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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-334-5 | CAS number: 3069-25-8
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 17 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatlisches Gewerbeaufsichtsamt Hildesheim, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations and sampling method: the concentration of the test item was verified in the test vessel media, the pH control media and the control media when freshly prepared, after 0 and 72 h and from the corresponding 24 h aged test media after 24 and 96 h. Only the hydrolysis product of the test item was analytical verified, since the test substance hydrolysis very rapidly.
- Sample storage conditions before analysis: all samples were stored at room temperature until sample preparation and in an autosampler until start of analysis, if necessary - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 5 L stock solution of 100 mg/L were prepared with dilution water and stirred for 24 h (1100 rpm, room temperature: 23.0 °C ± 0.2 °C). The total volume of 5 L was separated into two individual replicates (2.5 L). For one replicate the pH value was adjusted to 8.00 ± 0.20 with HCI. This replicate served as pH control compared to the non-adjusted replicate. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: Umweltbundesamt, Berlin, Germany
- Holding: at 23 ± 2 °C and diffuse light (7 - 750 lux, natural photoperiod). The water (tap water, filtered on activated charcoal and aerated for at least 24 h ) was changed at least once per week. The dissolved oxygen concentration was > 80% of the air saturation value. Zebrafish with at least 12 d of acclimatisation and mortality < 5% within these days prior to the start of exposure were used for testing. No disease treatments were administered throughout holding and testing. Fish were fed (Sera Vipan, SERA GMBH) 3 times per week (4% of their body weight per feeding day). The test fish were not fed 24 h before test start. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 57 mg/L CaCO3
- Test temperature:
- 22.7 - 23.5°C
- pH:
- Control: 7.01 - 7.52
100 mg/L test item: 7.41 - 9.85
100 mg/L test item with pH adjustment: 7.42 - 8.14 - Dissolved oxygen:
- 79 - 100%
- Nominal and measured concentrations:
- 0 (control), 100 mg/L (nominal), 100 mg/L (nominal with pH adjustment)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 3 L glass aquaria (11.5/13/20 cm)
- Fill volume: 2.5 L
- Aeration: no
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per concentration with pH adjustment (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.404 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, temperature and oxygen saturation were measured in all test vessels every 24 h and after renewal of the test media. Total hardness was determined at the start of the exposure in the control. The water temperature was recorded once per hour with a data logger.
OTHER TEST CONDITIONS
- Adjustment of pH: yes, in one replicate
- Photoperiod: 16 h light/8 h dark
- Light intensity: 7 - 750 Lux
EFFECT PARAMETERS MEASURED : observations for death, abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation) were made after 2, 24, 48, 72 h. Size and weight determinations of the control fish were made at the end of exposure - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: no
- Observations on body length and weight: average body weight at the test end: 0.144 g/L test solution, average body length at the test end: 2.50 (2.4 to 2.6) cm
- Mortality of control: no
- Other adverse effects control: no - Sublethal observations / clinical signs:
- No sublethal effects were observed in any test vessel and observation time point (2, 24, 48, 72, 96 h).
- No mortalities occured in any of the test vessels after 2, 24, 48, 72, 96 h.
- The measured concentrations of the hydrolysis product of the test item were between 116 and 120 % in the fresh media and between 113 to 117 % of nominal values in the old media. Therefore, all effect values were based on the nominal concentration of the test item.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In the limit test with a nominal concentration of 100 mg test item/L, no toxic effects on Danio rerio were observed.
Reference
Description of key information
LC50 (96 h) > 100 mg/L (nominal, OECD 203, D. rerio)
Key value for chemical safety assessment
Additional information
A reliable study is available for the toxicity of N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8) to fish according to OECD 203 and GLP standards (Noack Laboratories, 2017a). The test organism, Danio rerio, was exposed in a semi-static test regime to a single test item concentration of 100 mg/L (nominal). An additional vessel with the same test item concentration was prepared, in which the pH was adjusted to 8 ± 0.2. Analytical monitoring was performed by LC-MS. The silanol hydrolysis product of the test substance was quantified since the substance hydrolyses very rapidly.
Recoveries were between 116 and 120% in the fresh media and between 113 to 117 % of nominal values in the old media.
The test showed no lethal effects on fish resulting in an LC50 (96 h) > 100 mg/L (nominal).
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.