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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported pre-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline available
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): 17-alpha-hydroxy-19-norproegsteronecaproate

Test animals

Species:
dog
Strain:
Beagle
Sex:
female

Administration / exposure

Route of administration:
intramuscular
Vehicle:
castor oil
Doses:
500 and 2000/animal; max 150 mg/kg bw
No. of animals per sex per dose:
2/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 150 mg/kg bw

Any other information on results incl. tables

Transient local intolerance reactions at the application site up to Day 10 after administration and secondary effects on general condition in one animal at the high dose (increased body temperature, apathy and anorexia). All animals survived the observation period.

Applicant's summary and conclusion

Conclusions:
Based on the results there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
Executive summary:

No acute toxicity studies were conducted with ZK 5686 (gestonorone). Results of studies conducted with an ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative as most likely ester cleavage occurs in vivo after administration.

The single intramuscular administration of a microcristalline suspension of ZK 5623 to female Beagle dogs at a maximum dose of appr. 150 mg/kg caused transient local intolerance reactions at the application site up to Day 10 after administration and secondary effects on general condition in one animal at the high dose (increased body temperature, apathy and anorexia). All animals survived the observation period. No necropsy was performed. The acute toxicity of ZK 5623 after intramuscular administration in Beagle dogs is above approximately 150 mg/kg (2000 g/dog).