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EC number: - | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2021-04-12 to 2021-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test item cyclic Glucamide C12-14
Batch number S148866
Purity 100 % (UVCB)
Sum formula main compounds : C19H37NO5 (C12-acyl-derivative);
C21H41NO5 (C14-acyl-derivative)
Molecular weight main compounds : 359.5 g/mol (C12-derivative); 387.5 g/mol (C14-derivative)
Density 1.07 g/cm3
Water solubility soluble/miscible
Appearance slightly turbid brown solid mass
Expiry date 2022-09-30
Recommended storage Room temperature, dry - Analytical monitoring:
- yes
- Details on sampling:
- Chemical Analysis of Test Item Concentrations
Determination of the test item
Samples were analyzed with a LC-MS/MS method, implemented under non-GLP and documented finally in the GLP raw data. The method was validated according to Annex I.
Sampling schedule
The limit loading rate and the control were analytically verified in in the fresh media at the start of exposure and at the renewal of the test solutions (0 and 72 hours) as well as in the 24-hours old media at the renewal and at the end of the exposure (24 and 96 hours). - Vehicle:
- no
- Details on test solutions:
- Test method A semi-static test with daily renewal of the test media was performed.
Limit loading
A water accommodated fraction (WAF) of 4.00 mg/L was tested as a threshold concentration in a limit test. The selection of the test concentration is based on the derivation of a threshold concentration (TC) from the data of the test item of results of a daphnia toxicity test (EL50 (48 h) = 3.68 (95% CI: 3.11 – 4.29) mg/L, nominal test item loading) and of an alga toxicity test (ErL50 (0-72 h) = 11.8 (95% CI: 11.0 – 13.8) mg/L, nominal test item loading) and (EYL50 (0-72 h) = 5.32 (95% CI: 4.88 – 5.81) mg/L, nominal test item loading).
Water Accommodated Fraction
A water accommodated fractions (WAF) was prepared because the test item an UVCB substance with constituents of different water solubility. This procedure is in accordance with the OECD guidance document No. 23 (2018).
Using this approach, aqueous media was prepared by mixing the test item with water for a prolonged period sufficient to ensure equilibration between the test item and the water phase.
Preparation of the water accommodated fractions
One water accommodated fraction (WAF) was prepared with a nominal loading rate of the test item of 4.00 mg/L.
For the loading rate, an appropriate amount of the test item was weighed out and transferred into a measuring flask with an appropriate amount of dilution water. The WAF’s were treated with ultrasound for 5 minutes at room temperature. This procedure was carried out for each study day.
Control
7 fish in dilution water (without test item but treated in the same way as the test solution) were tested under the same test conditions as the test replicates. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Test organism
Danio rerio (zebrafish)
Vertebrata, Gnathostomata, Pisces, Osteichthyes, Teleostei, Cypriniformes, Cyprinidae
Reason for the selection of the test system
According to the guideline, Danio rerio is suitable for this kind of study.
Origin
All fish used in the test were gained at Noack Laboratorien GmbH from a single brood stock (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin)
Holding
Holding was performed at the test facility at 23 ± 2 °C and diffuse light (540 – 1000 Lux, photoperiod of 12 to 16 h light / 12 to 8 h dark). The water was changed at least once per week. The dissolved oxygen concentration was more than 80% of the air saturation value.
Zebrafish with at least 9 days of acclimatization and mortality < 5% within these days prior to the start of the exposure were used in the test.
No mortality was observed during this time. No disease treatments were administered throughout holding and testing.
Water Tap water of local origin was used for holding. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine. Nominal water parameters:
Total hardness: 40 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
Oxygen saturation: ≥ 80 % of air saturation value
Acidity: 0.1 mmol/L (recent measurement 2021-01-04)
Alkalinity: 0.6 mmol/L (recent measurement 2021-01-04)
Conductivity: 150 µS/cm (recent measurement 2021-01-04)
Acclimatization
A sufficient number of fish were acclimatized to dilution water and environmental conditions equivalent to the test conditions for at least 9 days.
Feeding
Food was provided 3 times per week. Food was given to satiation (4% of the fish body weight) per feeding day. The test fish were not fed 24 h before test start.
