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Diss Factsheets
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EC number: 944-951-8 | 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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 13, 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Cas Number:
- 190445-18-2
- Molecular formula:
- C9H19NO7
- IUPAC Name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Reference substance name:
- gluconic acid, aminopropanol salt
- Molecular formula:
- C9 H21 N1 O8
- IUPAC Name:
- gluconic acid, aminopropanol salt
- Test material form:
- liquid
- Remarks:
- 50% solution in water
- Details on test material:
- % solids in water: 48.0 - 52.0
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test Item Name FiberHance BM Solution
Batch/Lot Number SMSN-071916
CAS Name D-Gluconic acid, δ-lactone, reaction products with propanolamine
CAS Number (CAS RN) 2060570-71-8
Analysed Purity 49.71% w/w (Refer Certificate of Analysis in APPENDIX 5)
Supplied to JRF by Ashland Services B.V.
Date of Manufacture July 19, 2016
Date of Expiry July 19, 2017
Appearance Colourless, Odorless clear liquid
Storage Condition
(at JRF) As per the instruction received from the Sponsor on storage of the test item, the test item was stored :
Storage Temperature : 20 -25 °C
Storage Container : In original container as supplied by the Sponsor
Storage Location : Test Item Control Office, JRF
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- 10 mL of test samples from each replicates were drawn and mixed together to get a total volume of 40 mL for each group at every renewal. The samples were divided into two equal portions. One portion (20 mL) was sent for test concentration analysis and the second portion (20 mL) was stored at -20 ± 5 ºC temperature till the study completion.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- 10 mL of test samples from each replicates were drawn and mixed together to get a total volume of 40 mL for each group at every renewal. The samples were divided into two equal portions. One portion (20 mL) was sent for test concentration analysis and the second portion (20 mL) was stored at -20 ± 5 ºC temperature till the study completion.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Source: Healthy Daphnia magna (showing no signs of stress such as ephippia, delay in the production of the first brood, discolouration, etc. and having normal behavior) less than 24 h old (first instar nymph) cultured and bred in the Laboratory of Ecotoxicology, Jai Research Foundation, were used for the study. The master culture of Daphnia magna was originally procured from the MicroBio Test Inc, Kleimoer 15, 9030 Mariakerke (Gent), Belgium. The test system was validated for its sensitivity by conducting a validation study (Kamle, M.K., 2016: JRF Study N° 502-3-07-15505) with potassium dichromate as a positive control.
Acclimatisation: The test system (daphnids) were collected in a glass bottle containing 1000 mL of reconstituted water at the mean temperature of 20.1 ± 0.1 °C, mean dissolved oxygen level of 8.48 ± 0.02 mg/L as air saturation value, mean pH of 7.40 ± 0.01 measured daily and kept under a 16 h light and 8 h dark photoperiod during acclimatisation. The total hardness measured was 190.4 mg/L as CaCO3 and light intensity measured was 1320 lux, on the day of acclimatisation.
Selection: First instar daphnids (less than 24 h old, neonates) were separated from the adults in a culture of daphnia derived from a single mother. This culture had previously been acclimatised to the study conditions and was immediately transferred to labeled glass beakers (five for each replicate). Transfer was performed using a micropipette having a capacity of 100 – 1000 μL. The mobility of the test organisms was verified immediately after their introduction by gentle swirling of the test container.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 207.2 mg/L as CaCO3
- Test temperature:
- 20.1 and 21.2 °C
- pH:
- between 7.48 and 7.97
- Dissolved oxygen:
- 8.26 - 8.45 mg/L
- Nominal and measured concentrations:
- Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide: 0 and 100 mg/L
- Details on test conditions:
- Test Procedure: Static toxicity testing procedure (test medium was not changed during the study).
Loading : Each replicate comprising of five daphnids in 100 mL of test media
Container : Glass beaker of 600 mL capacity
Group Size : 20 daphnids per group. Each group consisted of four replicates of 5 daphnids per replicate
Duration : 48 h exposure period
Photoperiod : 16 h light and 8 h dark cycle
Feeding : None during exposure - Reference substance (positive control):
- yes
- Remarks:
- using potassium dichromate as a positive control
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide
- Basis for effect:
- mobility
- Remarks on result:
- other: Measured concentration was in agreement with nominal
- Results with reference substance (positive control):
- Study Period: October 17, 2016 to October 24, 2016.
The 24 and 48 h EC50 of potassium dichromate were determined 1.63 and 0.67 mg/L, respectively.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide is not toxic to invertebrates as no immobility of Daphnia magna exposed has occurred at a concentration of 100 mg/L. The EC50 is > 100 mg/L.
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