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EC number: 429-290-0 | CAS number: 3380-30-1
- 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
Bioaccumulation: aquatic / sediment
Administrative data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- other: Transformation product of Diclosan
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- deficiencies: no information on solvent (methanol) concentration in stock/test solutions; In the upper treatment level, the fish did not take up any food during the uptake phase (reversible effect); no vehivle control; data do not indicate if calculation basis is wet weight or dry weight (wet weight assumed for this assessment based on missing description of dry matter determination of fish)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- Version / remarks:
- (1996)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.13 (Bioconcentration: Flow-through fish test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4640-07-7
- Cas Number:
- 4640-07-7
- IUPAC Name:
- 4640-07-7
- Details on test material:
- - Name of test material (as cited in study report): FAT 80'221/B
- Physical state: solid, white homogeneous powder
- Analytical purity: 99.7%
- Purity test date: no data
- Lot/batch No.: ETH-636/2A
- Expiration date of the lot/batch: 31 July 2007
- Stability under test conditions: stable, not volatile
- Storage condition of test material: at room temperature, closed polyethylene vessel
Constituent 1
- Radiolabelling:
- no
Sampling and analysis
- Details on sampling:
- - Sampling intervals/frequency for test organisms:
- uptake period: after 8 h, 3 d, 6 d, 10 d, 14 d, 17 d, 18 d, 19 d
- depuration period: after 4 h, 8 h, 3 d, 6 d, 9 d, 13 d, 18 d
- Sampling intervals/frequency for test medium samples:
- uptake period: after 8 h, 3 d, 6 d, 10 d, 14 d, 17 d, 18 d, 19 d
- depuration period: after 4 h, 8 h, 3 d, 6 d, 9 d, 13 d, 18 d
- Sample storage conditions before analysis: no data
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods): 4 fish/sampling; fish were pooled for replicate (2 fish = 1 replicate = 2 replicates per sampling); sampling of fish and test medium performed at the same time
Test solutions
- Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stock solutions (upper treatment: 10 g/L; lower treatment: 1 g/L)
- Controls: negative control (water-only)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): methanol
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): no data
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No undissolved test matreial in stock solutions, control and lower treatment levels; upper treatment level: Undissolved particles could be observed in case the test item added to the upper treatment surpassed 90% of the water solubility or in case the outflow of the stock solution was not directed into the outflow of the water pump.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: Pet's Best, Neustadt/Weinstraße, Germany
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (lenght definition, mean, range and SD): 3.1 ± 0.3 cm
- Weight at study initiation (mean and range, SD): 506 ± 38 mg
- Weight at termination (mean and range, SD):
- Method of breeding: no data
- Health status: mortality < 5% during housing period of 14 d prior to test start
- Description of housing/holding area: glass aquaria and polyethylene vessels; water: chlorine-free drinking water (Cu < 0.01 mg/L)
- Feeding during test
- Food type: warm-water fish food (tablets: Pet's Best Tabs; flakes: Zierfisch Futter; food analyzed for methyl-diclosan: no traces detected)
- Amount: 1-2% of body weight per day
- Frequency: 3 times per day
ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): yes
- Type and amount of food: same as above
- Feeding frequency: same as above
- Health during acclimation (any mortality observed): mortality < 5% during housing period of 14 d prior to test start
Study design
- Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 20 d
- Total depuration duration:
- 19 d
Test conditions
- Hardness:
- Uptake period: 0.90 - 1.05 mmol/L
Depuration period: 0.93 - 0.96 mmol/L - Test temperature:
- 23 ± 2 °C
- pH:
- Uptake period: 7.7 - 8.2
