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EC number: 224-388-8 | CAS number: 4337-75-1
- 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:
- 2012-11-19 to 2012-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-Across Study
- Justification for type of information:
- This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. See section 13 for the full read-across justification.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.625 – 1.25 – 2.50 – 5.00 – 10.0 mg test item/L
- Sampling method: Analytical evaluation of various concentrations of Sodium methyl cocoyl taurate and the control were carried out via LC/MS-MS at start and end of the exposure or whenever 100 % mortality occurred.
- Sample storage conditions before analysis: All original samples were stored room temperature until sample preparation. Prepared samples were stored at room temperature until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Directly weighing
- Eluate: Dilution water
- Differential loading: 0.625 – 1.25 – 2.50 – 5.00 – 10.0 mg test item/L
- Controls: 7 fish in dilution water without test item were tested under the same test conditions as the test replicates. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: All fish used in the test originate from a single brood stock at DR.NOACK-LABORATORIEN from a single brood stock. (supplier: Niedersächsischer Landesbetrieb für Wasserwirtschaft, Küsten- und Naturschutz, An der Scharlake 39, D-31135 Hildesheim)
- Length at study initiation (length definition, mean, range and SD): Average body length: 2.3 cm
- Weight at study initiation (mean and range, SD): Average body weight: 0.230 g
- Method of breeding: Holding was performed at the test facility at 23+/-2 °C and diffuse light (0.1 - 10 µmol photons • m-2 • s-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. No disease treatments were administered throughout holding and testing. Food was provided 3 times per week. The amount of food was 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started.
- Feeding during test: No feeding during test
ACCLIMATION
- Acclimation period: Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study starts were used in the test.
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started. Food: Sera Vipan; SERA GMBH, D-52518 Heinsberg
- Feeding frequency: 3 times per week.
- Health during acclimation (any mortality observed): No mortality observed, no disease treatments were administered throughout holding and testing. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- Total Hardness at day 0: 48 mg/L
- Test temperature:
- Please refer to "Any other information on materials and methods"
- pH:
- Please refer to "Any other information on materials and methods"
- Dissolved oxygen:
- Please refer to "Any other information on materials and methods"
- Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- Please refer to "Any other information on materials and methods"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): open, loosely covered by glass tops
- Material, size, headspace, fill volume: glass, 10 L test volume per vessel
- Aeration: Gentle aeration
- Renewal rate of test solution (frequency/flow rate): application at test start
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: less than 1 g fish per L test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Same as for holding
- Culture medium different from test medium: Tap water of local origin was used for holding. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
Nominal water parameters:
Total hardness: 10 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
- Intervals of water quality measurement: pH-value, temperature and oxygen saturation were measured in all vessels at the beginning of the test and every 24 h (from old and new media). Total hardness of the water was determined at the beginning out of the test control. During the test the water temperature was recorded continuously with a data logger (once per hour).
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: natural
- Light intensity: 0.1 - 10 µmol photons x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.). Observations were made after 24, 48, 72 and 96 h.
TEST CONCENTRATIONS
- Range finding study:
Cumulative Mortality [%] in the Preliminary Test
(n = 5)
Nominal test item concentration
[mg/L] Test Duration [hours]
24 48 72 96
10 100 --- --- ---
1 0 0 0 0
Control 0 0 0 0 - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 5.04 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- is UVCB means 100% act.ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI 5-10 mg/L
- Details on results:
- - Behavioural abnormalities: Not observed
- Mortality of control: 0%
- Other adverse effects control: Not observed
- Abnormal responses: Not observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test item was clearly dissolved in the tested loading levels during exposure. - Results with reference substance (positive control):
- No reference substance tested
- Reported statistics and error estimates:
- After 24 hours only 0 and 100 % mortality occurred. Hence the LC50 after 24 hours is the geometric mean value of the nominal concentrations with 0 and 100 % mortality. The concentrations causing 0 and 100 % were chosen as lower and upper confidence limit, respectively. Therefore LC10,20-values were not applicable and were given as a range of these concentrations.
After 48 hours 14 and 100 % mortality and after 72 to 96 hours 43 and 100 % occurred.
The LC50-values after 48 to 96 hours of exposure were calculated by non linear regression (0-100, sigmoidal dose response, variable slope). The concentrations causing 14 and 100 % and 43 and 100 % were chosen as lower and upper confidence limit, respectively. LC10,20-values could not be estimated and were given as a range of concentrations causing 0 and 14 % (48 h) and 0 and 43 % (72 – 96 h) mortality since only one single concentration level gave a partial response.
