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EC number: 940-284-1 | CAS number: 1591782-62-5
- 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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-10-10 to 2013-10-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study performed under GLP, no deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 940-284-1
- Cas Number:
- 1591782-62-5
- Molecular formula:
- C15H31NO6 C17H35NO6
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Reference substance name:
- Glucamide 810
- IUPAC Name:
- Glucamide 810
- Details on test material:
- - Physical state: Colourless powder
- Sum formula: C15H31NO6 (C8-Glucamide) C17H35NO6 (C10-Glucamide)
- Molecular weight:
C8-Glucamide: 321.42 g/Mol
C10-Glucamide 349.47 g/Mol
- Storage condition of test material: Room temperature, protected from light, in original container.
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: The limit concentration of 100 mg/L is based on the results of preliminary range finding tests.
- Sampling method:
Analytical evaluation of the limit concentration of C8/C10-Glucamide AC93/13 was carried out via LC-MS/MS from freshly prepared test media at start of the exposure (0 h) and from corresponding 96 h aged test media at the end of the exposure.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Directly weighing. The test media was mixed with an ultraturrax (1 min, 17000 rpm).
- Eluate: Dilution water
- Differential loading: Limit concentration of 100 mg/L
- Controls: 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicates.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: All fish used in the test were gained at DR.NOACK-LABORATORIEN from a single brood stock. (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin)
- Length at study initiation (length definition, mean, range and SD): Average body length: 2.74 cm
- Weight at study initiation (mean and range, SD): Average body weight: 0.28 g
- Method of breeding:Holding was performed at the test facility at 23 +/- 2 °C and diffuse light (0.1 - 10 µmol photons • m-2 • s-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. No disease treatments were administered throughout holding and testing. Food was provided 3 times per week. The amount of food was 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started.
- Feeding during test: No feeding during test
ACCLIMATION
- Acclimation period: Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study starts were used in the test.
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started. Food: Sera Vipan; SERA GMBH, D-52518 Heinsberg
- Feeding frequency: 3 times per week.
- Health during acclimation (any mortality observed): No mortality observed, no disease treatments were administered throughout holding and testing.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- Total Hardness at day 0: 43 mg/L
- Test temperature:
- Please refer to "Any other information on materials and methods"
- pH:
- Please refer to "Any other information on materials and methods"
- Dissolved oxygen:
- Please refer to "Any other information on materials and methods"
- Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- Please refer to "Any other information on materials and methods incl. tables"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): open, loosely covered by glass tops
- Material, size, headspace, fill volume: glass, 10 L test volume per vessel
- Aeration: Gentle aeration
- Renewal rate of test solution (frequency/flow rate): None, static design
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: less than 1 g fish per L test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove possible chlorine.
Nominal water parameters:
Total hardness: 10 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH-value, temperature and oxygen saturation were measured in all vessels at the beginning of the test and every 24 h. Total hardness of the water was determined at the beginning out of the test control. During the test the water temperature was recorded continuously with a data logger (once per hour).
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: natural
- Light intensity: 0.1 - 10 µmol photons x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.). Observations were made after 24, 48, 72 and 96 h.
TEST CONCENTRATIONS
- Range finding study:
Cumulative Mortality [%] in the Preliminary Test
(n = 5)
Nominal Test Item Concentration
[mg/L] Cumulative mortality [%] after different exposure periods [hours]
24 48 72 96
100 0 0 0 0
Control 0 0 0 0 - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: highest test item concentration with 0% mortality after 96h
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: Not observed
- Mortality of control: 0%
- Other adverse effects control: Not observed
- Abnormal responses: Not observed
- Any observations (e.g. precipitation): The test solution was clearly dissolved throughout exposure. - Results with reference substance (positive control):
- No reference substance tested
- Reported statistics and error estimates:
- The concentrations leading to 0 and 100 % mortality (LC0 and LC100) after 96 h were determined directly from the test results. LC10,20,50-values had not to be calculated in a limit test.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Observations in the Definitive Test
Nominal test item
concentration
[mg/L]Obser-vations *
Number of fish effected at observation time [hours]
24
48
72
96
100
(1)
7/7
7/7
7/7
7/7
Control
(1)
7/7
7/7
7/7
7/7
Cumulative Mortality [%] in the Definitive Test
Nominal test item
concentration
[mg/L]Cumulative mortality at observation time [hours]
24
48
72
96
100
0
0
0
0
Control
0
0
0
0
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, C8/C10-Glucamide AC93/13 was found to cause no lethal effects to Zebrafish after 96 hours at a nominal test concentration of 100 mg/L (highest tested concentration).
The LC50 after 96 hours is > 100 mg/L. All effect levels are given based on the nominal concentrations of the test item C8/C10-Glucamide AC93/13. - Executive summary:
The acute toxicity of the test item C8/C10-Glucamide AC93/13(batch no.:AC93/13) to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2013-10-10 to 2013-10-14 at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.
A static test was performed with nominal test item concentration of 100 mg/L. Duration of the test was 96 hours. 7 test organisms were exposed to each concentration and the control. Water quality parameters pH-value, temperature and oxygen-saturation, measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits.
The measured concentration of the test item at the start of the exposure (0 h) was 94 % of the fraction C8-Glucamid and 96 % of the fraction C10-Glucamid of the nominal value. The measured concentrations of the test item at the end of the exposure (96 h) was 105 % of the fraction C8-Glucamid and 103 % of the fraction C10-Glucamid of the nominal value.LC-Values (0 – 96 hours)
Based on nominal test item concentrations [mg/L].
Test duration
[hours]C8/C10-Glucamide AC93/13[mg/L]
LC10
LC20
LC50
24
> 100
> 100
> 100
48
> 100
> 100
> 100
72
> 100
> 100
> 100
96
> 100
> 100
> 100
LC0=
Highest test item concentration with
0 % mortality after
96 hours100
LC100=
Lowest test item concentration with
100 % mortality after
96 hours> 100
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