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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-06-14 to 2010-07-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
An aliquot of 10 mL of the treatment and control samples were diluted with 10 mL methanol giving a sample preparation factor of two before they were deep-frozen and protected from light until analysis was performed.
Immediately after sampling, methanol (10 mL methanol to 10 mL sample volume) was added to each sample in order to stabilize the latter during the storage period. Thereafter, all samples were stored deep-frozen (at about -20 °C). In pre-experiments for investigation of the storage stability of the samples, the two main components of the test item proved to be stable under these storage conditions.
Vehicle:
no
Details on test solutions:
In order to assess the toxicity of Partially unsaturated IQAC, DMS quaternised containing different components to daphnids, water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L were tested. Additionally, a control (test water without test item) was tested in parallel. The preparation of the test media was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
For preparation of the WAFs with the two highest loading rates of 3.2 and 10 mg/L, individual dispersions of the test item were prepared. The dispersions were stirred for 3 hours to dissolve a maximum amount of the different components of the test item in the dispersion. Then, the dispersions were filtered through membrane filters (0.45 μm) and the undiluted filtrates were tested as WAFs. Due to technical reasons, the WAFs with the lower loading rates of 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L were prepared as dilutions of the WAF with the loading rate of 3.2 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Straus
- Source: In-house laboratory culture with a known history.
- Age at study initiation (mean and range, SD): 6-24 hours old, not first brood progeny
- Method of breeding: no data
- Feeding during test: not fed during the test

ACCLIMATION
- Acclimation period: no data
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
21°C
pH:
between 7.9 and 8.0
Dissolved oxygen:
at least 8.0 mg/L
Nominal and measured concentrations:
Initial concentrations: 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L based on water accommodated fractions (WAFs). At the start of the first test medium renewal period (Day 0), the measured test item concentrations (based on two main components of the test item) in the test media with the loading rates of 0.32, 1.0, 3.2 and 10 mg/L were 6.4, 22, 71 and 3332 μg/L, respectively. At the end of this period (Day 1), the values were 5.9, 14, 43 and 1173 μg/L, respectively. At the start of the second test medium renewal period (Day 1), concentrations of 33, 90, 289 and 2550 μg/L were measured, respectively. At the end of this period (Day 2), the values were 16, 69, 215 and 1374 μg/L, respectively.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL glass beakers filled with 50 mL of test medium, covered with glass plates
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): medium renewal after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 20

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water according to ISO 6341

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16-hour light to 8-hour dark cycle with a 30-minute transition period
- Light intensity: during the light period was approximately between 520 and 680 Lux

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study: yes
- Test concentrations: water accommodated fractions (WAFs) with the loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L were tested.
The volume of test solution provided for each daphnia was 10 mL. Thus, the requirement of the test guidelines for the minimum volume of 2 mL test medium per daphnia was fulfilled.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2Cr2O7).
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
5.7 mg/L
Nominal / measured:
estimated
Conc. based on:
other: water accommodated fractions (WAFs)
Basis for effect:
mobility
Remarks on result:
other: 3.2-10 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
3.7 mg/L
Nominal / measured:
estimated
Conc. based on:
other: water accommodated fractions (WAFs)
Basis for effect:
mobility
Remarks on result:
other: 2.6-4.9 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.32 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fractions (WAFs)
Basis for effect:
mobility
Remarks on result:
other: no data
Details on results:
At the start of the first test medium renewal period (Day 0), the measured test item concentrations (based on two main components of the test item) in the test media with the loading rates of 0.32, 1.0, 3.2 and 10 mg/L were 6.4, 22, 71 and 3332 μg/L, respectively. At the end of this period (Day 1), the values were 5.9, 14, 43 and 1173 μg/L, respectively.

At the start of the second test medium renewal period (Day 1), concentrations of 33, 90, 289 and 2550 μg/L were measured, respectively. At the end of this period (Day 2), the values were 16, 69, 215 and 1374 μg/L, respectively.
During the first 24 hours of the test, no immobilized test organisms were determined in the control and up to and including the loading rate of 3.2 mg/L (corresponding to a mean measured test item concentration of 152 μg/L). At the highest loading rate of 10 mg/L (corresponding to a mean measured test concentration of 1924 μg/L), all test organisms were found to be immobile after 24 hours.

The 24-hour EC50 based on loading rates was calculated to be 5.7 mg/L with 95% confidence limits of 3.2 and 10 mg/L. The 24-hour EC50 based on mean measured concentrations of the test item was calculated to be 541 μg/L with 95% confidence limits of 152 and 1924 μg/L.

The 24-hour EC0 was 3.2 mg/L based on loading rates and 152 μg/L based on mean measured concentrations.
The 24-hour EC100 was 10 mg/L based on loading rates and 1924 μg/L based on mean measured concentrations.

After 48 hours of exposure, no immobilized test organisms were determined in the control and up to and including the loading rate of 0.32 mg/L (corresponding to a mean measured test item concentration of 15 μg/L). At the loading rates of 1.0, 3.2 and 10 mg/L (corresponding to mean measured concentrations of 48, 152 and 1924 μg/L) 15, 30 and 100% of daphnids, respectively, were found to be immobile.

The 48-hour EC50 based on loading rates was calculated to be 3.7 mg/L with 95% confidence limits of 2.6 and 4.9 mg/L. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L.

The 48-hour EC0 and the 48-hour NOEC of test substance were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations, since no immobility was observed up to and including this test concentration.

The 48-hour EC100 was 10 mg/L based on loading rates and 1924 μg/L based on mean measured concentrations.

