Registration Dossier
Registration Dossier
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EC number: 200-350-6 | CAS number: 57-83-0
Repeated dose toxicity: other routes
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:
- 1 979
- 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
- 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
Constituent 1
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.
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