Registration Dossier
Registration Dossier
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EC number: 279-767-0 | CAS number: 81457-65-0
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:
- other: comparable to guideline study with acceptable restrictions (no details on test animals, 7-day observation period; purity not specified; non GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Fed. Reg. 38 No. 187 § 1500.42
- Deviations:
- yes
- Remarks:
- eyes of 3 animals were rinsed 30 s after treatment, eyes of other 3 treated animals not; no details on test animals, 7-day observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.
- EC Number:
- 279-767-0
- EC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.
- Cas Number:
- 81457-65-0
- Molecular formula:
- Unspecified
- IUPAC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.
- Details on test material:
- - Lot/batch No.: 8538/71
No additional details provided
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
The substance was tested on 6 rabbits (3 males/3 females); only rabbits showing normal ophthalmic findings were included in the test.
- Housing: individually in V2A wire cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rabbit food; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
No additional details provided
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- continuously (3 animals without rinsing) or 30 second (3 animals with rinsing)
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 3 without rinsing and 3 with rinsing
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes of 3 rabbits were each rinsed with 10 ml lukewarm water
- Time after start of exposure: about 30 seconds after treatment
SCORING SYSTEM: comparable to the OECD scoring system after 24, 48, 72 and 96 hours, and after 7 days.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation was observed (with or without washing). It therefore can be assumed that the test substance is not irritating to the rabbit eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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