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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-108-6 | CAS number: 60209-82-7
- 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
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:
- key study
- Study period:
- 14 Nov - 10 Jan 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- 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): The stock solutions were prepared in ethanol. The concentrations were calculated so that the test item treatments were achieved by adding 2.0 mL of stock solution to 10 g of sand. Ethanol was then allowed to evaporate and the coated sand was mixed with the soil. De-ionised water was added to moisten the soil up to 45-55% of its total water holding capacity.
- Controls: yes, water control
- Chemical name of vehicle: ethanol
- Evaporation of vehicle before use: yes - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: earthworm
- Source: Adult specimens born at the laboratory site.
- Age at test initiation (mean and range, SD): Older than 2 months, and younger than one year. The specimens did not differ in age by more than 4 weeks.
- Weight at test initiation (mean and range, SD): 300 - 600 mg (acute toxicity test), 250 - 600 mg (reproduction test) - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Test temperature:
- 20 ± 2 °C
- pH:
- 5.9 - 6.3 (study initiation)
5.1 - 5.7 (study termination) - Moisture:
- Moisture of the soil substance was controlled to represent 44.8% of the soil total water holding capacity at the end of the test.
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 2 L glass containers covered with plastic mesh
- Amount of soil or substrate: 500 g dw artificial soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
- No. of replicates per vehicle control: 8
SOURCE AND PROPERTIES OF SUBSTRATE
- Composition (if artificial substrate): Sphagnum peat (grounded and sieved): 10%; kaolinite clay: 20%; quartz sand 150-210 µm: 70%. Calcium carbonate (CaCO3) was added to each container that was previously calculated to give a pH value of 6.0 ± 0.5, in the control.
- Maximum water holding capacity (in % dry weigth): calculated according to ISO 11274 (1992). Result not given in the report.
OTHER TEST CONDITIONS
- Photoperiod: continuous light (acute test), 16 h light / 8 h dark (reproduction test)
- Light intensity: 400 - 800 lux
EFFECT PARAMETERS MEASURED: mortality, mean weight, number of juveniles
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study
- Test concentrations: water control, solvent control, 0.1, 1.0, 10.0, 100.2, 1001.6 mg/kg
- Results used to determine the conditions for the definitive study: No mortality was observed after 7 and 14 d. A NOEC (biomass) of 100.2 mg/kg dw resulted. The definitive test was thus performed as a definitive test for test item treatments between approx. 10 and 1000 mg/kg. - Nominal and measured concentrations:
- nominal: water control, solvent control, 16.3, 29.3, 52.8, 95.0, 171.4, 308.6, 555.4, 999.9 mg/kg
- Reference substance (positive control):
- yes
- Remarks:
- Carbendazim
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 29.3 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 52.8 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 56 d
- Dose descriptor:
- EC50
- Effect conc.:
- 132.4 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: 95% CI: 33.0 - 531.2 mg/kg soil dw
- 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:
- mortality
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 308.6 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: biomass
- Details on results:
- - Mortality at end of exposure period: 0%
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: > 100% up to a concentration of 308.6 mg/kg; 87.4% (555.4 mg/kg); 62.4% (999.9 mg/kg) compared to the initial biomass.
- No. of offspring produced: In the water control group, the mean number of juveniles was 309.5 per unit with a relative standard deviation of 15.4%. The solvent control gave similar values. Mean number of juveniles was 269.0. Statistical analysis did not indicate a significant reduction of juveniles. Therefore, both control were pooled and resulted in a mean value of juveniles/unit of 289.3 with a standard deviation of 8.8%. Statistical analysis showed that the reproductive performance was similar to the controls for the two lowest test concentrations. For the six highest test item treatments the production of juveniles was considered as significantly reduced. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: The EC50 value for Carbendazim was between 1 and 5 mg/kg soil. - Reported statistics and error estimates:
- F-variance analysis at 5% confidence level served to judge upon significant deviation of the number of juveniles as compared to that of the control group. The percentage of inhibition for the production of juveniles as compared to the controls was plotted against Log concentration of the corresponding soil concentration. The regression analysis was performed using Excel spreadsheet. The resulting regression curve was used for the calculation of the concentration susceptible to induce 50% reduction of the reproductive performance and its statistical 95% confidence internval.
