Registration Dossier
Registration Dossier
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EC number: 268-387-0 | CAS number: 68083-38-5
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:
- guideline study with acceptable restrictions
- Remarks:
- Study conducted prior to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Juli 1983
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- m-(4,5-dihydro-5-imino-3-methyl-1H-pyrazol-1-yl)benzenesulphonic acid
- EC Number:
- 268-387-0
- EC Name:
- m-(4,5-dihydro-5-imino-3-methyl-1H-pyrazol-1-yl)benzenesulphonic acid
- Cas Number:
- 68083-38-5
- Molecular formula:
- C10H11N3O3S
- IUPAC Name:
- 3-(5-imino-3-methyl-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill, Ltd., Huntingdon, England
- Weight at study initiation: 3.02 - 3.47 kg
- Housing: in individual cages
- Diet (e.g. ad libitum): Ssniff K Pellets, ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 40-60 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h / 12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 d (1h, 24h, 48h, 72h and 7 days)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was washed with physiological NaCl solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize-grading
TOOL USED TO ASSESS SCORE: optical aids (cornea and iris), fluorescein (cornea- affected area after 24h observation)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h-7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h-7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 1h-7d
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52
- Time point:
- other: 1h-7d
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 53
- Time point:
- other: 1h-7d
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 54
- Time point:
- other: 1h-7d
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- Test item is not irritating to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted according to OECD guideline 405 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the eye irritating properties of the test substance in rabbits. The substance has been determined to be not irritating to the eye.
- Executive summary:
In a primary eye irritation study (OECD guideline 405), female rabbits (three animals, New Zealand White) were exposed to 100 µL of test substance (undiluted). Animals then were observed for 7 days; irritation was scored by the method of Draize. The substance has been determined to be not irritating to the eye.
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