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EC number: 612-957-7 | CAS number: 62211-93-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 July 2012 to 20 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Acetylfuranoside
- IUPAC Name:
- Acetylfuranoside
- Reference substance name:
- ß-D-Ribofuranose, 5-deoxy-, triacetate (6CI,9CI)
- EC Number:
- 612-957-7
- Cas Number:
- 62211-93-2
- Molecular formula:
- C11 H16 O7
- IUPAC Name:
- ß-D-Ribofuranose, 5-deoxy-, triacetate (6CI,9CI)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Acetylfuranoside (also known as ß-D-Ribofuranose, 5-deoxy-, 1,2,3-triacetate)
CAS number: 62211-93-2
Batch number: 201203272009
Quantity received: 1.2 kg
Purity: 98.7%
Retest date: 31 Mar 2013
Date of receipt: 14 September 2012
Storage details: When not in use the test item was stored in a sealed container, at room temperature, in the dark.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaCrl
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Age at study initiation: 9 to 10 weeks old
- Weight at study initiation: 18 to 21 g
- Housing: The animals were group housed during acclimatisation and individually housed from Day –1 in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, expanded, from Special Diets Services Ltd, Witham, UK was freely available to the animals at all times.
- Water (e.g. ad libitum): Mains water was provided, ad libitum, via cage-mounted water bottles.
- Acclimation period: 8 to 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): The animal rooms were designed to permit 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.
IN-LIFE DATES: From: 23 October 2012 To: 06 November 2012
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Low concentration: 10% w/v
Intermediate concentration: 25% w/v
High concentration: 50% w/v - No. of animals per dose:
- 4 animals per dose
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- mercaptobenzothiazole (CAS No 149-30-4)
- Statistics:
- Not applicable
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 10%
- Remarks on result:
- other: see Remark
- Remarks:
- Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0. Low concentration: 1.1 SI Intermediate concentration: 1.0 SI High concentration: 1.1 SI
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 50%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle control: 1598 DPM Low concentration: 1807 DPM Intermediate concentration: 1591 DPM High concentration: 1814 DPM
Any other information on results incl. tables
Mortality
All animals survived treatment.
Clinical signs
There were no clinical signs indicative of a systematic effect.
The vehicle and test formulation application sites remained free of irritation.
Body weights
There was no idication of a treatment related effect on body weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The Local Lymph Node Assay demonstrated that Acetylfuranoside does not have the potential to cause skin sensitisation.
The test item did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). - Executive summary:
This study was conducted to assess the potential of the test item, Acetylfuranoside, to cause skin sensitisation in the mouse.
Following a preliminary screening test using a 50% w/v formulation, the test item was prepared for administration at 10, 25 and 50% w/v in dimethylformamide. Groups of four female CBA / CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated 3H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later, the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.
Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.
Concentration of test item in applied formulation (% w/v)
10%
25%
50%
Stimulation Index
1.1
1.0
1.1
The Local Lymph Node Assay demonstrated that Acetylfuranoside does not have the potential to cause skin sensitisation.The test item did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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