Registration Dossier
Registration Dossier
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EC number: 276-657-4 | CAS number: 72428-99-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with 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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)
- EC Number:
- 276-657-4
- EC Name:
- Hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)
- Cas Number:
- 72428-99-0
- Molecular formula:
- C32H13CuN8O4S2.(SO3H)m.(C4H11NO)n.(C8H18N) (3-m-n).C15H17N3
- IUPAC Name:
- hydrogen [[[(2-ethylhexyl)amino]sulphonyl][[(3-methoxypropyl)amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with N,N'-di(o-tolyl)guanidine (1:1)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 10 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: caged individually in stainless steel cages, with automatic drinking water supply and cleaning system
- Diet: pelleted standard Kliba 341, rabbit maintenance diet(ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2
- Humidity (%): 55+-10
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye was taken for control
- Amount / concentration applied:
- 0.1 g of the substance was placed into the conjunctival sac of the left eye of each animal after gently pulling the lower lids from the eye ball
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- SCORING SYSTEM:
cornea. 0 - 4
iris: 0 - 2
conjunctivae: 0 - 3
chemosis: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #888, #889, #890 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- iris score
- Basis:
- animal: #888, #889, #890 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #888
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- other: initial slight signs of irritation were fully reversible within 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #889
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: initial slight signs of irritation were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #890
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- other: initial slight signs of irritation were fully reversible within 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #888, #889, #890
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this experiment the substance was found to cause no irritation when applied to the rabbit eye mucosa
- Executive summary:
The substance was tested for eye irritation according to OECD guideline 405. 0.1 g of the test substance was placed into the conjunctival sac of the left eye of each animal (1 male and 2 female New Zealand White rabbits). After 1and 24 hours, initial symptoms could be seen for conjunctivae redness but they disappeared after 48 hour.
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