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Diss Factsheets
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EC number: 249-047-0 | CAS number: 28473-19-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study similar to guideline performed on read-across substance, with limited reporting
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only four animals in test group (a minimum of 10 animals is recommended); no further details to judge compliance with guideline
- GLP compliance:
- no
- Remarks:
- predates GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted prior to the introduction of the LLNA method legislation.
Test material
- Reference substance name:
- Diisodecyl adipate
- EC Number:
- 248-299-9
- EC Name:
- Diisodecyl adipate
- Cas Number:
- 27178-16-1
- Molecular formula:
- C26H50O4
- IUPAC Name:
- bis(8-methylnonyl) adipate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): di-isodecyl adipate
- Molecular formula (if other than submission substance): C26H50O4
- Molecular weight (if other than submission substance): 426.677
- Smiles notation (if other than submission substance): C(CCCCC(OCCCCCCCC(C)C)=O)(OCCCCCCCC(C)C)=O
- InChl (if other than submission substance): InChI=1S/C26H50O4/c1-23(2)17-11-7-5-9-15-21-29-25(27)19-13-14-20-26(28)30-22-16-10-6-8-12-18-24(3)4/h23-24H,5-22H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: no data
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous (no details on level of occlusion)
- Vehicle:
- water
- Concentration / amount:
- Induction: 100%
Challenge: 1%, 10% or 100%
Challengeopen allclose all
- Route:
- other: epicutaneous (no details on level of occlusion)
- Vehicle:
- water
- Concentration / amount:
- Induction: 100%
Challenge: 1%, 10% or 100%
- No. of animals per dose:
- Four animals treated at induction (sex unspecified). No details on the number of these which were given the 1%, 10% or 100% challenge treatment [but probably all four given all three challenge applications].
- Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: "three days" - presumably three treatments
- Exposure period: no data [possibly 24 hours]
- Test groups: four guinea pigs given undiluted DIDA
- Control group: no data
- Site: ears
- Frequency of applications: no data
- Duration: three days of treatment, then challenge four days later
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: no data
- Exposure period: no data
- Test groups: guinea pigs given 1%, 10% or 100%, but no data on numbers
- Control group: no data
- Site: clipped flank
- Concentrations: 1%, 10% or 100%
- Evaluation (hr after challenge): no data
OTHER: - Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Results
- Reading:
- other: challenge reading
- Group:
- test chemical
- Dose level:
- challenge with 1%, 10% or 100% DIDA
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: other: challenge reading. Group: test group. Dose level: challenge with 1%, 10% or 100% DIDA. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no data.
Any other information on results incl. tables
No erythema was seen - no data is given on whether other parameters (e.g. oedema) were checked, but presumably these would have been reported, if observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- DIDA was not sensitising to the skin of four guinea pigs in a pre-GLP study, similar to that described by OECD Guideline 406 (with limitations).
- Executive summary:
In a pre-GLP study, similar to that described by OECD Guideline 406, the potential for diisodecyl adipate (a structurally-similar read-across candidate for diisodecyl sebacate) to sensitise the skin of guinea pigs was investigated.
Four albino guinea pigs were given topical applications of undiluted DIDA to the ear for three days, then challenged with 1%, 10% or 100% DIDA four days later. No erythema was seen, and diisodecyl adipate was not considered to be a strong sensitiser on this basis.
In this study, DIDA showed limited evidence for a lack of skin sensitising potential.
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