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EC number: 919-274-6 | CAS number: -
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 7 August 2007 to 20 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- yes
- Principles of method if other than guideline:
- Due to a technical oversight, particulate maner, pH, hardness, alkalinity, conductivity and Total Organic Carbon analysis of the diluent water was not performed at the start of the definitive test. Given that the control daphnids showed no adverse effects of exposure, the diluent water was considered not to contain any deficiencies in the above water quality parameters that would affect the outcome or integrity of the study.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's identification: AS305BD
Description: dark brown, viscous liquid
Lot number: TS07002
Analytical purity: 100%
Storage conditions: room temperature in the dark
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The recovery values for the pre-study samples were observed to be low. Therefore, in order to increase detection and improve accuracy a larger volume of sample was taken for the definitive test. A Strata C8 (500 mg/ 3 mL) solid phase extraction (SPE) cartridge was sequentially preconditioned with methanol and water. A volume (500 mL) of test sample was eluted through the cartridge and the cartridge dried on the SPE manifold. The test material was eluted from the cartridge with methanol (10 mL).
Water samples were taken from the control (replicates R1 - R4 pooled) and the 100% v/v saturated solution test group (each replicate analysed separately) at 0 and 48 hours for quantitative analysis.
Duplicate samples were taken and stored at approximately -20°C for further analysis if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- An amount of test material (2250 mg) was dispersed in 22.5 Iitres of dechlorinated tap water with the aid of propeller stirring at approximately 1500 rpm at a temperature of approximately 21°C for a period of 24 hours. After 24 hours the stirring was stopped and the undissolved test material removed by filtration (0.2 µm Sartopore filter, first approximate 1 litre discarded in order to precondition the filter) to give the 100% v/v saturated solution.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Source: in-house laboratory cultures
- Age at study initiation (mean and range, SD): less than 24 hours old
- Method of breeding: parthenogenesis
- Feeding during test: no
ACCLIMATION
not applicable to laboratory bred Daphnia.
QUARANTINE (wild caught)
not applicable to laboratory bred Daphnia.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Not applicable.
Test conditions
- Hardness:
- The reconstituted water has an approximate theoretical total hardness of 250 mg/l as CaCO3. Due to a technical oversight water hardness was not tested at the beginning of the definitive test.
- Test temperature:
- 20°C
- pH:
- 7.1-8.0
Due to a technical oversight pH was not tested at the beginning of the definitive test. - Dissolved oxygen:
- 8.8-9.0 mg O2/L
- Salinity:
- Not stated
- Nominal and measured concentrations:
- Following a range-finding tests, a 'limit test' was conducted at a concentration of 100% v/v saturated solution.
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): covered to reduce evaporation
- Material, size, headspace, fill volume: 250 mL glass jars
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Stock Solutions:
a) CaCI,.2H,O 11.76 g/L
b) MgSO,.7H,O 4.93 g/L
c) NaHCO, 2.59 g/L
d) KCI 0.23 g/L
- Preparation:
An aliquot (25 mL) of each of solutions a-d was added to each litre (final volume) of deionised water with a conductivity of <5 µS cm-I. The reconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl and was aerated until the dissolved oxygen concentration was approximately air-saturation value.
The reconstituted water had an approximate theoretical total hardness of 250 mgIL as CaCO3.
- Total organic carbon: Due to a technical oversight TOC was not measured at the start of the definitive test.
- Particulate matter: Due to a technical oversight particluate matter was not measured at the start of the definitive test.
- Pesticides: not reported.
- Chlorine: not reported.
- Alkalinity: Due to a technical oversight alkalinity was not measured at the start of the definitive test.
- Conductivity: Due to a technical oversight conductivity was not measured at the start of the definitive test.
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24 hours
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours light / 8 hours dark (20 minute dawn/dusk period).
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Immobilisation:
The criterion of effect used was that Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation. Any immobilisation or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure.
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: 100% v/v saturated solution preparation was used as the substance is highly insoluble in water (<0.01mg/l).
- Range finding study
- Test concentrations: 1.0, 10, 100% v/v saturated solution.
