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Diss Factsheets
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EC number: 947-862-2 | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Jun - 02 Aug 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- : no positive control data mentioned in study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- no positive control mentioned in study report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted in 1996, prior to adoption of LLNA method in 2002.
Test material
- Reference substance name:
- Fatty acids C8-18 (even numbered), mono- and diesters with sucrose
- EC Number:
- 947-862-2
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Fatty acids C8-18 (even numbered), mono- and diesters with sucrose
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Borchen, Germany
- Microbiological status of animals, when known: SPF breeding colony
- Weight at study initiation: 361 - 453 g
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: Commercial diet, (ssniff Ms-H(V2233), ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 11 Jun - 17 Jul 1996
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- On each of days 1, 8, and 15 for 6-hour exposure duration
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- On day 29, 6-hour exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 negative control
20 test animals - Details on study design:
- RANGE FINDING TESTS:
Six animals were used for determination of non-irritant concentration: 4%, 20% and 100% in deionized water was applied topically to two guinea pigs per concentration. The hair on the left flank of the animals was removed mechanically. An amount of 0.5 mL of the test substance was applied to a 2 x 2 cm cellulose patch, which was fixed to the left flank and covered occlusively for 6 hours with a bandage and film. After 24 hours following removal of the patches, the treated skin areas were examined for erythema and oedema, and skin reactions were assessed according to Draize scoring system.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: During Day 1-15 topical exposure was done once a week.
- Test groups: 20 animals
- Control group: 10 animals
- Site: Left flank: 0.5 mL of the test substance was applied over a 2 x 2 cm patch. Control animals were treated with analogously with water.
- Frequency of applications: once a week
- Duration: 6 hour exposure under occlusive bandage
- Concentrations: 100%
After induction exposure the occlusive bandage was removed and the skin washed. Clinical signs and irritant effects were recorded.
B. CHALLENGE EXPOSURE
The hair of the previously untreated right flank was removed mechanically.
- No. of exposures: 1
- Day(s) of challenge: Day 29
- Exposure period: 6 hour exposure under occlusive bandage
- Test groups: 20 animals
- Control group: 10 animals
- Site: Right flank: 0.5 mL of the test substance was applied over a patch.
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches.
After removal of the occlusive bandage, any remnants of the substance were carefully washed off with warm water. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No information on positive control data available from study report.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none, no erythema, no oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none, no erythema, no oedema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none, no erythema, no oedema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none, no erythema, no oedema
- Group:
- positive control
- Remarks on result:
- other: no information on positive control mentioned in study report.
Any other information on results incl. tables
Range finding test: As no signs of irritation occurred after application of the different test concentrations, 100 % was selected for challenge application.
The body weight gains of the animals were not impaired.
The animals of the treatment and control group showed no signs of irritation during induction phase.
No signs of irritation (no erythema and no oedema) were observed in the control and the treatment group 24 and 48 hours after removal of challenge patches.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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