Food Sera Vipan; SERA GMBH, 52518 Heinsberg, Germany - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- TOC and Total Hardness from the Dilution Water
Parameter Study Days [mg/L]
TOC 0 to 4 < 2
Total Hardness 0 to 4 67 - Test temperature:
- Water Temperature in the Control (Continuous Measuring) in the Definitive Test
Period of Measurements 2021-04-12 to 2021-04-16
Minimum Temperature [°C] 22.8
Maximum Temperature [°C] 24.2
Mean Temperature [°C] 23.4 - pH:
- see " Any other information on materials and methods incl. tables"
- Dissolved oxygen:
- see " Any other information on materials and methods incl. tables"
- Nominal and measured concentrations:
- A water accommodated fraction (WAF) of 4.00 mg/L was tested as a threshold concentration in a limit test. The selection of the test concentration is based on the derivation of a threshold concentration (TC) from the data of the test item of results of a daphnia toxicity test (EL50 (48 h) = 3.68 (95% CI: 3.11 – 4.29) mg/L, nominal test item loading) and of an alga toxicity test (ErL50 (0-72 h) = 11.8 (95% CI: 11.0 – 13.8) mg/L, nominal test item loading) and (EYL50 (0-72 h) = 5.32 (95% CI: 4.88 – 5.81) mg/L, nominal test item loading).
The measured concentrations of the test item in the fresh and the old media were between 80 and 120 % throughout the test. - Details on test conditions:
- Duration of the test 96 hours
Test vessel Glass aquaria of 3 L were used (dimensions: 11.5/13/20 cm, depth of water: approx. 17 cm) and covered with a glass plates.
Test volume About 2.5 L per vessel
Aeration No aeration was provided.
Dilution water Same as used for holding
Number of fish 7 zebrafish were used for the limit concentration and the control. For the whole study 14 fish were used.
Loading, length of fish Fish density in the tanks was 0.132 g fish per liter test solution. Average body length at the test end: 1.46 cm
Average body weight at the test end: 0.047 g
Age of fish Juvenile
Replicates One replicate each for the loading and the control
Introduction of fish The fish were introduced randomly to individual replicates.
Feeding of test fish The fish were not fed during the exposure.
Water temperature (target) 21 - 25 °C, controlled at ± 1 °C
Dissolved oxygen Not less than 60% of air saturation value.
Concentration (target)
Light intensity (target) 540 – 1000 Lux
Photoperiod A photoperiod (light / dark cycle: 16 / 8 h) was maintained during exposure.
Observation intervals Observations were made after 2 ± 0.5 h and 5 ± 1 h after the start of the exposure. On days 1-4 of the test, all vessels with living fish were inspected twice per day.
Criteria of effects 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 behavior, respiratory function, pigmentation, etc.).
Measurement of fish size and weight
For measurements of size and weight all control fish were used at the end of the exposure.
Water quality and light intensity measurements
The pH-value, temperature and oxygen saturation were measured daily in all test vessels at the start and the end of exposure intervals from fresh and old test media. Chlorine and nitrate were measured from each batch of dilution water used in the test.
Total hardness and TOC were determined at the start of the exposure in the dilution water. During the test, the water temperature was recorded continuously (once per hour) with a data logger. The light intensity on the surface of the test aquaria was measured at the start of the exposure.
The solution appearance and behavior was observed daily before and after renewal. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- >= 4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Biological Data
Observations and effects on behavior in the test vessels are given in the table below. No mortality, no presence of visible abnormalities in regard to equilibrium, appearance, swimming behavior, ventilatory behaviour function and no additional clinical signs were observed. All effect levels are given based on the nominal test item loading. The LL0 after 96 hours was the nominal test item loading rate of ≥ 4.00 mg/L.
Observations of Sub Lethal Effects and Normal Behavior in the Test Vessels
(n = 7, number of fish)
Nominal Test Item loading
[mg/L] Effect *
Number of fish affected at observation time [hours]
day 0 day 1 day 2 day 3 day 4
2 4 23 30 47 53.5 72 78 94 96
4.00 (1) 7 7 7 7 7 7 7 7 7 7
Control (1) 7 7 7 7 7 7 7 7 7 7
*) The numbers in brackets correspond to the following observations:
(1) = Normal behavior
Cumulative Mortality % in the Test Vessels
Nominal Test Item loading
[mg/L] Cumulative mortality [%] at observation time [hours]
day 0 day 1 day 2 day 3 day 4
2 4 23 30 47 53.5 72 78 94 96
4.00 0 0 0 0 0 0 0 0 0 0
Control 0 0 0 0 0 0 0 0 0 0
The environmental conditions (pH-value, temperature and oxygen-saturation) were determined to be within the acceptable limits. Light intensity was measured at the start of the exposure and ranged from 693 to 773 (mean value 735) Lux. - Sublethal observations / clinical signs:
Measured Exposure Concentrations during the Definitive Test
The concentration of the test item cyclic Glucamide C12-14 was analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours and 72 hours) and in the corresponding old media at the end of the exposure (24 hours and 96 hours) in the limit test item concentration and the control.
