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Diss Factsheets
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EC number: 401-700-2 | CAS number: 3100-36-5 CYCLOHEXADECENON; CYCLOHEXADECENONE
- 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
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Mixture of cis- and trans-cyclohexadec-8-en-1-one
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: There are no GLP studies available for this substance covering the endpoint of long-term toxicity to fish.
- Available non-GLP studies: There are no non-GLP studies available for this substance covering the endpoint of long-term toxicity to fish.
- (Q)SAR: QSAR approaches are currently not well fitted-for-purpose for long-term toxicity to fish and consequently no firm recommendations can be made concerning their routine use in a testing strategy in this area (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance, 2017).
- In vitro methods: There are no in vitro methods available to fully cover the endpoint of long-term toxicity to fish.
- Weight of evidence: There is no weight of evidence information available to cover the endpoint of long-term toxicity to fish.
- Grouping and read-across: There are no substances which apply for read-across addressing long-term toxicity to fish.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The substance is fully registered according to REACH Annex IX. Therefore, one long-term toxicity test to fish is legally required. The test substance has been tested in a series of short-term aquatic tests. In the short-term toxicity to fish test according to OECD guideline 203, an LC50 (96 h) of 0.75 mg/L was observed. In the short-term toxicity test to Daphnia according to OECD guideline 202, the EC50 value was 275 µg/L based on mobility effects. In the toxicity to aquatic algae test according to OECD guideline 201, the EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 470 µg/L and 122 µg/L, respectively. The EC10-values for inhibition of growth rate (ErC10) and yield (EyC10) after 72 hours were 119 µg/L and 25.3 µg/L, respectively. The NOEC-values for both inhibition of growth rate and yield after 72 hours were 28.4 µg/L. The EC50 (3h) of the test item to the respiration of microorganisms was determined to be above 10000 mg/L. In the long-term toxicity to aquatic intervertebrates test according to OECD guideline 211, the values of 21d-NOEC (reproduction and mortality) were determined to be above 0.0141 mg/L based on the mean measured concentrations. Based on the obtained short-term data, it can be stated that there is evidence for a potential long-term aquatic toxicity of the test substance. Thus, all adaption options from Annex IX are not applicable for the substance and the basic fish early life-stage study design is proposed.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The registrant intends to conduct a standard OECD 210 study based on the results of the pre-tests, which has to be performed beforehand.
The current testing proposal will be submitted under EU REACH to address the data gap in the study requirements.
The registrant requests the Authority to take into account that CROs are currently fully booked with regard to long-term fish tests and that a pre-test incl. method development would need to be performed, when setting the deadline for submission of the test results.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Test material
- Reference substance name:
- A mixture of cis- and trans-cyclohexadec-8-en-1-one
- EC Number:
- 401-700-2
- EC Name:
- A mixture of cis- and trans-cyclohexadec-8-en-1-one
- Cas Number:
- 3100-36-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one
Constituent 1
Results and discussion
Applicant's summary and conclusion
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.