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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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

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.