Reference
Table 1: Number of juveniles at the end of the test period.
Concentration |
Replicates |
Mean ± SD |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
||
Water control |
388 |
311 |
321 |
335 |
303 |
321 |
275 |
222 |
309.5 ± 47.8 |
Solvent control |
220 |
326 |
220 |
345 |
250 |
294 |
260 |
237 |
269.0 ± 47.7 |
Test item |
|
|
|
|
|
|
|
|
|
16.3 mg/kg |
262 |
336 |
283 |
220 |
- |
- |
- |
- |
275.3 ± 48.2 |
29.3 mg/kg |
313 |
242 |
323 |
267 |
- |
- |
- |
- |
286.3 ± 38.3 |
52.8 mg/kg |
120 |
181 |
135 |
189 |
- |
- |
- |
- |
156.3 ± 33.9 |
95.0 mg/kg |
156 |
129 |
180 |
204 |
- |
- |
- |
- |
167.3 ± 32.2 |
171.4 mg/kg |
117 |
136 |
129 |
164 |
- |
- |
- |
- |
136.5 ± 19.9 |
308.6 mg/kg |
118 |
133 |
175 |
156 |
- |
- |
- |
- |
145.5 ± 25.1 |
555.4 mg/kg |
11 |
14 |
0 |
26 |
- |
- |
- |
- |
12.8 ± 10.7 |
999.9 mg/kg |
0 |
0 |
0 |
0 |
- |
- |
- |
- |
0.0 ± 0.0 |
Carbendazim |
|
|
|
|
|
|
|
|
|
1.0 mg/kg |
201 |
216 |
134 |
163 |
- |
- |
- |
- |
178.5 ± 37.1 |
2.0 mg/kg |
127 |
83 |
42 |
94 |
- |
- |
- |
- |
86.5 ± 35.1 |
5.0 mg/kg |
0 |
0 |
0 |
0 |
- |
- |
- |
- |
0.0 ± 0.0 |
Table 2: Mean biomass deviation over the 4-week exposure period for the adults
Treatment |
Body weight deviation |
Water control |
107.3% |
Sovlent control |
105.3% |
Test item concentration |
|
16.3 mg/kg |
103.7% |
29.3 mg/kg |
113.3% |
52.8 mg/kg |
113.1% |
95.0 mg/kg |
105.3% |
171.4 mg/kg |
117.2% |
308.6 mg/kg |
110.4% |
555.4 mg/kg |
87.4% |
999.9 mg/kg |
62.4% |
Carbendazim |
|
1.0 mg/kg |
100.2% |
2.0 mg/kg |
64.8% |
5.0 mg/kg |
-4.6% |
Description of key information
NOEC (56 d) 29.3 mg/kg dry weight based on reproduction of Eisenia fetida (OECD 222)
Key value for chemical safety assessment
Additional information
One study is available investigating the long-term effects of isodecyl pivalate (CAS 60209-82-7) to earthworms. The study was performed according to OECD 222 under GLP-conditions and the effects of the test substance on reproduction, mortality and biomass of Eisenia fetida were recorded. A preliminary range-finding test did not result in any mortality up to 1001.6 mg/kg dry weight after 14 d. Based on this result, the definitive test was performed with eight concentrations (4 replicates) up to a concentration of 999.9 mg/kg dry weight including a water and solvent control. After 56 d no mortality was observed whereas a significant reduction of biomass was recorded at concentrations above 308.6 mg/kg dry weight and a signification reduction of reproduction was observed at concentrations above 29.3 mg/kg dry weight. Thus, a NOEC (56 d) of 29.3 mg/kg dry weight was derived for reproduction. Reproduction was the most sensitive endpoint since the NOEC (56 d) for mortality was ≥ 1000 mg/kg dry weight and 308.6 mg/kg dry weight for biomass, respectively.
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.