Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): AR-FD 26 ( phase X )
- Physical state: powder
- Lot/batch No.: 01010

Test animals

Species:
mouse
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 24 - 26 g
- Diet (e.g. ad libitum): Conventional feeding
-
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- 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:
5 male per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : 1 - 4 hours after application and once daily on Day 1, 2, 3 ,4, 7 and 14

Results and discussion

Effect levels
Sex:
male
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The dose tested during the experimentation period of 14 days did not cause any death or any symptoms visually detectable was observed. Therefore, the test article was non toxic under the conditions of this study ( i.e. LD50 > 2000 mg/kg bw ).