The chosen methods for determination of LCx-values were in accordance with the OECD series on testing and assessment No. 54 (2006). The concentrations leading to 0 and 100 % mortality (LC0 and LC100) after 96 h were determined directly from the test results. - Sublethal observations / clinical signs:
Observations in the Test Vessels
Nominal test item concentration
Effect *
Test duration [hours]
[mg/L]
24
48
72
96
10.0
(E)
7/7
---
---
---
5.00
(E)
-
1/7
2/6
-
(2.2)
-
1/7
-
-
(2.4)
-
5/7
4/6
4/4
(2.6)
-
-
4/6
4/4
(1)
7/7
-
-
-
2.50
(1)
7/7
7/7
7/7
7/7
1.25
(1)
7/7
7/7
7/7
7/7
0.625
(1)
7/7
7/7
7/7
7/7
Control
(1)
7/7
7/7
7/7
7/7
Cumulative Mortality [%]
Nominal
test item concentrationTest duration [hours]
[mg/L]
24
48
72
96
10.0
100
100
100
100
5.00
0
14
43
43
2.50
0
0
0
0
1.25
0
0
0
0
0.625
0
0
0
0
Control
0
0
0
0
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, the source substance Sodium methyl cocoyl taurate (SMCT) was found to cause lethal effects to Zebrafish after 96 hours at a nominal test item concentration of 5.00 mg/L, corresponding to 3.62 mg a.i./L. The LC50 (96 hours) based on nominal test item concentrations was 5.04 (5.00 – 10.0) mg/L, corresponding to 3.65 (3.62 – 7.23) mg a.i./L.
All effect levels are given based on the nominal concentrations of the test item Sodium methyl cocoyl taurate and its active ingredient concentrations
Based on read-across, this acute fish toxicity result is applied to the registration (target) substance SMLT. This is a conservative read-across since the available data on other alkyl taurate amide salts indicates toxicity increases with increasing chain length, and SMCT contains constituents with chain lengths in the range C12-C18 whilst SMLT is essentially 'pure' C12. - Executive summary:
The acute toxicity of the structurally analagous source substance Sodium Methyl Cocoyl Taurate (SMCT; batch no.: DEB4003323)to fish (zebrafish), was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2012-11-19 to 2012-11-23, at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.
A static test with one application at start of the exposure phase conducted with the nominal test item concentrations of 0.625 – 1.25 – 2.50 – 5.00 – 10.0 mg/L (factor 2) corresponding to active ingredient concentrations of 0.452 – 0.904 – 1.81 – 3.62 – 7.23 mg a.i./L. Duration of the test was 96 hours. 7 test organisms were exposed to each test concentration and control. Water quality parameters temperature, pH-value and O2-saturation measured at 0, 24, 48, 72 and 96 hours were determined to be within the acceptable limits.
The determination of various concentrations of the test item Sodium methyl cocoyl taurate and the control was carried out via LC/MS-MS from freshly prepared media after 0 hours and from old test media after 96 hours or whenever 100 % mortality occurred.
The measured concentrations of the main component (the registration/target substance SMLT) of the test item Sodium methyl cocoyl taurate media were in the range of 100 – 117 % of the nominal concentrations in freshly prepared media. At the end of the exposure, they were in the range of 36 – 109 % of the nominal values. Exposures are expressed in terms of the nominal concentrations of the test item Sodium methyl cocoyl taurate and its active ingredient concentrations, irrespective of the actual concentration of the main component (SMLT) because toxic effects cannot be attributed to single compounds of UVCB substances.
IMPORTANT NOTE TO AVOID CONFUSION:
As the registration substance is a UVCB this means that the test item is 100% active ingredient.
LC-Values with 95 % Confidence Intervals (0 – 96 hours)
Based on nominal test item concentrations [mg/L]
Due to only one partial response, the LC10 and LC20 values were given as a range. For the same
reason no calculation of confidence intervals was carried out for the LC50 value.Test duration [hours]
LC10 (p = 95 %)
LC20 (p = 95 %)
LC50 (p = 95 %)
24
5.00 LC10 10.0
5.00 LC20 10.0
7.07 (5.00 – 10.0)
48
2.50 LC10 5.00
5.00 LC20 10.0
5.26 (5.00 – 10.0)
72
2.50 LC10 5.00
2.50 LC20 5.00
5.04 (5.00 – 10.0)
96
2.50 LC10 5.00
2.50 LC20 5.00
5.04 (5.00 – 10.0)
LC0 =
2.50
Highest test item concentration with
0 % mortality after
96 hoursLC100 =
10.6
Lowest test item concentration with
100 % mortality after
96 hoursBased on read-across, this acute fish toxicity result for SMCT is applied to the registration (target) substance SMLT. This is a conservative read-across since the available data on other alkyl taurate amide salts indicates toxicity increases with increasing chain length, and SMCT contains constituents with chain lengths in the range C12-C18 whilst SMLT is essentially 'pure' C12. See attached read-across justification in section 13 for additional details
Reference
Description of key information
In this study, the source substance Sodium methyl cocoyl taurate (SMCT) was found to cause lethal effects to Zebrafish after 96 hours at a nominal test item concentration of 5.00 mg/L, corresponding to 3.62 mg a.i./L. The LC50 (96 hours) based on nominal test item concentrations was 5.04 (5.00 – 10.0) mg/L, corresponding to 3.65 (3.62 – 7.23) mg a.i./L.
All effect levels are given based on the nominal concentrations of the test item Sodium methyl cocoyl taurate and its active ingredient concentrations
Based on read-across, this acute fish toxicity result is applied to the registration (target) substance SMLT. This is a conservative read-across since the available data on other alkyl taurate amide salts indicates toxicity increases with increasing chain length, and SMCT contains constituents with chain lengths in the range C12-C18 whilst SMLT is essentially 'pure' C12.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 5.04 mg/L
Additional information
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.