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EC number: 269-915-2 | CAS number: 68390-97-6 This substance is identified by SDA Substance Name: C16-C18 alkyl dimethyl amine and SDA Reporting Number: 19-040-00.
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Analysis of the new media was performed on the days: 0, 5, 12 and 19. Analysis of the old media was performed on days 2, 7, 14 and 21.
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- > 90 mg CaCO3/L, <=111 mg/L
- Test temperature:
- 20 +/- 2 deg C
- pH:
- 7.3 - 7.96
- Dissolved oxygen:
- 7.65 - 8.29 mg/L
- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 47 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: RA from C12-14-DMA; value converted based on MW
- Basis for effect:
- reproduction
- Remarks on result:
- other: Orig. value source: 36 µg/L; river water test
- Details on results:
- The number of juveniles produced in the 10 replicates of the test and control groups between the 8th and 21 th day were added to the total turnover and plotted versus concentration of the test item. The mean number of offspring alive produced per parent animal surviving at the end of the test was 79.4 juveniles in the control group indicating Böhme water to be a suitable medium for testing the reproductive output of daphnids.
The coefficient of variation around the mean number of living offspring produced per parent in the control group was 5.1 % (see table in section "Any other information on resutls incl. tables"). The quality criteria that the coefficient of variation in the control should be < 25 % was fulfilled.
The mean number of juveniles of the surviving daphnids of the treatment groups were compared by the multiple comparisons Method of Dunnett's for significance of differences (a = 0.05) from controls. The differences in the mean values among the treatment groups were greater than would be expected by chance. There was a statistically significant difference (p < 0.05) in the concentration 0.32 mg/L compared to control.
No statistically significant difference was seen in the tested concentration levels ranging from 0.0013 to 0.108 mg/L compared to control.
The concentration that caused a 50 % reduction in reproduction ( EC50 reproduction ) was calculated to be 0.31 mg/L with confidence interval (CI) ranging from 0.21 to 0.44 mg/L.
The number of stillborn juveniles in the treatment groups 0.0013 to 0.32 mg/L are shown in Table 2 section "Any other information on resutls incl. tables". A significant number of stillborn juveniles occurred in the concentration 0.108 mg/L. No stillborns were found in the lower dosage levels and untreated control. Regarding these observations as well as the well running development of the parental animals which had been introduced as juveniles at test initiation, the significant number of stillborns at the 0.108 mg/L has to be seen as a test item related effect.
Number of aborted eggs producing no juveniles: No unhatched eggs were observed at all.
The immobilisation rates of parental animals in % after 7, 14 and 21 days of exposure are given in Table 3 section "Any other information on resutls incl. tables". After 21 days of exposure a biologically significant mortality of 70 % was seen at the concentration 0.32 mg/L. - Results with reference substance (positive control):
- Potassium dichromate p.a. (MERCK)
Test concentrations 0.58 - 1.0 - 1.8 - 3.2 - 5.8 mg/L
Range of validity 1.0 mg/L < EC50 (24 hours) < 2.5 mg/L
Test duration: 2000-12-20 to 2000-12-21
24 h EC10 : 1.4 mg/L
24 h EC50 :2.1 mg/L (1.9 - 2.4)
24 h EC100 : 5.8 mg/L
The 24 hours EC50 value is in the range 1.0 to 2.5 mg/L. - Reported statistics and error estimates:
- The NOEC and LOEC for the reproduction were determined directly from the results obtained.
The EC50 for reproduction and immobilisation was calculated by probit analysis.
Significant deviations concerning reproduction rate and body length were determined in comparison with the control group using the One Way Analysis of Variance (Normality Test, Equal Variance Test and Multiple Comparisons Method of Dunnett's).
The coefficient of variation around the mean number of living offspring produced per parent in the control group was evaluated.
The calculations were carried out using the software SIGMA STAT of Jandel Scientific Version No. 2.0 (Windows). The EC50-values for reproduction, immobilisation and the reference item were calculated with probit analysis using software SigmaPlot rel. 2000 (2000), SPSS CORPORATION.
Probit values were taken from Weber (1986). Confidence intervals were calculated according to a standard procedure (Breitig & Ttimpling 1982). - Validity criteria fulfilled:
- yes
- Executive summary:
The study used as source investigated the toxicity of C12-14-DMA in the Daphnia magna reproduction test according to OECD 211. The study results of the source substance were considered applicable to the target substance. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.
