Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Sep to Oct 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
17-Hydroxy-1,4,6-pregnatriene-3,20-dione
EC Number:
613-906-1
Cas Number:
66212-25-7
Molecular formula:
C21 H26 O3
IUPAC Name:
17-Hydroxy-1,4,6-pregnatriene-3,20-dione
Details on test material:
- Name of test material (as cited in study report): ZK 5668
- Batch No.: 14610801

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: physiol. saline + Myrj 53 in bidest.water
Doses:
2000 mg/kg (application volume 10 mL/kg)
No. of animals per sex per dose:
3
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.

Any other information on results incl. tables

No animal died in the course of the study. Moreover, no clinical signs, no effects on body weight and body weight gain and no abnormalities at necropsy were observed.

Applicant's summary and conclusion

Executive summary:

The single oral administration of the test substance (ZK 5668) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related clinical signs and effects on body weight were observed and there were no macroscopic pathological signs.

The acute oral toxicity of 1,4,6 -Trienol in rats is therefore above 2000 mg/kg body weight.