Registration Dossier

Administrative data

Description of key information

As a precautionary measure it is assumed that N-[3-Dimethylamino)propyl]methacrylamide may be a skin irritant. 
N-[3-Dimethylamino)propyl]methacrylamide was demonstrated to be corrosive to eyes.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Range-finding study, test procedure in accordance with national standard method (US FHSA prodedure) with acceptable restrictions. 24 h exposure, observation period only 72 h
Qualifier:
according to
Guideline:
other: according to Federal Hazardous Substances Act (FHSA) procedure
Principles of method if other than guideline:
FHSA PRIMARY SKIN IRRITATION/CORROSION

This study is designed to show the degree of skin irritation caused by the test article under evaluation. Six rabbits were used in the test. Twenty
four hours prior to dosing, the hair on each animal's back was removed with clippers. One inch square pieces of the test article were cut and
applied to intact and abraded areas on the skin of each animal. The squares of test article were held in place with surgical tape. To protect the
dosing sites and to promote occlusion, the trunks of each animal were wrapped with gauze, which was held in place with tape. The gauze was then wrapped with an elastic bandage.
After 24 hours, the animals were unwrapped and the article removed. The test sites were observed and scored 24 and 72 hours after dosing. Based on the scores, a Primary Irritation Index was calculated in order to evaluate the material's potential to be a primary irritant.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethylaminopropyl Methacrylamide
- Molecular weight (if other than submission substance): 170.25 g/mol
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted 3-Dimethylaminopropyl methacrylamide
Duration of treatment / exposure:
24 hours
Observation period:
24h and 72h post application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back of the animals
- coverage: one inch square pieces
- Type of wrap if used:


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after dosing


SCORING SYSTEM: Draize J.H. et al. (1944) (original values)
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
intact and abraded skin; evaluation of erythema and edema
Basis:
mean
Remarks:
Draize score (Draize J.H. et al. 1944)
Time point:
other: 24 and 72 hours
Score:
4.3
Max. score:
8
Reversibility:
no data
Remarks:
structure of tissue not destroyed or changed irreversibly in 24 hours. No formation of edema (intact skin).
Remarks on result:
other: Original data, evaluation according to Draize et al., 1944
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
intact skin; evaluation of erythema and edema
Basis:
mean
Remarks:
reevaluation according to GHS-criteria
Time point:
other: 24 and 72 hours
Score:
2.8
Max. score:
8
Reversibility:
no data
Remarks:
structure of tissue not destroyed or changed irreversibly in 24 hours. No formation of edema (intact skin).
Remarks on result:
other: GHS-category: 2
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact shaved skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
intact shaved skin, no scoring at 48 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
intact shaved skin, no scoring at 48 h

Skin irritation scores (original data)

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

Erythema (animals 1 -6)

Edema (animals 1 -6)

Max. score: 4

Max. score: 4

24 h intact skin

24 h scarified skin

4/4/3/3/3/3

4/4/3/3/3/3

0/0/0/0/0/0

2/3/3/3/3/3

72 h intact skin

72 h scarified skin

 3/3/2/2/2/2

4/4/3/3/3/3

 0/0/0/0/0/0

2/3/2/2/2/2

Average 24h, 72h intact skin

Average 24h, 72h scarified skin

2.8

3.3

0

2.5

Average 24h, 72h intact and scarified skin

3.05

1.25

 

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

Erythema/ 24h   

 Erythema/72h

 Oedema/24h

 Oedema/72h

 animal 1

 4

 3

 0

 0

 animal 2

 4

 3

 0

 0

 animal 3

 3

 2

 0

 0

 animal 4

 3

 2

 0

 0

 animal 5

 3

 2

 0

 0

 animal 6

 3

 2

 0

 0

 average (single scores: animal 1-6)

3.3

 2.3

 0

 0

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

 2.8

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

 0

 

 For evaluation according to GHS classification system (mean value):

