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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive system
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: animal hous SGS Life Science Services
- Age at study initiation: data not available
- Weight at study initiation: 2 - 2.5 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: 19.9 - 22.4 °C
- Humidity: 60 - 64%
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available

IN-LIFE DATES: from 14 March to 28 March 2008

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the right untreated side was kept as control area
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Initial test (1 animal): 3 minutes, 1 hour, 4 hours
Confirmatory test (2 animals): 4 hours
Observation period:
72 hours
Number of animals:
Initial test: 1 animal (male)
Confirmatory test: 2 animals (male)
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- % coverage: data not available
- Type of wrap if used: gauze patch, hold in place using occlusive gauze bandage and tape

REMOVAL OF TEST SUBSTANCE
- Washing: after exposure the exposure sites were wiped with sterilized cotton soaked in distilled water
- Time after start of exposure: 3 min, 1 or 4 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
no effect observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
no effect observed
Irritant / corrosive response data:
all the scores observed in each animal were 0 (no effect observed)

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 skin in rabbit according to this test
Executive summary:

In a primary dermal irritation study (Thanikaivel V, 2008), New Zealand White rabbits (3 males) were dermally exposed to 0.5 mL of undiluted Vegeflux soy for 4 hours to ca. 6 cm2 (occlusive test system). Animals then were observed for 3 days. Irritation was scored by the method of Draize.

 

No sign of irritation was observed during the 72-hour exposure period:

-        mean erythema score (24, 48, 72 h) = 0

-        mean edema score (24, 48, 72 h) = 0

 In this study, Vegeflux soy is not a dermal irritant. It is not classified according to EU criteria.