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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 17 July, 1990 to 19 July, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No analytical measurement was performed.
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
as published in 84/449/EEC
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
The test sample was prepared by direct dissolution in water. 1.0 g of the test substance was dissolved in water and the volume adjusted to 1 L. This stock solution was then diluted to give a 0.10 mg/L stock solution from which serial dilutions were made to give the test series.

The test substance was known to absorb to glassware and so saturation of the absorption sites was achieved by soaking the test vessels overnight prior to the start of the test with the test solutions. At 0 h the test vessels were emptied, rinsed with the solution to be tested and then refined with the fresh test solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: Laboratory culture originating from a strain supplied by I.R.C.H.A., France.
- Culture: At 21˚C in polypropylene vessels containing 2 L of dechlorinated and aged tap water. Cultures were fed daily with a mixture of fry fish food (liquifry) and a suspension of mixed algae (predominantly Chlorella spp.). Culture conditions ensure that reproduction is by parthenogenesis.
- Selection: Gravid adults were isolated 24 h prior to initiation of the test. Young daphnids produced overnight were used for testing.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No
Hardness:
50 mg/L of CaCO3
Test temperature:
21 ± 1˚C
pH:
7.1-7.2
Dissolved oxygen:
8.3-8.6 mg O2/L
Nominal and measured concentrations:
Nominal concentrations: 0.0010, 0.0018, 0.0032, 0.0056, 0.010, 0.018, 0.032, 0.056 and 0.10 mg/L
Details on test conditions:
TEST SYSTEM:
- Test water: Dechlorinated (with sodium thiosulphate) and aged laboratory tap water. Total hardness approximately 50 mg/L as CaC03.
- No. of organisms per vessel: 10 per replicate
- No. of vessels per concentration (replicates): Two

EXPOSURE CONDITIONS:
- Test vessels: Glass beakers each containing 200 mL test solution
- Experimental design: 9 test concentrations plus one control, each in duplicate. 20 animals per concentration
- Method of initiation: Daphnia were placed in the test solutions after addition of the test substance
- Loading: 20 mL test solution per organism
- Photo-period: 16h light: 8h dark
- Aeration: None
- Medium renewal: None

CRITERIA OF EFFECT: Daphnia were considered to be immobilised if they were unable to swim for approximately 15 sec after gentle agitation.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.091 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: (95% CL = 0.015-0.025 mg a.i./L)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.009 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Remarks on result:
other: (95% CL = 0.0072-0.012 mg a.i./L)
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 0.006 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 0.003 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility

For result tables and figures, kindly refer to the attached background material section of the IUCLID.

Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the read across study, the 48 h EC50 and NOEC were 0.0091 and 0.0026 mg a.i./L, respectively.
Executive summary:

A study was conducted to determine the short-term toxicity of the read across substance, C16-18 TMAC (46.5% active in isopropanol and water) to Daphnia magna under static conditions according to OECD Guideline 202, in compliance with GLP. Ten daphnids per group were exposed to the read across substance at nominal concentrations of 0.0010, 0.0018, 0.0032, 0.0056, 0.010, 0.018, 0.032, 0.056 and 0.10 mg/L for 48 h followed by determination of immobilisation. No analytical determination of the read across substance was performed. The 24 and 48 h EC50 value were calculated as 0.035 (95% confidence limits (CL): 0.027-0.044) and 0.019 mg/L (95% CL: 0.015-0.025) respectively, which was equivalent to 0.016 (95% CL: 0013-0.021) and 0.0091 (95% CL: 0.0072-0.012) mg a.i./L respectively. The 24 and 48 h NOEC values were determined to be 0.010 (i.e., 0.0047) and 0.0056 mg/L (i.e., 0.0026 mg a.i./L) respectively. Under the study conditions, the 48-h EC50 and NOEC were 0.0091 and 0.0026 mg a.i./L, respectively (Handley and Wetton, 1990). Based on the results of the read across study, similar EC50 and NOEC values can be expected for the test substance.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study was conducted similar to OECD guideline 202.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
Because of the very rapid removal of the test substance from the water column, the geometric mean of the 0, 24 and 48-h concentrations was considered to be the overall exposure concentration in the acute toxicity tests.
Hardness:
Laboratory blended water (total hardness ~150 mg/L)
Southwest well water (total hardness ~350 mg/L)
River water (total hardness ~300-350 mg/L)
Nominal and measured concentrations:
Please refer to the table 1 of the attached background material for details on nominal and measured concentrations of all three test water types.
Details on test conditions:
Three water types were used in this test: laboratory blended water (total hardness ~150 mg/L), Southwest well water (total hardness ~350 mg/ L) and river water (total hardness ~300-350 mg/L).