 2.8

 Cat.2 (skin irritating)

 

 

Interpretation of results:
Category 2 (irritant)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
N-Dimethylaminopropylmethacrylamide is slightly irritating according to the Draize et al. (1944) scoring system.
The reevaluation of the study results according to GHS-criteria reveal to GHS-category: 2 for N-Dimethylaminopropylmethacryamide. Therefore
N-Dimethylaminopropylmethacrylamide would be classified as skin irritating according to GHS-criteria.
Executive summary:

In a primary dermal irritation study 6 rabbits (strain: no data, sex: no data) were dermally exposed via a covered patch (FHSA-procedure) to 0.5 ml undiluted (intact and abraded skin) Dimethylaminopropyl Methacrylamide (purity: >=98%) for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al. 1944.

In this study, Dimethylaminopropyl Methacrylamide is not a dermal irritant as primary irritation score of 4.3 out of 8 is less than 5.0 evaluation

according to Draize et al., 1944.

No formation of edema (intact skin, mean primary irritation index: 0). It is slightly irritating to the skin based on scoring according to Draize et al., 1944. Reevaluation of the study results according to GHS-criteria N-Dimethylaminopropylmethacryamide would be classified as skin irritating, GHS-category: 2. 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:
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Range-finding study, test procedure in accordance with national standard methods with acceptable restrictions.
Guideline:
other: according to Federal Hazardous Substances Act (FHSA) procedure
Principles of method if other than guideline:
In the FHSA test six eyes are exposed, but not rinsed. A fixed dose of 0.1 ml of Dimethylaminopropyl methacrylamide is used. This is placed inside the lower eyelid, which forms a culdesac. Ocular reactions are read either with the unaided eye or a magnifier at 24, 48 and 72 h after exposure. In
the FHSA test, no readings after 72 h are specified. Use of fluorescein after 24-h reading is optional in the FHSA version, but is not mentioned in
the Draize procedure. Readings are recorded as separate scores for lesions of the cornea, iris, and conjunctiva. Serious lesions such as pannus,
phlyctena, or ulceration of the cornea are considered to be off-scale responses that are to be noted separately.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethylaminopropyl Methacrylamide
- Molecular weight (if other than submission substance): 170.25 g/mol
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eyes of the test animals serve as the control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of the test substance


SCORING SYSTEM: Draize J.H. et al. (1944) (original values)
Irritation parameter:
other: Primary irritation index
Basis:
mean
Remarks:
according to Scoring system of Draize et al. 1944
Time point:
24/48/72 h
Score:
66.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: A corrosive-like action to the eye lids of 4 rabbits was determined. The iris could not be viewed because of corneal opacity in 3 of 4 rabbits.
Remarks:
Reversibility scores were not measured after 7 and 21 days.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
60
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
80
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
80
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
80
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
5
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested

Classification of eye irritation studies according GHS-criteria/original values

 

Substance: 3-Dimethylaminopropyl methacrylamide                         DMAPMA                           CAS: 5205-93-6

 

Internal No.: LITSU 96-0160

 

Date/Expert: 06-12-18/Am

 

Evaluation at the end of the table

 

Animal No.

Corneal opacity/Hornhauttrübung[Scores]

 orignal values

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

60 

60 

60 

 

 

 

 

2

80 

80 

80 

 

 

3

80

80 

80 

 

 

 

 

4

80 

80 

80 

 

 

 

 

 

 

 

 

 

 

 

Animal No.

Iritis/Regenbogenhautentzündung[Scores]

original values 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

 5

5

 

 

 

2

0

 0

0

 

 

3

 0

 

 

 

0

 0

 

 

 

 

 

 

 

 

 

 

 

Animal No.

Conjunctiva /Bindehautrötung/ödem[Scores]

original values

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

16

16 

 16

 

 

2

16 

16 

 16

 

 

 

3

16

16

 16

 

 

 

4

16 

16

16 

 

 

 

There was a discernible opacity or ulceration of the cornea during the readings made at 24, 48 or 72 hours. There was an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids.There was destruction or irreversible change at any tissue in 24 hours or less.

