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EC number: 268-074-9 | CAS number: 68002-61-9 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl trimethyl ammonium chloride and SDA Reporting Number: 11-045-00.
- 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From April 14, 1991 to May 28, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Information on the category justification can be found in the Quaternary ammonium salts (QAS) category and section 13.2 of IUCLID.
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA FIFRA 72-4(a)
- Deviations:
- yes
- Remarks:
- the slight deviations from the protocol (such as hardness level, renewal of test solutions, temperature) did not have any impact on the test results
- GLP compliance:
- yes
- Remarks:
- US EPA GLP
- Analytical monitoring:
- yes
- Details on sampling:
- See below under 'Details on test solutions'
- Vehicle:
- yes
- Details on test solutions:
- - The test solutions used in this study were prepared from a single primary stock solution. The primary stock was prepared by mixing appropriate amounts of 14C-a.s. test substance and non-radiolabelled a.s. test substance in de-ionized water to yield a nominal concentration of 3.93 mg/mL 14C-a.s. test substance/a.s. test substance. The concentration of the radiolabelled a.s. test substance in the stock solution was verified by liquid scintillation counting (LSC).
- Test solutions were prepared by adding measure aliquots of the primary stock solution to dilution water. All test solutions were re-newed daily and prepared immediately before use. The 24h old test solutions were siphoned remained in the vessel. To complete the renewal process, newly prepared test solution or control water was gently poured along the side of the appropriate vessel.
- Triplicate one mL samples were collected and counted for all LSC analyses. - Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- Test organism:
- Common name: Fathead minnow
- Source: The U. S. EPA-Environmental Monitoring and Support Laboratory (Newtown, OH)
- Age at study initiation: <24 h
Method for preparation and collection of fertilized eggs:
- Method of collection of fertilised eggs: Eggs were obtained from in-house culture
- Subsequent handling of eggs: Fertilized eggs ≤24 h old were exposed in prepared test containers. They were examined daily to monitor hatching. For 5-7 d after test initiation, fry were observed for development, hatching and survival on a daily basis.
Post-hatch feeding:
- Type/source of feed: Newly hatched brine shrimp (Artemia salina) nauplii was used as food source
- Frequency of feeding: At least twice per day (second feeding prior to test water renewal) - Test type:
- other: Daily static-renewal without aeration
- Water media type:
- freshwater
- Total exposure duration:
- 34 d
- Remarks on exposure duration:
- (6d pre-hatch + 28d post-hatch)
- Hardness:
- 75 mg/L CaCO3
- Test temperature:
- 24.2 to 26.3°C
- pH:
- 6.7 to 7.6
- Dissolved oxygen:
- 5.0 to 9.2 mg/L (61 to 111% air saturation) at 25°C
- Nominal and measured concentrations:
- Nominal concentrations: 0, 27, 74, 135, 180, 270 and 490 µg/L
Measured concentrations: 0, 32.2, 75.9, 134.2, 186.8, 273.2 and 488.7 µg a.i./L - Details on test conditions:
- Test sytem:
- Test vessel: 1 L glass beakers containing 0.5 L of test solution with an approx. depth of 65 cm.
- Type: Closed - to minimise evaporation and keep out foreign matter
- Aeration: No aeration
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of fertilized eggs/embryos per vessel: 20 eggs per replicate. After 7 d of exposure, surviving fry from two replicates were thinned to 10 animals per replicate for each test concentration and control.
- No. of vessels per concentration (replicates): 4 replicates per group
Test medium / water parameters:
- Source/preparation of dilution water: Dilution water consisted of water from two deep wells. Water was treated to remove iron and organic impurities, passed through reverse-osmosis purifiers, and treated to obtain a hardness of approximately 75 mg/L as CaCO3.
