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EC number: 268-596-7 | CAS number: 68130-53-0
- 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
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 25 Oct 2012 - 20 Feb 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. For read-across, maximum reliability score is 2.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on preparation and application of test substrate:
- - Method of mixing into soil (if used): A stock solution was prepared by dissolving the test substance in aceton (250 mg test substance/mL acetone). A serial dilution of the stock solution was prepared for the required test substance concentrations. The solutions were subsequently mixed with sand. The mixture was added to 496.4 g ww of artificial soil. 2.8 g calcium carbonate, 5 g food (horse manure), and 143.6 mL purified water were added and the substate was mixed in a laboratory mixer.
- Chemical name of vehicle: acetone
- Evaporation of vehicle before use: yes - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Source: Blades Biological Ltd, Cowden, United Kingdom
- Age at test initiation: adult, with clitellum
- Weight at test initiation (range): 310 - 594 mg
ACCLIMATION
- Acclimation period: 3 days
- Acclimation conditions : same as in test - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Remarks:
- After 28 days the adult earthworms were removed and the cocoons and juveniles remained in the test substrate for another 28 days
- Test temperature:
- 19 - 22 °C
- pH:
- 6.1 - 6.3
- Moisture:
- 33-41% of water holding capacity (WHC: 64.2 g /100 g dry soil).
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Plastic boxes (16.5 cx 12 x 6.5 cm, area about 200 cm2)
- Amount of soil or substrate: 650 g
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8 (incl. vehicle control)
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 10% Sphagnum peat, 20% Kaolin clay, 69% Sand
OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day-night regime
- Light intensity: 656-749 Lux
EFFECT PARAMETERS MEASURED:
Mortality and body weight of adult earthworms after 28 days, reproduction rate after 56 days - Nominal and measured concentrations:
- Nominal test substance concentrations: 62.5, 125, 250, 500 and 1000 mg/kg dry soil.
- Reference substance (positive control):
- yes
- Remarks:
- Carbendazim, Batch No.: 12001/03
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality at end of exposure period: control: no mortality observed; test substance: <2.5%
- Results with reference substance (positive control):
- 75% mortality at a reference substance concentration of 8.33 mg/kg dry soil
- Reported statistics and error estimates:
- Changes in body weight and differences regarding mortalilty between treatment and control were evaluated by multiple Dunnett t-test (Dunnett, 1955; Dunnett, 1964) after a one-way analysis of variance (ANOVA).
The body weight change of the surviving worms in the positive control was compared to the control and was statistically evaluated by means of a Student-t test (Sachs, 1984).
Reproduction rates were analysed using a multiple Dunnett t-test [Dunnett, 1955; Dunnett, 1964] after a one-way analysis of variance (ANOVA).
Reference
Mortality, number of hatched juveniles and changes in body weight
Treatment (mg/kg dry weight) |
Mortality (%) after a 4-week exposure |
Juveniles per vessel (mean) |
Juvenils per vessel (% of control) |
Mean body weight per worm (% difference from test start) |
Control |
0 |
168 |
100 |
9 |
62.5 |
0 |
137 |
81 |
17 |
125 |
0 |
141 |
84 |
14 |
250 |
2.5 |
150 |
90 |
15 |
500 |
2.5 |
155 |
92 |
17 |
1000 |
0 |
152 |
90 |
14 |
Reference substance |
7.5 |
0 |
0 |
-54 |
Description of key information
No relevant studies are available for decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane. An earthworm reproduction study is available for read-across substance, CAS 78-16-0.
As discussed in ECHA Decision number CCH-D-2114343360-61-01/F, ECHA notes that additional toxicity testing on fish and aquatic invertebrates is being requested as part of the present Decision and the results of these tests may subsequently allow the derivation of PNECwater. If the results allow the subsequent derivation of a PNECwater, the Registrant may consider the ITS as recommended in section R.7.11.6., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (May 2008), and determine the need for further testing on terrestrial organisms. In this case it may be possible to waive the corresponding terrestrial toxicity tests by including a justified argument for adaptation of Annex IX, 9.4.3. and Annex X, 9.4.6. or of Annex IX, 9.4.1. and Annex X, 9.4.4. in the registration dossier.
As discussed above, the Daphnia study is still in progress due to significant analytical issues. Once the study is completed, then the ITS will be evaluated, and determined if these studies are actually required. On the basis of existing study data, the substance is considered to be non-toxic and biodegradable. Structural analogues do not show toxicity, nor does existing study data on soil micro-organisms. The registrant considers that it is highly likely that the ITS will demonstrate this fact. Therefore a decision on whether to conduct these tests or not will be taken once the ITS investigation can be completed.
Key value for chemical safety assessment
Additional information
An earthworm reproduction study (in accordance with OECD Guideline 222) was conducted with read-across substance, CAS 78-16-0. The NOEC (28 day) based on mortality was determined to be =/> 1000 mg/kg soil dw and the NOEC (56 day) based on reproduction was determined to be =/> 1000 mg/kg soil dw. Therefore, by read-across, the test substance is not expected to have toxic effects on soil macroorganisms.
A report justifying the read-across approach is included in IUCLID Chapter 13.
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.