Reference
Number of juveniles in the control and test groups after 21 days |
||||||||||||||||
Conc. (mg/L) |
Number of juveniles in replicates no. |
Total number |
Number of parentals alive |
Juveniles per parent mean. +/-SD |
CV (%) |
Comparision vs. Control |
||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
Red. (%) |
Stat.* |
|||||
0.32 |
- |
- |
41 |
- |
- |
- |
- |
36 |
- |
35 |
112 |
3 |
37.3 ± 3.2 |
8.6 |
53 |
yes |
0.108 |
70 |
96 |
64 |
69 |
76 |
65 |
61 |
100 |
82 |
77 |
760 |
10 |
76.0 ± 13.3 |
17.5 |
4 |
no |
0.036 |
64 |
76 |
74 |
64 |
86 |
110 |
76 |
69 |
65 |
78 |
762 |
10 |
76.2 ± 13.8 |
18.2 |
4 |
no |
0.012 |
86 |
68 |
73 |
84 |
100 |
87 |
76 |
74 |
71 |
75 |
794 |
10 |
79.4 ± 9.7 |
12.2 |
0 |
no |
0.004 |
69 |
63 |
68 |
77 |
70 |
86 |
81 |
68 |
65 |
58 |
705 |
10 |
70.5 ± 8.5 |
12.1 |
11 |
no |
0.0013 |
82 |
85 |
70 |
80 |
68 |
97 |
108 |
78 |
78 |
- |
746 |
9 |
82.9 ± 12.6 |
15.3 |
0 |
no |
control |
79 |
83 |
76 |
81 |
77 |
82 |
76 |
84 |
72 |
84 |
794 |
10 |
79.4 ± 4.1 |
5.1 |
- |
- |
Stat.*= Statistical significance (Dunnett's Method)
yes= Statistically significant
no= statistically significant
Red.= Reduction of reproduction
- = Animal died before end of test
Conc. = Concentration
CV= Coefficient of variation
Number of stillborn juveniles:
Nominal concentration |
Number of stillborn juveniles |
0.32 |
0 |
0.108 |
13 |
0.036 |
1 |
0.012 |
1 |
0.004 |
0 |
0.0013 |
0 |
control |
0 |
Immobilisation [%] of daphnids after 7, 14 and 21 days of exposure (n = 10):
Conc. |
Immobilisation [%] |
||
7 days |
14 days |
21 days |
|
0.32 |
70 |
70 |
70 |
0.108 |
0 |
0 |
0 |
0.036 |
0 |
0 |
0 |
0.012 |
0 |
0 |
0 |
0.004 |
0 |
0 |
0 |
0.0013 |
01) |
01) |
01) |
control |
0 |
0 |
0 |
1) one animal died by manual mistreatment, death was not considered to significance immobilisation and not
test item induced.
Summary of all Test Item Related Effects in the Test Concentrations:
Effects | Nominal concentrations (mg/L) | |||||
0,0013 | 0,004 | 0,012 | 0,036 | 0,108 | 0,32 | |
Number of juveniles (Reproduction rate) | --- | --- | --- | --- | --- | ++ |
Stilborn juveniles | --- | --- | --- | --- | ++ | --- |
Aborted eggs | --- | --- | --- | --- | --- | --- |
Immobilisation of the parental | --- | --- | --- | --- | --- | ++ |
Dry weight of the parental | --- | --- | --- | --- | --- | ++ |
Lenght of the parental | --- | --- | --- | --- | --- | --- |
Occurrence of males, winter eggs | --- | --- | --- | --- | --- | --- |
Summary of all item related effects | --- | --- | --- | --- | ++ | ++ |
---: no significant effect
++: statistically significant effect
Description of key information
For two category members reliable studies (reliability category 1) are available resulting in NOEC values (21 d, reproduction) between 0.163 µM (C12-14 DMA) and 0.347 µM (C16-18 DMA).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Effect concentration:
- 36 µg/L
Additional information
Dimethyl Alkyl Amines (DMA), which are cationic surfactants at pH relevant in the environment, exhibit strong sorption to test organisms and walls of test vessels due to a combination of ionic and hydrophobic interaction. The sorption coefficient was found to be concentration dependent. Due to these properties, the test items are difficult to test in synthetic water and results from such tests depend on the test settings applied. In river water, which contains particulate as well as dissolved organic carbon, Dimethyl Alkyl Amines (DMA) are either dissolved in water or adsorbed to dissolved and particulate matter. This reduces the difficulties encountered in tests with synthetic water caused by the high adsorption potential (adsorption losses due to settling on surfaces). In general, the adsorbed fraction of DMA is difficult to extract from the test system, which normally leads to low analytical recoveries especially in the old media, while initially measured concentrations (fresh media) are generally within +/- 20% as recommended by the guidelines. Due to the short exposure periods applied in these tests (semi-static design) these low recoveries cannot be explained by biodegradation. No, or negligible sorption to glassware occurs under these conditions, which was confirmed by measurements. This ensures reliable as well as reproducible results and means that the test substance is present in the test system and therefore available for exposure (dissolved in water and adsorbed, also called bulk). This so-called Bulk Approach is described by ECETOC (2003). Consequently, nominal concentrations were used for these tests instead of measured ones.
