[Name confidential or not available]

Acute Toxicity: oral

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

Test material information

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