Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-769-9 | CAS number: 858956-08-8
- 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
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 Apr - 01 May 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 1998
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all treatments at test initiation, at the beginning and the end of the longest renewal cycle each week, and at test termination
- Sampling method: from mid-depth in the test solutions
- Sample storage conditions before analysis: processed immediately - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: test concentration preparation three times per week during the first two weeks of the test, and twice during the last week of the test. A primary stock solution was prepared in dilution water at a nominal concentration of 50 mg a.s./L and sonicated for five minutes. Proportional dilutions of the primary stock solution were made in dilution water to prepare test solutions.
- Differential loading: no
- Controls: yes, dilution water only
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Age at study initiation: < 24 h
- Method of breeding: same conditions as in test
- Source: bred at testing facility
Feeding during test
- Food type: mixture of yeast, cereal grass media, and trout chow and a suspension of the freshwater green alga, Pseudokirchneriella subcapitata
- Frequency: once daily - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 132 - 148 mg/L as CaCO3
- Test temperature:
- 19.1 - 20.6 °C
- pH:
- 8.1 - 8.4
- Dissolved oxygen:
- 7.8 - 8.9 mg/L
- Conductivity:
- 315 - 361 µmhos/cm
- Nominal and measured concentrations:
- Nominal test substance concentrations: 0.38, 0.75, 1.5, 3.0 and 6.0 mg a.s./L
Mean meas. test substance concentrations: 0.37, 0.73, 1.5, 3.0 and 6.0 mg a.s./L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass beakers
- Type: loosely covered with a plastic petri dish
- Fill volume: 220 mL
- Headspace: 30 mL
- Aeration: no
- Renewal rate of test solution: three times per week in week 1 and 2, twice in week 3
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 20
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water located on the Wildlife International, Ltd. site, passed through sand filter and aerated. Prior to use filtered to 0.45 μm and passed through an ultraviolet sterilizer
- Total organic carbon:< 2 mg C/L
- Alkalinity: 182 mg/L as CaCO3 (range: 180 - 186 mg/L as CaCO3)
- Conductivity: 303 μmhos/cm (range: 300 - 310 µmhos/cm)
- pH: 8.2 (range: 8.1 - 8.3)
- Intervals of water quality measurement: Temperature, dissolved oxygen and pH: at day 0, and at day 21 in the old and new solutions on renewal days (in two alternating replicate test chambers of each treatment and control group), hardness, alkalinity and specific conductance: at day 0, 8 and 15 (negative control and the highest test concentration) and at day 21 (pooled replicate solutions at test termination)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h day-night cycle
- Light intensity: 235 lux (Fluorescent light)
EFFECT PARAMETERS MEASURED: immobility, clinical signs of toxicity, presence of eggs in the brood pouch, aborted eggs, males or ephippia: daily, neonates produced (three times per week and at day 21), body length and dry weight of each surviving first-generation daphnid (day 21) - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Remarks:
- adult survival/growth
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Remarks:
- immobility
- Details on results:
- - Observations on body mean length and weight:
negative control: 5.3 mm (length), 1.55 mg (dry weight), 0.37, 0.73, 1.5, 3.0 and 6.0 mg a.s./L treatment groups: 5.1, 5.4, 5.4, 5.3 and 5.4 mm (length), 1.53, 1.71, 1.72, 1.65 and 1.64 mg (dry weight)
- Mortality of control: 10% - Reported statistics and error estimates:
- Discrete-variable data were analyzed using Chi-square and Fisher’s Exact test to identify treatment groups that showed a statistically significant difference (p ≤ 0.05) from the control. All continuous-variable data were evaluated for normality using the Shapiro-Wilk or Chi-Square test and for homogeneity of variance using Levene’s test (p = 0.01). The reproduction and dry weight data passed the assumptions of normality and homogeneity. Analysis of variance (ANOVA) was used to determine whether or not statistically significant differences existed among the experimental groups (p = 0.05). Those treatments that were significantly different from the control means were identified using either Bonferroni’s t-test or Dunnett’s test (p ≤ 0.05). All statistical tests were performed using a personal computer with TOXSTAT or SAS software.
- Validity criteria fulfilled:
- yes
- Remarks:
- Please see Table 2 at "Any other information on results and tables" for more details
Reference
Table 1: Summary of effects following exposure of Daphnia magna
for 21 days
Mean, measured technical concentration (mg a.s./L) |
Mean % adult survival a) |
Mean first day of reproduction b) |
Mean total live young c) |
Mean total immobile young d) |
Mean adult length (mm) e) |
Mean adult dry weight (mg) e) |
Water Control (0.0) |
90 |
7 |
296 |
0 |
5.3 |
1.55 |
0.37 |
60 |
7 |
285 |
0 |
5.1 |
1.53 |
0.73 |
70 |
7 |
306 |
0 |
5.4 |
1.71 |
1.5 |
60 |
7 |
305 |
0 |
5.4 |
1.72 |
3.0 |
90 |
7 |
292 |
0 |
5.3 |
1.65 |
6.0 |
90 |
7 |
310 |
2 |
5.4 |
1.64 |
a) Percent of adult daphnids alive at the end of the test (immobility was synonymous with death)
b) First day that reproduction was observed in the replicates
c) Mean of live young produced per surviving female
d) Mean of immobile young produced per surviving female; calculated from 14 immobile neonates, of 98 neonates, counted for Replicate I on Day 17
e) There were no significant differences from the control (adult length and dry weight: Dunnett’s t-test, alpha = 0.05)
Table 2: Validity criteria for OECD 211.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The mortality of the parent animals in the control (female Daphnia) does not exceed 20% at the end of the test. |
10% |
yes |
The mean number of living offspring produced per parent animalsurvivingat the end of the test is ≥ 60 in the control. |
296 |
yes |
Description of key information
NOEC (21 d) = ≥ 6.0 mg a.s./L (mean measured, OECD 211, Daphnia magna)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 6 mg/L
Additional information
One experimental GLP study is available testing the chronic toxicity towards aquatic invertebrates. This study was conducted according to OECD 211 with water flea Daphnia magna.
In the semi-static
experiment, daphnids were exposed to mean measured concentrations
between 0.37 and 6.0 mg a.s./L for 21 days. The test solutions were
renewed three times per week. The targeted test substance concentrations
were analytically measured by high
performance liquid chromatography (HPLC) with UV detection. The mean
measured ranged from 97 to 100% of the targeted nominal concentrations. The
daphnids showed no significant reduction in survival rate, reproduction
or growth at any of the concentrations tested. Consequently, the NOEC
(21 d) was ≥ 6.0
mg a.s./L (mean measured).
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.