Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-11-23 to 1999-12-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Directive 96/54
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
1996
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: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No details on the source of the test material were provided. Batch number: 206.
- Expiration date of the lot/batch: No details provided.
- Purity test date: No details reported.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, protected from light.
- Stability under test conditions:Not reported
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was freshly mixed prior to application and stirred throughout dose administration to guarantee stability and homoegeniety.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was freshly mixed prior to application and stirred throughout dose administration to guarantee stability and homoegeniety.
- Preliminary purification step (if any):No details reported.
- Final dilution of a dissolved solid, stock liquid or gel:No details reported.
- Final preparation of a solid:No details reported.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Animals: 3 female and 3 male Wistar rats
- Weight at study initiation: female 148 - 179 g and male 164 - 187 g
- Fasting period before study: over-night and after dose administration food was withheld for further 3-4 hours
- Housing: the animals were individually kept in Macrolon cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 55 +/- 10%
- Air changes: 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours artificial light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g test item in 8 ml Carboxymethylcellulose (1% in aqua bidest.)

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data were available. Therefore 2000 mg/kg bw were chosen as the starting dose for the study.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days after dosing
- Frequency of observations and weighing: The animals were weighed prior to first application and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: twice a day on the day of dosing and once a day thereafter; Cageside observations including changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behavior pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma.
Statistics:
Not performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The oral application of the test substance in a dose of 2000 mg/kg bw caused no compound related mortalities.
Clinical signs:
On the day of application, slight signs of apathia were found in all animals, which lasted until day 1 in one male rat. No other clinical signs of toxicity were observed throughout the observation period.
Body weight:
Throughout the 14-days observation period no weight loss was recorded. The weight gain for the male and female animals was within the expected range.
Gross pathology:
Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally and is therefore not related to the test substance. No other macroscopic necropsy findings were recorded.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of the test substance in Wistar rats was determined to be > 2000 mg/kg bw. Therefore, the test substance is not classified for acute toxicity according to CLP.