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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:
January 2008 - March 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study; the study was conducted on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated December 17'h, 200 land the test method B.I tris of the Directive N° 2004173/EC.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Elevage JANVIER (53940 Le Genest St lsle - France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 189-208 g
- Fasting period before study: food was removed at day 1 and then redistributed 4 hours after the test item administration.
- Housing: Three healthy female rats were kept in solid-bottomed cJear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet (e.g. ad libitum): M20-rat/mouse maintenance (Speciel Diets Service)
- Water (e.g. ad libitum): tap-water from public distribution system
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20°C and 22°C
- Humidity (%): between 36% and 57%
- Air changes (per hr): conventional air conditioning
- Photoperiod (hrs dark / hrs light): lighting time: 12 hours daily

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg bw.
- Amount of vehicle (if gavage): 10 mL/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female rats were treated
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
1. Daily examination: systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet. Observations and a mortality report were then carried out every day for 14 days.
2. Periodical examinations: the animals were weighed on day 0 (D0)(just before administering the test item) then on D2, D7, and D14. Weight changes were calculated and recorded.
3. Examination at the end of the test: on D14, the animals were anaesthetised with sodiun pentobarbital and administration continued to
fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of aeute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic exanimations.

- Necropsy of survivors performed: yes
Statistics:
no data given in the test report

Results and discussion

Preliminary study:
no preliminary study was conducted
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item is > 5,000 mg/kg body weight by oral route in the rat
Executive summary:

The test item was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2,000 mg/kg body weight.

No mortality occurred during the study.

No clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50of the test item is > 5,000 mg/kg body weight by oral route in the rat.