Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 214-426-1 | CAS number: 1126-79-0
- 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
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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
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: n-butyl phenyl ether
- Name of the substance for which the testing proposal will be used [if different from tested substance]: not applicable
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies - There are no existing GLP studies that adequately address the endpoint.
- Available non-GLP studies - There are no existing non-GLP studies that adequately address the endpoint.
- Historical human/control data - There are no existing historical human data that adequately address the endpoint.
- (Q)SAR - There are no currently validated in silico or (Q)SAR approaches to characterize long term toxicity to fish. Additionally, there are no existing data on suitable analogs that adequately address the endpoint that would allow for such a QSAR model to be generated.
- In vitro methods - There are no currently validated in vitro approaches to characterize long term toxicity to fish.
- Weight of evidence - Due to a lack of GLP and non-GLP studies, adequate data on suitable analogs, historical human data, and (Q)SAR and in vitro methods, it is not possible to synthesis a weight of evidence approach to fulfill the long-term toxicity to fish test requirement.
- Grouping and read-across - There are no existing data on suitable analogs that adequately address the endpoint.
- Substance-tailored exposure driven testing - As the product is a fuel marker, there will be no exposure to water bodies, as the product will be combusted upon final use. However, per recent BoA decisions (for example Case #A-010-2019), Column 2 of Section 9.1. of Annex IX to the REACH Regulation is neither a ‘trigger’ nor a ‘waiver’ for the requirement to submit information on long-term toxicity to fish, regardless of whether or not the chemical safety assessment indicates a need for further testing. Thus, a long-term toxicity to fish test is required.
- Approaches in addition to above [if applicable] - not applicable
- Other reasons [if applicable] - not applicable
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:
- There are no specific adaptation possibilities outlined in Annex IX for long-term toxicity testing on fish.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The study design and methodology has not been finalized. The material is volatile from water, which will make long-term exposure challenging. It is anticipated that a flow-through or daily renewal system will be needed. However, a long-term toxicity test on aquatic invertebrates is currently underway. The observations and information obtained in the performance of this study will be used to guide the design of the long-term toxicity to fish study to ensure an appropriate study design.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Deviations:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-butyl phenyl ether
- EC Number:
- 214-426-1
- EC Name:
- N-butyl phenyl ether
- Cas Number:
- 1126-79-0
- Molecular formula:
- C10H14O
- IUPAC Name:
- butoxybenzene
- Test material form:
- solid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Study design
- Test type:
- other: A flow through or daily renewal system will need to be used due to the volatility of the substance from water.
- Water media type:
- freshwater
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.
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