Registration Dossier
Registration Dossier
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EC number: 268-692-9 | CAS number: 68133-60-8
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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-benzyl-3-carboxylatopyridinium sodium chloride
- EC Number:
- 268-692-9
- EC Name:
- 1-benzyl-3-carboxylatopyridinium sodium chloride
- Cas Number:
- 68133-60-8
- Molecular formula:
- C13H12NO2.Cl.Na
- IUPAC Name:
- 1-benzyl-3-carboxylatopyridinium sodium chloride
- Details on test material:
- - Name of test material (as cited in study report): LUGALVAN BPC dry
- Physical state: solid
- Analytical purity: 95.5 area-%
- Lot/batch No.: 467602
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 3 months
- Weight at study initiation: 3.37kg – 3.63 kg
- Housing: single housing
- Diet: STANRAB (P) SQC ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ±3°C
- Humidity (%): 30-70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe; reading were done after 1, 24, 48 and 72 h
SCORING SYSTEM: according to OECD 405 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: The mean individual scores of the animals were: 0.7 in 3/3 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: The mean individual scores of the animals were: 0 in 2/3 animals, 0.3 in 1/3 animals
Any other information on results incl. tables
Slight conjunctival redness (grade 1) was noted in two out of three animals 1 hour after application and persisted until hour 48 in these animals. The third animal showed obvious conjunctival redness (grade 2) 1 hour after application, which decreased to slight conjunctival redness at hour 24 and 48.
Slight conjunctival chemosis (grade 1) was noted in one out of three animals 24 hours after application only.
Slight discharge (grade 1) was noted in all animals 1 hour after application and persisted in one animal up to 24 hours after application.
Additional findings like injected scleral vessels in a circumscribed area were noted in all animals at hour 1 after application and persisted in one animal each until 24 or 48, respectively.
The ocular reactions were reversible in all animals within 72 hours after application.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.7, 0.7 and 0.7 for redness of the conjunctiva and 0.3, 0.0 and 0.0 for chemosis.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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