Registration Dossier
Registration Dossier
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: 813-120-0 | CAS number: 1262967-45-2
- 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:
- 29 August - 29 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark and under nitrogen.
- Stability under test conditions: Asumed stable .
- Solubility and stability of the test substance in the solvent/vehicle: Acetone stock solution prepared at 300 mg/mL
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: N/A
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material): Solubilised in an acetone stock solution which was incorporated into quartz sand and mixed with the artificial soil.
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): N/A
OTHER SPECIFICS: No - Analytical monitoring:
- no
- Details on sampling:
- N/A
- Vehicle:
- yes
- Details on preparation and application of test substrate:
- - Method of application to filter paper (if used): N/A
- Method of mixing into soil (if used): An aliquot (16 mL) of an acetone stock solution was added to quartz sand and mixed. The sand was incorportated into the artificial soil and homgenised.
- Method of application to soil surface (if used): N/A
- Controls: Solvent control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Concentration of vehicle in test medium (stock solution and final test solution): 16 mL acetone added to 4720 g soil (dry weight) i.e. 0.003 % v/w.
- Evaporation of vehicle before use: Not reported - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Eisenia foetida (redworm)
- Source: Chenggong Earthworm Raising Farm, Dongli District, Tianjing, China.
- Age at test initiation (mean and range, SD): > 2 months old
- Weight at test initiation (mean and range, SD): 300 - 430 g
ACCLIMATION
- Acclimation period: Not reported
- Acclimation conditions (same as test or not): Not reported
- Health during acclimation (any mortality observed): Not reported - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 28 d
- Test temperature:
- 18.16 - 19.50 ºC
- pH:
- 5.53 - 5.62
- Moisture:
- 35 %
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Container measuring 19 cm x 12 cm x 9 cm (H x L x W)
- Amount of soil or substrate: 750 g wet weight
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 8
- No. of replicates per control: 0
- No. of replicates per vehicle control: 8
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Artificial soil prepared as per OECD guidance. Adjusted and maintained at 35 % moisture content with deionised water for the duration of the test.
OTHER TEST CONDITIONS
- Photoperiod: 16:8 light: dark
- Light intensity: 400-800 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Adult mortality, weight and sub-lethal effects, reproduction
VEHICLE CONTROL PERFORMED: Yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A, limit test.
- Justification for using less concentrations than requested by guideline: Limit test
- Range finding study: No
- Test concentrations: N/A
- Results used to determine the conditions for the definitive study: N/A - Nominal and measured concentrations:
- Nominal: 1000 mg/kg dry weight
- Reference substance (positive control):
- no
- Key result
- Duration:
- 28 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- 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:
- reproduction
- Details on results:
- - Mortality at end of exposure period:
No adult mortality was observed during the test.
- Total mass of adults at beginning of test: 300-430 g
- Changes in body weight of live adults (% of initial weight) at end of exposure period: +12 % and +7 % in the control and 1000 mg/kg groups, respectively
- No. of offspring produced: 51.8 and 42.1 for the control and 1000 mg/kg groups, respectively (mean values).
- No. of unhatched cocoons: Not reported
- Morphological abnormalities: Some cocoons in the 1000 mg/kg test grup looked smaller vs the control group.
- Behavioural abnormalities: No
- Other biological observations: No - Validity criteria fulfilled:
- yes
- Conclusions:
- The 28 day LC50 was > 1000 mg/kg dry soil weight. The 28 day NOEC for reproduction was 1000 mg/kg dry soil weight.
- Executive summary:
OECD 222 (2012) - In a 28-day reproduction toxicity study, earthworms (Eisenia foetida) were exposed to Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid at a nominal concentration of 1000 mg a.i./kg dry weight of artificial soil in a limit test. The experiment was carried out in accordance with the OECD 222 testing guideline.
The test item was solubilized in acetone, an aliquot of which was mixed with quartz sand and incorporated in the artificial soil, prepared in accordance with the testing guideline. The soil was adjusted and maintained at 35 % moisture content throughout the testing period using deionized water. A solvent control was also prepared and run in parallel with the treated soil group.
At Day 28, the number of surviving adults was determined. It was noted that there was no mortality observed in any of the control or test replicates. The LC50 was therefore estimated to be >1000 mg/kg dry weight soil. No sub-lethal effects or significant weight gain changes were observed in the treated group versus the control.
The number of cocoons and juveniles produced in the control and test group was counted. No adverse effects on reproduction was observed and the NOEC was concluded to be 1000 mg/kg dry soil.
This study is classified as acceptable and satisfies the guideline requirements for a chronic reproduction toxicity study with earthworms.
Reference
Table 1 Earthworm weights
Concentration (mg/kg dry soil) |
Mean weight of earthworms ± sd (g) |
% Increase |
|
Day 0 |
Day 28 |
||
Control |
338.0 ± 36.9 |
378.2 ± 62.6 |
+12 |
1000 |
343.9 ± 34.0 |
368.4 ± 46.3 |
+7 |
Table 2 Adult earthworm mortality
Concentration (mg/kg dry soil) |
Mean surviving adults |
Mean % mortality |
Sub-lethal effects |
Control |
10 |
0 |
None |
1000 |
10 |
0 |
None |
Table 3 Juvenile worms
Concentration (mg/kg dry soil) |
Rep |
Adult worm number |
Cocoon number |
Total juvenile worms |
Mean number of juvenile worms ± sd |
Reproductive abnormalities |
Control |
1 |
10 |
16 |
47 |
51.8 ± 14.6 |
None |
2 |
10 |
17 |
50 |
|||
3 |
10 |
15 |
42 |
|||
4 |
10 |
13 |
37 |
|||
5 |
10 |
13 |
42 |
|||
6 |
10 |
23 |
73 |
|||
7 |
10 |
24 |
76 |
|||
8 |
10 |
14 |
47 |
|||
1000 |
1 |
10 |
15 |
44 |
42.1 ± 7.2 |
Some cocoons looked smaller vs control |
2 |
10 |
16 |
46 |
|||
3 |
10 |
19 |
55 |
|||
4 |
10 |
11 |
30 |
|||
5 |
10 |
13 |
42 |
|||
6 |
10 |
14 |
43 |
|||
7 |
10 |
14 |
39 |
|||
8 |
10 |
13 |
38 |
Description of key information
28 d LC50: >1000 mg/kg dw soil; OECD 222; Hairong, Y. (2012)
28 d NOEC (reproduction): => 1000 mg/kg dw soil; OECD 222; Hairong, Y. (2012)
Key value for chemical safety assessment
Additional information
OECD 222 (2012) - In a 28-day reproduction toxicity study, earthworms (Eisenia foetida) were exposed to Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid at a nominal concentration of 1000 mg a.i./kg dry weight of artificial soil in a limit test. The experiment was carried out in accordance with the OECD 222 testing guideline.
The test item was solubilized in acetone, an aliquot of which was mixed with quartz sand and incorporated in the artificial soil, prepared in accordance with the testing guideline. The soil was adjusted and maintained at 35 % moisture content throughout the testing period using deionized water. A solvent control was also prepared and run in parallel with the treated soil group.
At Day 28, the number of surviving adults was determined. It was noted that there was no mortality observed in any of the control or test replicates. The LC50 was therefore estimated to be >1000 mg/kg dry weight soil. No sub-lethal effects or significant weight gain changes were observed in the treated group versus the control.
The number of cocoons and juveniles produced in the control and test group was counted. No adverse effects on reproduction was observed and the NOEC was concluded to be 1000 mg/kg dry soil.
This study is classified as acceptable and satisfies the guideline requirements for a chronic reproduction toxicity study with earthworms.
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.
