N-(hydroxymethyl)methacrylamide

Eye irritation

Administrative data

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: Comparable to guideline study. Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize protocol, published in J. Officiel de la Rep. Francaise, 21 April 1971 and 5 June 1973

Principles of method if other than guideline:

Method: according to The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Draize J. H. 1959

GLP compliance:

no

Remarks:

pre-GLP, but in compliance with OECD GLP principles

Test material

Test material information

Constituent 1

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-methylacrylamide

Test material form:

other: liquid

Details on test material:

Approx. 60 % aqueous solution, density = 1.10

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits Ltd., Lea Valley, Essex
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.13 - 2.53 kg
- Housing: single housing
- Diet: ad libitum, Rabbit diet, A.W. Tindall Ltd, Holbeach, Lincolnshire
- Water: Tap water, ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 4.5 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): approx. 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

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:

single treatment, unrinsed

Observation period (in vivo):

up to 7 days after treatment

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Score:

8.3

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

other: maximum individual score

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

other: maximum individual score

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

Classification of eye irritation according EU-GHS-criteria: none

 

 

 

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	2 1	1 1	1 0	1.33  0.66	0 0	-
3, 4	2 2	2 2	1 1	1.66 1.66	0 0	-
5, 6	1 1	1 1	0 1	0.66 1	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	1 1	1 1	0 0	0.66 0	0 0	-
3, 4	2 2	2 2	1 1	1.66 1.66	0 0	-
5, 6	1 1	1 0	0 0	0.66 0.33	0 0	-
							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

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 in an eye irritation study with rabbits. Effects observed were redness and chemosis of the conjunctiva which were fully reversible after 7 days. The classification according EU and GHS criteria is "not irritating".

Executive summary:

In an eye irritation study according to Journal Officiel de la Republique,White rabbits were exposed to 0.1 ml N-methylol methacrylamide (approx. 60 % aqueous solution). 

Animals then were observed up to 7 days. Irritation was scored by the method of Draize et al, 1959.

Redness and Chemosis of slight to moderate grade was observed. The effects decreased after 3 days and were fully reversible after 7 days.

There was no evidence for corneal opacity or iritis.

 

Therefore, the test substance has to be classified - according to EU-GHS classification criteria - as non irritant to eyes (EU-GHS-hazard category: none).

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