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EC number: 483-980-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- End on 02 MAY 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Vegeflux soy
- Substance type: UVCB
- Physical state: viscous liquid
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: animal house, SGS Life Science Services
- Age at study initiation: data not available
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: animals were housed individually in stainless steel rabbit cages
- Diet: rabbit pellet feed (Amrut brand), ad libitum
- Water: potable water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20.0 - 21.9 °C
- Humidity: 60 - 65 %
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available
IN-LIFE DATES: from 24 MARCH 2008 to 30 MARCH 2008
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye, which remains untreated, serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 0.1 mL of the test item was directly applied into the conjunctival sac of the left eye of the rabbits by gently pulling the lower lid. The eyelid was held for approximately 1 second after instillation.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after test item instillation
- Number of animals or in vitro replicates:
- initial test: 1 animal (female)
confirmatory test: 2 animals (female) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: data not available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no effect observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no effect observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- no effect observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no effect observed
- Irritant / corrosive response data:
- In each animal, all the scores were equal to 0 at 1, 24, 48 and 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Vegeflux soy is not irritating to the eye in rabbit according to this test
- Executive summary:
In a primary eye irritation study (Thanikaivel V, 2008), 0.1 mL of undiluted Vegeflux Soy was instilled into the conjunctival sac of the left eye of three New Zealand White rabbits (female). The eyes were then observed at 1, 24, 48 and 72 hours after instillation. Irritation was scored by the method of Draize.
No effect was observed during the observation period; all the scores (cornea, iris, conjunctivae, chemosis) were equal to zero.
In this study, Vegeflux Soy is not an eye irritant in the rabbit. Vegeflux soy is not classified according to EU criteria.
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