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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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:
- From January 16th to February 04th, 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM-Recommended Test Method Protocol: Hen’s Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method
- Version / remarks:
- November, 2006
- GLP compliance:
- no
Test material
- Reference substance name:
- Set Retard Plus
- IUPAC Name:
- Set Retard Plus
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: white Leghorn
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- System: hen's egg.
- Number: 4 per sample.
- Source: Couvoir de Cerveloup
- Weight at study initiation: 50 - 60 g
TISSUE PREPARATION
- Incubation: after receipment, eggs were kept for 24 hours at a temperature of 12 ± 2.5 °C, then moved to an incubator at a temperature of 37.8 ± 1°C, and humidity percentage 50-60 %, for a period of 10 days.
- Mambrane extraction: at day 11th of incubation, eggs were moved from that incubator and vertically placed on a specific prop. The shells were cut at empty inner space level and then removed in order to expose the membranes.
- Membrane preparation: membranes were humified with a physiological solution at 37 °C, then gently chipped off. Egges showing imperfections in chorioallantoic membrane were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 0.3 g of test item were gently put on chorioallantoic membrane.
- Duration of treatment / exposure:
- 20 seconds
- Number of animals or in vitro replicates:
- 4 eggs/sample
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: sample was removed, softly washing the membrane with a physiological solution.
- Time after start of exposure: contact of 20 seconds.
OBSERVATIONS
Each possible reaction was observed during a post-exposure period of 5 minutes and the arising time recorded.
The procedure evaluated the development of the response at specific time points after the test substance was applied to the CAM. In these reports, the blood vessels on the CAM were examined and scored at 0.5, 2, and 5 minutes after exposure to the test substance.
In particular, the membranes were checked for the reactions described bolow.
- Hemorrhage: bleeding from the vessels or from areas of mambrane.
- Vascular lysis: capillaries, not visible before the substance treatment, becoming visible, dilated and inflamed. Also vessels with a larger diameter can undergo this reaction.
- Coagulation (opacity and/or thrombosis): opacity can be observed by the membrane that appears as a thin opalescent veil. Thrombosis can determine the interruption of the blood flow in vessels, which appear segmented.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Conc: 100 %; eggs number: 4
- Value:
- 6.8
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- POSITIVE CONTROL
Lauryl sulfobetaine (0.8 %) score: 12 (4 eggs).
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosives or severe irritants, i.e. the substance does not meet the criteria to be classified as Eye Dam. 1, according to the CLP Regulation
- Conclusions:
- Non corrosives or severe irritants, i.e. the substance does not meet the criteria to be classified as Eye Dam. 1, according to the CLP Regulation
- Executive summary:
Method
A toxicological study on test substance was performed in order to get preliminary foretelling data for in vivo eye irritation test. The used method is Het Cam Test, performed on a chorioallantoic membrane of hen's eggs, between day 10 and 11 of incubation. This type of membrane is vascularized.
The method' principle is based on visual observation, from qualified technicians, of prospective irritations coming out during 5 minutes following the product application on the chorioallantoic membrane.
Observations
Observed irritations were registered not on intensity basis, but on pop up time basis. The reactions observed were vascular conjestion, haemorrhage, coagulation (opacity and/or thrombosis).
Results
Keeping on registered data, the test substance Set Retard Plus, tested with Het Cam Test, can be considered considered as not serious eye damage.
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