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EC number: 306-248-9 | CAS number: 96690-53-8
- 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:
- 2008-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- First addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 406, "Skin Sensitisation" adopted July 17, 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The registration substance is esters of unsaturared fatty acids. Unsaturated fatty acids are known to induce false positive responce in LLNA (i.e. Roberts et al., Regul Toxicol Pharmacol. 2016 Oct;80:260-7; Kreiling et al., Food Chem Toxicol. 2008 Jun;46(6):1896-904):
Test material
- Reference substance name:
- Sunflower oil, ester with sorbitol
- EC Number:
- 306-248-9
- EC Name:
- Sunflower oil, ester with sorbitol
- Cas Number:
- 96690-53-8
- IUPAC Name:
- sunflower seed oil sorbitol esters
- Test material form:
- liquid
- Details on test material:
- Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.5 mL
- Day(s)/duration:
- 6h /weekly for three weeks
- Adequacy of induction:
- other: In the prelliminary test no significant irritation was found up to the concentration of 100%.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %/ 0.5mL
- Day(s)/duration:
- 6hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 for test group, 10 for negative control group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: reading at 24/48/72h after challenge treatment
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: reading at 24/48/72h after challenge treatment
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Vaseline was used as negative control
Any other information on results incl. tables
Number of animals showing skin reactions after |
||||||||
Challenge concentration of test substance (%) |
First challenge |
Second challenge |
||||||
|
First challenge |
Second challenge |
24h |
47h |
72h |
24h |
47h |
72h |
Test group |
100 |
- |
0 |
0 |
0 |
- |
- |
- |
Negative control group |
100 |
- |
0 |
0 |
0 |
- |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitization property fo the registration substance was investigated using Bühler Test according to the Guideline OECD 406. No significant skin sensitization property was found.
- Executive summary:
The skin sensitization property fo the registration substance was investigated using Bühler Test according to the Guideline OECD 406. The undiluted substance was applied to 20 guinea pigs epicutaneously for 6 hours once per week for three weeks, at volume of 0.5mL. After two weeks the animals were challenged by epicutaneous treatment of 0.5mL of undiluted substance for 6hours. None of these animals responded at reading times 24, 48h and 72h after treatment. No significant skin sensitization property was found for the registration substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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