Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TOXICOOP LTD.
- Age at study initiation: 7 weeks old
- Weight at study initiation: 216 - 262 g
- Fasting period before study: 24 hours
- Housing: 3 animas/cage type MAKROLON II; laboratory bedding
- Diet (e.g. ad libitum): ad libitum (exept after test item administration for 3 hours)
- Water (e.g. ad libitum): tap water ad libitum in MAKROLON type drinking bottles
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -24.9 ºC
- Humidity (%): 32.8-65.8 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % aquesous MC (methylcellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 g/ 5ml and 3 g/30 ml
- Amount of vehicle (if gavage): 20 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
200 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
3 male /3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 6 hours after the treatment, and thereafter twice a day.
weighing: before treatment (1st day), on the 8th day, on the 14th day
- Necropsy of survivors performed: yes/no yes (macroscopic)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
in the normal range

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU