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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 445-910-2 | CAS number: 1388152-30-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 2005 to 23 March 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in 2002 according to OECD Method # 202 and in accordance with GLP. The study material is well characterized
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 445-910-2
- EC Name:
- -
- Cas Number:
- 1388152-30-4
- Molecular formula:
- Hill formula: C24 H32 N2 O7 Si CAS formula: C15 H20 O3 Si . C9 H12 N2 O4
- IUPAC Name:
- (1R,2R)-1,3-Dihydroxy-1-(4-nitrophenyl)propyl-2-ammonium (1R, 5S)-5-(dimethylphenylsilyl)-2-(hydroxymethyl)cyclopent-2-ene-1-carboxylate
- Details on test material:
- extremely light tan coloured powder; stored at room temperature in the dark; received at testing laboratory on 15 February 2005 .
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
potassium dichromate. Test series (0.32,0.56, 1.0, 1.8 and 3.2 mg/L) were made from 100 mg/L and 10 mg/L stock solutions in reconstituted water.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Water samples were taken from the control (replicates R1 -R2 pooled) and the 100 mg/L test group (replicates R1-R2 and R3 -R4 pooled) 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:
- yes
- Details on test solutions:
- An amount of test material (200 mg) was dissolved in reconstituted water with the aid of ultrasonication for approximately 20 minutes, and the volume adjusted to 2 litres to give the 100 mg/L test concentration. The prepared concentration was inverted several times to ensure adequate mixing and homogeneity. The concentration and stability of the test material in the test preparations were verified by chemical analysis at 0 and 48 hours.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: first in star daphnia magna
- Source: in -house laboratory cultures
- Age at study initiation (mean and range, SD): less than 24 hours old
- Method of breeding: Culture conditions ensured that reproduction was by parthenogenesis.
- Feeding during test - Food type: suspension of algae (Chlorella sp.).
- Frequency: daily
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- approximate theoretical total hardness of 250 mg/L as CaC03
- Test temperature:
- Temperature ranged from 21.3 C at 0 hour to 20.6 C at 24 and 48 hour test vessels
Temperature ranged from 21.3 C at 0 hour to 20.6 to 20.8 C at 24 hr and 20.6 to 20.7 C at 48 hour for control vessels - pH:
- pH 7.8 +/- 0.2 for test vessels
pH 8.0 at 0 hour and 48 hr for controls - Dissolved oxygen:
- air saturation value (ASV) of 96 % at 0 and 48 hour for test vessels( one value of 94%)
air saturation value (ASV) of 96 % at 0 ( one 94%) and all 94% at 48 hour for control vessels - Nominal and measured concentrations:
- Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 97% to 98% of nominal value and so it was considered justifiable to estimate the EC50 values in terms of the nominal test concentrations only.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass jars
- The test vessels were then covered to reduce evaporation
- 250 mL glass jars , approximately 200 mL of test preparation
- Not aerated
- No. of organisms per vessel: 5 daphnids were placed in each test and control vessel at random
- No. of vessels per concentration (replicates) and No. of vessels per control (replicates): 4 replicate test and control vessels were prepared.
-The test preparations were not renewed during the exposure period.
TEST MEDIUM / WATER PARAMETERS: Water temperature was recorded daily throughout the test. Dissolved oxygen concentrations and pH were recorded at the start and termination of the test. The pH and dissolved oxygen concentration were measured
OTHER TEST CONDITION: test and control vessels were maintained in a temperature controlled room at 20.6 C to 21.4 C with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods. The daphnids were not individually identified, received no food during exposure and the vessels were not aerated.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any immobilisation or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. 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. An estimate of the EC50 values was given by inspection of the immobilisation data
TEST CONCENTRATIONS
Water samples were taken from the control (replicates R1 -R2 pooled) and the 100 mg/L test group (replicates R1-R2 and R3 -R4 pooled) at 0 and 48 hours for quantitative analysis. Duplicate samples were taken and stored at approximately -20°C for further analysis if necessary.
- Range finding study
- Test concentrations: eries of nominal test concentrations of 1.0, 10 and 100 mg/L.
- Results used to determine the conditions for the definitive study: Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100 mg/L to confirm that at the maximum concentration given in the OECD/EEC Test Guidelines, no immobilisation or adverse reactions to exposure were observed. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate as the reference material was conducted using test concentrations of 0.32,0.56 , 1 .0, 1.8 and 3.2 mg/L
Results and discussion
Effect concentrations
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL
- Details on results:
- n the range finding study no immobilisation was observed at the test concentrations of 1.0, 10 and 100 mg/L.There was no immobilisation in 20 daphnids exposed to a test concentration of 100 mg/L for a period of 48 hours. The No Observed Effect Concentration after 24 and 48 hours exposure was 100 mg/L. The No Observed Effect Concentration is based upon zero immobilisation at this concentration.
- Results with reference substance (positive control):
- The No Observed Effect Concentrations after 24 and 48 hours were 1.0 mg/L and 0.56 mg/L respectively. The No Observed Effect Concentration is based upon zero immobilisation at this concentration.
The results from the positive control with potassium dichromate were within the normal range for this reference material. The mean 48-Hour ECso value calculated from all positive controls was 0.78 mg/L (sd = 0.24). - Reported statistics and error estimates:
- An estimate of the EC50 value at 3 hours was given by inspection of the immobilisation data. The EC50 values and associated confidence limits at 24 and 48 hours were calculated using the trimmed Spearman-Karber method (Hamilton et a1 1977) using the ToxCalc computer software package (ToxCalc 1999).
Any other information on results incl. tables
The test preparations were observed to be clear, colourless solutions throughout the duration of the test. While there were no treatment related differences for oxygen concentration, concentration dependent differences in pH were observed throughout the test.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- The test is considered invalid if >= 10% of the control daphnids appear to be immobilised or stressed after 48 hours( test result was 0%) or if the oxygen concentration of the control vessels falls below 60% of Air Saturation Values (ASV) at the end of t
- Conclusions:
- The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated and gave a 48-Hour ECS0 of greater than 100 mg/L. Correspondingly the No Observed Effect Concentration was 100 mg/L.
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.