Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

Short-term toxicity to fish

Administrative data

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:

other: GLP Guideline study, no deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

EC Number:

939-529-5

Cas Number:

1471313-51-5

Molecular formula:

not applicable

IUPAC Name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

Details on test material:

- Name of test material (as cited in study report): Sodium methyl cocoyl taurate
- Physical state: Slightly yellowish coarse powder, solid
- Stability under test conditions: Not applicable
- Storage condition of test material: Room temperature, protected from light, in original container

Sampling and analysis

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.

Test solutions

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

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.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

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

Results and discussion

Effect concentrations

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.

Any other information on results incl. tables

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 concentration	Test 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

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this study Sodium methyl cocoyl taurate 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

Executive summary:

The acute toxicity of the test item Sodium methyl cocoyl taurate (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 C12-part) 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 (the C12-part) 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 hours
LC100 =	10.6
Lowest test item concentration with 100 % mortality after 96 hours