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Diss Factsheets
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EC number: 908-300-1 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40bis
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- short chain Fructo-Oligosaccharides
- EC Number:
- 908-300-1
- Molecular formula:
- C6H11O5(C6H10O5)nOH
- IUPAC Name:
- short chain Fructo-Oligosaccharides
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identification: Actilight 950P
Substance: Short-chain fructo-oligosaccharides
EC No.: 908-300-1
Appearance: White powder
Purity: 96%
COMPOSITION:
scFOS is short chains of fructose molecules linked to a molecule of sucrose (glucose-fructose disaccharide). Thus, scFOS is a multiconstituent substance composed of three oligosaccharides: 1-kestose (GF2), nystose (GF3) and fructosyl-nystose (GF4).
With:
- TOTAL FOS: 96% expressed as dry matter
- Kestose (GF2): 37.1% FOS
- Nystose (GF3): 50.5% FOS
- 1F-Fructofuranosylnystose (GF4:) 12.4% FOS
- Glucose +Fructose + Saccharose : 4.0% expressed as dry matter
Constituent 1
- Specific details on test material used for the study:
- • Sponsor’s identification: ACTILIGHT® 950P
• Form: powder
• Colour: White
• Storage : room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epidermal Skin Test EST-1000, Cell Systems
- Tissue batch number(s): - Batch No. EST- 110502-001)
The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The insert was placed in a 6 wells culture plate which has been previously filled with 1 mL of maintenance medium (Cell Systems MM-160511). The culture dishes were incubated at 37°C, 5% CO2 during 20 hours and 25 minutes before treatment.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room température
- Temperature of post-treatment incubation (if applicable):
REMOVAL OF TEST MATERIAL AND CONTROLS
3 minutes and 1 hour after the test item application, the human epidermis was washed 20 times with 1 mL of PBS (PAN BIOTECH GmbH, Batch No. 4721010).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration / Incubation time: The skin sample was placed in MTT solution of 1 mg/mL concentration for 3 hours at 37°C, 5% CO2.
The precipitated blue formazan product is then extracted using isopropanol during 2 hours under agitation in the dark, and the concentration of formazan was measured by determining the Optical Density (OD) at 570 nm, just after dilution of the extraction in isopropanol (1:3).
The absorbance was measured in triplicate of MTT extract.
The measured absorbances are proportional to the number of live cells.
The direct interaction of MTT with the test item was checked by adding 25 mg of ACTILIGHT® 950P to 0.3 mL of the solution of MTT at 1 mg/mL. No blue or purple coloration was noted after 3 hours of incubation at 37°C, 5% CO2. Therefore, there is no direct interaction between the test item and MTT.
PREDICTION MODEL / DECISION CRITERIA:
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is striçtly less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.] - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL:
The test item has been applied, as supplied, at the dose of 25 mg, to the epidermal surface of 2 human skin models, then 25 µL pf PBS was added.
NEGATIVE CONTROL
In the same experimental conditions, a negative control (PBS ) has been carried out.
POSITIVE CONTROL
In the same experimental conditions, a positive control (8N KOH) has been carried out. - Duration of treatment / exposure:
- The test item remained on the epidermis during 3 minutes and during 1 hour at room température
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 115.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1hour
- Value:
- 97.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - Direct-MTT reduction:
The direct interaction of MTT with the test item was checked by adding 25 mg of ACTILIGHT® 950P to 0.3 mL of the solution of MTT at 1 mg/mL. No blue or purple coloration was noted after 3 hours of incubation at 37°C, 5% CO2.
Therefore, there is no direct interaction between the test item and MTT
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- under the conditions of the test, 3 minutes and 1 hour after the test item application, the mean viability of the epidermis skins treated with the test item was 115.6% (considered as 100%) and 97.3%, versus 2.7% and 1.0%, respectively, in the positive control (potassium hydroxide 8N). The substance is considered as not corrosive to the skin in accordance with the Regulation EC No. 1272/2008, the test item must not be classified in category 1 “Corrosive”.
- Executive summary:
The aim of the study was to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (Epidermal Skin Test EST-1000, Cell Systems). The experimental protocol was established in accordance with the OECDguideline No 431 dated April 13th, 2004 and the method B.40bis of the Council regulation No. 440/2008.
The test item ACTILIGHT® 950P was applied, as supplied, at the dose of 25 mg, to 2 Human skin model surfaces (Epidermal Skin Test EST-1000, Cell Systems), then 25 µL of PBS was added to ensure a good contact with the epidermis during 3 minutes and 1 hour.
3 minutes and 1 hour after the test item application, the mean viability of the epidermis skins treated with the test item was 115.6% (considered as 100%) and 97.3%, versus 2.7% and 1.0%, respectively, in the positive control (potassium hydroxide 8N).
The results obtained, under these experimental conditions, enable to conclude that the test item must not be classified in category 1 “Corrosive” in accordance with the Regulation EC No. 1272/2008. The substance is considered a not corrosive to the skin.
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