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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
Long-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- long-term toxicity to aquatic invertebrates
- 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:
- GLP Guideline study with deficiencies: Poor analytical recovery of the test item in the aged test solutions; high parental mortality at the selected test concentrations; according to OECD 211 “the range of test concentrations should preferably not include any concentrations that have a statistically significant effect on adult survival since this would change the nature of the test […].”; The effect concentrations are based on the initially measured concentrations of the new test solutions. Since the fate of the test item is not proven and effects were not only observed directly after addition of the test solutions, the effect values should be based on average concentrations (preferably time-weighted average). This is a methodological error. The time-weighted average concentrations have been recalculated for this robust study summary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4640-07-7
- Cas Number:
- 4640-07-7
- IUPAC Name:
- 4640-07-7
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FAT 80'221/B (Methyldiclosan, degradation product of Diclosan)
- Molecular formula (if other than submission substance): C13H10O2CI2, 2-Methoxy-4,4'-dichlorodiphenylether
- Molecular weight (if other than submission substance): 245.1 g/mol
- Physical state: white powder
- Analytical purity: 99.7%
- Lot/batch No.: ETH-636/2A
- Expiration date of the lot/batch: expiration date: 31 July 2007
- Storage condition of test material: at room temperature, closed polyethylene vessel
- Other: Water solubility: 0.322 ± 0.018 mg/L; Homogeneous and stable, not volatile; Log Pow: 4.58 (estimated)
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0 and 100 mg/L at test start and test end
- No data on sampling technique and sample storage
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A super-saturated stock solution of the test item was prepared. This was done by mixing 100 mg/L of the test item with dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 µm filters. The stock solution then was used to prepare the solutions of the concentrations to be tested.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: waterflea
- Strain/clone: Berlin
- Source: LAUS GmbH
- Age of parental stock (mean and range, SD): no data; method of breeding: Females multiplied by parthenogenesis; Holding: glass beakers (2 L), medium M4 (Elendt), feeding with, change of medium twice a week, photo period 16/8 h (fluorescent tubes), T = 21±2°C; feeding: Tetra Aminin® (cold-water fish food) suspended in M4 and boiled for three seconds; green algae Pseudokirchneriella subcapitata
- Feeding during test
- Food type: Unicellular green alga (Pseudokirchneriella subcapitata)
- Amount: 0.15 mg org. C/animal/day
- Frequency: 3 times per week
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
Test conditions
- Test temperature:
- - 19.7 to 20.7 °C (test concentrations with living daphnids at test end)
- 19.8 to 21.8 °C (test concentrations where all parental animals did not survive until test end) - pH:
- Control: 6.5 to 8.0
Test concentrations: new: 6.0 to 7.3; aged: 6.7 to 8.4 - Dissolved oxygen:
- 8.6 to 9.8 mg/L
- Nominal and measured concentrations:
- nominal (loading): 0, 625%, 12,5%, 25%, 50%, and 100% of super-saturated solutions
measured (TWA, µg/L): 0, 5.6, 12.3, 34.7, 56.1, 181.4 - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass beakers, 100 mL (nominal), 80 mL fill volume
- Aeration: Dilution water was aerated prior to preparation of test solutions. Test solutions were not aerated.
- Renewal rate of test solution (frequency/flow rate): Three times per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 80 mL/parent animal
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4-medium (Drinking water with an enrichment of minerals is used in the test (calcium chloride, magnesium sulphate, sodium chloride, potassium chloride).)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: not specified (breeding and holding conditions: 16/8hours,usingneontubes
- Light intensity: ≤ 2000 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study: - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.3 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 34.7 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 34.7 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- < 5.6 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- adult mortality
- Details on results:
- The validity criteria for the control replicates were kept. Therefore the study is to be regarded as valid according to OECD 211. Nevertheless, the poor analytical recovery of the test item in the aged test solutions is critical. In addition the high parental mortality at the selected test concentrations should be regarded as a deficiency of this study. According to OECD 211 “the range of test concentrations should preferably not included any concentrations that have a statistically significant effect on adult survival since this would change the nature of the test […].”
Any other information on results incl. tables
Analytically determined test concentrations (TWA = time-weighted average)
Saturation |
Solution |
Measured test item concentraion (µg/L) on day |
Mean |
TWA |
||||||||
0 |
2 |
5 |
7 |
9 |
12 |
14 |
16 |
21 |
||||
0 |
new |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0 |
aged |
- |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.6 |
0.1 |
||
6.25 |
new |
7.5 |
24.2 |
18.6 |
15.0 |
20.7 |
7.8 |
23.7 |
20.2 |
- |
17.2 |
5.6 |
aged |
- |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
7.7 |
1.0 |
||
12.5 |
new |
16.5 |
49.6 |
42.2 |
37.5 |
36.4 |
23.5 |
41.4 |
47.1 |
- |
36.8 |
12.3 |
aged |
- |
5.4 |
0.0 |
2.9 |
0.4 |
0.0 |
0.6 |
0.0 |
11.0 |
2.5 |
||
25 |
new |
74.7 |
105.9 |
91.3 |
73.4 |
69.4 |
53.1 |
92.1 |
74.3 |
- |
79.3 |
34.7 |
aged |
- |
21.9 |
4.9 |
44.8 |
6.3 |
0.0 |
0.0 |
0.0 |
42.2 |
15.0 |
||
50 |
new |
158.0 |
188.3 |
178.2 |
145.1 |
140.2 |
- |
- |
- |
- |
162.0 |
56.1 |
aged |
- |
31.8 |
6.7 |
30.8 |
19.9 |
0.0 |
- |
- |
- |
17.8 |
||
100 |
new |
345.6 |
410.1 |
- |
- |
- |
- |
- |
- |
- |
377.9 |
181.4 |
aged |
- |
90.6 |
53.8 |
- |
- |
- |
- |
- |
- |
72.2 |
Fecundity (living offspring per parent animal alive at test termination)
Saturation% |
control (0) |
6.25 |
12.5 |
25 |
50 |
100 |
Parent animals alive at test end |
9 |
7 |
6 |
4 |
0 |
0 |
Mortality |
10% |
30% |
40% |
60% |
100% |
100% |
Mean |
71 |
71 |
76 |
57 |
0 |
0 |
Min |
60 |
46 |
55 |
47 |
0 |
0 |
Max |
88 |
89 |
96 |
61 |
0 |
0 |
SD |
8 |
15 |
16 |
7 |
- |
- |
CV |
0.11 |
0.21 |
0.21 |
0.12 |
- |
- |
Fecundity (% of control) |
- |
99% |
106% |
80% |
0% |
0% |
In the treatment 50%, all parent animals except for replicate 7 and 8 were found dead on day 5. In the treatment 100% all parent animals were found dead on day 4
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.