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Toxicological information

Acute Toxicity: oral

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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
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Dastib 845
IUPAC Name:
Dastib 845

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
exposition: 14 days
Doses:
5000, 10000, 15000 mg/kg
No. of animals per sex per dose:
dose 5000 mg/kg - 5 males + 5 females
dose 10000m mg/kg -5 males + 5 females
dose 15000 mg/kg - 5 males
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 10000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 15000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 10000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Nach einer Einfachdosierung wurden uber einen Zeitraum von
14 Tagen bei keinem der Geschlechter Anzeichen von Toxizitat
festgestellt.
Gross pathology:
Effects on organs:
Es wurden weder Nekrose bei behandelten Tieren noch
histologische Veranderungen festgestellt.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU