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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 30 to April 9, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Hens Egg Test on the Chorio-Allantoic Membrane (HET-CAM).
- Version / remarks:
- Journal officiel de la République Française of December 26, 1996 with some modifications described in the Standard Operation Procedure N°TAM-01-v2
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was performed according to national and/or international guidelines applying a study plan and Standard Operating Procedures. Although the performing laboratory is not GLP certified, test procedures are generally following GLP guidance and rules.
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:
- ID: Samson 18+
Appearance: liquid
Storage: room temperature
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- Eggs reception and incubation
- Upon receipt, the cracked or broken eggs are discarded. Before incubation, the eggs are stored in egg boxes (blunt ends upwards). If the incubation didn’t take place in few hours after reception, eggs are stored at 8°C; and kept away from light for a maximum of 7 days, then for 24 h at 20°C before being placed in an incubator.
- Clean and fertile White Leghorn chicken eggs are placed in an incubator for eight days with a rotating tray at 37.8 ± 0.5ºC and 52 ± 2% relative humidity.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- S18+ at 100%; 10%; 5% in 300 µL.
- Duration of treatment / exposure:
- 300 seconds
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- Test article groups: 4; Controles: 2
- Details on study design:
- This test is carried out on 9 days’ old, fertilized and embryonated chicken eggs. The eggshell and inner membrane are carefully removed taking care that the CAM is not injured.
- Each test substance (if included, benchmark and solvent/vehicle controls) is applied to 4 eggs. Positive and negative controls are applied to only two eggs.
- 300 μl of test product are then deposited on the membrane. A timer is started immediately after application.
- At 20 seconds, test substance is removed from the membrane by rinsing the CAM with approximately 2x2.5 ml of DPBS 1X.
- The CAM reactions are observed over a period of 300 seconds. The time of the appearance of HAEMORRHAGE, HYPERAEMIA and COAGULATION should be monitored and recorded, in seconds
- Pictures are taken at 0, 30, 120 and 300 seconds and recorded as t=0s, t=30s, t=120s and t=300s for the corresponding tested substance.
- For each egg, the numerical time-dependant scores for HAEMORRHAGE, HYPERAEMIA and COAGULATION are summed to give a single numerical value.
- The Irritation Score (IS) of the tested product is the arithmetic average, rounded to the decimal, of the scores obtained on four eggs (treated with a same test substance). Therefore, the maximal score is 21.
IS < 1 = Practically not irritant
1 ≤ IS < 5 = Slightly irritant
5 ≤ IS < 9 = Moderately irritant
IS ≥ 9 = Irritant
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 100%
- Value:
- 2.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Value = 0
- Positive controls validity:
- valid
- Remarks:
- Values: NaOH 1N = 19; NaOH 0.1N= 10
- Remarks on result:
- other: Slightly irritant
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 10%
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to HET-CAM test, Samson S18+ at 100% is identified as Slightly irritant and Samson S18+ at 10% in H2O is identified as Practically not irritant.
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