree of Doctor of Philosophy

Justification for classification or non-classification

In non-GLP toxicity studies conducted according to standard acute methods, no signs of eye irritation and only minor signs of skin irritation were observed. These results do not lead to classification. Therefore, EGDMA is not classified according to the Annex I to the Directive 67/548/EEC and annex VI of the CLP Regulation (1272 /2008/EC) nor according to UN-GHS. According to annex VI of the CLP regulation (1272/2008/EC) EGDMA is classified as a respiratory irritant (STOT SE cat. 3). The justification for that classification is unknown.