Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Test material form:
solid: bulk

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 24 - 26 g- Diet (e.g. ad libitum): Conventional feedingENVIRONMENTAL CONDITIONS- Temperature (°C): 22°C- Humidity (%): 30 - 70%- Photoperiod (hrs dark / hrs light): 12 : 12

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2000 mg/1000 g body weight
No. of animals per sex per dose:
3 males / 3 females / dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Necropsy of survivors performed: no

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:
No Mortality
Clinical signs:
No clinical signs
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
other: "not classified" according CLP
Conclusions:
The dose tested during the experimentation period of fourteen days did not cause any death or any symptoms visually detectable.