Registration Dossier
Registration Dossier
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EC number: 701-305-8 | CAS number: -
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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 83/467/EEC.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pitch, coal tar, high-temp.
- EC Number:
- 266-028-2
- EC Name:
- Pitch, coal tar, high-temp.
- Cas Number:
- 65996-93-2
- Molecular formula:
- not applicable
- IUPAC Name:
- Pitch, coal tar, high-temp.
- Test material form:
- solid: particulate/powder
- Details on test material:
- Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Substance type: organic
Constituent 1
- Specific details on test material used for the study:
- Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Physical state: solid, black powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremerförde/Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: cage, single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2 °C
- Humidity (%): 50 - 86 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
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 mg - Observation period (in vivo):
- 1, 24, 48, and 72 h post-application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, eye not rinsed
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein after 24 and 72 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- No irritation effects after 24 h (scores 0)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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