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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
- Directive CEE
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Strain: Sprague-Dawley (SPF) ; 5 /sex – 1 treated group
- Age/Bodyweight at start: 6-week old; 175 +/-6g (males); 148+/-6g (females)
- Temperature: 21+/-2°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 5 rats/sex/cage, on sawdust
- Food and water ad libitum, except before dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % MC (Methyl cellulose)
Details on oral exposure:
- overnight fasting before dosing
- dose volume: 10ml/kg
Doses:
2000 mg / kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- 2-week observation period after dosing
- monitoring: clinical signs and mortality, bodyweight
- terminal kill on Day 15: macroscopic examination

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
no clinical signs
Body weight:
isolated body weight loss in 1/5 females
Gross pathology:
no macroscopic abnormality
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Lethal dose > 2000mg/kg per os.