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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
Study period:
August - October 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed in compliance with test guidelines in compliance with GLP, performed on Gistex which has a comparable composition on salt free dry matter

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Cream coloured powder
Batch FM 8850-03
protein content: 68.9%
carbohydrates: 5.1%
ash content: 12.1%
Lipids: 0.51%

Test animals

Species:
mouse
Strain:
other: Swiss outbred (Crl:CD1)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, F.R. Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: Males: 32-35 g; Females: 24-28 g
- Fasting period before study: not applicable
- Housing: Makrolon cages with a bedding of dustfree woodshavings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity(%): 40-70%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: August 22,1989 To: September 22, 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 ml/kg bodyweight
- Justification for choice of vehicle: not provided
- Lot/batch no. (if required): FM 8850-03
- Purity: not provided
MAXIMUM DOSE VOLUME APPLIED: 0.35 ml
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: recommended for limit test
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently observed for signs of intoxication during the first 4 post-treatment hours, and at least once daily, thereafter. Individual body weights were recorded on day 0, 3, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occured
Clinical signs:
signs of intoxication were not observed after treatment
Body weight:
All animals gained weight during the observation period
Gross pathology:
No treatment-related gross alterations were seen
Other findings:
- Organ weights: not determined
- Histopathology: not performed
- Potential target organs: not identified
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance Gistex is not harmful if swallowed, under the conditions of this study and according to the EEC standards (EEC directive 83/467/EEC published in the Official Journal of European Communities, L257, volume 26, 16 September 1983)