Vegeflux Soy

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive system

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Results

Results 1

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

Results 2

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.