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Diss Factsheets
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EC number: 259-423-6 | CAS number: 54982-83-1
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- The Buehler test is performed before the REACH regulation came into force. The Buehler test is considered sufficiently reliable because 100% substance has been used for induction and challenge.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no control group used
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed before the LLNA method was an OECD TG method.
Test material
- Reference substance name:
- 1,4-dioxacyclohexadecane-5,16-dione
- EC Number:
- 259-423-6
- EC Name:
- 1,4-dioxacyclohexadecane-5,16-dione
- Cas Number:
- 54982-83-1
- Molecular formula:
- C14H24O4
- IUPAC Name:
- 1,4-dioxacyclohexadecane-5,16-dione
- Test material form:
- liquid
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300g
- Diet: Standard diet (Ssniff/Intermast), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- 0.5ml of the pure substance is applied to a plaster of 19*25 mm. This was then fixed with an Elastoplaster on the left site of the animal. This area was shaved. The animal was then fixed in a holder for 6 hours. This treatment was performed twice a week for three weeks
- Challenge controls:
- All animals were retreated on both sides 14 days after the last treatment. Plaster was removed after 6 hours and after another 2 hours the assessment was made.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 32
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Animals showed a normal clinical appearance throughout the study. No contact hypersensitivity was observed. Skin reaction and oedema formation was observed. The redness of the skin was measured with a refractometer and was assesed with Draize score. Results: Draize score 0 - 1 for all 20 animals with remark: hair removal reaction. Results refractometer shows average values of 135 (left) and 137 (right).
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin sensitiser
- Remarks:
- according to EU CLP (EC 1272/2008 and its amendments)
- Conclusions:
- Under the conditions of this study the test substance is not sensitizing
- Executive summary:
In a skin sensitisation study, performed similar to OECD guideline 406, twenty guinea pigs were dosed with 0.5 mL of the substance in an Elastoplaster on the left site of the animal for six hours. The treatment was repeated twice a week for three weeks. No positive control group was included in the study. Fourteen days after topical induction, challenge dosing for detection of sensitisation was performed on both left and right sides of the animals. For challenge undiluted test substance was used. The redness of the skin was measured with a refractometer and was assessed according to the Draize score. There were no deaths or clinical findings. Draize scores from 0 to 1 were observed for all 20 animals. A hair removal reaction was noted. There were no sensitisation differences between left and right side of the animals detected. No contact hypersensitivity was observed in this study.
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