Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Directive Comunitary 88/320/CEE e 90/18/CEE
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Zanthoxylum, ext.
EC Number:
310-094-8
EC Name:
Zanthoxylum, ext.
Cas Number:
102242-62-6
Molecular formula:
NA
IUPAC Name:
Zanthoxylum ext
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
615 mg/kg; 456 mg/kg; 337 mg/kg and 250 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
416 mg/kg bw
Based on:
test mat.
95% CL:
>= 344 - <= 503
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
416 mg/kg bw
Based on:
test mat.
95% CL:
>= 344 - <= 503
Mortality:
males: 100% at 615 mg/kg - 60% at 456 mg/kg - 20% at 337 mg/kg and 0% at 250 mg/kg
females: 100% at 615 mg/kg - 60% at 456 mg/kg - 20% at 337 mg/kg and 0% at 250 mg/kg
Clinical signs:
the animals treated with the letal doses had the following toxic symptoms:
piloerection - swollen abdomen - nose and mouth bleeding - tremors
Body weight:
males: 179 g average value
females: 188 g average value
Gross pathology:
gastro enteric hemorrhage

Applicant's summary and conclusion

Conclusions:
The LD50, estimated on the test item, Zanthoxylum extract., is equal to 416 mg/kg with confidence limits from 344 mg/kg to 503 mg/kg for both males and females