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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: Equivalent to Guideline study with acceptable limitations (screening of 34 substances; documentation of results not sufficient).

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Evaluation of the In vitro uridine uptake inhibition assay in comparison with the In vivo eye irritation test as prescribed by the EEC
Author:
Jacobs GA, Dierickx PJ, & Martens MA
Year:
1988
Bibliographic source:
ATLA 15: 290-296
Reference Type:
publication
Title:
An objective method for the evaluation of eye irritantion in vivo
Author:
Jacobs GA & Martens MA
Year:
1989
Bibliographic source:
Fd Chem Toxic 27: 255-258
Reference Type:
publication
Title:
OECD eye irritation tests on two formamides
Author:
Jacobs GA
Year:
1992
Bibliographic source:
Acute Toxic. Data 1: 187-188

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
according to Annex V, part B of Directive 79/831/EEC of the European Community
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-methylformamide
EC Number:
204-624-6
EC Name:
N-methylformamide
Cas Number:
123-39-7
Molecular formula:
C2H5NO
IUPAC Name:
N-methylformamide
Details on test material:
Purity 99%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no details

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
no washing
Observation period (in vivo):
scoring 4, 24, 48, 72, 96 and 168 h after instillation
Number of animals or in vitro replicates:
6
Details on study design:
The eyes of each animal examined by means of sodium fluorescein 72 hours before testing; only eyes showing no lesions selected for testing.
100 µl of the undiluted test substance placed into one healthy eye of each animal by gently pulling the lower lid away from the eyeball; the lids were then gently held together for one second and the animal was replaced in its cage. The other, untreated, eye served as a control.
Grade of ocular reaction was recorded at 4, 24, 48, 72, 96 and 168 hours. Erythema, chemosis, iritis and corneal opacity were scored according to the Draize scores (1944). Means calculated from scores of 6 animals for 3 observation times (24, 48, 72 h).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.61
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: standard deviation 0.16
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0.23
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
2.13
Max. score:
3
Reversibility:
not fully reversible within: 4 days
Remarks on result:
other: standard deviation 0.09
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
Mean percentage corneal swelling: 34% (n=3).

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

Guideline study but limited documentation (screening of 34 substances; mean scores over time and 6 animals).

Six New Zealand White were treated with instillation of 100 µl undiluted test substance into the conjunctival sac. Scorring was performed 4, 24, 48, 72, 96 and 168 h after instillation (no washing). Means were calculated from scores of 6 animals for 3 observation times (24, 48, 72 h): corneal opacity 0.61, iritis 0.23, erythema 2.13, chemosis 0.83; the mean percentage of corneal swelling was 34% (n=3). Corenal, iris and chemosis effects were reversible within max. 4 days.

Conclusion: Due to the mean scores over 6 animals, the substances is considered to be irritating to the eye.

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