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Administrative data

Endpoint:
acute toxicity: dermal
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.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure

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:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: moistened by water
Duration of exposure:
24 hours
Doses:
2000mg/kg
No. of animals per sex per dose:
5 animals females
5 animals males
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000
Based on:
test mat.
Remarks on result:
other: No mortality, without patological changes,without clinical signs of intoxication
Mortality:
no death
Clinical signs:
no clinical signs of intoxication
Body weight:
males weight increment average 58.49g after 15days
females weight increment average 24.81g 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, body weight changes, clinical signs of toxicity during the observation period and necropsy findings in the end of study
The test substance applied on skin in dose 2000 mg/kg did not cause death of animals.
No clinical signs of intoxication of animals were observed. 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 this respect

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