Registration Dossier

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:
2009
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

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.