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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
Endpoint summary
Administrative data
Description of key information
In the decision letter from ECHA of 21 October 2021 (CCH-D-2114569822-39-01/F) Long-term toxicity testing on terrestrial invertebrates (OECD TG 222 or 220 or 232) or a Long-term toxicity test to terrestrial plants (OECD TG 208 with at least six species or ISO 22030) with Cyclaprop was requested. Based on the substance properties, it was decided by the lead registrant to conduct an OECD TG 222. In addition, an Effects on soil micro-organisms test (EU C.21./OECD TG 216) with Cyclaprop was requested. The deadline for submission is January 26th 2023, but unfortunately, the test report will not be available before that date. Quotations from several labs were requested, but due to non-availability of some labs, it took some time to find the right lab to perform the study on the shortest notice. The OECD 216 study was initiated on 16 November 2022 and the final results are expected to be available by the end of February 2023. The OECD 222 study will be initiated on 23 February 2023 and the final results are expected to be available by the end of June 2023. The dossier will be updated as soon as possible after receiving the final reports.
Cyclaprop and its terrestrial toxicity
Test species | Method | Result EC10 / NOEC (mg/kg soil dw) |
Eisenia fetida | Read across from Verdox tested in OECD TG 222 | 45 (EC10) |
Plants (6 species) | Read across from Verdox tested in OECD TG 208 | 44 (EC10) |
Soil micro-organisms | Read across from Verdox tested in OECD TG 216 | 100 (NOEC) |
Additional information
The PNEC soil for Cyclaprop derived based on Equilibrium Partitioning from aquatic toxicity result in a value of 2.24 mg/kg dw soil, showing similar results as when the PNEC is derived from long-term terrestrial toxicity based on read across from Verdox, which results in a PNEC of 4.4 mg/kg soil dw. Cyclaprop's terrestrial toxicity is derived from Verdox. The read across justification is presented below.
Cyclaprop (Cas no 68912-13-0) and its terrestrial toxicity using read across from Verdox (Cas no 20298-69-5)
Introduction and hypothesis for the analogue approach
Cyclaprop is a propionic ester attached to a tricyclodecenyl fused ring backbone. For this substance no experimental terrestrial toxicity information is available. In accordance with Article 13 of REACH, lacking information can be generated by means of applying alternative methods such as QSARs, grouping and read-across. For assessing the terrestrial toxicity of Cyclaprop the analogue approach is selected because for one closely related analogue reliable soil toxicity information is available.
Hypothesis: Cyclaprop’s terrestrial EC10/NOEC values can be derived from Verdox based on structural similarity and similarity in environmental fate and aquatic toxicity.
Available experimental information: For Verdox, long-term terrestrial toxicity information is available for earthworms (OECD TG 222), plants (OECD TG 208, 6 species) and on soil micro-organisms (OECD TG 216) performed according to current guidelines, which all receive Klimisch 1. The EC10/NOEC values are presented in the Data matrix.
Target chemical and source chemical(s)
Chemical structures of the target chemical and the source chemicals are shown in the data matrix below. Physico-chemical properties thought relevant for aquatic and terrestrial toxicity are listed in the Data matrix.
Purity and impurities
Cyclaprop is a reaction mass and is a mixture of two very similar isomers which differ in the position of the double bond at a 5yl or 6yl-position. The impurities are all below 1%.
Analogue approach justification
According to Annex XI 1.5 read across can be used to replace testing when the similarity can be based on a common backbone and a common functional group. When using read across the result derived should be applicable for C&L and/or risk assessment and it should be presented with adequate and reliable documentation, which is presented below.
Structural similarities and differences: Cyclaprop and Verdox have a hydrocarbon backbone to which the same ester functionality is attached. These backbones have the same number of carbons. The difference is that Cyclaprop has an additional hydrocarbon ring structure in which an unreactive double bond is present, while Verdox has a hydrocarbon tert-butyl group attached to its cyclohexyl ring. In addition, Verdox is an acetic ester while Cyclaprop is a propionic ester.
Bioavailability: Cyclaprop (target) and Verdox (source) have similar bioavailability based on the similarity in chemical structure, molecular weight and log Kow values.
Environmental fate: Cyclaprop and Verdox are both not readily biodegradable and have the same adsorption potential: Log Koc is 3.1.
Mode of action (MoA): Cyclaprop and Verdox have both a hydrocarbon backbone and an ester as functional group and therefore the MoA is the considered the same. As the difference in log Kow between Cyclaprop and Verdox is below 0.5 (4.4 and 4.75, respectively) and log Koc values are 3.1 no conversion of effect levels is needed. This is supported with the aquatic effect levels, which are similar between Cyclaprop and Verdox (see data matrix).
Uncertainty of the prediction: There are no other uncertainties than those already accounted for.
Data matrix
The relevant information on physico-chemical properties and toxicological characteristics are presented.
Conclusions for terrestrial toxicity
For Cyclaprop no terrestrial toxicity information is available, but for the related analogue Verdox long-term terrestrial toxicity is available and read across can be applied. When using read across information, the result derived should be applicable for risk assessment and it should be presented with adequate and reliable documentation, which is presented in the current document. For Verdox long-term terrestrial toxicity is available resulting in EC10/NOECs of 45, 44 and 100 mg/kg dw soil for earthworm, plants and micro-organisms, respectively. This effect levels can be used for Cyclaprop without conversion because the log Kow values are sufficiently similar.
Final conclusion: Cyclaprop has EC10/NOEC values of 45, 44 and 100 mg/kg dw for earthworms, plants and micro-organisms, respectively.
Data matrix supporting the Cyclaprop terrestrial toxicity information using read across from Verdox
Common names |
Cyclaprop |
Verdox |
|
Target |
Source |
Chemical structures |
||
Cas no generic |
68912-13-0 |
20298-69-5 |
EINECS no |
272-805-7 |
243-718-1 |
REACH registration |
Registered |
Registered |
Empirical formula |
C13H18O2 |
C12H22O2 |
Molecular weight |
206 |
198 |
Physico-chemical data |
|
|
Physical state |
liquid |
Liquid |
Melting point (°C) |
< -20 |
29.8 |
Boiling point (°C) |
263 |
232 |
Water solubility |
57 |
10 |
Log Kow |
4.4 |
4.75 |
Fate |
|
|
Log Koc |
3.11 |
3.12 |
Aquatic toxicity |
|
|
Acute fish LC50 mg/L |
6.7 (OECD TG 203) |
5.6 (OECD TG 203) |
Acute invertebrates EC50 in mg/L |
>14 (OECD TG 202) |
17 (OECD TG 202) |
Acute algae EC50 in mg/L |
2.5 (OECD TG 201) |
4.2 (OECD TG 201) |
Chronic fish EC10 in mg/L |
0.86 (OECD TG 210) |
No data |
Chronic invertebrates EC10 in mg/L |
1.0 (OECD TG 211) |
0.99 (OECD TG 211) |
Chronic algae EC10 in mg/L |
1.9 (OECD TG 201) |
0.57 (OECD TG 201) |
Terrestrial toxicity |
|
|
Earthworm (EC10) mg/kg soil dw |
RA Verdox |
45 (OECD TG 222) |
Terrestrial plants (EC10, average of 6 species) mg/kg soil dw |
RA Verdox |
44 (OECD TG 208) |
Micro-organisms (NOEC) mg/kg soil dw |
RA Verdox |
100 (OECD TG 216) |
EPM method mg/kg bw |
2.24 |
In absence of experimental long-term fish toxicity this is not calculated. |
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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