Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 218-378-2 | CAS number: 2137-18-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
there is no mutagenicity assay performed with ZK 5686 (gestonorone), results of studies with a different ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative as most likely ester cleavage occurs in vivo after administration
ZK 5623 (gestonorone caproate) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA 100, TA 102, TA 1535 and TA1537) up to the highest tested concentration of 2.5 mg/plate (at which precipitates of test compound were observed) in the absence or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats). [Schering AG, Report 3024, 1978-02-01]
Results of a dominant-lethal test in male mice with ZK 5623 did not indicate a mutagenic potential up to the highest tested dose of 200 mg/kg. [Schering AG, Report No. 3038, 1978-02-16]
Results of a dominant-lethal test in male rats with ZK 5623 showed decrased insemination and pregnancy indices at the high dose of 60 mg/kg. No other findings were described even at the high dose indicating that ZK 5623 does not have a dominant lethal effect. [Schering AG, Report 4057, 1979-11-15]
A mutagenic potential of ZK 5623 is also not expected based on negative results with other steroid hormones in mutagenicity assays.
Short description of key information:
There are no data with ZK 5686; read across with results of studies with gestonorone caproate (ZK 5623):
Gene mutation (bacterial reverse mutation assay / Ames test, non-GLP): negative with and without metablic activation
[Schering AG, Report 3024, 1978-02-01]
Dominat-lethal test (Mouse, male, non-GLP, subcutaneous, doses: 0/ 2/ 20/ 200 mg/kg, twice weekly, 7 weeks): negative
[Schering AG, Report No. 3038, 1978-02-16]
Dominat-lethal test (Rats, male, non-GLP, Doses: 0/ 2/ 20/ 60, twice weekly, 10 week): negative
[Schering AG, Report 4057, 1979-11-15]
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Not classified according to German legislation (TRGS-905) for gestagens. No mutagenicity expected.
Based on the results no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.