Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06.09.2005 - 20.10.2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

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 material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Test material (Batch No. 05030139/131) provided by the sponsor Raschig GmbH
- Expiration date of the lot/batch: not available
- Purity test date: not available

RADIOLABELLING INFORMATION (if applicable): not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: highly soluable in water, stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

FORM AS APPLIED IN THE TEST (if different from that of starting material): not applicable

OTHER SPECIFICS: none

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53490 Le Genest St Isle, France)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: not available
- Weight at study initiation: 184 - 208 g
- Fasting period before study: not available
- Housing: not available
- Diet (e.g. ad libitum): not available
- Water (e.g. ad libitum): not available
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 37 - 56%
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): not available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not available
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: not available
- Lot/batch no. (if required): not required
- Purity: not applicable

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not available
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3
Control animals:
yes
Remarks:
6 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 times (day 0, 2, 7, 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical signs
Statistics:
not applicable

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
developed normal (as compared to the control group)
Gross pathology:
no findings

Any other information on results incl. tables

In a GLP-study according to OECD TG 423, no mortality or other effects were observed at 2000 mg substance per kg body weight.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP-study according to OECD TG 423, Sprague-Dawley rats were administered 2000 mg test substance per kg body weight by gavage.

No mortality or other effects were observed until day 14.

According to the results of this study the GHS category of the substance is not classified in the absence of any relevant toxicological findings at the tested concentration and the LD50 value of the test substance is considered to be >2000 mg/kg.