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Toxicological information

Eye irritation

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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:
2013
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

Constituent 1
Chemical structure
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.

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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