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EC number: 246-376-1 | CAS number: 24634-61-5
- 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: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Justification for type of information:
- Since sorbic acid is the corresponding acid to potassium sorbate, the substance in question, extrapolation of the obtained results is not considered to be restricted.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2003-12-08
- Specific details on test material used for the study:
- Name: Sorbic acid
Batch/ Lot number: 0000005661
GAB code: 20021004
Chemical name: trans, trans-2,4-hexadienoic acid
CAS number of a.s.: 110-44-1
Purity (nominal): 99 - 101 %
Purity (analysed): 99.8 %
Certificate of analysis: 13/03/2001
Expiry date: 11/03/2004
Appearance / Colour:
Storage conditions: cristalline powder / white
Control: deionized water
cristalline powder / white - Analytical monitoring:
- no
- Details on sampling:
- not applicable
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil (if used): Pre-mixing with 10 g of quartz sand.
- Method of application to soil surface (if used): Direct blending of the sand/test substance mixture with dry artificial soil. Adjustment of soil moisture content to 35 % with deionised water. - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Age at test initiation (mean and range, SD): 2–12 months
- Weight at test initiation (mean and range, SD): 300–600 mg
ACCLIMATION
- Acclimation period: 24 h acclimation to the untreated test substrate - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 14 d
- Post exposure observation period:
- no data
- Test temperature:
- 19–22 °C
- pH:
- 5.6–6.1
- Moisture:
- 29.7–35.3 %
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 1 L glass jars
- Amount of soil or substrate: 0.75 kg wet weight/container
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 10 % sphagnum peat (pH 5.5–6.0), ‘Floratorf’, Floragard Vertriebs GmbH für Gartenbau, Oldenburg, Germany;
20 % kaolin clay (kaolinite content above 30 %), ‘Kaolin W gemahlen’, Erbslöh GmbH & Co.KG, Geisenheim, Germany; 69 % industrial sand, ‘Dorfner Quarzsand Nr. 9’, Goldmann Baustoffe GmbH & Co. KG, Pforzheim, Germany; approx. 1 % calcium carbonate – precipitated extra pure (soil pH adjusted to 6.0 ± 0.5 at the start of the test before adding the test item), Merck, Darmstadt, Germany
- Pre-treatment of soil: Dry components blended in an electric mixer.
- pH adjustment: Yes, prior to addition of the test substance by adding calcium carbonate .
OTHER TEST CONDITIONS
- Photoperiod: continuous lighting
- Light intensity: Artificial light, approx. 600 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, lack of motility, burrowing activity, colour changes by visual examination 7 and 14 days after start of exposure
VEHICLE CONTROL PERFORMED: no
TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 10, 100, 200, 500, 1000 mg/kg soil dry weight
- Results used to determine the conditions for the definitive study: yes - Nominal and measured concentrations:
- 350, 455, 592, 769, 1000 mg/kg soil dry weight
- Reference substance (positive control):
- yes
- Remarks:
- 2-chloroacetamide, 99.1 % purity, concentrations: 10, 18, 32, 56, 100 mg/kg
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- 675 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: 95 % CL = 647–703 mg/kg
- Key result
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 455 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC100
- Effect conc.:
- 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- - Range-finding study: No mortality up to 500 mg/kg.
- Controls: No control mortality.
- Mortality at end of exposure period: n=6 (592 mg/kg group), n=34 (769 mg/kg soil group) and n=40 (1000 mg/kg soil group)
- Changes in body weight of live adults (% of initial weight) at end of exposure period: There were no significant differences in body weight development.
- Morphological abnormalities: none
- Behavioural abnormalities: none
- Other biological observations: none - Results with reference substance (positive control):
- LC50 was in the range between 10 and 18 mg/kg, thus corroborating the suitability of the test system.
- Reported statistics and error estimates:
- Body weight changes: ANOVA with Bonferroni test
LC50: Spearman-Kärber estimator - Validity criteria fulfilled:
- yes
- Remarks:
- Mortality of control animals < 10% . Since no deviations from the guidelines or other unusual circumstances were reported, the test was considered valid and reliable.
- Conclusions:
- Sorbic acid did not cause any adverse effects, mortality or effects on body weight up to concentrations of 455 mg/kg. The LC50 (14 d) was calculated as 675 mg/kg soil dw (647-703). Since the sorbate anion in the (eco-) toxicologically relevant moiety and its presence in dissociated or non-dissociated form is entirely determined by pH, extrapolation to potassium sorbate, the substance in question, is not considered to be restricted.
- Executive summary:
The study according to the OECD 207 Guidelines was conducted with earthworms (Eisenia fetida), from in-house culture, adult worms (with clitellum, weight> 300 mg < 600 mg) less than one year old exposed to Sorbic Acid at 350, 455,592, 769, 1000 mg/kg soil for 14 days. Worm mortality and behavioural effects at 7 and 14 d were assessed and weight chages were measured. The LC50 was determined to be 675 mg/kg soil dry weight.
Reference
Table 3: Earthworm mortality after 14 d of exposure to sorbic acid in the range-finding test; n= 10 earthworms/replicate.
Sorbic acid [mg/kg]1) |
Number of dead earthworms |
Mortality [%] |
0 (control)2) |
0 |
0 |
10 |
0 |
0 |
100 |
0 |
0 |
200 |
0 |
0 |
500 |
0 |
0 |
10002) |
56 |
93.3 |
1)based on soil dry weight |
Table 4: Mortality data (main test).
Test substance |
Mortality |
|||
Number |
Percentage |
|||
7 d |
14 d |
7 d |
14 d |
|
Control |
0 |
0 |
0 |
0 |
350 |
0 |
0 |
0 |
0 |
455 |
0 |
0 |
0 |
0 |
592 |
5 |
6 |
12.5 |
15 |
769 |
33 |
34 |
82.5 |
85 |
1000 |
40 |
40 |
100 |
100 |
Temperature [°C]: |
19–22 °C |
|||
pH: |
seeTable 2 above |
|||
Moisture content: |
seeTable 1 above |
Description of key information
LC50 = 675 mg/kg soil dry weight (Eisenia fetida, 14 days)
NOEC = 455 mg/kg soil dry weight (Eisenia fetida, 14 days)
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 864 mg/kg soil dw
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 582 mg/kg soil dw
Additional information
In an acute toxicity tests with earthworms, the 14 -day LC-50 of sorbic acid was 675 mg/kg soil dry weight and the 14 -day NOEC was 455 mg/kg soil dry weight. Within the evaluation under the Biocidal Products Directive 98/8/EEC, the rapporteur member state Germany recalculated these endpoints to potassium sorbate, resulting in a 14 -day LC50 of 864 mg/kg soil dry weight and a NOEC of 582 mg/kg soil dry weight.
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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