Depuration period: 8.1 - 8.3 - Dissolved oxygen:
- Uptake period: 6.8 - 8.6 mg/L
Depuration period: 8.5 - 9.6 mg/L - TOC:
- DOC
Uptake period: 1.31 - 12.28 ppm
Depuration period: < 1 ppm (on one occasion: 1.48 ppm in lower treatment and 1.35 ppm in upper treatment) - Salinity:
- Uptake period: 248 - 259 µS/cm
Depuration period: 248 - 259 µS/cm - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 40*60*40 cm³, nominal volume: 80 L, fill volume: 60 L
- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): tubing pump
- Renewal rate of test solution (frequency/flow rate): 5 volumes per day (preheated water: 210 mL/min; stock solution: 6.18 µL/min )
- No. of organisms per vessel: 60
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: 1 fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: chlorine-free drinking water (Cu < 0.01 mg/L)
- Particulate matter: no data
- Metals: Al: < 0.02 mg/L; Cd: < 0.0001 mg/L; Cr: < 0.001 mg/L; Fe: < 0.01 mg/L; Hg: < 0.00005 µg/L; Mn: < 0.005 mg/L; Ni: < 0.001 mg/L; Pb: < 0.001 mg/L
- Pesticides: < 0.0001 µg/L
- Chlorine: 11.1 mg/L
- Alkalinity: no data
- Ca/mg ratio: 29.0 mg/L / 5.0 mg/L
- Conductance: 246 µS/cm
- Holding medium different from test medium: no
- Intervals of water quality measurement: no data (last analysis performed in Sep. 2002)
- Intervals of test medium replacement: flow-through conditions with replacement of 5 volumes per day
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12h
- Light intensity: no data (use of fluorescent tubes) - Nominal and measured concentrations:
- measured: < LOD (control); 26.9 ± 4.8 µg/L; 263.5 ± 27.3 µg/L
- Reference substance (positive control):
- no
Results and discussion
Lipid contentopen allclose all
- Lipid content:
- 9.28 %
- Time point:
- start of exposure
- Remarks on result:
- other: control
- Lipid content:
- 6.38 %
- Time point:
- end of exposure
- Remarks on result:
- other: control
- Lipid content:
- 6.13 - 9.28 %
- Time point:
- other: range over uptake period
- Remarks on result:
- other: control
- Lipid content:
- 8.54 %
- Time point:
- start of exposure
- Remarks on result:
- other: lower treatment
- Lipid content:
- 6.6 %
- Time point:
- end of exposure
- Remarks on result:
- other: lower treatment
- Lipid content:
- 5.42 - 12.52 %
- Time point:
- other: range over uptake period
- Remarks on result:
- other: lower treatment
- Lipid content:
- 8.08 %
- Time point:
- start of exposure
- Remarks on result:
- other: upper treatment
- Lipid content:
- 4.74 %
- Time point:
- end of exposure
- Remarks on result:
- other: upper treatment
- Lipid content:
- 4.74 - 8.75 %
- Time point:
- other: range over exposure period
- Remarks on result:
- other: upper treatment
Bioaccumulation factoropen allclose all
- Type:
- BCF
- Value:
- 21 285
- Basis:
- whole body w.w.
- Time of plateau:
- 11 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Conc.in environment / dose:26.9 ± 4.8 µg/L
- Type:
- BCF
- Value:
- 15 060
- Basis:
- whole body w.w.
- Time of plateau:
- 11 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Conc.in environment / dose:263.5 ± 27.3 µg/L
- Type:
- BCF
- Value:
- 23 084
- Basis:
- whole body w.w.
- Time of plateau:
- 11 d
- Calculation basis:
- kinetic
- Remarks on result:
- other: Conc.in environment / dose:26.9 ± 4.8 µg/L
- Type:
- BCF
- Value:
- 16 738
- Basis:
- whole body w.w.
- Time of plateau:
- 11 d
- Calculation basis:
- kinetic
- Remarks on result:
- other: Conc.in environment / dose:263.5 ± 27.3 µg/L
- Type:
- BCF
- Value:
- 302 440
- Remarks on result:
- other: Conc.in environment / dose:26.9 ± 4.8 µg/L
- Details on kinetic parameters:
- - Mean values: BCFss: 18173; BCFk: 19911
- Uptake rate constant (k1): lower treatment: 3592/day; upper treatment: 2437/day; mean: 3015/day
- Depuration (loss) rate constant (k2): lower treatment: 0.1509/day; upper treatment: 2437/day; mean: 0.1483/day
- Indication of bi- or multiphasic kinetics: no
- Computation / data analysis: - Details on results:
- - Mortality of test organisms: 0%
- Behavioural abnormalities: The fish of the upper treatment level consumed almost no food during the uptake period. In addition they showed slackened movements. During the depuration period they behaved normally.
- Observations on body length and weight:
- Other biological observations:
- Organ specific bioaccumulation: no data
- Bound residues forming a plateau:
- Mortality and/or behavioural abnormalities of control: none
- Loss of test substance during test period:
- Results with vehicle control: not performed
Any other information on results incl. tables
Uptake period: Chemical analysis of fish and water as well as lipid content of fish during
Day of exposure |
M-DCPP |
Lipid content (%) |
|||||
Water (µg/L) |
Fish (mg/kg) |
Repl. 1 |
Repl. 2 |
Mean |
|||
Repl. 1 |
Repl. 2 |
Mean |
|||||
Control |
|||||||
0.33 |
9.28 |
9.28 |
|||||
1 |
9.10 |
9.10 |
|||||
3 |
8.51 |
8.51 |
|||||
6 |
6.82 |
6.82 |
|||||
10 |
7.82 |
7.82 |
|||||
14 |
7.69 |
7.69 |
|||||
17 |
6.28 |
6.28 |
|||||
18 |
6.13 |
6.13 |
|||||
19 |
6.38 |
6.38 |
|||||
Mean |
7.56 |
||||||
Lower treatment |
|||||||
0 |
32 |
||||||
0.33 |
32 |
77 |
8.44 |
8.44 |
|||
1 |
33 |
201 |
12.52 |
12.52 |
|||
3 |
19 |
247 |
9.88 |
9.88 |
|||
6 |
26 |
356 |
6.42 |
6.42 |
|||
10 |
26 |
558 |
Plateau 572 |
9.33 |
9.33 |
||
14 |
25 |
626 |
7.82 |
7.82 |
|||
17 |
29 |
736 |
5.86 |
5.86 |
|||
18 |
30 |
409* |
6.76 |
6.76 |
|||
19 |
31 |
533* |
5.42 |
6.60 |
6.01 |
||
Mean |
28 |
8.05 |
8.18 |
8.12 |
|||
Upper treatment |
|||||||
0 |
244 |
355 |
|
8.08 |
8.08 |
||
0.33 |
296 |
|
|||||
1 |
267 |
879 |
|
8.28 |
8.28 |
||
3 |
1981 |
|
8.71 |
8.71 |
|||
6 |
270 |
2800 |
|
7.60 |
7.60 |
||
10 |
314 |
3094 |
Plateau 3769 |
7.27 |
7.27 |
||
14 |
223 |
3835 |
4347 |
6.84 |
8.75 |
7.80 |
|
17 |
2372* |
3696 |
5.00 |
7.17 |
6.09 |
||
18 |
245 |
3475 |
6.40 |
6.40 |
|||
19 |
262 |
4489 |
2485* |
7.87 |
4.74 |
6.31 |
|
Mean |
265 |
|
|
7.41 |
Depuration period: Chemical analysis and lipid content of fish
Day of |
M-DCPP |
Lipid content (%) |
||||
Fish (mg/kg) |
||||||
Repl. 1 |
Repl. 2 |
Mean |
Repl. 1 |
Repl. 2 |
Mean |
|
Control |
||||||
0.17 |
4.15 |
|
4.15 |
|||
0.33 |
6.05 |
|
6.05 |
|||
1 |
6.09 |
|
6.09 |
|||
3 |
6.24 |
|
6.24 |
|||
6 |
6.08 |
|
6.08 |
|||
9 |
6.19 |
|
6.19 |
|||
13 |
6.22 |
|
6.22 |
|||
18 |
4.79 |
|
4.79 |
|||
Mean |
|
|
|
|
|
5.73 |
Lower treatment |
||||||
0.17 |
130 |
4.69 |
|
4.69 |
||
0.33 |
96 |
5.54 |
|
5.54 |
||
1 |
257 |
65* |
257 |
7.18 |
5.47 |
6.33 |
3 |
158 |
158 |
8.99 |
|
8.99 |
|
6 |
75 |
75 |
5.67 |
|
5.67 |
|
9 |
54 |
54 |
5.73 |
|
5.73 |
|
13 |
65 |
65 |
7.58 |
|
7.58 |
|
18 |
18 |
18 |
5.33 |
|
5.33 |
|
Mean |
|
|
|
|
|
6.23 |
Upper treatment |
||||||
0.17 |
2756 |
2756 |
7.02 |
|
7.02 |
|
0.33 |
3601 |
3601 |
7.24 |
|
7.24 |
|
1 |
3674 |
3278 |
3476 |
5.55 |
9.26 |
7.41 |
3 |
2050 |
2050 |
6.68 |
|
6.68 |
|
6 |
593 |
4347 |
2470 |
4.63 |
|
4.63 |
9 |
829 |
3696 |
2263 |
6.60 |
|
6.60 |
13 |
788 |
788 |
4.72 |
|
4.72 |
|
18 |
224 |
224 |
7.38 |
|
7.38 |
|
Mean |
|
6.46 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.