N-[3-(dimethylamino)propyl]methacrylamide

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]methacrylamide

EC Number:

226-002-3

EC Name:

N-[3-(dimethylamino)propyl]methacrylamide

Cas Number:

5205-93-6

Molecular formula:

C9H18N2O

IUPAC Name:

N-[3-(dimethylamino)propyl]-2-methylacrylamide

Test material form:

liquid

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

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system 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

Test system

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)

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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

Results 13

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

Results 14

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

Results 15

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

Results 16

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

Results 17

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

Results 18

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

Results 19

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

Results 20

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

Results 21

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

Results 22

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

Results 23

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

Results 24

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

Results 25

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

Results 26

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

Any other information on results incl. tables

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)

Applicant's summary and conclusion

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.