Registration Dossier
Registration Dossier
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EC number: 947-892-6 | 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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulations
Test material
- Reference substance name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- EC Number:
- 307-259-1
- EC Name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- Cas Number:
- 97592-62-6
- Molecular formula:
- not available
- IUPAC Name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name as used in study report: FAT 60149/A
- Batch No.; Versuch 124 - 4 + 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgau, Germany and MADOERIN AG, 4414 Fülllinsdorf, Switzerland
- Age at study initiation: adult
- Weight at study initiation: 2 to 3 kg
- Housing: individual in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- - In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals (3 male, 3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: In 3 animals
- Time after start of exposure: In 3 animals 30 seconds after insertion of the test substance
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: results from unrinsed eyes
- Irritant / corrosive response data:
- Rinsing the eyes following instillation was of no effect.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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