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EC number: 217-568-2 | CAS number: 1889-67-4
- 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:
- adult fish: sub(lethal) effects
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- The performance of a test for long-term toxicity to fish was considered scientifically not justified. REACH Regulation (EC) No 1907/2006, Annex VIII, Sect. 9.1.3, Col. 2, states as follows:
“9.1.3: The study (long-term toxicity to fish) does not need to be conducted if: - there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.”
or
"Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment."
The chemical safety assessment does not indicate the need to further investigate effects on aquatic organisms as outlined in the following. This is also in line with the rule of information requirement adaptation due to no scientific necessity as stated in Annex XI section 1.
The substance was investigated in OECD and GLP compliant studies for its acute toxicity to algae, daphnia, and fish, respectively. The test item is practically insoluble in aquatic media, therefore, supersaturated solutions of the test item were prepared for each test and the biological effects are based on loading rates. In all three trophic level tests, the test item showed no effects up to the water solubility. The E(L)C50 values were determined to be for all three species above 1000 mg/L (loading rate). The NOECs for all performed aquatic studies was determined to be ≥1000 mg/L (loading rate).
Taken together, the test item did not induce any effects in fish, daphnia and algae up to the water solubility. This is also assumed for long-term toxicity. NOEC values for a long-term fish test are expected to be well above the water solubility of the test item. Therefore, long-term toxicity studies in fish are not expected to provide more relevant information in regards to hazard conclusion and would therefore not improve chemical safety assessment.
Furthermore, based on the chemical safety assessment the environmental risk is considered to be adequately controlled. There are no concerns regarding the safe use of the substance. For the aquatic environment RCR values are beyond the threshold of 1.
Taking together the points outlined above, it is concluded that the criteria of Annex IX Section 9.1, column 2 are fulfilled justifying the adaptation of the information requirements, accordingly. Therefore, and considering animal welfare reasons, further studies on long-term toxicity to fish are neither scientifically nor from a regulatory point of view justified.
This is also in line with the rule of information requirement adaptation as stated in Annex XI section 1. Further testing does not appear to be scientifically necessary.
Reference
Description of key information
The performance of a test for long-term toxicity to fish was considered scientifically not justified.
REACH Regulation (EC) No 1907/2006, Annex VIII, Sect. 9.1.3, Col. 2, states as follows:
“9.1.3: The study (long-term toxicity to fish) does not need to be conducted if: - there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.” or "Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment."
The test item is practically insoluble in aquatic environment. Thus, the chemical risk assessment does not show a need for an additional long-term aquatic test. Risk assessment is based on the short-term tests for all trophic levels.
No adverse effects in long-term studies are expected and due to animal welfare, an additional study would thus not improve the environmental risk assessment.
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.

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