C10-13-alkyl(branched, unsaturated)-succinic acid-4-(3-methyl-butyl)-ester

Acute Toxicity: oral

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

Test material information

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:

other: 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.

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.