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EC number: 700-937-1 | CAS number: 1312021-45-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August-14-16, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was performed according to GLP requirements. Chemical analysis was performed at a laboratory approved by the Swedish Medical Products Agency to be in compliance with Good Manufacturing Practice according to GMP guidelines laid down in Directive 2003/94/EC.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- EU Method C.2. Acute toxicity for daphnia
- Deviations:
- no
- Remarks:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0,2,5,10,20,50 mg/L
- Sampling method:Samples were collected from test solutions at t(0), t(24h) old and new solutions, t(48h) termination of test
- Sample storage conditions before analysis: Samples of 40 ml were stored in 50 ml glass bottles and stored at -20°C +/- 2.0°C - Vehicle:
- no
- Details on test solutions:
- Test medium: ISO-medium prepared from MQ water and salts were added to the water according to the standard procedure. pH was 7.9 and hardness was 250 +/- 25 mg/L expressed as CaCO3.
Test solutions: Stock solution of 50mg/L was prepared at t(0) and t(24) by weighing out 50 mg of test product and dissolving it in 1 L of test medium. pH was adjusted from 7.4-7.9 at t(0) and from 7.3-7.7 (t=24h) with one droplet of 1 M NaOH. The test solutions of minor concentrations were prepared by diluting appropate amounts of the stock solution in the test medium. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus
- Source: Langedam, Birkerod, cultured at DHI since 1979
- Age at study initiation (mean and range, SD): < 24 h - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 250 +/- 25 mg/L expressed as CaCO3
- Test temperature:
- 20.3 +/- 0.4°C
- pH:
- 7.8 - 8.0
- Dissolved oxygen:
- Start: 100% saturation
End: 99% saturation - Salinity:
- n.a.
- Nominal and measured concentrations:
- Nominal concentrations: 0, 2,5,10,20 and 50 mg/L
Measured concentration: (Average based on measurement of 10,20 and 50 mg/L nominal concentration at 0,24(old/fresh) and 48h , n=4))
10.6, 27.4, 46,5 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 50 ml glass beakers with 25 ml of test solution
- Type (delete if not applicable): closed
- Aeration: none
-Renewal rate of test solution (frequency/flow rate): At t(24h) the test solution were renewed
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates): 6
- Biomass loading rate: ca. 1 daphnia/5 ml test medium
TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: none
- Light intensity: total darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation at t(24h) and t(48h)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: n.a. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr2O7)
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 29 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- mobility
- Remarks on result:
- other: 25-32
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 34 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- mobility
- Remarks on result:
- other: 30-42
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 21 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: n.d.
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 27 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 22-n.d.
- Details on results:
- - Behavioural abnormalities: none
- Mortality of control: 0
- Other adverse effects control: none
- Abnormal responses: no
- Effect concentrations exceeding solubility of substance in test medium: no, water solubility of test substance is 0,12 g/L - Results with reference substance (positive control):
- EC10 (24h): 1.1 mg/L
EC50 (24h): 1.6 mg/L
Validity is fulfilled. The EC50 value (24h) of the reference substance potassium chromate is within the range specified in ISO 6341 (0.6-2.1 mg/L) - Reported statistics and error estimates:
- EC values for test product and reference substance were calculated by use of the standard procedure Probit Analysis.
Chi-square statistic for heterogeneity of variance is calculated, and the tablular value at the 0.05 level.
Estimated EC10 and EC50, and associated 95% confidence limits - Validity criteria fulfilled:
- yes
- Remarks:
- please refer to "Any other information on results incl. tables"
- Conclusions:
- EC10 (24h): 33 mg/l
EC 10 (48h): 29 mg/L
EC50 (24h): 29 mg/L
EC50 (48h): 34 mg/L - Executive summary:
The test was performed to specify the acute toxic effects of the reaction products of racemic lactic acid, partially neutralized with sodium hydroxide, and decanoic acid and dodecanoic acid on the crustacean Daphnia magna. The test was carried out in fully accordance with OECD 202 Daphnia sp.; Acute immobilization test further specified in ISO Standard 6341 Water quality - determination of the inhibition of the mobility of Daphnia magna STRAUS (Cladocera, Crustacea)-Acute toxicity test.
OECD 202 also corresponds to EU testing Method C.2. Acute toxicity for daphnia.
Number of immobilized animals was recorded after 24h and 48 h.
Postive control was performed by using Potassium dichromate.
No deviations to study protocol are documented.
Result: EC 50 (24h): 29 mg/L; EC 50(48h): 34 mg/L
Reference
Table 1 Test results
Nominal concentration [mg/L] |
Total number of animals per concentration |
Number of immobile after 24 h |
Number of immobile after 48 h |
Control |
30 |
0 |
0 |
2 |
20 |
0 |
0 |
5 |
20 |
0 |
0 |
10 |
20 |
0 |
0 |
20 |
20 |
0 |
1 |
50 |
20 |
15 |
20 |
Table 2: Validity criteria for OECD 202.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
0% |
yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
Start: 100% saturation End: 99% saturation |
yes |
Description of key information
EC50 (48h): 34 mg/L (arith. mean, measured OECD 202)
Key value for chemical safety assessment
Additional information
One study investigating the acute toxicity to aquatic invertebrates is available. The study was performed with a semi-static test regime following OECD guideline 202 and GLP. Daphnia magna were exposed to nominal concentrations of 2, 5, 10, 20 and 50 mg/L. The test solutions were renewed daily. Analytical dose verification of the three highest test concentrations was performed (HPLC) with newly prepared and old test media. The arith. mean measured concentrations were 10.6, 27.4, 46,5 mg/L. Immobilisation was observed at the highest test concentration. The determined EC50 (48 h) was 34 mg/L (arith. mean measured concentration).
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