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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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- see analogue justification attached to chapter 13
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.37 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- Source: Reaction products of oleoyl sarcosine with sodium hydroxide, MAL, M 0409-1424/006-3, 2004, B. rerio, 96 h
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.43 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- Source: EC 701-177-3, Schill+Seilacher, 2010, LAUS, 09070901G504, D.rerio
- Conclusions:
- The LC50 (96h) for D. rerio is 0.37 mg/L (nominal).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A definite amount of the test substance (stock solution concentration: 350 mg/L) was weighted into measuring flask and the total volume was filled up with dilution water. The test bottles were conditioned about 15 min before the test was started.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Length at study initiation: 2.0 cm
- Feeding during test: none
ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): same as test
- Feeding frequency: daily - Test type:
- not specified
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 19.0 - 20.1 °C
- pH:
- 7.7 - 8.1
- Dissolved oxygen:
- 5.6 - 7.7 mg O2/L
- Nominal and measured concentrations:
- nominal: control, 0.1, 0.25, 0.5, 1.0, 2.0 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Fill volume: 7 L
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water without chlorine (pH 8.0)
- Ca content: 37.4 mg/L
OTHER TEST CONDITIONS
- Photoperiod: 12 h light and 12 h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality was recorded every 24 h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.37 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0%
- Reported statistics and error estimates:
- The statistical evaluation bases on a Probit analysis. The Probit transformation served for the graphical linearisation, the verification of the normal distribution of the experimental data and for the evaluation of the effective concentration.
- Sublethal observations / clinical signs:
Table 1: Mortality
Concentration [mg/L]
Mortality of fishes [%]
24 h
48 h
72 h
96 h
0.1
0
0
0
0
0.25
14
29
43
43
0.5
29
43
57
57
1.0
43
86
86
86
2.0
100
100
100
100
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 30 Jul - 03 Aug 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: At test start, at test end and every 24 h, the test item concentration was determined.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: On the day of the start of the study, a stock solution containing 10 g/L test item in deionised water was prepared. 10 g test item was mixed with 1.1 g NaOH (45%). Then, 40 mL deionised water (80 – 100 °C) was added. After homogenisation with a glass stirrer, 85 mL deionised water (room temperature) was added. Then the vessel was stirred on a magnetic stirrer. NaOH (0.5 M) was added until the resulting solution was clear. The pH of the solution was adjusted to 7.8 ± 0.2 with 1 M HCl. The solution was transferred into a volumetric flask and filled up to 1 L with deionised water. From this stock solution, a solution (nominal concentration: 25 mg/L) in drinking water was prepared. This solution then was used to prepare the solution of the concentration to be tested. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebra fish
- Strain: Hamilton-Buchanan
- Source: Received on 08 Jul 2010 from Dehner Garten Center, Neustadt/Weinstrasse, Germany
- Age at study initiation: Sexually immature young fish
- Length at study initiation: 2 ± 1 cm
- Feeding during test: None
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Warmwater fish food and daphnia, totalling to about 1 - 2% of body weight per day
- Feeding frequency: three times a day until 24h prior to test start
- Health during acclimation (any mortality observed): Mortality was < 5%. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 1.18 mM
- Test temperature:
- 21.7 - 22.3 °C
- pH:
- 8.1 - 8.4
- Dissolved oxygen:
- 7.7 - 9.1 mg/L
- Nominal and measured concentrations:
- Nominal: 0.43 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquaria
- Material, size: Glass, 10 L
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): approx. every 5 h
- No. of organisms per vessel: 8 (test item), 7 (control)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Drinking water
- Total organic carbon: < 1.0 mg/L
- Metals: Na 3.8 mg/L, K 2.4 mg/L, Ca 23.8 mg/L, Mg 1.9 mg/L, other metals < 0.0001 to < 0.01
- Pesticides: < LOD
- Chloride: 7.0 mg/L
- Ca/Mg ratio: 12.5:1
- Conductivity: 142 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Oxygen concentration and pH were measured every 24 h.
OTHER TEST CONDITIONS
- Photoperiod: 12h light/12 h dark, neon tubes
EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Mortalities and abnormal behaviour were documented every 24 h.
TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: Threshold approach concentration, lowest EC50 in alga and daphnia test - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.43 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.43 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- behaviour
- Details on results:
- - Behavioural abnormalities: None
- Mortality of control: None
- Mortality in the test vessels: None
- Analytics: 91% to 107% of the nominal concentration was measured at test start and every 24 h until test end. - Sublethal observations / clinical signs:
The substance showed a strong absorption, the test was performed with the highest achievable concentration in water.
- Validity criteria fulfilled:
- yes
Referenceopen allclose all
Description of key information
LC50 (96 h) = 0.37 mg/L (nominal) for D. rerio (OECD 203); read-across
LC50 (96 h) > 0.43 mg/L (nominal) for D. rerio (OECD 203); read-across
Key value for chemical safety assessment
Additional information
No studies investigating the short-term toxicity to freshwater fish 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 Reaction products of oleoyl sarcosine with sodium hydroxide and N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) were conducted.
The chemical properties of the target and source substances 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 are the source substances. As a result, the chemistry of the target and source substances, in solution (above pH 6), are expected to be similar. The sodium cation (Na+) found in one source substance is not expected to create much difference in properties, particularly for solution behavior, such as Log Kow and water solubility. In aqueous solution, these cations are dissociated from the molecule. Thus, the source substances are considered suitable representatives 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 Reaction products of oleoyl sarcosine with sodium hydroxide and N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was performed according to OECD 203 (GLP) with the zebra fish Danio rerio. Fish were exposed to five nominal concentrations of 0.1, 0.25, 0.5, 1.0 and 2.0 mg/L. No analytical measurement was conducted. After an exposure of 96 h, a LC50 of 0.37 mg/L (nominal) was calculated.
The study conducted with the source substance N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) was carried out according to OECD guideline 203 and GLP. In this limit-test, zebra fish (Danio rerio) were exposed to a concentration of 0.43 mg/L under flow-through conditions. Analytical measurements verified the test item concentration to be 91 – 107% throughout the exposure period. As no mortalities were observed, the LC50 was determined to be > 0.43 mg/L (nominal).
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 freshwater fish.
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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