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Diss Factsheets
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EC number: 429-750-0 | CAS number: 180898-37-7
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence:
Neo Heliopan® AP is not readily biodegradable under the conditions of the ready biodegradability tests performed. However, Neo Heliopan® AP was identified non-toxic in these tests. Respective QSAR calculations confirm that the substance is not ready biodegradable.
An atmospheric degradation by reaction with OH-radicals can safely be assumed given a calculated half-life of ~19 hours. As the substance has a half-life in air < 2 days, it is not expected to stay in the atmosphere for long and there is a limited potential for long range atmospheric transport.
In a weight-of-evidence approach, considering a combination of test results and QSAR predictions of NeoHeliopan® AP, a certain persistency potential cannot be excluded.
Bioaccumulation:
According to ECHA “Guidance on information requirements and chemical safety assessment / Part C: PBT assessment” (December 2011), the criteria for bioaccumulation (B and vB) are not fulfilled, if the logPow is ≤ 4.5.
For organic substances with a log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 L/kg ww.
Furthermore, there is no convincing evidence that Neo Heliopan® AP can biomagnify in the food chain (BMF < 1). Therefore, the criteria for “bioaccumulating” and for “very bioaccumulating” are not fulfilled. The substance Neo Heliopan® AP does not qualify as a “B” or “vB” substance.
Toxicity:
The T criteria to clarify if a substance is toxic are not fulfilled for the substance Neo Heliopan® AP for the following reasons:
1. Regarding aquatic toxicity:According to ECHA guidance, a substance is considered to potentially meet the T criteria when an acute L/EC50value from a standard E/LC50toxicity test is less than 0.1 mg/L.
Acute toxicity data are available for fish, daphnia and algae. None of the E/LC50values are < 0.1 mg/L.
According to the REACH legislation (Annex XIII), a substance fulfils the toxicity criterion (T) regarding aquatic toxicity when the long-term NOEC for marine or freshwater organisms is less than 0.01 mg/L.
Chronic data available for algae and daphnia indicate that NOEC and 72-h ErC10 values are far above 0.01 mg/L (Algae NOEC (72 h) ≥ 88.2 mg/L; Daphnia EC10>1 mg/L).
Regarding aquatic toxicity, the Toxicity criteria are not fulfilled for the substance NeoHeliopan® AP.
2. Regarding carcinogenicity, mutagenicity, or reproductive toxicity, a substance is considered to potentially meet the T criteria if it classifies for carcinogenicity (cat 1/2), mutagenicity (cat 1/2), or reproductive toxicity (cat 1/2/3). None of the relevant tests conducted with NeoHeliopan® AP, including a 13-w oral toxicity study in rats (OECD 408), prenatal developmental toxicity study (OECD 414) and relevant in vitro mutagenicity tests (OECD 471, 473 and 476) indicate a potential for carcinogenicity, mutagenicity, or reproductive toxicity. Regarding carcinogenicity (cat 1/2), mutagenicity (cat 1/2), or reproductive toxicity (cat 1/2/3), the Toxicity criteria are not fulfilled for the substance NeoHeliopan® AP.
3. Regarding other evidence of chronic toxicity, a substance is considered to potentially meet the T criteria if it classifies T, R48, or Xn, R48 according to Directive 67/548/EEC. None of the relevant tests conducted with NeoHeliopan® AP, including a 13-w oral toxicity study in rats (OECD 408), prenatal developmental toxicity study (OECD 414) and relevant in vitro mutagenicity tests (OECD 471, 473 and 476) indicate a potential for chronic toxicity according to Directive 67/548/EEC. Regarding chronic toxicity, the Toxicity criteria are not fulfilled for the substance NeoHeliopan® AP.
Thus, Neo Heliopan® AP does not qualify as a “T” substance.
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.
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