Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydroxyprogesterone acetate
EC Number:
206-119-6
EC Name:
Hydroxyprogesterone acetate
Cas Number:
302-23-8
Molecular formula:
C23H32O4
IUPAC Name:
(1R,3aS,3bR,9aR,9bS,11aS)-1-acetyl-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl acetate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Executive summary:

The single oral administration of ZK 5189 to male and female Wistar rats was tolerated without any treatment-related clinical or macroscopic pathological findings. Acute oral toxicity of ZK 5189 in Wistar rats is above 2000 mg/kg body weight. [Schering AG, Report No. X053; 1995-11-27]

Since LD50 > 2000 mg/kg there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).