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % v/v
- Nominal / measured:
- nominal
- Conc. based on:
- other: Saturated
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 other: % v/v
- Nominal / measured:
- nominal
- Conc. based on:
- other: Saturated
- Basis for effect:
- mobility
- Details on results:
- There was no immobilisation in 20 daphnids exposed to a test concentration of 100% v/v saturated solution for a period of 48 hours. The test concentration of 100% v/v saturated solution was the highest attainable test concentration that could be prepared due to the limited solubility of the test material in water.
- Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- An estimate of the EC50 values was given by inspection of the immobilisation data.
Any other information on results incl. tables
No significant immobilisation was observed at any test concentration throughout the test. A single daphnid was observed to be immobile after 24 and 48 hours exposure however, this was considered to be due to natural causes and not a toxic effect as no immobilisation was observed at the higher test concentrations throughout the test. Based on this information, a single test concentration of four replicates, of 100% v/v saturated solution was selected for the definitive test. This experimental design conforms to a "Limit test" to confirm that at the highest attainable test concentration of 100% v/v saturated solution, no immobilisation or adverse reactions to exposure were observed.
Table 1. Cummulative Immobilisation data in the range-finding test.
Nominal concentration (% v/v saturated solution) |
Cumulative immobilised Daphnia (initial population: 10 per replicate) |
|
24 hours | 48 hours | |
Control | 0 | 0 |
1 | 1* | 1* |
10 | 0 | 0 |
100 | 0 | 0 |
* Immobilisation considered to be due to natural causes and not a toxic effect as no immobilisation was observed at the higher tier concentrations.
Table 2. Cummulative immobilisation data in the definitive test.
Nominal concentration (% v/v saturated solution) |
Cumulative immobilised Daphnia (initial population: 10 per replicate) |
||||||
No. Per replicate | Total | % | No. Per replicate | Total | % | ||
Control | R1 | 0 | 0 | 0 | 0 | 0 | 0 |
R2 | 0 | 0 | |||||
R3 | 0 | 0 | |||||
R4 | 0 | 0 | |||||
100 | R1 | 0 | 0 | 0 | 0 | 0 | 0 |
R2 | 0 | 0 | |||||
R3 | 0 | 0 | |||||
R4 | 0 | 0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- validity criteria (as stated above) fulfilled.
- Conclusions:
- The acute toxicity of the test material to Daphnia magna gave a 48-hour EC50 of >100% v/v saturated solution and a corresponding NOEC of 100% v/v saturated solution.
- Executive summary:
Introduction.
A study was performed to assess the acute toxicity of the test material to Daphnia magna.The method followed that described in the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp, Acute Immobilisation Test" referenced as Method C.2 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC), US Code of Federal Regulations, Title 40, Part 797, Section 1300 and US EPA Draft Ecological Effects Test Guidelines OPPTS 850.1010.
Methods.
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a saturated solution of the test material for 48 hours at a temperature of approximately 20°C under static test conditions. The test material solution was prepared by stirring an excess (100 mg/L) of test material via propeller stirrer in reconstituted water at approximately 1500 rpm at a temperature of approximately 21°C for 24 hours prior to removing any undissolved test material by filtration (0.2µm Sartopore filter, first approximate 1 litre discarded in order to pre-condition the filter) to produce a saturated solution. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours.
Results.
The 48-Hour EC50 for the test material to Daphnia magna based on nominal test concentrations was greater than 100% v/v saturated solution and correspondingly the No Observed Effect Concentration was 100% v/v saturated solution.
The chromatograms for the saturated solutions of the test material showed two sets of peaks, one set at approximately 4 to 6 minutes and one set at 8 to 12 minutes. The peaks at 8 to 12 minutes were consistent with the test material standard and were considered to be the test material AS305BD. It was considered, and agreed with the Sponsor, that the peaks at 4 to 6 minutes were consistent with those of AL305B a starting component in the production of the test material AS305BD. The test preparations were therefore analysed for both the notifiable material AS305BD and unreacted AL305B present. Analysis of the test preparations at 0 and 48 hours showed the measured concentrations for AS305BD and AL305B to be less than the limit of quantitation of the analytical method. This does not infer that no test material was in solution but that the dissolved concentration (i.e. bioavailable to the test organisms) was below the limit of quantitation which was assessed down to 0.019 and 0.0045 mg/L respectively.
This study showed that there were no toxic effects at saturation.
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