Registration Dossier
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EC number: 265-449-9 | CAS number: 65113-55-5
- 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

Bioaccumulation: aquatic / sediment
Administrative data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING:
In the R7 guidance, commenting the column 2 of Annex IX of REACH, it is state that a study is not necessary if direct and indirect exposure of the aquatic compartment is unlikely (implying a low probability of – rather than low extent of – exposure). At the manufacture stage strict risk management measures are taken to avoid water exposure. During the formulation stage there is no release to water as all fluids, used for cleaning equipment, are sent to external waste treatment. For the consumer use (“dye for ink for ballpoint and cartridge) the exposure to waste water is probably overestimated by using the generic environmental release factor ER11a and is still very low.
However, the probability of exposure is not completely absent, and dietary bioaccumulation test (that is practically much easier to conduct for poorly water-soluble substances than the OECD 305 guideline) may be proposed. The realization of the test was pending to the results of the long-term studies.
Based on the results of the OECD 211 Daphnia magna Reproduction test, Semi-static, 21 days the substance is now T in addition to being P/vP. The outcome of the OECD 210 Fish, Early-Life Stage (FELS), which covers several life stages of the fish from the newly fertilised egg, through hatch to early stages of growth, does not allow to conclude with sufficient confidence on the B criterion: at the highest tested doses (0.1 and 0.25 mg/L) all the larvae died within 2 days after hatching. However, at the 3 other testing doses, no effects were observed until 30 days post-hatching up to 40 µg/L.
Therefore, the bioaccumulation potential of the substance needs to be assessed according to the ITS provided by the guidance documents:
• No literature data was found on the substance nor on any analogues,
• An attempt to better estimate the Log Kow of the substance will be made,
• The support of an ecotoxicologist expert is seeked,
• Several non-commercial Q(S)AR models were used, indicating a BCF < 2000, but the substance was not failing in the applicability domain of the models: other commercial models are still available for the prediction of the BCF, like CATALOGIC v5.11.1 (BCF base-line model v01.04), however a license must be bought. Before bying any license, the applicability domain must be evaluated,
• Exchanges with the laboratory for the feasibility of the in vitro study.
If finally, no conclusions can be made, an experimental study plan will have to be submitted.
Data source
Materials and methods
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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