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EC number: 947-850-7 | CAS number: -
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See analogue justification attached to chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 183 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, LAUS, 2017, D. magna, 21 d
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Nov - 06 Dec 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidance no. 23 on Aquatic Toxicity Testing of Difficult Substances and Mixtures
- Version / remarks:
- 14 Dec 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany (08 Apr 2015)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Samples for analytical determinations were taken from the new solutions at the beginning of the tests, and from the old solutions (with and without daphnia and algae) at the end of the test (set 1).
Additional samples from the new and the old solutions were taken on day 5, day 7, day 9 and day 12. In the control, the content of the test item was measured at the beginning and at the end of each study. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: For the test, a saturated solution of 100 mg/L was prepared by mixing respective amounts of test item in dilution water and shaking vigorously for 24 h. The resulting solution was then filtered through a 0.45 µm cellulose ester filter after which the solutions were clear and colorless. The lower concentrations for both Experiments were prepared by dilution of the membrane filtered, saturated solution with dilution water.
- Differential loading: No
- Controls: Dilution water without test item
- Evidence of undissolved material: No, the solutions were clear and colorless after filtration. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Planktonic crustacean / water flea
- Strain/clone: Berlin
- Source: Umweltbundesamt Berlin, Germany (27 Sep 2007)
- Animal husbandry: In-house according to ES IS 6341, following SOP 115 002 01, edition 12 (adopted 12 Feb 2015). Vessels: 2L glass beakers; Medium: M4 medium (Elendt); Food: Green alga Desmodesmus subspicatus, twice a week; Photo period: 16 h light / 8 h dark (neon tubes); Temperature: 20 ± 2 °C
- Feeding during test: The animals were fed on each working day. On weekends, the Daphnia were not fed. On Fridays, the double amount of alga suspension was added into the test vessels.
- Sex and age at test start: Females between 0 - 24 h old
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
23 h before the start of set 1 and 21 h before the start of set 2, the adult animals were separated from the young. 22 h (set 1) and 20 h (set 2) later, the adults were caught with the help of a glass tube, and the newborn daphnia, aged 0 - 23 h (set 1) and 0 - 22 h (set 2), were sieved from the medium and immediately placed into a 250 mL beaker containing diliution water. After a settling period of 30 min, animals which showed no apparent damage were used for the tests. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 267 - 356 mg CaCO3/L
- Test temperature:
- 19.5 - 21.5 °C
- pH:
- 7.5 - 8.7
- Dissolved oxygen:
- 8.5 - 9.7 mg/L
- Nominal and measured concentrations:
- Control, 4.6, 10, 22, 46 and 100 mg/L (nominal)
Control, 27, 47, 102, 183 and N.A. µg/L (time-weighted mean) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL glass beakers
- Renewal rate of test solution: 3 times/week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 80 mL/animal, animals were kept individually
- Other: 1 additional replicate for analytical measurement
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionised water enriched with minerals, according to the M4 composition by Elendt, as described in the OECD guideline.
- CaCl2*2H2O: 293.80 mg/L
- MgSO4*7H2O: 123.30 mg/L
- NaHCO3: 64.80 mg/L
- KCl: 5.80 mg/L
- NaNO3: 274 µg/L
- K2HPO4: 143 µg/L
- Na2SiO3*9H2O: 10 mg/L
- H3BO3: 2.86 mg/L
- Na2EDTA*2H2O: 2.5 mg/L
- FeSO4*7H2O: 0.9955 mg/L
- MnCl2*4H2O: 0.3605 mg/L
- LiCl: 0.306 mg/L
- SrCl2*6H2O: 0.152 mg/L
- RbCl: 0.071 mg/L
- Na2MoO4*2H2O: 0.0615 mg/L
- CuCl2*2H2O: 16.75 µg/L
- NaBr: 16 µg/L
- ZnCl2: 13 µg/L
- CoCl2*6H2O: 10 µg/L
- KI: 3.25 µg/L
- Na2SeO3 *5 H2O: 3.33 µg/L
- NH4VO3: 0.575 µg/L
- ThiaminHCl: 75 µg/L
- Cyanocobalamin: 1 µg/L
- D+Biotin: 0.75 µg/L
- Culture medium different from test medium: Culture medium same as dilution water (M4-medium).
