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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 468-880-2 | CAS number: 102985-93-3
- 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
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Study period:
- The study will be performed in 2021 or in the following years depending on ECHA decision.
- 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: 2,2-dimethyl-3-oxopropyl dodecanoate
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 weigh 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 no mortalities were observed at the water solubility limit (1 mg/L), thus, the EC50 was determined to be greater than 1 mg/L. In the short-term toxicity test to Daphnia a dose-responce was observed and the EC50 was extrapolated to be 1.02 mg/L, a little bit above the water solubility. In the toxicity to aquatic algae test, an EC50 greater than 1 mg/L was also determined as only slight inhibition on the growth rate of the algae was observed at the water solubility limit. Based on the obtained short-term data, it can be stated that the test substance falls in the category of "difficult to test substances which do not reach equilibrium in during short-term exposure", 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 indends to conduct a standard OECD 210 study based on the results of the pre-tests, which would have to be performed beforehand.
The current testing proposal will be submitted both under EU REACH and UK REACH to adress 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. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Water media type:
- freshwater
Reference
Description of key information
A testing proposal on the endpoint "Long-term toxicity to fish" has been submitted and after finalisation of the formalities, such a test will be performed with the test substance and included in a future dossier update.
Key value for chemical safety assessment
Additional information
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.