Measured Concentrations of the active substances of the Test Item cyclic Glucamide C12 14 during the Definitive Test
Sampling date: 0 hours,
Fresh medium 24 hours,
Old medium 72 hours,
Fresh medium 96 hours,
Old medium
Nominal
concentration of C12-acyl-derivative
the test item [mg/L] the active substance
[mg a.s./L] Meas. conc.
[mg a.s./L] % Meas. conc.
[mg a.s./L] % Meas. conc.
[mg a.s./L] % Meas. conc.
[mg a.s./L] %
4.00 2.64 2.46 93 2.78 105 2.80 106 2.63 99
Control < LOQ < LOQ < LOQ < LOQ
Sampling date: 0 hours,
Fresh medium 24 hours,
Old medium 72 hours,
Fresh medium 96 hours,
Old medium
Nominal
concentration of C14-acyl-derivative
the test item [mg/L] the active substance
[mg a.s./L] Meas. conc.
[mg a.s./L] % Meas. conc.
[mg a.s./L] % Meas. conc.
[mg a.s./L] % Meas. conc.
[mg a.s./L] %
4.00 0.792 0.800 101 0.692 87 0.913 115 0.730 92
Control < LOQ < LOQ < LOQ < LOQ
Meas. conc. = measured concentration of the active substance, dilution factor taken into account
% = percent of the nominal concentration of the test item
a.s. = active substance
LOQ = limit of quantification of the analytical method (0.500 mg test item/L, corresponding to
0.331 mg C12 acyl-derivative and 0.0990 C14-acyl-derivative)
- Validity criteria fulfilled:
- yes
- Conclusions:
- The effect level is given based on the nominal test item loading of cyclic Glucamide C12-14. The threshold concentration of the test item at the nominal loading of 4.00 mg/L was found to have neither lethal nor sub lethal effects on zebrafish.
In conclusion, the LL0 corresponds to the nominal loading of ≥ 4.00 mg test item/L. - Executive summary:
The acute toxicity of the test item cyclic Glucamide C12-14 (batch no. S148866) to fish (zebrafish) was determined according to the principles of the OECD-Guideline for Testing of Chemicals No. 203 (2019) from 2021-04-12 to 2021-04-16 at the test facility.
An acute toxicity test under semi-static conditions was performed. The test item cyclic Glucamide C12-14 is a slightly turbid brown solid mass. The test item is soluble/miscible in water.
A water accommodated fraction (WAF) as a limit loading of 4.00 mg/L was tested as a threshold concentration. The concentration was based on the derivation of a threshold concentration (TC) from the data of the test item of results of a daphnia toxicity test (EL50 (48 h) = 3.68 (95% CI: 3.11 – 4.29) mg/L, nominal test item loading) and of an alga toxicity test (ErL50 (0-72 h) = 11.8 (95% CI: 11.0 – 13.8) mg/L, nominal test item loading) and (EYL50 (0-72 h) = 5.32 (95% CI: 4.88 – 5.81) mg/L, nominal test item loading).
The study was performed over a period of 96 hours under semi-static conditions with daily renewal of the test solutions. Seven test organisms were exposed to the limit concentration and the control. No mortality was observed in the definitive test. Water quality parameters (temperature, pH-value and oxygen-saturation) measured at 0, 24, 48, 72 and 96 hours were determined to be within the acceptable limits.
The limit loading of the test item cyclic Glucamide C12-14 and the control was analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours and 72 hours) and in the corresponding old media at the end of the exposure (24 hours and 96 hours).
The measured concentrations of the test item in the fresh and the old media were between 80 and 120 % throughout the test.
All effect values given were based on the nominal loading rate of the test item.
All validity criteria of the OECD 203 (2019) test guideline were met. The results of the study are summarized in Table 1. The threshold concentration of the test item at the nominal loading rate of 4.00 mg/L was found to have neither lethal nor non lethal effects on zebrafish.
LL-Values (96 hours) of the Test item
based on the nominal test item loading rate [mg/L]
LL0 =
Highest test item loading with
0% mortality after 96 h ≥ 4.00 mg/L (nominal loading)
Reference
Description of key information
The effect level is given based on the nominal test item loading of cyclic Glucamide C12-14. The threshold concentration of the test item at the nominal loading of 4.00 mg/L was found to have neither lethal nor sub lethal effects on zebrafish.
In conclusion, the LL0 corresponds to the nominal loading of ≥ 4.00 mg test item/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Remarks:
- LL50 LL0 ≥ 4 mg/L
- Effect concentration:
- > 4 mg/L
Additional information
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