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EC number: 607-854-9 | CAS number: 2605-78-9
- 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:
- November 6th, 2007 - July 4th, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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 (incl. QA statement)
- Specific details on test material used for the study:
- - Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water. - Analytical monitoring:
- yes
- Details on sampling:
- Water samples were taken from the control and the test group (replicates R1-R2) at 0 hour (fresh media), 24 hours and 96 hours (old media) for quantitative analysis. Duplicates samples were taken and stored at approximately -20°C for further analysis if necessary.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Dissolved directly in dechlorinated tap water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout
- Strain: Oncorhynchus mykiss
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): Same as test conditions
- Type and amount of food: Commercial trout pellets discontinued 24 hours prior to study initiation
- Health during acclimation (any mortality observed): Less than 1% mortality - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 140 mg/L as CaCO3
- Test temperature:
- 14°C
- pH:
- 7.7
- Dissolved oxygen:
- 10.3 mg O2/L
- Nominal and measured concentrations:
- Limit test: 100 mg a.i./L (analytically confirmed nominal concentration)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass fibre tank (20L)
- Type: Closed (vessels covered to reduce evaporation)
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.55g bodyweight/litre
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated (Purite series 500 carbon filter) and partly softned (Elga Nimbus 1248D Duplex Water Softner)
- Total organic carbon: 1.429mg/l
- Pesticides: 0.019 µg/l
- Chlorine: 0.274mg/l
- Conductivity: 403.577 µS/cm at 20°C
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Photoperiod: - Photoperiod: 16 hours light / 8 hours dark cycles with dawn/dusk transition periods
TEST CONCENTRATIONS
- Range-finding test(s) : Yes (one)
- Test concentrations (range-finding test): 0, 10, 100 mg a.i./L - Reference substance (positive control):
- not specified
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- 1-octanamine, N, N-dimethyl-, N-oxide
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- 1-octanamine, N, N-dimethyl-, N-oxide
- Basis for effect:
- mortality (fish)
- Details on results:
- - Range-finding test: the results showed no mortalities at the test concentrations of 10 and 100 mg a.i./L; there were no sub-lethal effects of exposure observed.
- Definitive test: the results showed no mortalities at the test concentrations of 100 mg a.i./L; there were no sub-lethal effects of exposure observed. - Sublethal observations / clinical signs:
Cumulative Mortality Data in the Range Finding test
Nominal Concentration (mg a.i./L)
Cumulative Mortality (Initial Population = 3)
3
Hours
6
Hours
24 Hours
48 Hours
72 Hours
96 Hours
Control
0
0
0
1*
1
1
10
0
0
0
0
0
0
100
0
0
0
0
0
0
* = Mortality considered to be due to bullying by other fish within test vessel
Cumulative Mortality Data in the Definitive Test
Nominal Concentration (mg a.i./L)
Cumulative Mortality Data (Initial Population 7)
% Mortality
3 Hours
6 Hours
24 Hours
48 Hours
72 Hours
96 Hours
96 Hours
Control
0
0
0
0
0
0
0
100 R1
0
0
0
0
0
0
0
100 R2
0
0
0
0
0
0
0
- Validity criteria fulfilled:
- yes
- Conclusions:
- The results showed neither mortalities nor sub-lethal effects at the limit test concentrations of 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide). The 96-hour 50% lethal concentration LC50 was greater than 100 mg a.i./L and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.
- Executive summary:
The acute toxicity of the test material to rainbow trouts (Oncorhynchus mykiss) was determined in a GLP-compliant study performed in accordance with OED Guideline 203 and EU Method C.1. The results showed neither mortalities nor sub-lethal effects at the limit test concentrations of 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide). The 96-hour 50% lethal concentration LC50 was greater than 100 mg a.i./L and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.
.
Reference
Description of key information
The acute toxicity of the test material to rainbow trouts (Oncorhynchus mykiss) was determined in a GLP-compliant study performed in accordance with OED Guideline 203 and EU Method C.1. The results showed neither mortalities nor sub-lethal effects at the limit test concentrations of 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide). The 96-hour 50% lethal concentration LC50 was greater than 100 mg a.i./L and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.
Key value for chemical safety assessment
Additional information
The acute toxicity of the test material to rainbow trouts (Oncorhynchus mykiss) was determined in a GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and was selected as key study for the endpoint.
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.
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