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Diss Factsheets
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EC number: 947-760-8 | 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:
- 23 October 1979 to 28 November 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Hartley Albino guinea pigs, approx 5 weeks old were acclimatized for one week in the laboratory. 10 were selected for dosing. The animals were identified by cage tags noting hte test material, starting date, animal number and sex.
- GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Conducted prior to LLNA test introduced
Test material
- Reference substance name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- EC Number:
- 249-793-7
- EC Name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- Cas Number:
- 29710-25-6
- Molecular formula:
- C26H52O3
- IUPAC Name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- Test material form:
- other: oil
- Details on test material:
- a-ethyl-hexyl-oxystearate
Constituent 1
- Specific details on test material used for the study:
- Wickenol 171, 2ethylhexyl oxystearate, Lot #424-9
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Hartley Albino rats approximatley 5 weeks old were received and equilibrated for at least a week in the laboratory. 10 healthy animals were selected for testing.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.05 ml initially then 0.1ml for subsequent injections
- Day(s)/duration:
- 3 consecutive days/week for 3 weeks
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Day(s)/duration:
- first day of the series in the fourth week
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Day(s)/duration:
- second day of the series
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No.:
- #5
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No.:
- #7
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No.:
- #4
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No.:
- #6
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No.:
- #8
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No.:
- #9
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1
- Adequacy of challenge:
- not specified
- No.:
- #10
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- The test material was injected intradermally
- Challenge controls:
- No
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Treatment Number | Erythema | Edema |
1 | 0.4 | 0 |
2 | 0.5 | 0.1 |
3 | 0.4 | 0.1 |
4 | 0.5 | 0.2 |
5 | 0.4 | 0 |
6 | 0.5 | 0.2 |
7 | 0.8 | 0.5 |
8 | 0.5 | 0.5 |
9 | 1.3 | 0.9 |
10 | 1.9 | 1.1 |
average | 0.71 | 0.36 |
challenge 0.66 0
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the test, the material does not appear to be a sensitizer.
- Executive summary:
10 Hartley albino rats were injection intradermally for 3 consecutive days/week for three weeks. 14 days after the last induction exposure, the animals were challenged in the same manner at a site removed from the sites of the induction treatment.
There was no evidence of a significant increase in these scores to indicate that the test material is a sensitiser.
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