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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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- 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 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- July 17, 1992
- 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:
- 20 mL of test samples from each group was drawn at 0 and 24 h of first renewal. The representative samples were divided into two equal portions (10 mL). One portion (10 mL) was sent for test concentration analysis and the second portion (10 mL) was stored at -20 ± 5 ºC temperature till the study completion.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- An amount of 2012 mg FiberHance BM Solution was dissolved in RO water and made up to 10 L in fish tank to achieve a test concentration of 201.2 mg FiberHance BM Solution/L equivalent to a dissolved solid fraction concentration of 100 mg/L. The test solutions were thoroughly mixed to achieve uniform distribution of the test item within the aquaria. The test medium in the aquaria was changed every 24 h and replaced with the freshly prepared test item solution. At each renewal, 100% of volume of the tank was renewed. During renewal, fish was transferred by netting to new test vessels.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- Test System: Healthy Rainbow Trout, Oncorhynchus mykiss were originally procured from the Indo- Norwegian Trout Farming Project Patlikuhal, Katrain, Distt. Kullu, Himachal Pradesh- 175129 and maintained at Section – Ecotoxicology, Jai Research Foundation were used for study.
Feeding: The fish were fed daily with Trout starter feed. Feed was withheld 24 h before the exposure to FiberHance BM Solution and throughout the exposure period.
Acclimatisation: A total of 20 healthy fish were received into the experimental room and allowed to acclimatise for 8 days prior to testing in a glass aquarium containing water identical to that to be used in the main study. The water was maintained between 16.2 and 16.8 °C temperature with 87.4 and 93.1% dissolved oxygen content as air saturation value, pH was maintained between 7.20 and 7.41 and total hardness of 100.8 mg/L as CaCO3 (TABLE 3). No signs of physical or behavioural abnormalities or mortalities of fish were observed during the acclimatisation period.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 89.6 to 100.8 mg/L as CaCO3
- Test temperature:
- 16.0 to 16.6 °C
- pH:
- 7.08 to 7.54
- Dissolved oxygen:
- 70.1 to 92.1%
- Nominal and measured concentrations:
- Dissolved solid fraction: 100 mg/L, corresponding with 201 mg Fiberhance BM Solution/L
- Details on test conditions:
- Test Procedure: Semi-static toxicity test - Test solutions were changed every 24 h with freshly prepared solutions. The test solutions were not aerated during the exposure.
Loading: A maximum loading of 0.9 g of fish per liter of water was used. The volume of water used was 10 liters in a glass tank of 20 liters capacity for control and treated groups.
Test Concentrations: 0.0 (control) and 100 mg a.i./L
No of Fish per Group: 10 fish per group
Duration : 96 h exposure
Photoperiod : 16 h light and 8 h dark
Feeding : None during test period - Reference substance (positive control):
- not required
Results and discussion
Effect concentrations
- Duration:
- 96 h
- Dose descriptor:
- LC50
- 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:
- mortality (fish)
- Remarks on result:
- other: Measured concentration in agreement with nominal
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 fish as no mortality has occurred at a concentration of 100 mg/L. The LC50 is > 100 mg/L.
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