- Alkalinity: 80-84 mg/L
- Conductivity: 206-211 umhos
Other test conditions:
- Photoperiod: 16 h light : 8 h dark
- Light intensity: Fluorescent light of 76.4 to 80.5 fc intensity
Effect parameters measured (with observation intervals if applicable) : Toxicity, mortality, effects on hatchability and growth
Vehicle control: Yes
Range-fingind study:
- Test concentrations: 100, 300, 600 and 900 µg/L
- Duration of exposure: 10d
- Number of eggs/vessel: 30 eggs for each test concentration, transferred using a wide-bore pipette
- Results used to determine the conditions for the definitive study: Yes; fry mortality was ≤10% in the control and 100 ug/L; 80% in 300 µg/L and 100% in the 600 and 900 µg/L nominal test concentrations during the 10-d exposure.
Post-hatching details:
- Begin of post-hatch period: After 6d - Reference substance (positive control):
- no
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 273.2 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- number hatched
- Key result
- Duration:
- 28 d
- Dose descriptor:
- LC50
- Remarks:
- (post hatch)
- Effect conc.:
- ca. 94 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Remarks on result:
- other: 95% confidence interval: 64-126 µg a.i./L
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Remarks:
- (post hatch)
- Effect conc.:
- 32.2 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Remarks:
- (post hatch)
- Effect conc.:
- > 32.2 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Details on results:
- Hatchability:
- Hatchability in the mean measure test concentrations 32.2 through 273.2 µg/L ranged from 78 to 91 percent. None of these differences were significantly (P>0.05) different from the control (89% hatchability).
- Percent hatchability in the 488.7 µg/L was 68 percent which was significantly (P <0.05) lower than the control.
- The NOEC for hatchability, therefore was 273.2 µg/L.
Mortality:
- The 28-d LC50 value was calculated to be 94 ug/L with a 95% confidence interval of 64 to 126 µg/L.. See below Table 1 under ány other information on results incl. tables'
- 10% mortality occured in the dilution water control during the 28-d post-hatch exposure period.
- The survival after 28 d post-hatch in the mean measure test concentration 32.2 µg/L (74%) was not significantly lower (P>0.05) when compared to control survival (90%); however survival in all other test concentrations was significantly lower (P<0.05) than the control.
Growth:
- The average dry weight of the surviving fish generally increased as the concentration of the test substance increased (range, 0.972 mg/fish to 1.908 mg/fish), and in each case was higher than the control (0.800 mg/fish). The trend of increased growth also correlated with the decreased numbers of fish present in each test concentration suggesting food and space may have been the reason for the increased weights in the higher concentrations which were lethal to the less tolerant or weaker fish.
- Since no reduction in growth was observed at any of the test concentrations, th IC50 and LOEC values were not determined.
- The NOEC for gowth was determined to be >32.2 ug/L, the lowest concentration tested without significant decrease in survival. - Reported statistics and error estimates:
- Estimate of LC50 values were obtained using version 2 of the computer program TOXSTAT (Peltier and Weber). IC50calculated using monotonic regression analysis. The 28-d post-hatch survival data were analyzed using Fisher’s Exact Test. Analysis of variance (ANOVA) and Dunnett’s multiple comparison tests were used (SAS-Version 6.03) for comparing hatchability and weight data.
- Validity criteria fulfilled:
- not specified
- Conclusions:
- Based on the results of the source study, the 7-d NOEC for hatchability was 273.2 µg/L, the 28-d NOEC for survival was 32.2 µg a.i./L and the 28 d NOEC for growth was > 32.2 µg a.i./L
- Executive summary:
A study was conducted to determine the long-term toxicity of the source substance, C12-16 ADBAC (30% active in water, radiochemical purity: 96.5% (TLC) / 95.5% (HPLC)) to Fathead minnow (Pimephales promelas), according to U.S. EPA FIFRA 72-4(a), in compliance with GLP. Eighty fish eggs per concentration were exposed to the radiolabeled source substance for 34 d (6 d pre-hatching and 28-d post-hatching) at nominal concentrations of 0, 27, 74, 135, 180, 270 and 490 µg/L. Analytical determination was performed, and the sample concentrations were verified by liquid scintillation counting. The mean measured concentrations were determined to be 0, 32.2, 75.9, 134.2, 186.8, 273.2 and 488.7 µg a.i./L of the radiolabelled source substance (with 95.5-96.5% radiolabelled purity). After 7 d, surviving fry from two replicates were thinned to 10 animals per replicate for each exposure group (total of 20 animals per concentration) and exposed to the same concentrations for 28 d (post-hatch period) under daily static renewal test conditions. Observations of symptoms and mortality were conducted daily. Under the conditions of the study, the NOEC for hatchability was 273.2 µg/L and the 34-d NOEC and LC50 for survival were determined to be 32.2 and 94 µg a.i./L, respectively. Further, no reduction in growth was observed at any of the tested concentration, therefore the 28-d NOEC for growth was considered to be greater than 32.2 µg a.i./L (lowest concentration tested without a significant decrease in survival) (McIntyre and Pate, 1992). Based on the results of the source study, similar effect levels can be considered for the target substance.
