Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
similar to OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents)
GLP compliance:
no
Limit test:
no

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
Details on test material:
- Name of test material (as cited in study report): progesterone

Test animals

Species:
monkey
Strain:
other: Macacus mulatta
Sex:
female

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
castor oil
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.5, 5.0 and 50.0 mg/kg
No. of animals per sex per dose:
4/group
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
< 0.5 mg/kg bw/day (nominal)
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

 Acyclic menses in all doses, lack of vaginal cornification, increase of parenchymal breast cells and lacktic efflux at 5.0 and 50.0 mg/kg. Increased insulin level and decrease in adrenal gland weight. Increased fibrinogen and prolactin concentration at 50 mg/kg. Reduced prolactin cells and lutenising hormon cells in hypophysis at 50 mg/kg progesterone.

Applicant's summary and conclusion

Conclusions:
Progesterone provoked effects on the sexual organs and the hormone regulation in female monkeys.
Executive summary:

Female monkeys received daily progesterone subcutaneously over 12 weeks.

This resulted in acyclic menses in all doses, lack of vaginal cornification, increase of parenchymal breast cells and lacktic efflux at 5.0 and 50.0 mg/kg. Additionally increased insulin level and decrease in adrenal gland weight was observed. Progesterone provoked effects on the sexual organs and the hormone regulation in female monkeys.