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EC number: 241-477-7 | CAS number: 17463-34-2
- 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:
- 2016-05-11 to 2016-05-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octanoic acid, compound with octylamine (1:1)
- EC Number:
- 241-477-7
- EC Name:
- Octanoic acid, compound with octylamine (1:1)
- Cas Number:
- 17463-34-2
- Molecular formula:
- C8H19N.C8H16O2
- IUPAC Name:
- octan-1-amine; octanoic acid
- Test material form:
- other: Pale brown, waxy solid
- Details on test material:
- Test Item: Caprylamine caprylate
Chemical name: Octanoic acid, compound with octylamine
CAS number: 17463-34-2
Molecular formula: C8H19N.C8H16O2
Molecular weight: 273.5 g/mol
Appearance: Pale brown, waxy solid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item monitoring
All concentration levels and the control were analytically verified via
LC-MS/MS at the start (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours).
The method was validated prior to this study according to SANCO 3029/99 rev.4 (2000). Details of the analytical method are presented.
Sampling for the analytical
At the start of the exposure intervals (0 and 24 hours), sampling was
carried out from the newly prepared test concentrations.
At the end of the exposure intervals (24 and 48 hours), samples were taken directly from the test vessels.
Range (target)
Recoveries of the test item should be within ± 20% of the nominal or initially measured concentrations.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Stock solution
The stock solution (10.0 mg/L of the test item were weighed out) was freshly prepared with dilution water (Table 2) before the start of the exposure intervals (at 0 and 24 hours).
Treatment
The stock solution was mixed thoroughly by manual agitation.
Test concentrations
5 test item concentrations in a geometric series with a separation factor of 2, prepared by dilution of the stock solution with dilution water, were tested as follows:
0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L
The test concentrations mentioned above were selected based on the results of a non-GLP preliminary range finding test.
Control
Dilution water without test item incubated under the same conditions as the test groups.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS (Clone 5).
Reason for the selection of the test system
Daphnia magna is the preferred species in accordance with the test guideline and is bred at the test facility.
Origin
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2 °C, in an incubator, 16 hours illumination, light intensity of max. 20 µE.m-2 . s-1 (max. 1340 lx)
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), modified to a total hardness of 160 to 180 mg CaCO3/L, is used. The composition of the culture medium is presented
Culture feeding
The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 106 cells/mL. The algae were cultured at the test facility.
Origin of the food algae
Sammlung von Algenkulturen (SAG),
Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, 37073 Göttingen, Germany
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- Dilution water
2016-05-11: 174 mg CaCO3/L
2016-05-12: 178 mg CaCO3/L - Test temperature:
- Dilution water
2016-05-11: 20.2 °C
2016-05-12: 20.1 °C - pH:
- Dilution water
2016-05-11: 8.53
2016-05-12: 8.77 - Dissolved oxygen:
- Dilution water
2016-05-11: 8.89 mg/L
2016-05-12: 8.77 mg/L - Conductivity:
- Dilution water
2016-05-11: 473 µS/cm
2016-05-12: 484 µS/cm - Nominal and measured concentrations:
- The concentrations of the test item Caprylamine caprylate were analytically verified via LC-MS/MS at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours) in all tested concentration levels and in the control. Details of the analytical method are presented.
The measured concentrations of the test item Caprylamine caprylate were in the range of 95 to 116% of the nominal values at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours). The analytical results are presented.
The measured test item concentrations remained stable within ± 20% of the nominal concentrations throughout the exposure period. This indicates that the test item concentrations were successfully maintained for the duration of the test. - Details on test conditions:
- Test duration
48 hours
Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
Renewal of the test solutions
The test solutions were renewed after 24 hours. For this purpose, a second set of test vessels was filled with the freshly prepared test solutions and the daphnids were transferred by pipette (see ‘Application’).
Dilution water
Same as culture medium (see Table 2)
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids, were used per concentration level and control.
Age of the daphnids at the start of the exposure
Less than 24 hours old daphnids from a healthy stock were used for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.