Reference
Table 1. LC50
LC50 (µg/L) |
7-d post hatch |
14-d post hatch |
21 -d post hatch |
28-d post hatch |
|
198 |
104 |
98 |
94 |
95% confidence limits (µg/L) |
(164-231) |
(72-138) |
(68-130) |
(64-126) |
Table 2. NOECs LOECs values
LOEC (µg/L) hatchability |
488.7 |
NOEC (µg/L) hatchability |
273.2 |
NOEC(µg/L) survival |
32.2 |
NOEC (µg/L) growth |
>32.2 |
For further details on results, please refer to the attachment under 'attached background material'.
Description of key information
Based on the results of the study with a structurally similar substance, the 28-d NOEC value of 32.2 µg a.i./L for long-term toxicity to fish has been considered further for hazard/risk assessment.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- NOEC
- Effect concentration:
- 32.2 µg/L
Additional information
A study was conducted to determine the long-term toxicity of the source substance, C12-16 ADBAC (30% active in water, radiochemical purity: 96.5% (TLC) / 95.5% (HPLC)) to Fathead minnow (Pimephales promelas), according to U.S. EPA FIFRA 72-4(a), in compliance with GLP. Eighty fish eggs per concentration were exposed to the radiolabeled source substance for 34 d (6 d pre-hatching and 28-d post-hatching) at nominal concentrations of 0, 27, 74, 135, 180, 270 and 490 µg/L. Analytical determination was performed, and the sample concentrations were verified by liquid scintillation counting. The mean measured concentrations were determined to be 0, 32.2, 75.9, 134.2, 186.8, 273.2 and 488.7 µg a.i./L of the radiolabelled source substance (with 95.5-96.5% radiolabelled purity). After 7 d, surviving fry from two replicates were thinned to 10 animals per replicate for each exposure group (total of 20 animals per concentration) and exposed to the same concentrations for 28 d (post-hatch period) under daily static renewal test conditions. Observations of symptoms and mortality were conducted daily. Under the conditions of the study, the NOEC for hatchability was 273.2 µg/L and the 34-d NOEC and LC50 for survival were determined to be 32.2 and 94 µg a.i./L, respectively. Further, no reduction in growth was observed at any of the tested concentration, therefore the 28-d NOEC for growth was considered to be greater than 32.2 µg a.i./L (lowest concentration tested without a significant decrease in survival) (McIntyre and Pate, 1992).
Based on the above study, same effect levels were concluded in the biocide assessment report on C12-16 ADBAC by RMS Italy (ECHA biocides assessment report, 2015). While in the biocides assessment report on TMAC C, a similar chronic NOEC value (i.e., 0.0322 mg a.i./L) for fish was concluded based on a read across study to DDAC. Applying a MW correction factor of 0.75, the chronic NOEC value for Coco TMAC was extrapolated to 0.024 mg a.i./L (ECHA biocides assessment report, 2016). In line with the C12 -16 ADBAC biocides assessment report and given that the read across to C12-16 ADBAC can be justified for the target substance based on a category approach, the 28-d NOEC value of 32.2 µg a.i./L has been considered further for hazard/risk assessment.
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