No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the entire test duration.

The biological test results (based on loading rates and mean measured concentrations): 

 

Loading rate (mg/L)

Mean measured concentration (μg/L)

24-hour EC0

3.2

152

24-hour EC50

95% confidence limits

5.7

541

3.2 - 10

152 - 1924

24-hour EC100

10

1924

48-hour EC0

 

0.32

 

15

48-hour NOEC

48-hour EC50

95% confidence limits

3.7

253

2.6 - 4.9

146 - 688

48-hour EC100

10

1924

Effect of test substance on the Mobility of Daphnia magna 

 

Loading rate (mg/L)

 

 

*Mean measured concentration (μg/L)

 

 

No. of daphnids tested

 

Immobilized daphnids after 24 hours

 

 

Immobilized daphnids after 48 hours

 

No.

%

No.

%

Control

n.a

20

0

0

0

0

0.010

--

20

0

0

0

0

0.032

--

20

0

0

0

0

0.10

--

20

0

0

0

0

0.32

15

20

0

0

0

0

1.0

48

20

0

0

3

15

3.2

152

20

0

0

6

30

10

1924

20

20

100

20

100

n.a.: not applicable

-- : not analyzed, since below NOEC

* : measurement based on two main components

 

 

Results Obtained for the Concentrations of the Spiked Test Water Samples 

Sample No.

Nominal Concen-tration of Test Item cnom

 

[μg/L]

Measured Concentration of Test Item in the Spiked Sample x

 

[μg/L]

Concentration of Test Item Determined in the Spiked Sample c

 

[μg/L]

Recovery Rate R

 

 

 

 

[%]

 

Average

 

 

 

 

 

[%]

 

1

0

<LOQana

n.a

n.a

--

2

10.2

3.68

7.37

72

 

3

10.2

4.30

8.59

84

78

4

10297

26.2

8774

85

 

5

10297

26.5

8872

86

86

 

 

 

 

Overall mean:

82

LOQana= 0.276μg test item/L

n.a. = not applicable

The tabulated values of the samples represent rounded results obtained by calculation using the exact raw data.

Validity criteria fulfilled:
yes
Remarks:
The test is considered to be valid, as in the control, no daphnids showed immobilization or other signs of disease or stress. The dissolved oxygen concentration at the end of the test was ≥3 mg/L in the control and test vessels.
Conclusions:
The 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied According to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
Executive summary:

The 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied According to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Results Synopsis

Test Organism Age: < 24 h

Test Type: semi-static

48 -hour NOEC: 0.32 mg/L                                                 (15 μg/L based on mean measured concentrations)

48-hour EC50: 3.7 mg/L; 95% C.l.: 2.6 to 4.9 mg/L (253 μg/L 95% C.I.: 146 to 688 μg/L based on mean measured concentrations)

Endpoint(s) Effected: immobilization

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study, that satisfies basic scientific requirements, however not all data are reported
Qualifier:
according to guideline
Guideline:
other: DIN 38 412 Part 11
GLP compliance:
not specified
Analytical monitoring:
not specified
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Age at study initiation : <= 24 h
no feeding during the test



Test type:
static
Water media type:
freshwater
Total exposure duration:
24 h
Nominal and measured concentrations:
control, 0.001, 0.005, 0.01, 0.05, 0.1, 0.5, 1.0 mg/L (nominal)
Details on test conditions:
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water, filtered through charcoal
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
0.45 - 0.9 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
0.09 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
0.9 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
- Mortality of control: None

Effect concentrations:

24 h EC50 = 0.5 — 1 mg test mat./ L (nominal)
24 h EC0 = 0.1 mg/ test mat L(nominal)
24 h EC100 = 1 mg test mat test mat /L (nominal)
24 h EC50 = 0.90 mg act.ingr / L(nominal)
24 h EC0 = 0.09 mg/ act.ingr L(nominal)
24 h EC100 = 0.9 mg/ act.ingr.L (nominal)

The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.

Executive summary:

The 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions.  Daphnids were exposed to nominal concentrations of 0, 0.001, 0.005, 0.01, 0.05, 0.1, 0.5, 1.0 mg test mat. /L for 24 hr according to DIN 38 412 Part 11.  Mortality/immobilization were observed.  The 24 – hour EC50was 0.45 – 0.9 mg a.i../L.  The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L.

The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.
This study is classified
scientifically acceptable, that satisfies basic scientific requirements, however not all data are reported.

Results Synopsis

Test Organism Age (e.g. 1st instar): Daphnia magna
Test Type: static

24 h EC50:
0.45 - 0.9 mg a.i. /L
24 h EC0:  0.09 mg a.i./L
24h EC1000:  0.9 mg a.i./L

Endpoint(s) Effected: mortality, mobility 

Description of key information

The nominal 48–hr-acute toxicity of Partially unsaturated IQAC,, DMS quaternised to Daphnia magna under semi-static conditions was EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits (OECD 202). The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
3.7 mg/L

Additional information

The 48–hr-acute toxicity of partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied according to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

In another study, the 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions.  Daphnids were exposed for 24 hr according to DIN 38 412 Part 11.  Mortality/immobilization was observed.  The 24 – hour EC50 was 0.45 – 0.9 mg a.i../L.  The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L. The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.

According to REACH Endpoint specific Guidance R.7b, pp 24, 24 hour values can have considerable variability in the repeatability of results. Therefore standard 48 hour values are favoured over 24 hour values. 24 hour values should only be used in the absence of good quality 48 hour values with other available supporting data.