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Short-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
16 July 2012 - 17 October 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: CLP study acoording to Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
EC Number:
284-664-9
EC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
Cas Number:
84961-74-0
IUPAC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine (1:1)
- Substance type: technical product (BIO-SOFT 411-E)
- Physical state: viscous liquid
- Analytical purity: 97% (communication with sponsor)
- Lot/batch No.: 50148
- Expiration date of the lot/batch: 30 June 2013
- Storage condition of test material: room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were taken from the control and each test group (replicates R1 - R4 pooled) at 0 and 48 hours for quantitative analysis. All samples were stored at approximately -20°C prior to analysis.

Test solutions

Vehicle:
no
Details on test solutions:
An amount of test item (3300 mg) was dispersed in 11 liters of reconstituted water with the aid of propellor stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item removed by filtration through a 0.2µm Sartorius Sartopore filter (first approximate 1 liter discarded in order to pre-condition the filter) to give a 100% v/v saturated solution of the test item. A series of dilutions was made from the 100% v/v saturated solution test concentration to give further test concentrations of 56, 32, 18, 10, 5.6, 3.2, 1.8 and 1.0% v/v saturated solution

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: not reported
- Source: in-house laboratory culture
- Age at study initiation (mean and range, SD): <24 hours old
- Method of breeding: Adult Daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room at approximately 20°C. The lighting cycle was controlled to give 16 hours light and 8 hours darkness cycle with 20 minutes dawn to dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours
- Feeding during test: None

ACCLIMATION
- Acclimation period: not necessary, conditions in culture are equal to test conditions

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
250 mg/L as CaCO3
Test temperature:
20-21°C
pH:
start: 7.9 - 8.0
after 48 hours: 7.1 - 8.0
Dissolved oxygen:
start: 8.8 - 9.2 mg O2/L
after 48 hours: 8.7 - 8.8 mg O2/L
Nominal and measured concentrations:
Nominal:
Control, 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100% saturated solution

Measured:
Control, 0.71, 1.3, 2.5, 5.0, 9.1, 13, 28, 44 and 86 mg test material/L
Details on test conditions:
TEST SYSTEM
- Test vessel:250 mL glass jars
- Type (delete if not applicable): covered to reduce evaporation
- Material, size, headspace, fill volume:250 mL glass jars filled to 200 mL
- Aeration: no
- Renewal rate of test solution (frequency/flow rate):static (no renewal)
- No. of organisms per vessel:5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water prepared according to OECD 202 guideline
- Conductivity: <5 µS/cm
- Culture medium different from test medium: culure medium was Elendt M7
- Intervals of water quality measurement:pH and dissolved oxygen concentration were measured at the start and end of the test (t = 0 and t = 48 hours)

OTHER TEST CONDITIONS
- Adjustment of pH: not reported
- Photoperiod: 16 hours light and 8 hours darkness cycle with 20 minutes dawn to dusk transition periods
- Light intensity: 354 - 383 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation at 24h and 48h after start of exposure

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study
- Test concentrations:0.10, 1.0, 10 and 100% saturated solution of test material
- Results used to determine the conditions for the definitive study:0% immobilization at 0.10 and 1.0%, 80% immobilization at 10% and 100% immobilization at 100% saturated solution of test material
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
7.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 3.7-12 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
2.5 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
5 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: not reported
- Observations on body length and weight: not reported
- Other biological observations: not reported
- Mortality of control: 0%
- Other adverse effects control: none reported
- Abnormal responses: none reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no. Nominal values were expressed as percentage of a saturated solution. Measured concentrations in the range of 90% to 115% of the 0-hour measured concentrations were obtained at 48 hours, hence it was considered justifiable to base the results on the 0-hour measured test concentrations only.
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
- Results with reference substance valid? yes
48-h EC50 (immobilization) was 0.45 mg potassium dichromate/L (95% CL 0.42 - 0.48 mg/L).
The 48-h NOEC was found to be 0.32 mg/L.
These results are within the normal range for this reference item.
Reported statistics and error estimates:
The EC50 values and associated confidence limits at 24 and 48 hours and the slope of the response curve and its standard error were calculated by the maximum-likelihood probit method (Finney, 1971) using the ToxCalc computer software package (ToxCalc, 1999).

Any other information on results incl. tables

Table 1. Cumulative immobilization of Daphnia magna exposed to 97% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)

0-hour measured test concentration (mg/L)*

Cumulative immobilizedDaphnia

(initial population: 5 per replicate)

24 hours

48 hours

R1

R2

R3

R4

Total

%

R1

R2

R3

R4

Total

%

Control

0

0

0

0

0

0

0

0

0

0

0

0

0.71

0

0

0

0

0

0

0

0

0

0

0

0

1.3

0

0

0

0

0

0

0

1

0

0

1** 

5

2.5

0

0

0

0

0

0

0

0

0

0

0

0

5.0

1

0

2

0

3

15

3

0

1

2

6

30

9.1

2

2

0

0

4

20

3

2

0

3

8

40

13

5

5

5

5

20

100

5

5

5

5

20

100

28

5

5

5

5

20

100

5

5

5

5

20

100

44

5

5

5

5

20

100

5

5

5

5

20

100

86

5

5

5

5

20

100

5

5

5

5

20

100

*Note that these concentrations are not corrected for purity (purity test material: 97% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)).

**Single immobilized daphnid considered to be due to natural causes rather than a true toxic effect given that less than 10% immobilization occurred.

Analytical results:

Measured concentrations in the range of 90% to 115% of the 0-hour measured concentration were obtained at 48 hours and hence it was considered justifiable to base the results on the 0-hour measured test concentrations only.

The 24-hour EC50 based on immobilisation was 9.0 mg test material/L with 95% CL of 6.2 - 12 mg/L.

The slopes and their standard errors of the response curves at 24 and 48 hours were 6.1 (SE = 1.8) and 3.7 (SE = 1.1) respectively.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) to Daphnia magna was 7.1 mg/L.
Executive summary:

The acute toxicity of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) (purity 97%)

to the fresh-water crustacean Daphnia magna was determined as decribed in the OECD 202 guideline and according to Good Laboratory Practice.

The test was carried out with 4 x 5 daphnias for each concentration and control, and the test solutions were not replaced.

The exposure duration was 48 hours.

The concentrations tested were 0, 0.71, 1.3, 2.5, 5.0, 9.1, 13, 28, 44 and 86 mg/L and results were based on measured initial concentations.

All validity criteria were achieved and the results for the positive control were within the normal range, so the test is considered valid. The 48 h EC50 value based on mobility was 7.1 mg benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine (1:1)/L, with 95% CL of 3.7 to 12 mg/L. This toxicity study is classified as acceptable and satisfies the guideline requirement for the OECD 202 method (Daphnia acute immobilisation test).