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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-11-02 to 1999-12-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline and GLP conform well documented scientific study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Hostacor 4323
- Chemical name: Tetrapropenylbernsteinsaeuremonoisobutylester
- Physical state: light brown viscous liquid
- Density: 0.969 g/cm3 (at 20°C)
- Analytical purity: n.a.
- Certificate of analysis: 1999-09-06
- Lot/batch No.: 6K FMLW015
- Expiration date of the lot/batch: 2000-12-28
- Storage condition of test material: darkness at room temperature in a fume cup-board
- Other:
Stability and homogeneity in the Vehicle is garanteed fo 4 hours

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Doses:
single dose: 2000 mg/kg bw (as a 20 % solution in Sesame oil)
No. of animals per sex per dose:
5/sex/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the whole study period.
Clinical signs:
The following clinical signs were observed after the administration of Hostacor 4323: hypoactivity, squatting posture and bristling coat. Additionally, diarrhea was observed. From day 4 on until the end of the study no findings were observed.
Body weight:
Development of body weight was not impaired
Gross pathology:
No macroscopically changes visible.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of Hostacor 4323 for male and female rats is greater than 2000 mg/kg body weight.
Executive summary:

Acute oral toxicity testing of Hostacor 4323 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. After administration of a single dose of the test substance at 2000 mg/kg body weight in sesame oil as vehicle no mortality occurred. The animals showed hypoactivity, squatting posture and bristling coat. Additionally, diarrhea was observed. At day 4 of the study all clinical signs were reversible. Development of body weight was not impaired. All animals were killed at the end of the observation period. No macroscopically visible changes were observed.

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