- Intervals of water quality measurement: Day 2, 5, 12 and 19
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 1000 lux (neon tubes)
EFFECT PARAMETERS MEASURED:
- Mortality and Reproduction of surviving daphnia: 3 times/week
TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 2.17
- Range finding study: Not specified - Reference substance (positive control):
- not specified
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 183 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Behavioural abnormalities: No abnormal behaviour or appearance of the surviving daphnia was observed.
- Mortality of control: 0%
- Any observations that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- Statistical analyses were performed with ToxRat Professional v3.2.1.
Statistical design: Hypothesis testing (NOEC) and regression (ECx). - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Referenceopen allclose all
VALIDITY CRITERIA
The study fulfilled the validity criteria defined by the guideline (Table 1). Furthermore, the oxygen concentration was ≥ 8.5 mg/L (required: ≥, 3.0 mg/L) the pH range 7.5 - 8.4 (required 6 - 9) and the pH variation was 0.6 (required: ≤ 1.5). Thus, the test is considered valid and reliable.
Table 1: Validity criteria for OECD 211.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The mortality of the parent animals in the control (femaleDaphnia) does not exceed 20% at the end of the test. |
Mortality of parent animals in the control was 0%. |
Yes |
The mean number of living offspring produced per parent animalsurvivingat the end of the test is ≥ 60 in the control. |
The mean surviving offspring in the control was 93. |
Yes |
ANALYTICAL RESULTS
There was a weak correlation between the nominal concentrations and the measured concentrations and a weak stability of the test item during the exposure period (Table 2 - 5). In aged test solutions, hardly any test item was detectable. Therefore, results were based on the time-weighted mean of the measured concentrations in the new and old solutions. For the calculation of the time-weighted mean, the limit of detection (10 µg/L) was used for calculation where no test item was detectable.
Table 2.Measured Concentrations Days 0 – 5 set 1
Nominal Conc. in mg/L |
Measured Conc. day 0 in µg/L |
Measured Conc. day 5 old solution with algae in µg/L |
Measured Conc. day 5 old solution without algae in µg/L |
Measured Conc. day 5 new solution algae in µg/L |
4.6 |
126 |
10** |
n. d. |
62 |
10 |
252 |
10** |
n. d. |
151 |
22 |
514 |
31 |
n. d. |
344 |
46 |
1061 |
41 |
87 |
657 |
100 |
2177 |
* |
* |
* |
n. d. = not detectable
* not measured because all daphnia were found dead on day 2
**10 µ/L = LOD (lowest calibration level)
Table 3.Measured Concentrations Days 7 – 9 set 1
Nominal Conc. in mg/L |
Measured Conc. day 7 old solution with algae in µg/L |
Measured Conc. day 7 old solution without algae in µg/L |
Measured Conc. day 7 new solution algae in µg/L |
Measured Conc. day 9 old solution with algae in µg/L |
Measured Conc. day 9 old solution without algae in µg/L |
4.6 |
10** |
n. d. |
40 |
10** |
n. d. |
10 |
10** |
n. d. |
100 |
10** |
n. d. |
22 |
12 |
n. d. |
255 |
45 |
n. d. |
46 |
37 |
38 |
417 |
92 |
11 |
n. d. = not detectable
**10 µ/L = LOD (lowest calibration level)
Table 4.Measured Concentrations Days 9 – 21 set 1
Nominal Conc. in mg/L |
Measured Conc. day 9 new solution algae in µg/L |
Measured Conc. day 12 old solution with algae in µg/L |
Measured Conc. day 12 old solution without algae in µg/L |
Measured Conc. day 12 new solution algae in µg/L |
Measured Conc. day 21 old solution with algae in µg/L |
4.6 |
53 |
10** |
n. d. |
30 |
10** |
10 |
108 |
10** |
n. d. |
78 |
10** |
22 |
271 |
10** |
n. d. |
172 |
17 |
46 |
481 |
15 |
n. d. |
327 |
22 |
n. d. = not detectable
**10 µg/L = LOD (lowest calibration level)
Table 5. Time-Weighted Mean set 1
Nominal Conc. in mg/L |
Time-Weighted Mean in µg/L |
4.6 mg/L |
27 |
10 mg/L |
47 |
22 mg/L |
102 |
46 mg/L |
183 |
BIOLOGICAL RESULTS
No toxicity (mortality and inhibition) was observed at the nominal concentration of 22 mg/L (experimental set 1). Therefore, the lower concentrations of 1.0 and 2.2 mg/L, which were additionally tested in the experimental set 2, were not necessary for evaluation and the entire set 2 was aborted on Day 14.
