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Diss Factsheets
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EC number: 916-899-6 | CAS number: -
- 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
- 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: Bayscript Blaukomponente TEA (EC No 916-899-6).
- Name of the substance for which the testing proposal will be used [if different from tested substance]: This substance itself only.
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Acute toxicity studies are available for daphnids, fish and algae. In addition, a daphnia reproduction study is available. There are no GLP-compliant fish early-life stage studies available on the substance.
- Available non-GLP studies: There are no non-GLP-compliant fish early-life stage studies available on the substance.
- Historical human data: Not relevant for this endpoint.
- (Q)SAR: There are no QSAR models available for this higher tier ecotoxicological endpoint that are sufficiently validated and acceptable (according to OECD Q/SAR validation criteria).
- In vitro methods: The registrant is not aware of any validated alternative tests that use in vitro methodologies that could be used to meet the standard requirement of the REACH regulation for fish early-life stage toxicity.
- Weight of evidence: No data are available for use in a weight of evidence approach.
- Grouping and read-across: Grouping and read-across approaches have been evaluated and are not considered in this case.
- Substance-tailored exposure driven testing [if applicable] : Not applicable
- Approaches in addition to above [if applicable] : Not applicable
- Other reasons [if applicable] : Not applicable
Overall, the registrant has carefully considered all general adaption procedures as listed in Annex XI of the Reach regulation, however the registrant has come to the conclusion that the lack of available data through studies and the level of extensiveness of the study proposed herein, the conduction of an OECD TG 210: Fish Early Life Stage (FELS) toxicity test is considered the best course of action in order to elucidate the long-term toxicity towards fish of Bayscript Blaukomponente TEA.
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:
According to REACH Annex IX, 9.1.6. ‘Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements)’ is a standard information requirement and cannot be generated otherwise. The Fish Early Life Stage (FELS) toxicity test (OECD TG 210) is regarded as the most suitable test guideline for addressing the information requirements.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: Not relevant - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Reference
Description of key information
In order to comply with the standard information requirements of Annex IX of REACH at this tonnage level the registrant proposes a study according to OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test) as best course of action. The study result from thise test will be adequate for the purpose of classification and labelling and risk assessment. Furthermore, this will elucidate the long-term behavior towards the aquatic compartment.
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.