Registration Dossier
Registration Dossier
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EC number: 204-624-6 | CAS number: 123-39-7
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: 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:
- 1 988
- 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:
- 1 989
- Bibliographic source:
- Fd Chem Toxic 27: 255-258
- Reference Type:
- publication
- Title:
- OECD eye irritation tests on two formamides
- Author:
- Jacobs GA
- Year:
- 1 992
- 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
- 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%
Constituent 1
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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