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Diss Factsheets
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EC number: 604-018-5 | CAS number: 137433-01-3
- 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientific and detailed study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- (2S,3S,5R)-2-hexyl-3-hydroxy-5-(phenylmethoxy)-Hexadecanoic acid compd. with (S)-α-methylbenzenemethanamine (1:1)
- EC Number:
- 604-018-5
- Cas Number:
- 137433-01-3
- Molecular formula:
- C29 H50 O4 . C8 H11 N
- IUPAC Name:
- (2S,3S,5R)-2-hexyl-3-hydroxy-5-(phenylmethoxy)-Hexadecanoic acid compd. with (S)-α-methylbenzenemethanamine (1:1)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- eight concentrations: 0.25, 0.5, 2.5, 1, 10, 25, 50, 75 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- eight concentrations: 0.25, 0.5, 2.5, 1, 10, 25, 50, 75 %
- No. of animals per dose:
- 3 per dose
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- redness score of 1 on the test article site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: redness score of 1 on the test article site.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- redness score of 1 at the test article site
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: redness score of 1 at the test article site.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was a mild skin sensitizer under the test conditions but does not require labeling as skin sensitizer under EU criteria.
- Executive summary:
The cutaneous allergenic potential of THL-PE salt was assessed using the Magnusson-Kligman method carried out on Harley Albino guinea pigs (acc. to OECD 406). Fifteen femals and fifteen males were assigned to the study. At challenge, erythma was absent to moderate on the test article site and absent on the vehicle dose site. 2 of 20 animals were observed to have a redness score of 1 at the 24 hour observation period; 3 of 20 animals had a redness score of 1 at the 48 hour observation period. The test substance was considered a mild sensitiser under the test conditions but does not require labeling as a skin sensitizer under EU criteria.
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