Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 415-490-5 | CAS number: 141773-73-1 HELVETOLIDE
- 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:
Introduction:
The registered substance is a reaction mass of three constituents. Two diastereomers with a cyclohexyl group (here called C6 diastereomers) and one structural isomer with a cycloheptyl group (here called C7 isomer). The C6 constituents represent ca. 78% of the substance, and the C7 constituent ca. 10%.
The environmental data available lead to the use of the constituent approach for the PBT assessment.
The registered substance disappears completely, as primarily biodegraded following STP treatment as demonstrated in a ready biodegradation test with analytical monitoring. Hence, the PBT assessment is performed in two parts, first, for the registered substance and then for the transformation product.
The transformation product is composed of the same ratios of isomers as the parent but in the alcohol form.
PBT Assessment:
The registered substance is not considered readily biodegradable. However, the key experimental biodegradation study, performed on the C6 isomers of the registered substance, demonstrates that this substance disappears in a ready test and therefore is not considered persistent (non-P). Indeed, total primary biodegradation of the C6 isomers of the registered substance is demonstrated (to form the C6 isomers of the transformation product at 79% and Propionic acid at ca. 20% but mineralised). The same primary biodegradation is observed for the C7 isomer of the registered substance, based on QSAR predictions (Catalogic 301C v.08.12).
To conclude on the persistence of the transformation product, a screening non-GLP ready biodegradation study (OECD 301F) was performed on the transformation product (C6 and C7 isomers) and only 0 to 4% biodegradation was observed after 28 and 60 days. This result is also confirmed based on QSAR prediction (Catalogic 301C v.08.12). Therefore, the transformation product of the registered substance can be considered as potentially persistent (potential P) or potentially very persistent (potential vP), in the absence of simulation studies.
The BCF values are much lower than 2000 L/kg for the registered substance and the transformation product, based on estimated and experimental/estimated BCFs, respectively. Therefore, the registered substance and it's transformation product are not considered bioaccumulable (non-B) or very bioaccumulable (non-vB).
The registered substance is not considered Toxic (non-T) based on the lowest NOEC value at 0.20 mg/L (aquatic invertebrates) and the absence of evidence of chronic toxicity.
The transformation product is not considered Toxic (non-T) based on the estimated acute and chronic toxicity. The estimated L(E)C50 values and chronic values are well greater than 0.1 and 0.01 mg/L, respectively. In addition, one experimental acute fish study is available on the C6 isomers of the transformation product (but considered not assignable due to lack of information). The experimental 96h-LC50 (Danio rerio) was 10.7 mg/L (far higher than 0.1 mg/L). All these data demonstrate that the transformation products of the registered substance is not Toxic (non-T).
In conclusion, the registered substance and it's transformation product should not be considered as PBT or vPvB substances.
- Likely routes of exposure:
None
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.