Registration Dossier
Registration Dossier
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EC number: 616-307-3 | CAS number: 76205-19-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 616-307-3
- EC Number:
- 616-307-3
- Cas Number:
- 76205-19-1
- Molecular formula:
- C9 H7 Cl N2 O
- IUPAC Name:
- 616-307-3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): pyrazolon
- Physical state: crystalline powder, light-beige
- Analytical purity: 100.5 g/100 g (H-NMR and IR spectroscopy)
- Storage condition of test material: room temperature, exclusion of light
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: animal 1: White New Zealand; animal 2 and 3: HSDIF: NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Federal Republic of Germany (animal 1), Harlan-Winkelmann GmbH (Interfauna, United Kingdom) (animals 2 and 3)
- Age at study initiation: young adults
- Weight at study initiation: 3.77 kg (animal 1), 3.57 kg (animal 2), 3.17 kg (animal 3)
- Housing: single housing, sainless steel wire mesh cages with grating
- Diet (e.g. ad libitum): about 130g/animal/day (Kliba labor diet 341, regularly assayed for chemical and microbiological contaminants)
- Water (e.g. ad libitum): about 250 ml/animal/day (tap water, regularly assayed for chemical contaminants)
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C (there were no deviations from these ranges which influenced the results of the study)
- Humidity (%): 30-70% (there were no deviations from these ranges which influenced the results of the study)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 72 mg of the comminuted test substance)
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was washed with tap water
- Time after start of exposure: 24 hours (before 24 h reading)
SCORING SYSTEM:
readings at 1h, 24h, 48h, and 72 h after application (scoring according to OECD 405)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Table1: Irritant response data for each individual animal at each observation time as well as calculation of the means
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Chemosis |
1h |
1 |
0 |
0 |
2 |
1 |
2 |
0 |
0 |
1 |
1 |
|
3 |
0 |
0 |
1 |
1 |
|
24h |
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
48h |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
72h |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
Mean |
1 |
0.0 |
0.0 |
0.3 |
0.0 |
2 |
0.0 |
0.0 |
0.7 |
0.0 |
|
3 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Mean |
0.0 |
0.0 |
0.3 |
0.0 |
For calculation of the means of corneal opacitiy, iris, redness and swelling of the conjuntiva only the readings of 24, 48 and 72 hours are used.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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