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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:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, pre-GLP but in compliance with OECD GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize protocol, published in J. Officiel de la Rep. Francaise, 21 Feb 1982
GLP compliance:
no
Remarks:
pre-GLP, but in compliance with OECD GLP principles

Test material

Constituent 1
Reference substance name:
N-(hydroxymethyl) methacrylamide
IUPAC Name:
N-(hydroxymethyl) methacrylamide
Constituent 2
Chemical structure
Reference substance name:
N-(hydroxymethyl)methacrylamide
EC Number:
213-086-1
EC Name:
N-(hydroxymethyl)methacrylamide
Cas Number:
923-02-4
Molecular formula:
C5H9NO2
IUPAC Name:
N-(hydroxymethyl)-2-methylprop-2-enamide
Details on test material:
Approx. 60 % aqueous solution, density = 1.10

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nottingham Univ., School of Agriculture, Sutton Bonington, Leics., England
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: mean value 22.73 - 3.04 kg
- Housing: single housing
- Diet: ad libitum, Rabbit Diet, A.W. Tindall Ltd., Holbeach, Lincolnshire, England
- Water: ad libitum, tap water
- Acclimation period: 5 days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±4°C
- Humidity (%): 53 - 60 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted, 0.5 ml
Duration of treatment / exposure:
24 hrs, thereafter removal of the test material
Observation period:
24h and 72h post application
Number of animals:
6
Details on study design:
SCORING SYSTEM according to Draize, 1959:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.33
Max. score:
4
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:
0.17
Max. score:
4
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Any other information on results incl. tables

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

 1

 0

 0

 0

 animal 3

 0

 0

 0

 0

 animal 4

 0

 0

 0

 0

 animal 5

 1

 0

 0

 0

 animal 6

 1

 0

 1

 0

 average (single scores: animal 1-6)

 0.66

 0

 0.33

 0

 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

 0,17

 

 

 

 

 

 

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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
N-methylol methacrylamide (approx. 60 % aqueous solution) was slightly irritating after 24 hours in a primary skin irritation study with rabbits (24/72-hour application, removal of the
test substance after 24 hours). The substance is very slightly irritating, but the effect is fully reversible after 72 hours. The classification according EU and GHS criteria is "not irritating".
Executive summary:

In a primary dermal irritation study, New Zealand White rabbits were dermally exposed (occluded, intact and scarified skin) to 0.5 ml N-methylol methacrylamide (approx. 60 % aqueous solution) for 24 hours. Thereafter, the test material was removed.

 

Animals then were observed up to 72 hours. Irritation was scored by the method of Draize et al, 1959.

The mean erythema score  was determined to be 0.33 out of 4 and the mean oedema score 0.17 out of 4

(average value of  the single scores animals no. 1-6, intact skin, 24h and 72h). 

The slightly irritating effects occurred only after 24 hours and were fully reversible after 72 hours.

Therefore, the test substance has to be classified - according to EU-GHS classification 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 re-evaluated according to OECD criteria and test scores  (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

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