Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
study completion date: 02 MAY 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is 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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

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:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Animal House, SGS Life Science Services
- Age at study initiation: data not available
- Weight at study initiation: 202 - 290 g
- Fasting period before study: data not available
- Housing: animals were housed individually in Standard polypropylene cages with stainless steel top grill
- Diet: rat pellet feed (Amrut brand), ad libitum
- Water: potable water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20.0 - 21.4 °C
- Humidity: 60 - 65%
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available

IN-LIFE DATES: from 02-APR-2008 to 16-APR-2008

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 10% dorsal skin area of each rat was clipped free of hair without any abrasion 24h before the test
- % coverage: 10%
- Type of wrap if used: porous gauze dressing and non irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: the residual test item was wiped gently from the skin using cotton soaked with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Concentration: undiluted
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
- Range-finding test: 1 male and 1 female
- Limit test: 5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> body weight: body weight of each animal was recorded just prior to application of dose (day 0) and on days 7 and 14 following the dosing
> mortality: all animals were observed for mortality daily throughout the observation period
> toxicity signs: all animals were observed for clinical signs of toxicity soon after dosing and once daily throughout the observation period until day 14
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Preliminary study:
mortality was not observed at 2000 mg/kg bw in the range-finding study
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality observed
Mortality:
No mortality was observed in animals treated with the test item throughout the observation period.
Clinical signs:
No clinical signs of toxicity were observed in animals treated with the test item throughout the observation period.
Body weight:
All the animals showed a normal trend of body weight gain on days 7 and 14.
Gross pathology:
The lesions observed i nthis study matched with the historical gross pathology data. Hence the lesions cannot be related to the test item.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Vegeflux Soy is > 2000 mg/kg bw by dermal application
Executive summary:

In an acute dermal toxicity study (Venkatasubramani R, 2008), groups of Wistar rats (5/sex) were dermally exposed to Vegeflux soy undiluted for 24 hours to 10% of body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days. The test was performed according to OECD guideline 402 and GLP.

 

Dermal LD50 (Males & Females) > 2000 mg/kg bw (limit test)

No mortality, clinical signs, body weight changes or gross pathology changes were observed during the observation period.

 

Vegeflux Soy is of low toxicity based on the LD50 in males and females by dermal application. Vegeflux soy is not classified as dangerous according to EU criteria, by dermal application.