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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Venpure SF Powder
- Physical state: solid, powder
- Analytical purity: 99.2%
- Lot/batch No.: 1686951
- Expiration date of the lot/batch: June 12, 2008
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc, Boyertown, Pennsylvania, USA
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 196-229 g
- Fasting period before study: overnight
- Housing: one/cage in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina rodent chow #5012
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13-20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 deg C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light


IN-LIFE DATES: From: July 11, 2005 To: July 25, 2005

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: mineral oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% w/w suspension




Doses:
32 and 100 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing or until death occurred.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
56.57 mg/kg bw
95% CL:
ca. 32 - ca. 100
Mortality:
All animals survived at 32 mg/kg.
All animals at 100 mg/kg died within three hours of administration.
Clinical signs:
No effects at 32 mg/kg.
Incidence of hypoactivity, hunched posture, piloerection were observed prior to death at 100 mg/kg.
Body weight:
No effects
Gross pathology:
No gross abnormalities were observed at 32 mg/kg.
At 100 mg/kg, intestines were extremely red.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 was determined to be 56.57 mg/kg.