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Registration Dossier
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EC number: 203-438-2 | CAS number: 106-88-7
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Remarks:
- Waiver
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Description of key information
Based on the fate behavior of the substance and the outcome of the Chemical Safety Assessment no significant long term exposure of aquatic invertebrates is expected. Therefore, in accordance with section 3.2 a) of Annex XI to Regulation (EC) No 1907/2006 (REACH) the study on long-term toxicity to aquatic invertebrates is considered scientifically not necessary and was hence waived.
Key value for chemical safety assessment
Additional information
JUSTIFICATION FOR DATA WAIVING
In accordance with section 3.2 a) in Annex IX of Regulation (EC) No 1907/2006 (REACH) the testing stipulated in Annex IX of the same regulation may be omitted, based on the exposure scenarios developed in the Chemical Safety Report. A thorough and rigorous exposure assessment in compliance with section 5 of Annex I of REACH demonstrated that no significant exposure in all scenarios of the manufacture and all identified uses occur. The PNECs were derived from results of available test data and in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.10 (Characterization of dose [concentration]-response for environment), taking full account of the increased uncertainty resulting from the omission of the information requirement. The derived PNECs are considered relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes. For the substance only industrial uses are considered. During the life-cycle of the substance procedural and control technologies are used that minimize emission and any resulting exposure. Only properly trained and authorized personnel handle the substance. In cases of accident and where waste is generated, procedural and/or control technologies are used to minimize emissions and the resulting exposure during purification or cleaning and maintenance procedures. The substance-handling procedures are well documented and strictly supervised by the site operator. Further, it should be emphasized that concluding all available data on biodegradation of 1,2-epoxybutane, the substance can be assessed as readily biodegradable according to OECD criteria. The bioaccumulation potential of 1,2-epoxybutane is very low as its log Kow is clearly below the threshold value of log 3 stated in REACH Annex IX, section 9.3.2, column 2. Moreover, by taking into consideration of the calculated log Koc adsorption of the substance to the sediment matrix is not expected. The comparison of the PNECs with the results of the exposure assessment showed that exposures are always well below the respective PNEC. In conclusion, based on the fate behavior of the substance and the outcome of the Chemical Safety Assessment no significant long term exposure of aquatic invertebrates is expected. Therefore, in accordance with section 3.2 a) of Annex XI to Regulation (EC) No 1907/2006 (REACH), the study on long-term toxicity to aquatic invertebrates is considered scientifically not necessary. This is also in line with the rule of information requirement adaptation as stated in Annex IX Section 9.1 column 2. Further testing does not appear to be scientifically necessary and was hence waived.
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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