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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
EC Number:
700-258-0
Cas Number:
125971-95-1
Molecular formula:
C40H47FN2O5
IUPAC Name:
tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
2000mg/kg
No. of animals per sex per dose:
2000mg/kg -3 females( Step No.1): No deaths ->2000mg/kg-3 females (Step No. 2 ): No death -> END of study
Control animals:
no

Results and discussion

Preliminary study:
dose 2000mg/kg body weight
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000
Based on:
test mat.
Remarks on result:
other: No death
Mortality:
No death
Body weight:
Step No. 1 weight increment average 58.25g after 15days
Step No. 2 weight increment average 65.55g after 15days
Gross pathology:
Without patological changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings in the end of study.
The test substance administered at the dose of 2000 mg/kg caused no death of animals. Clinical signs of intoxication were not observed in all six animals. Macroscopic changes were not diagnosed during pathological examination in all animals.
Based on the test results and according to the EC criteria for classification and labeling requirements for dangerous substances and preparations, Acetonide Atorvastatine did not fall into any of quoted categories of toxicity and has no obligatory labeling requirement in this respect.