The iris could not be viewed because of corneal opacity in 3 of 4 rabbits.

A corrosive-like action to the eye lids of 4 rabbits. Corneal opacity in 3 of 4 rabbits!

 

Classification GHS:

Hazard Category

1

irreversible effects




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:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Dimethylaminopropyl methacrylamide has a corrosive-like action to the eye lids of 4 rabbits. Effects on the iris could not be evaluates in 3 of 4 rabbits due to severe corneal opacity.

Classification: risk of serious damage to eyes, GHS-category: 1, H318, causes serious eye damage
Executive summary:

In a primary eye irritation study, 0.1 mL of Dimethylaminopropyl methacrylamide (purity: >= 98%) was instilled into the conjunctival sac of 4 rabbits (strain, sex, source, age, weight: no data) for 72 hours. The eyes were not washed. Irritation was scored by the method of Draize et al. (1944).

In this study, Dimethylaminopropyl methacrylamide was a strong eye irritant. It was found to have a corrosive-like action to the eye lids of the rabbits and induced changes of the eye which were considered irreversible.

Based in EU and OECD criteria the DMAPMA is considered a category 1 eye irritant with the potential to cause irreversible damage to the eye.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Two independent studies exist with similar experimental design (IBR (International Bio-Research Institute), 1983; Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973). In both cases six rabbits were exposed under occlusive conditions to 0.5 ml of N-[3-Dimethylamino)propyl]methacrylamide on intact and abraded/scarified skin. For the evaluation only the test data with intact skin were taken into account. In both cases the dermal reaction was limited to erythema but the extent of irritation was very different. While in the first study (IBR (International Bio-Research Institute), 1983) only very slight erythema was observed which was completely reversible within 72 h, the other study ( Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973) showed pronounced erythema (3 to 4) which was only partly reversible within the 72 h observation period.

Information available on test material and test design do not provide an explanation for the highly variable test results and in the absence of further information it cannot be excluded that the test material is irritating to skin. As a precautionary measure it is assumed that N-[3-Dimethylamino)propyl]methacrylamide may be a skin irritant.

Eye irritation

In a primary eye irritation study, 0.1 mL of Dimethylaminopropyl methacrylamide (purity: >= 98%) was instilled into the conjunctival sac of 4 rabbits (strain, sex, source, age, weight: no data) for 72 hours. The eyes were not washed. Irritation was scored by the method of Draize et al. (1944).

In this study, Dimethylaminopropyl methacrylamide was a strong eye irritant. It was found to have a corrosive-like action to the eye lids of the rabbits and induced changes to the eye which were considered irreversible.



Justification for selection of skin irritation / corrosion endpoint:
Two independent studies exist with similar experimental design (IBR (International Bio-Research Institute), 1983; Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973). Information available on test material and test design do not provide an explanation for the highly variable test results and in the absence of further information it cannot be excluded that the test material is irritating to skin. As a precautionary measure it is assumed that N-[3-Dimethylamino)propyl]methacrylamide may be a skin irritant.

Justification for selection of eye irritation endpoint:
There is one relevant, adequate and reliable (Klimisch score = 2) study for N-[3-(dimethylamino)propyl]methacrylamide available (Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973). The test was performed in accordance with generally accepted scientific standards and described in
sufficient detail. Guideline study with acceptable restrictions. GLP (no data).

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results of the available studies, N-[3-(dimethylamino)propyl)methacrylamide has to be classified as follows: 67/548/EC: Xi, R38-41 Irritant; Irritating to skin; Risk of serious damage to eyes.

 

Under UN-GHS (2009) and CLP/EU-GHS, EG Regulation No. 1272/2008 DMAPMA has to be classified as follows: Skin irritation cat. 2, H315; Eye damage cat. 1, H318, Causes serious eye damage