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Toxicological information

Eye irritation

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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

Constituent 1
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
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

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Score:
8.3
Max. score:
110
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
other: maximum individual score
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
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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