At the nominal concentration of 46 mg/L only 1 animal survived but the number of offspring of the surviving animal was not significant compared to the control. Thus, no statistically significant inhibition of reproduction was observed in any treatment (Table 6). The effect values based on the time-weighted mean of the measured concentrations are summarized in Table 7 and Table 8.
Table 6. Fecundity (set 1)
Treatment |
Total Offspring |
Surviving Parent Animals |
Mean Offspring per Surviving Parent Animal |
Inhibition of Reproductionin % |
Blank Control |
934 |
10 |
93 |
0 |
4.6 mg/L |
1030 |
10 |
103 |
-10 |
10 mg/L |
952 |
10 |
95 |
-2 |
22 mg/L |
1098 |
10 |
110 |
-18 |
46 mg/L |
77 |
1 |
77 |
18 |
100 mg/L |
0 |
0 |
-- |
-- |
Table 7.Biological Results cumulative offspring per survived parent
Parameter |
Value |
NOEC |
≥183 µg/L |
LOEC |
> 183 µg/L |
EC50 |
> 183 µg/L |
Table 8.Biological Results Immobility
Parameter |
Value |
NOEC |
102 µg/L |
LOEC |
183 µg/L |
EC50 |
141.46 µg/L |
Description of key information
NOEC (21d) ≥ 183 µg/L for Daphnia magna (meas. TWA, OECD 211); read-across
Key value for chemical safety assessment
Additional information
No studies investigating the long-term toxicity to aquatic invertebrates are available for Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7). Therefore, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was conducted.
The chemical properties of the target and source substance are similar due to the structural similarities, i.e., sarcosine head group and the hydrocarbon tail. In addition, due to the pKa of the target substance (pKa = 3.96, major constituent), at physiological pH values (above 6) the target substance is expected to be in the anionic form, as is the source substance. As a result, the chemistry of the target and source substance, in solution (above pH 6), are expected to be similar. Thus, the source substance is considered suitable representative for the evaluation of the toxicity to aquatic invertebrates of the target substance. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.
The study conducted with the source substance N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was performed according to OECD 211 (GLP) with Daphnia magna under semi-static conditions. The test organisms were exposed to nominal concentrations of 4.6, 10, 22, 46 and 100 mg/L. After only 2 days strong mortality was observed in the two highest concentrations. Therefore, parallel to the ongoing experiment (set 1), on day 7, additional control and test replicates using lower test concentrations of 1.0 mg/L and 2.2 mg/L were started (set 2). As no toxicity, neither mortality nor inhibition of reproduction was observed in the first experiment at the nominal concentration 22 mg/L, the additional tested lower concentrations 1.0 mg/L and 2.2 mg/L were not necessary for evaluation and set 2 was aborted on day 14. Analytical measurements verified the test item concentration to be 27, 47, 102 and 183 µg/L(TWA) for the nominal test concentrations 4.6, 10, 22 and 46 mg/L. The NOEC (21d) was determined to be ≥ 183 µg/L (meas. TWA).
Based on the available results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5), which is characterized by a comparable structure and physico-chemical properties, it can be concluded that the target substance Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7) will exhibit comparable effects on aquatic invertebrates.
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