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Diss Factsheets

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
Study period:
05 February 1990 - 09 February 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: GLP, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
Qualifier:
according to guideline
Guideline:
other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agenct, (FIFRA) Title 40 Code of Federal Regulations Part 160, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Health and Welfare Notification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amendment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of International Trade and Industry, Directive 31 March 1984
Qualifier:
according to guideline
Guideline:
other: OECD ISBN 92-64-12367-9, Paris 1982
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-isopropylacrylamide
EC Number:
218-638-5
EC Name:
N-isopropylacrylamide
Cas Number:
2210-25-5
Molecular formula:
C6H11NO
IUPAC Name:
N-isopropylacrylamide
Test material form:
solid: particulate/powder
Details on test material:
Storage: 4 °C in the dark
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 13 weeks
- Weight at study initiation: 2965 g
- Housing: individually housed in metal cage with a perforated floor
- Diet (e.g. ad libitum): free acess to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 19 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (07:00-19:00)

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
75 mg of isopropyl acrylamide
Observation period (in vivo):
Examination of eyes was made after 1 hour and 1, 2, 3 and 4 days after instalation
Number of animals or in vitro replicates:
1 rabbit
Details on study design:
SCORING SYSTEM:
Cornea
Opticity: degree of density
- no ulceration or opacity 0
- scattered or difuse areas of apacity 1
- easily discernible translucent areas, details of iris slightly obscured 2
- narcous areas, no details of iris visible, size of pupil barely discerrnible 3
- opaque cornea, iris not discernible through the opacity

Iris
- normal 0
- markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting light 1
- no reaction to light, haemorrhage, gross destruction 2

Conjunctivae
Redness
- blood vessels normal 0
- some blood vessels definitely hyperaemic 1
- diffuse, crimson colour, individual vessels not easely discernible 2
- diffuse, beefy red 3

Chemosis
- no swelling 0
- any swelling above normal 1
- obvious swelling with partial eversion of lids 2
- swelling with lids about half-closed 3
- swelling with lids more than half-closed 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 96 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 96 hours
Remarks on result:
other: A positive result in the one animal the study was terminated on humane grounds
Irritant / corrosive response data:
There was no indication of reversibility of irritation up to 96 hours

Any other information on results incl. tables

The one treated animal gave a positive response.

A corneal opacity was observed 24 hours after instillation and persisted for the duration of the observation period.

Iridial inflammation was present two to four days following instillation.

A diffuse crimson-red colouration of the conjunctivae accompanied by obvious swelling with partial eversion of the eyelids and a copious discharge were observed.

Due to the severity of the ocular response only one animal was exposed to isopropyl acrylamide and the study was terminated on humane grounds four days after instillation.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Instillation of Isopropyl acrylamide intothe rabbit eye elicited a posistive response in the one treated animal according to T.S.C.A test criteria.
There is no justiication for exposing further animals.
Executive summary:

·        Effects were irreversible after 4 days of observation.

·        Study was terminated on humane grounds four days after instillation

·        Based on the irreversible effects, the severity of the ocular response in one rabbit and that the study was terminated after testing in one rabbit on humane grounds it can be concluded that the substance is classified as “Causes serious Eye damage Category 1”.