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Diss Factsheets
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EC number: 444-000-2 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- No justification given
Test material
- Reference substance name:
- -
- EC Number:
- 444-000-2
- EC Name:
- -
- Cas Number:
- Not specified
- Molecular formula:
- Not applicable because it is a UVCB substance.
- IUPAC Name:
- 3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate; 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: not specified
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- not specified
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
- Route:
- other: not specified
- Vehicle:
- arachis oil
- Concentration / amount:
- 25% w/v test material in arachis oil
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
- Route:
- other: not specified
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 25% w/v test material in Freund's Complete Adjuvant
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
- Route:
- other: Topical Induction
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted test material
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
Challengeopen allclose all
- Route:
- other: Topical Challenge
- Vehicle:
- other: undiluted and arachis oil
- Concentration / amount:
- undiluted and 75% v/v in arachis oil BP
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 25% w/v in arachis oilBP
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 100%
Signs of irritation during induction:
Skin reactions observed after intradermal induction presented as very slight to well defined erythema of all test animals at 24 and 48 -hour observation. Very slight erythema as noted at the intradermal induction sites of all control group animals at the 24 -hour observation an in two control animals at the 48 -hour observation.Skin reactions observed after topical induction presented as very slight or well-defined erythema and an isolated incident of very slight oedemawere noted at the induction sites of five test group animals at 24 -hour observation.Bleeding from the intradermal induction sites was noted in three test group animals at the 1 -hour observation. Residual test material was noted at the induction site of three test group animals at the 1 -hour observation. No evidence of skin irritation was noted at the treatment sites of control group animals at the 24 -hour observation.
Evidence of sensitisation of each challenge concentration: The test material produced a 0% (0/10) sensitisation rate.
Other observations:
None
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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