Registration Dossier
Registration Dossier
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EC number: 700-490-2 | CAS number: 36635-56-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[[(4-methylphenyl)sulfonyl]methyl]formamide
- EC Number:
- 700-490-2
- Cas Number:
- 36635-56-0
- Molecular formula:
- C9H11NO3S
- IUPAC Name:
- N-[[(4-methylphenyl)sulfonyl]methyl]formamide
- Details on test material:
- - Name of test material (as cited in study report): CGA 224433 tech.
- Physical state: solid
- Analytical purity: approx 100%
- Lot/batch No.: P. 709027
- Solubility in water: >1% at 20°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye used as control
- Amount / concentration applied:
- 0.1g to conjunctival sac
- Observation period (in vivo):
- 1, 24, 48 & 72 hrs
- Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: removal not commented, observation started from installation and continued from then on.
SCORING SYSTEM:
Opacity:
0 = no ulceration / opacity
1 = slight dulling, details of iris clearly visible
2 = easily discernible translucent area, details of iris slightly obscured
3 = nacrous area, details of iris not visible, size of pupil barely discernible
4 = opaque cornea, iris not visible through opacity
Iris:
0 = normal
1 = markedly deepened rugae, conjestion, swelling, moderate circumcorneal hyperaemia, injection (any of or combination of) iris still reactive to light
2 = no reaction to light, haemorrhage, gross destruction (or any of the above)
Conjunctivae:
0 = blood vessels normal
1 = some vessels definitely hyperaemic
2 = diffuse, crimson colour, individual vessels not easily discernible
3 = diffusy beefy red
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24hrs
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24hrs
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24hrs
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24hrs
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72hrs
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions CGA 224433 tech. induced irritation of the cornea, iris and conjunctiva when instilled into the corneal sac of albino rabbits.
In only one animal, reactions reached significance and the redness of conjunctival irritation was not fully reversible until the final test day at 21 days. - Executive summary:
Testing was performed to determine the acute eye irritation/corrosion potential of CGA 224433 tech. on albino rabbit eye.
Although the results show that readings reached the threshold of significance and irritation was not fully reversible until the final test day, as this was observed in only one out of three tested animals, then according to EC Directive No 83/467/1983, CGA 224433 tech. can be classified as non-irritant to albino rabbit eye.
Therefore no hazard symbol or warning should be assigned.
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