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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 May 2005 and 7 May 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in 2005 according to OECD Method 203 and EU Annex V test C.1 and in accordance with GLP. Study material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- 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:
- Test material is a extremely light tan colored powder which was received at testing laboratory on 15 February 2005 and stored at room temperature in the dark.
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Water samples were taken from the control and each replicate test vessel at 0 (fresh media), 24 and 96 hours (old media) for quantitative analysis.
Duplicate samples and samples at 24 (fresh media), 48 and 72 hours (fresh and old media) were taken and stored at approximately -20°C for further analysis if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test material was dissolved directly in dechlorinated tap water, ultrasonicated for approximately 120 minutes, and the volume adjusted to 2 litres to give a 2.00 g/L stock solution. The stock solution was cooled to approximately 14°C and thoroughly mixed prior to being diluted to the testing dose of 100 mg/L test concentration.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- Fish were maintained in a glass fibre tank with a "single pass" water renewal system and acclimatised for 14 days.
TEST ORGANISM
- Common name: juvenile rainbow trout (Oncorhynchus mykiss).
- Source: Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Length at study initiation (length definition, mean, range and SD): fish had a mean standard length of 4.1 cm (sd = 0.1) at the end of the definitive test.
- Weight at study initiation (mean and range, SD): mean weight of 1.21 g (sd = 0.07) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.42 g bodyweight/litre.
- Feeding during test- Food type: commerical trout pellets
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food:commercial trout pellets
- Health during acclimation (any mortality observed): zero
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- Laboratory tap water was dechlorinated partly softened to give a total hardness of approximately 100 mg/L as CaC03.
- Test temperature:
- Maintained at approximately 14 C throughout the study
- pH:
- For fresh media ranged from 7.4 to 7.7 throughout the study
For old media pH ranged from 7.7 to 8.2 thoughout the study - Dissolved oxygen:
- dissolved oxygen concentration expressed as a percentage of Air Saturation Value (ASV)
For fresh media ranged from 89 to 92 %
For old media ranged from 91 to 96 % - Nominal and measured concentrations:
- Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 96% to 99% of nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only.
- Details on test conditions:
- In the range-finding test 3 fish were used and in the definitive study 7 (seven) fish were placed in each test vessel glass fibre tank at random in the test preparations. For the range-finding test and the definitive test 20 litre glass fibre exposure vessels were used for each test concentration ( control, and 100 mg/L). The test vessels were then covered and maintained at approximately 14°C in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours. The test vessels were aerated via narrow bore glass tubes. The fish were not individually identified and received no food during exposure..
After 3, 6, 24, 48, 72 and 96 hours any mortalities or sub-lethal effects of exposure were determined by visual inspection of the test fish. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Range finding study:
-There were no sub-lethal effects of exposure during the range-finding test.
-The results showed no mortalities at the test concentration of 100 mg/L.
Definitive Study:
-There were no mortalities in 14 fish exposed to a test concentration of 100 mg/L for a period of 96 hours.
-The results of the definitive test showed the highest test concentration resulting in 0% mortality to be greater than or equal to 100 mg/L, the lowest test concentration resulting in 100% mortality to be greater than 100 mg/L and the No Observed Effect Concentration (NOEC) to be 100 mg/L. The No Observed Effect Concentration is based upon zero mortalities and the absence of any sub- lethal effects of exposure at this concentration - Reported statistics and error estimates:
- The 3, 6, 24, 48, 72 and 96-Hour LC50 values and associated 95% confidence limits will be calculated using the trimmed Spearman-Karber method. All LC50 (or values will be rounded to two significant figures).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LC50 of greater than 100 mg/L. Correspondingly the No Observed Effect Concentration was 100 mg/L.
- Executive summary:
A study was performed to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss). This key aquatic toxicity study was assigned reliability rating of 1 (reliable without restriction) and the results are considered valid.
Following a preliminary range-finding test fish were exposed, in two groups of seven, to an aqueous solution of the test material, at a single concentration of 100 mg/L for a period of 96 hours at a temperature of approximately 14 C under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.
The 96-Hour LC50 based on nominal test concentrations was greater than 100 mg/L and correspondingly the No Observed Effect Concentration was 100 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 96% to 99% of nominal and so the results are based on nominal test concentrations only.
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.