Sodium 1,4-diisotridecyl sulphonatosuccinate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Well documented GLP study, no dose verification analysis

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: the test solutions were prepared with 100 µL acetone/L
- Controls: beside an untreated control, a solvent control was set up
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 100 µL/L in the final test solution
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea (Daphnia magna Straus)
- Source: Aquatic Research Organisms, Hampton New Hampshire, USA in August 2000
- Age at study initiation (mean and range, SD): less than 24 hours old
- Method of breeding: The Daphnia were cultured in media consisting of reconstituted fresh water containing live Selenastrum algal cells and YCT suspension.
- Feeding during test: not fed during the test


ACCLIMATION
- Acclimation conditions (same as test or not): similar
- Type and amount of food: Selenastrum capricornutum algal cells and YCT suspension

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

80 mg/L as CaCO3

Test temperature:

20.1 - 20.8 °C

pH:

7.3 - 7.7

Dissolved oxygen:

4.1 to 9.2 mg/L. The 4.1 mg/L concentration was measured in the highest test concentration after 48 hours of exposure. Since 100 % immobilization was observed in this treatment level at 48 hours, the DO concentration is considered as not relevant for the immobilization. All other DO values were above 5.6 mg/L (this values was measured after 48 hours in the second highes treatment level).

Nominal and measured concentrations:

Nominal concentrations: 0 (control), 0 (solvent control), 0.5, 1.3, 3.2, 8 and 20 mg CT-737-2/L corresponding to 0, 0, 0.35, 0.91, 2.24, 5.6 and 14 mg a.i./L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): 50 mL glass beakers
- Material, size, headspace, fill volume: 50 mL fill volume
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): NA
- Biomass loading rate: NA


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted fresh water
- Alkalinity: 36 mg/L as CaCO3
-Specific conductivity: 439 µS
- Intervals of water quality measurement: at start and 48 hours


OTHER TEST CONDITIONS
- Photoperiod: 16:8 hours light dark cycle
- Light intensity: 12.7 - 13.9 micromole per square meter per second


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
EC50 at 24 and 48 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.5
- Justification for using less concentrations than requested by guideline: NA

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 14 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: Immobilization

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Immobilization

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.9 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: Immobilization

Remarks on result:

other: 95% C.I.: 3.99 - 5.95 mg a.i./L

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Immobilization

Remarks on result:

other: 95 % C.I.: 5.7 - 8.5 mg CT-737-02/L

Details on results:

- Behavioural abnormalities: After 24 hours of exposure, 5/20 daphnids were lethargic at 20 mg CT-737-02/L, after 48 hours all daphnis of this treatment level were immobilized. After 48 hours of lethargic behaviour was observed in all non-immobilized daphnids of the 8 mg CT-737-02/L treatment level.
- Mortality of control: none
- Other adverse effects control: one control daphnia was lethargic after 24 hours but normal after 48 hours.
- Abnormal responses: none

Reported statistics and error estimates:

The computer program ToxCalc was used, but the method for the calculation was not mentioned .

Table 1 Immobilization of Daphnids exposed to CT-737 -02

Concentration [mg CT-737 -02/L]	24 hour observation # immobilized/20(Percent mortality)	24 hour observation Orientation	48 hour observation Cumulative # immobilized/20(Percent mortality)	48 hour observation Orientation
0 (control)	0 (0%)	1 LETH, 19 N	0 (0%)	20  N
0 (solvent control)	0 (0%)	20 N	0 (0%)	20 N
0.5	0 (0%)	20 N	0 (0%)	20 N
1.3	0 (0%)	20 N	0 (0%)	20 N
3.2	0 (0%)	20 N	0 (0%)	20 N
8.0	0 (0%)	20 N	13 (65%)	7 LETH
20	1 (5%)	5/20 LETH	20 (100%)	-

N: none, normal

LETH: Lethargic

Validity criteria fulfilled:

yes

Conclusions:

48-hour EC50 = 4.9 mg active ingredient/L

Executive summary:

The acute toxicity of CT-737 -02 - which contains about 70% a.i. - to Daphnia magna was determined in a static GLP test. The test was performed according to OECD 202. The test was started with a control, solvent control and nominal 0.5, 1.3, 3.2, 8.0 and 20 mg CT-737 -02/L corresponding to 0 (control), 0 (solvent control), 0.35, 0.91, 2.24, 5.6 and 14 mg a.i./L. For each test concentration and the control, 4 replicates with 5 daphinds each were set up in 50 mL vessels filled with 50 mL test solution. The test was performed in a 16:8 hour light dark cycle. Dose-verification analysis was not performed and hence, the concentrations were reported as nominal concentrations. After 48 hours of exposure, 0, 0, 0, 0, 0, 65 and 100 % of the daphnids were immobilized at 0 (control), 0 (solvent control), 0.35, 0.91, 2.24, 5.6, and 14 mg a.i./L.

The corresponding 48 h EC50 value is 4.9 mg a.i./L.

This study is considered to be acceptable for the risk assessment.

Description of key information

EC50  freshwater invertebrates = 4.9 mg a.i./ L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

4.9 mg/L

Additional information

For the data endpoint “Short-term toxicity to aquatic invertebrates” one experimental Klimisch 2 study is available.

The GLP study from Cytec (Glover 2002) was classified as Klimisch 2 study. In this study the acute toxicity of formulated product - which contains 70% a.i.- to Daphnia magna was determined in a static test. The test was performed according to guideline OECD 202. Only minor deviations were observed. The test was started with a control, solvent control nominal 0.5, 1.3, 3.2, 8 and 20 mg formulated product/L corresponding to 0 (control), 0 (solvent control), 0.35, 0.91, 2.24, 5.6 and 14 mg a.i./L. For each test concentration and the control, 4 replicates with 5 daphnids each were set up in 50 mL vessels. The test was performed in 16:8 h light dark cycle. Dose-verification analysis was not performed and hence, the concentrations were reported as nominal concentrations. After 48 hours of exposure, 0, 0, 0, 0, 0, 65 and 100 % of the daphnids were immobilized at 0 (control), 0 (solvent control),0.35, 0.91, 2.24, 5.6 and 14 mg a.i./L. The corresponding 48 h EC50 value is 4.9 mg a.i./L.

The results of this study are considered as relevant for the risk assessment and the CSA.