Therefore, reliable (without restrictions, reliability category 1) tests with river water as dilution water were performed for two category members with different chain length (C12-14 DMA and C16-18 DMA). These tests were of semi-static test design (daily renewal for C16-18 DMA and 3 times/week for C12-14 DMA) and involved analytical determination of test item in the stock solution, adsorbed to glass walls (C16-18 DMA only) as well as initial and final test item concentration in test water and are regarded to be of higher reliability and relevance than tests performed with synthetic dilution water would be. Natural river water from river “Innerste” (Lower Saxony; C16-18 DMA) and “Boehme” (Lower Saxony; C12-14 DMA) was used as dilution water in these tests. These rivers had been chosen due to their properties representing typical conditions of German medium sized rivers. The concentrations of suspended matter measured in the river waters was 14.0 and 19 mg/L, respectively and the organic carbon concentration was 3.2 mg/L (NPOC, Innerste) and 6.6 mg/L (DOC, Boehme). Both tests were performed according to OECD 211, compliant to GLP and fulfilling validity criteria of the guideline.
For C16-18 DMA, the NOEC (21 d) for reproduction and adult mortality was 0.347 µM (100 µg/L test material). EC10- or EC50 values for the reduction of the reproductive output could not be estimated, because no reduction of the reproductive output > 10 % was observed within the tested concentration levels with surviving daphnids of 12.5 to 100 µg/L C16-18-DMA. At the next higher concentration (200 µg/L C16-18-DMA) there were no surviving adults, i.e. the endpoint reproduction wasn't any more sensitive than the endpoint adult mortality. Comparing the calculated chronic EC50 (21 d) for adult mortality of 141 µg/L C16-18-DMA with the determined acute toxicity of C16-18 DMA (48-h EC50: 190 µg/L; river water test) shows no significant higher sensitivity upon chronic exposure. This may point to toxicity due to adsorption of the test item to the surface of daphnids, i.e. physicochemical mechanism of toxicity.
Due to 13 stillborn juveniles found at 108 µg/L C12-14-DMA but n≤1 for all other tested concentrations of the test item, this effect was determined to be statistically significant in spite of a reproductive output of 760 living juveniles (n= 10 parental daphnids) at this concentration, corresponding to a statistically not significant reduction of the reproductive output by 4% compared to the control. At the next higher concentration (320 µg/L C12-14-DMA) only 3 parental daphnids survived (21-d EC50 immobilization: 280 µg/L C12-14-DMA) and the EC50 (21 d) for reproductive output was determined as 310 µg/L C12-14-DMA. In comparison, the 48-hour EC50 for immobilisation is lower than the chronic one. This uncommon finding is probably due to the higher concentrations of DOC (6.6 mg/L) and suspended matter (19 mg/L) of “Boehme” water compared to water from “Innerste” used in the acute daphnia test. Thus, in principle the same may hold true for C12-14 like what was stated above for C16-18 DMA, i.e. reproduction being not any more sensitive than survival and toxicity being probably due to physicochemical interaction (adsorption). However, due to the statistically significant number of stillborn juveniles found at 108 µg/L C12-14-DMA the NOEC (21 d, reproduction) was set at 0.163 µM (36 µg/L C12-14-DMA).
In conclusion, members of the DMA category are to be regarded as chronically toxic to aquatic invertebrates. However, chronic toxicity seems not to be pronouncedly higher than acute toxicity exerted by DMA and compared to immobilization the reproductive endpoint is of similar sensitivity.
Based on the highest toxicity observed for C12-14-DMA in the reliable river water test, this NOEC (21 d; reproduction) of 0.163 µM is used as the key value for the category. However, the original value obtained with C12-14-DMA of 36 µg/L C12-14-DMA is used as key value. This is justified because a) molar concentration cannot be used for environmental hazard and risk assessment and b) correction for MW would theoretically result in somewhat lower values for shorter chain DMAs, but the available reliable river water studies for acute Daphnia toxicity demonstrate a much lower toxicity for C10-DMA (EC50 4.99 µM) compared to C12-14-DMA (0.253 µM).
References
ECETOC, European Centre for Ecotoxicology and Toxicology of Chemicals (2003)
Technical Report No. 88. Environmental Risk Assessment of Difficult Substances
Brussels, Belgium
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