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EC number: 207-980-0 | CAS number: 504-02-9
- 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
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Dec 2009 to 11 Feb 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 15-09-2009 Date of Signature: 26-11-2009
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- other: by mass
Test material
- Reference substance name:
- Cyclohexane-1,3-dione
- EC Number:
- 207-980-0
- EC Name:
- Cyclohexane-1,3-dione
- Cas Number:
- 504-02-9
- Molecular formula:
- C6H8O2
- IUPAC Name:
- cyclohexane-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): 1,3 cyclohexane dione
- Substance type: Powder
- Physical state: Solid
- Analytical purity: 1,3 Cyclohexane Dione >97% W/W
- Impurities (identity and concentrations): Sodium Chloride 1%W/W Maximum
Water 0.5%W/W Maximum
- Composition of test material, percentage of components: 1,3 Cyclohexane Dione 99.2% W/W
Sodium Chloride 0.25%W/W
Water 0.4%W/W
- Purity test date: 18 November 2009
- Lot/batch No.: 184731091224
- Expiration date of the lot/batch: 18 May 2010
- Radiochemical purity (if radiolabelling): N/A
- Stability under test conditions: Stable
- Storage condition of test material: approximately 4 deg C in the dark
Constituent 1
Results and discussion
Particle size
- Percentile:
- D50
- Remarks on result:
- other: Too few particles were of a size less than 10µm to allow accurate assessment of mass median aerodynamic diameter(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Any other information on results incl. tables
Calculations
Using the values obtained from the cascade impactor method determinations, the cumulative mass and cumulative percentage were calculated as follows:
Table 10.22
Collection Stage |
Mass at Stage (g) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
Artificial Throat |
m0 |
M0 |
100 |
Sample Cup 1 |
m1 |
M1 |
100 x M1/M0 |
Sample Cup 2 |
m2 |
M2 |
100 x M2/M0 |
Sample Cup 3 |
m3 |
M3 |
100 x M3/M0 |
Sample Cup 4 |
m4 |
M4 |
100 x M4/M0 |
Sample Cup 5 |
m5 |
M5 |
100 x M5/M0 |
Final Filter |
m6 |
M6 |
100 x M6/M0 |
where:
m=mass of test material (g) found at collection stage
M=cumulative mass (g) from collection stage on (eg M3= m3+
m4+ m5+ m6)
Results
Screening test (sieve method)
The results of the sieving procedure are shown in the following table:
Table 10.23
Measurement |
Result |
Mass of test material transferred to sieve |
15.23 g |
Mass of test material passed through sieve |
9.97 g |
Proportion of test material <100 µm |
65.5 % |
Definitive test (cascade impactor method)
The results of the cascade impactor method determinations are shown as follows:
Determination1
Table 10.24
Collection Stage |
Particle Size Range Collected (µm) |
Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.3155 |
88.8033 |
2.4878 |
Cup 2 |
5.5 to 10.0 |
85.6313 |
85.6683 |
0.0370 |
Cup 3 |
2.4 to 5.5 |
86.0832 |
86.0934 |
0.0102 |
Cup 4 |
1.61 to 2.4 |
85.6145 |
85.6195 |
0.0050 |
Cup 5 |
0.307 to 1.61 |
85.9546 |
85.9595 |
0.0049 |
Filter |
<0.307 |
75.6423 |
75.6484 |
0.0061 |
Mass of test material found in artificial throat: 0.38 g.
Total mass of test material recovered in artificial throat, sample cups
and filter: 2.9310 g.
Determination 2
Table 10.25
Collection Stage |
Particle Size Range Collected (µm) |
Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
86.3163 |
88.8433 |
2.5270 |
Cup 2 |
5.5 to 10.0 |
85.6322 |
85.6585 |
0.0263 |
Cup 3 |
2.4 to 5.5 |
86.0838 |
86.0915 |
0.0077 |
Cup 4 |
1.61 to 2.4 |
85.6154 |
85.6189 |
0.0035 |
Cup 5 |
0.307 to 1.61 |
85.9557 |
85.9589 |
0.0032 |
Filter |
<0.307 |
75.6502 |
75.6536 |
0.0034 |
Mass of test material found in artificial throat: 0.36 g.
Total mass of test material recovered in artificial throat, sample cups
and filter: 2.9311 g.
Determination 3
Table10.26
Collection Stage |
Particle Size Range Collected (µm) |
Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
>10.0 |
85.9562 |
88.4845 |
2.5283 |
Cup 2 |
5.5 to 10.0 |
85.6172 |
85.6309 |
0.0137 |
Cup 3 |
2.4 to 5.5 |
86.0856 |
86.0883 |
0.0027 |
Cup 4 |
1.61 to 2.4 |
85.6341 |
85.6347 |
0.0006 |
Cup 5 |
0.307 to 1.61 |
86.3181 |
86.3192 |
0.0011 |
Filter |
<0.307 |
75.6401 |
75.6418 |
0.0017 |
Mass of test material found in artificial throat: 0.42 g.
Total mass of test material recovered in artificial throat, sample cups
and filter: 2.9681 g.
Cumulative amounts
The cumulative amounts of test material found in the three determinations for the individual particle size cut-points (µm) are shown in the following table:
Table 10.27
Particle Size Cut-point (µm) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
||||
Determination 1 |
Determination 2 |
Determination 3 |
Determination 1 |
Determination 2 |
Determination 3 |
|
10.0 |
0.0632 |
0.0441 |
0.0198 |
2.16 |
1.51 |
0.667 |
5.5 |
0.0262 |
0.0178 |
0.0061 |
0.894 |
0.607 |
0.206 |
2.4 |
0.0160 |
0.0101 |
0.0034 |
0.546 |
0.345 |
0.115 |
1.61 |
0.0110 |
0.0066 |
0.0028 |
0.375 |
0.225 |
9.43 x 10-2 |
0.307 |
0.0061 |
0.0034 |
0.0017 |
0.208 |
0.116 |
5.73 x 10-2 |
The overall cumulative percentage (%) of test material with a particle size less than 10.0 µm and 5.5 µm are shown in the following table:
Table10.28
Particle size |
Cumulative Percentage (%) |
|||
Determination 1 |
Determination 2 |
Determination 3 |
Mean |
|
<10.0 µm |
2.16 |
1.51 |
0.667 |
1.44 |
<5.5 µm |
0.894 |
0.607 |
0.206 |
0.569 |
Applicant's summary and conclusion
- Conclusions:
- Particle size data for the test material was as follows:
The proportion of test material having an inhalable particle size <100 µm, as determined by sieve method, was 65.5%
The proportion of test material having thoracic particle size <10.0 µm, as determined by cascade impactor was 1.44%
The proportion of test material having a respirable particle size <5.5 µm, as determined by cascade impactor was 0.569% - Executive summary:
Particle Size Distribution. Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisfies the requirements of OECD Guideline 110. The results are as follows:
Measurement
Method
Result
Proportion of test material having an inhalable particle size less than 100 µm
Sieve
65.5%
Proportion of test material having a thoracic particle size less than 10.0 µm
Cascade Impactor
1.44%
Proportion of test material having a respirable particle size less than 5.5 µm
Cascade Impactor
0.569%
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