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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:
1994-01-20 to 1994-02-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
modified according to the acute toxic class method
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: WISTAR / CHBB: THOM (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach, D
- Age at study initiation: young adult
- Weight at study initiation: 150 - 300 g (+-20% of the mean weight)
- Fasting period before study: at least 16 h
- Housing: single
- Diet: Kliba Labordiaet 343, Klingenthalmuehle AG, Kauseraugst, CH
- Water: municipal drinking water, regularly assayed
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): yes (undefined)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- olive oil DAB10
- Concentration in vehicle: 10 g/ 100 mL
- Justification for choice of vehicle: poor solubility of the test substance in water
Doses:
2000 mg/kg bw
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: several times on the day of administration, at least once each workday
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality observed.
Clinical signs:
males: no abnormalities.
females: impaired or poor general state, dyspnoea, apathy, staggering, tremor, piloerection; reversible within at least 2 day.
Body weight:
The expected body weight was observed.
mean males: day 0: 189 g; day 7: 255 g; day 13: 286 g
mean females: day 0: 180 g; day 7: 198 g; day 13: 210 g
Gross pathology:
no pathological findings observed.

Applicant's summary and conclusion