Acclimatisation
Acclimatisation of the daphnids was not necessary, because the dilution water was equivalent to the culture medium. - Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 3.09 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.57 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 6.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.42 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The percentage of immobility for the reference item was determined after 24 hours. The EC50-value with 95% confidence limits (CI) was calculated by sigmoidal dose-response regression. The EC50-value for the most recent of the monthly performed reference tests was:
EC50: 2.08 mg/L (CI 1.00 - 4.00 mg/L)
The EC50-value of the reference item potassium dichromate after 24 hours is within the required concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.
Any other information on results incl. tables
Measured Concentrations of the Test ItemCaprylamine caprylateduring the Definitive Test
Sampling date |
2016-05-11 Start of the exposure interval 0 hours |
2016-05-12 End of the exposure interval 24 hours |
2016-05-12 Start of the exposure interval 24 hours |
2016-05-13 End of the exposure interval 48 hours |
||||
Start of analysis |
2016-05-11 |
2016-05-12 |
2016-05-12 |
2016-05-13 |
||||
Nominal test item concentration [mg/L] |
Caprylamine caprylate |
|||||||
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
|
10.0 |
11.6 |
116 |
11.4 |
114 |
11.4 |
114 |
10.5 |
105 |
5.00 |
5.28 |
106 |
5.40 |
108 |
5.38 |
108 |
5.02 |
100 |
2.50 |
2.53 |
101 |
2.68 |
107 |
2.70 |
108 |
2.38 |
95 |
1.25 |
1.34 |
107 |
1.44 |
115 |
1.38 |
110 |
1.25 |
100 |
0.625 |
0.678 |
108 |
0.714 |
114 |
0.678 |
108 |
0.599 |
96 |
Control |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
Meas. conc.= measured concentration of the test item, mean value of 2 injections, dilution factors taken into account
% = percent of the nominal concentrations of the test item
LOQ = limit of quantification (20 µg/L of the test item)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal concentrations of the test item Caprylamine caprylate, the 48 hour EC50 for Daphnia magna was 5.42 mg/L
(95% confidence limits: 4.37 – 6.82 mg/L). - Executive summary:
In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the test item Caprylamine caprylate were determined according to OECD 202 (2004) from 2016-05-11 to 2016-05-13at the test facility.
The study was conducted under semi-static conditions over a period of 48 hours with five nominal concentrations of the test item Caprylamine caprylateranging from 0.625 to 10.0 mg/Lin a geometric series with a separation factor of 2.
The test item Caprylamine caprylateis a pale brown, waxy solid with a water solubility of 2.0 - 3.5 g/L (20 °C, cmc).A stock solution with a nominal concentration of 10.0 mg/L of the test item was freshly prepared with dilution water before the start of the exposure intervals (at 0 and 24 hours), mixed thoroughly by manual agitation and was used as the highest test concentration and as a stock solution for the preparation of the further concentration levels.
All test item concentrations were visually clear throughout the exposure period.
Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control.
The concentrations of the test item Caprylamine caprylate were analytically verified via LC-MS/MS at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours) in all tested concentration levels and in the control. Details of the analytical method are presented.
The measured concentrations of the test itemCaprylamine caprylate were in the range of 95 to 116% of the nominal values at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours).The analytical results are presented.
The measured test item concentrations remained stable within ± 20% of the nominal concentrations throughout the exposure period. This indicates that the test item concentrations were successfully maintained for the duration of the test. Therefore, the effect valuesare based on the nominal concentrations of the test item Caprylamine caprylate.
The validity criteria of the test guideline were fulfilled.
EC10-, EC50- (with 95% Confidence Limits) and EC100-Values
(based on the nominal concentrations of the test item)
Caprylaminecaprylate
Effect levels
Test duration
[hours]
Toxicity endpoint
based on the nominal concentrations the test item[mg/L]
EC10
(with 95% confidence limits)
24
3.09
(Cl: 2.36 – 3.91)
48
1.57
(Cl: 0.955 – 2.26)
EC50
(with 95% confidence limits)
24
6.50
(CI: 5.72 – 7.43)
48
5.42
(Cl: 4.37 – 6.82)
EC100
24
> 10.0
48
> 10.0
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