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EC number: 824-962-3 | CAS number: 14488-58-5
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is carried out in accordance to OECD guideline 202 and is GLP compliant.
- Justification for type of information:
- Please see attached read across justification for full details of the read across approach.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- In the range-finding test the Total Organic Carbon concentration was determined with the TOC instead of NPOC method. As this is an equivalent alternative it was not considered to affect the outcome of the test.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- yes
- Remarks:
- In the range-finding test the Total Organic Carbon concentration was determined with the TOC instead of NPOC method. As this is an equivalent alternative it was not considered to affect the outcome of the test.
- Principles of method if other than guideline:
- Combined limit/range finding study.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: A058/99
- Expiration date of the lot/batch: 6 March 2018
- Purity test date: Not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: None
- Final preparation of a solid: None - Analytical monitoring:
- yes
- Details on sampling:
- The confirmatory chemical analysis was based on the concentration of the fatty acid component (azelate) and on the concentration of the lithium ion. The concentration of total organic carbon (TOC) was also measured.
Samples for analysis were taken from the control and the 100 mg/L treatment at the start of the test and after 48 hours of exposure and stored in a refrigerator (TOC) or freezer (lithium and azelate) until analysis.
For the determination of the test substance based on azelate, the samples were diluted in a 1:1 (v:v) ratio with 2% formic acid in acetonitrile and analysed. If necessary, the samples were further diluted with 1% formic acid in 50/50 (v/v) acetonitrile/ISO-medium to obtain concentrations within the calibration range.
For the determination of the test substance based on lithium, the samples were diluted in a 24:1 (v:v) ratio with HNO3 and analysed. If necessary, the samples were further diluted with 4% HNO3 in ISO-medium to obtain concentrations within the calibration range. - Vehicle:
- no
- Details on test solutions:
- Nominal concentrations: 0.10, 1.0, 10 and 100 mg/L
Medium: Adjusted ISO medium
Solubility: The test item was completely soluble in test medium at the concentrations tested.
Preparation of test solutions: A solution with a concentration of 100 mg/L with vigorous shaking. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
Appearance: The final test solutions were all clear and colourless. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Source: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions from an in-house laboratory culture with a known history.
Batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress.
Age: Young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- Not reported. Breeding water: 180 mg CaCO3/L
- Test temperature:
- 20-21°C
- pH:
- pH 7.8-8.0
- Dissolved oxygen:
- 8.9-9.0 mg/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal concentrations: 0.1, 1, 10 and 100 mg/L.
The measured concentrations based on azelate were at the level of 91-93% of nominal during the exposure period.
The measured concentrations based on lithium were at the level of 99-101% of nominal during the exposure period.
The measured concentrations at 0h were 0.065 and 56 mg TOC/L and at 48h they were 0.17 and 55 mg TOC/L for the control and the highest concentration respectively. The TOC remained relatively stable throughout the test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL
- Material, fill volume: Glass, 80 mL
- Aeration: No aeration of test solutions
- No. of organisms per vessel: 5
- No. of daphnids per concentration: 20 for control and limit concentration, 10 for lower concentrations
-Introduction of daphnids: Within 39 minutes of preparation of the test solutions
OTHER TEST CONDITIONS
- Photoperiod: 16 hours
- Feeding: No feeding - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The 48h-EC50 exceeded the nominal concentration of 100 mg/L.
- Results with reference substance (positive control):
- The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of the Daphnia was within the range determined with the historical data collected at WIL Research Europe.
- Reported statistics and error estimates:
- Not reported.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No EC50 could be calculated because the test substance did not cause a significant difference to the mobility of the Daphnia magna (EC50 > 100 mg/L, the maximum concentration tested).
- Executive summary:
The effect of dilithium azelate on the mobility of the Daphnia Magna was investigated according to an OECD 202 guideline and EC method C2. A 48 hour combined range finder / limit test was conducted at 0.1, 1, 10 and 100 mg/L under static conditions. At the start of the test all solutions were clear and colourless. Analysis of the fatty acid (azelate) was between 91 and 93% nominal and the lithium concentration was between 99 and 101% of nominal throughout the test. The total organic carbon (TOC) measured at the start of the test was 56 mg/L and at the end of the test was 55 mg/L for the highest test concentration. The test concentrations were considered to be maintained and the results are reported based on nominal concentrations. The study met all the validity criteria for the test. As no effects on the mobility of Daphnia Magna were observed in the test the EC50 is > 100 mg/L dilthium azelate.
Reference
Time (h) |
Replicate |
Nominal concentration Dilithium azelate (mg/L) |
||||
Control |
0.10 |
1.0 |
10 |
100 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
|
|
|
5 |
|
D |
5 |
|
|
|
5 |
|
Total introduced |
20 |
10 |
10 |
10 |
20 |
|
24 |
A |
0 (1) |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
|
|
|
0 |
|
D |
0 |
|
|
|
1 |
|
Total immobilised |
0 |
0 |
0 |
0 |
1 |
|
Effect % |
0 |
0 |
0 |
0 |
5 |
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
|
|
|
0 |
|
D |
0 |
|
|
|
1 |
|
Total immobilised |
1 |
0 |
0 |
0 |
1 |
|
Effect % |
5 |
0 |
0 |
0 |
5 |
Parameter |
Nominal concentration Dilithium azelate (mg/L) |
24-48h-EC50 |
>100 |
Concentration K2Cr2O7 (mg/L) |
Number Exposed |
% immobile |
Expected response (%) After 48 hours1 |
|||
24h |
48h |
Minimal |
Maximal |
|||
control |
20 |
0 |
0 |
0 |
102 |
|
0.10 |
20 |
0 |
0 |
0 |
10 |
|
0.18 |
20 |
0 |
0 |
0 |
10 |
|
0.32 |
20 |
0 |
10 |
0 |
30 |
|
0.56 |
20 |
10 |
100 |
0 |
100 |
|
1.0 |
20 |
95 |
100 |
40 |
100 |
|
1.8 |
20 |
100 |
100 |
100 |
100 |
( ) between brackets: number of Daphnia observed trapped at the surface of the test solutions. This organism was reimmersed into the respective solution before recording of mobility.
1 – Based on historical data of the previous years (n>60).
2 – A maximum response of 10% does not invalidate the results of the test.
Description of key information
Calcium azelate is considered not toxic to aquatic invertebrates based on data read across from the structural analogue, dilithium azelate. No EC50 could be calculated because the test substance did not cause a significant effect on the mobility of the Daphnia magna (EC50 > 100 mg/L, the maximum concentration tested).
Key value for chemical safety assessment
Additional information
Data to assess the toxicity of calcium azelate to aquatic invertebrates has been read across from the structural analogue dilithium azelate. The effect of dilithium azelate on the mobility of the Daphnia magna was investigated according to an OECD 202 guideline in a 48 hour combined range finder / limit test at 0.1, 1, 10 and 100 mg/L under static conditions (Tabor-Kaplon 2015). At the start of the test all solutions were clear and colourless. The test concentrations were considered to be maintained, with analysis of the azelate being between 91 and 93% nominal and the lithium concentration between 99 and 101% of nominal throughout the test. The total organic carbon (TOC) was measured in the highest test concentration (start of the test 56 mg/L and end of the test 55 mg/L). The test results are reported based on nominal concentrations and, as no effects on the mobility of Daphnia magna were observed, the EC50 is > 100 mg/L.
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