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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 272-805-7 | CAS number: 68912-13-0
- 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
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
Description of key information
The DT50 of Cyclaprop is 17 days at 12°C, which is based on a compilation of data that resembles the outcome of the OECD TG 309 test sufficiently. This DT50 is derived from ready biodegradability curve (OECD TG 301F), showing maximum primary degradation after 6 days at 25°C, the identification of the degradation products in this test, correction to 12°C (using EUSES) and supporting QSAR model results from Arnot et al. (2005). The primary biodegradation product are Cycla-alcohol and Cycla-ketone (measured log Kow values are 2.4 and 3.3, respectively).
Key value for chemical safety assessment
- Half-life in freshwater:
- 17 d
- at the temperature of:
- 12 °C
Additional information
In this section it is outlined that Cyclaprop fulfils the Annex IX requirements. The derivation of the DT50 for the water compartment is presented in the Overall Endpoint summary because information from screening study in combination with other information is used.
Cyclaprop’s Annex IX requirements on derivation of half-lives in water without experimental testing (OECD TG 309) in these compartments.
Summary: Further biodegradation in water-simulation-systems for Cyclaprop is not needed because the substance is not PBT or vPvB, based on absence of bioaccumulation in fish, the substance is not T because it is not hazardous for human health and aquatic organisms (EC10/NOEC values are above 0.01 mg/L). In addition, a half-life of the parent substance can be estimated using information from its structure and propionic ester functionality, the ready biodegradability tests and the analysis and identification of the remaining parent substance and the metabolites, which is outlined in the DT50 derivation for water.
Introduction
The present document outlines the available information showing the absence of need for further simulation testing based on
1) ECHA guidance
2) A DT50 for Cyclaprop that can sufficient accurately be predicted, because Cyclaprop is a propionic ester
3) The outcome of the OECD TG 309 versus the results obtained with other than experimental methods.
4) QSAR estimates support the primary biodegradation of Cyclaprop into its alcohol and acid.
Annex IX requirements
According to Annex IX further biotic degradation shall be proposed by the registrant if the chemical safety assessment, according to Annex I, indicate the need to investigate further the degradation of the substance and its degradation products. In the LRs view the CSA does not indicate the need for further testing based on the following:
1) ECHA’s further guidance: In one of ECHAs tip and tricks webinars (2014) on degradation it is presented that degradation is an important endpoint to fulfil the following regulatory needs:
1a) Persistency assessment, to identify whether a chemical has PBT or vPvB properties;
1b) Hazard assessment: To determine the potential to cause long-term adverse effects in environmental hazard classification;
1c) Risk assessment: To determine the Predicted Environment Concentration (PEC) of a chemical in environmental exposure assessment for use in risk characterisation.
Applying this to Cyclaprop
1a) In Cyclaprop’s PBT assessment the substance is not considered PBT. The substance is not P because the DT50 of Cyclaprop is 17 days. It is not T because the EC10/NOEC values are above 0.01 mg/L and Cyclaprop is not classified as CMR nor is there any other evidence of chronic toxicity. The substance is not B for aquatic organisms, because its BCF in fish is 156 l/kg based on read across from verdox. This means that Cyclaprop is not PBT in absence of P, B and T. The overall PBT/vPvB conclusion will not change and therefore further testing is not required.
1b) The substance needs to be classified as H411 according to EU CLP (EC 1272/2008/ and its amendments) because the lowest NOEC / EC10 from the chronic tests available is <1 mg/L and Cyclaprop is not rapidly biodegradable. By performing additional biodegradation tests, irrespective of the outcome, Cyclaprop will still have to be classified for Aquatic Chronic toxicity. Furthermore, the classification will not become more stringent as a result of additional testing, so further biodegradation studies do not fulfil a regulatory need.
1c) In the current chemical safety assessment, there is no risk for the environment as all Risk Characterisation Ratios (RCR) are below 1. Therefore, further biodegradation studies are not needed.
2) Cyclaprop, its half-life and its metabolites
The Cyclaprop’s half-life can be sufficient accurately be derived for fulfilling Annex IX, using existing biodegradation pattern in screening studies, measuring the metabolites therein.
3) Cyclaprop’s ready biodegradability tests versus expected outcomes of OECD TG 309: Relation between the half-lives and degradation products presented:
3a) Firstly, all the ready biodegradation tests are considered very stringent tests but the OECD TG 309 test is more stringent. In the latter test lower substance concentrations, lower bacteria concentrations and a lower temperature are applied at which the test should be performed (12° versus 20-25°C) have to be used. As a result, the pseudo half-life found in the ready test will need to be converted to 12°C. It has been experimentally shown that the tricyclodecanyl backbone is more stable in the ready biodegradation tests and that these are still present after 60 days in prolonged tests (Cyclabute information). From these data and the expectation that the OECD 309 test is more stringent than the biodegradation ready test the same degradation products can be found.
3b) Secondly, from the OECD TG 309 test, more information can be retrieved compared to a ready biodegradation tests, but this additional information will have limited influence on the final results of the different frameworks C&L, PBT and RCR.
3c) Thirdly, difference in experimental procedures will have limited influence on the results. There is no mass balance but considering volatility, the evaporation loss is limited based on the Henry law’s constant of 1.16 Pa.m3/mol at 12°C. Considering adsorption, Cyclaprop’s adsorption to suspended solids will also be limited due to a low log Koc of 3.1. This value indicates that Cyclaprop will mainly remain in the water phase (84% as is estimated in the Simple Treat model). There is no lag phase seen in the degradation studies and because Cyclaprop has a propionic ester group this group will be biodegraded first, which will also occur in the OECD TG 309 test.
In summary on Cyclaprop’s ready tests versus the OECD TG 309: the key elements of the OECD TG 309 can be deduced from the ready biodegradability tests based on the pattern of degradation, and the experimental determination of the parent and the key metabolites.
4) QSAR models as included in the discussion on simulation testing show that the predicted half-lives are 10-13 days which is in line with the derived values. The QSAR model predictions are included in the derivation of the DT50.
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.