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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 7 to October 22, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

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

Test material

Constituent 1
Details on test material:
- Physical state: white solid
- Analytical purity: 99%
- Lot/batch No.: 08-018
- Expiration date of the lot/batch: July 26, 2013
- Storage condition of test material: room temperature (permissible range: 10-30°C, actual values: 18.1-25.3°C ) in light-shielded and air-tight container)

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Body weight at administration: 194-214g (all within ±20% of the mean value)
- Fasting period before study: 18 hours
- Housing: Autoclave-sterilized polycarbonate cages (W265*D426*H200)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4-23.5
- Humidity (%): 46.3-69.0
- Air changes (per hr): 6-20 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Tween80 and CMC-Na
Details on oral exposure:
VEHICLE
-Preparation: 0.5 w/v% CMC-Na and 0.1 w/v% Tween 80 dissolved in purified water (stored in refrigerator and used within 4 days)
- Concentration in vehicle: 30 and 200mg/mL
- Amount of vehicle (if gavage): 10mL/kg


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: There was no information on toxicity of the test substance or related substances.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Observations: before dosing and 10 and 30 minutes and 1, 3 and 6 hours after the dosing on the day of the administration and once daily for 14 days thereafter
-Measurement of body weight: on days 1(just before the administration) , 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and body weight gain

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no dead animals.
Clinical signs:
No abnormal clinical signs were noted.
Body weight:
No abnormal body weight change were noted.
Gross pathology:
There were no abnormal change in gross pathology.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of the test substance after single oral administration to rats was > 2000 mg/kg

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