The river water, exemplifying a natural surface water that received sewage effluent, was collected from the White River (Indiana) and transported for cold storage (~4°C).

Acute toxicity tests of 48-h duration were conducted in each water type employing seven concentrations of test substance plus control and an isopropanol (IPA) control. The tests were repeated to ensure reproducibility. The same procedures were utilized in the repeat tests with the exception of testing a more recently collected batch of White River water. There was no renewal of test waters throughout the 48-h test period. Mortality was recorded daily and water chemistry measurements were taken at the beginning and conclusion of the test period for control waters only. Each test substance concentration was verified by radiochemical counting of triplicate 10 mL samples collected from the fresh stock solution (0 h) and from a randomly selected beaker after 24 and 48 h.
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
ca. 17.5 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: In Southwest well water (LC50 values in the initial and repeat tests were 19.8 and 15.3 μg/L, respectively).
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
ca. 12.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: In blended water (LC50 values in the initial and repeat tests were 16.3 and 8.8 μg/L, respectively).
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
ca. 98.9 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: In river water (initial test result only).
Details on results:
In the initial acute toxicity tests, little difference existed between LC50 values for blended and well waters. The river water LC50, however, was 5 to 11 times higher, possibly related to the presence of solids causing test substance adsorption and reduced bioavailability. An additional factor may have been that the river water contained endogenous nutritional sources perhaps enhancing daphnid resistance to the effects of the test substance.

Please refer to the table 2 of the attached background material for mortality data.
Reported statistics and error estimates:
The 48-h LC50 values were determined by probit analysis based on the geometric mean of the 0, 24 and 48-h concentrations to reflect overall exposure concentrations.
Validity criteria fulfilled:
not specified
Conclusions:
Under the test conditions, the 48 h LC50 measured concentration were 17.5 μg a.i./L in Southwest well water, 12.6 μg a.i./L in blended water and 98.9 μg a.i./L in river water
Executive summary:

A study was conducted to determine the short-term toxicity of the test substance, C16-18 and C18-unsatd. TMAC (48.4% active in water, radiochemical purity: 98%) to Daphnia magna according to a method similar to OECD Guideline 202, under static conditions. Twenty Daphnids were exposed to seven nominal concentrations of the test substance in three different water types (i.e., laboratory blended water, Southwest well water and river water). The nominal concentration in Southwest well and blended water were 11.5, 15.5, 21.0, 28.0, 37.0, 49.0 and 65.0 µg/L and 115, 155, 210, 280, 370, 490 and 650 µg/L in river water. The tests were repeated to ensure reproducibility. The same procedures were utilized in the repeat tests with the exception of testing a more recently collected batch of river water. Mortality was recorded daily and water chemistry measurements were made at the beginning and end of the test period for control waters only. Each test substance concentration was verified by radiochemical counting of triplicate 10 mL samples collected from the fresh stock solution (0 hour) and from a randomly selected beaker after 24 and 48 h. Because of the very rapid removal of the test substance from the water column, the geometric mean of the 0, 24 and 48-hour concentrations was considered to be the overall exposure concentration in the acute toxicity tests. The initial and repeat 48-h LC50s values of the test substance based on the measured concentrations were determined to be 19.8 and 15.3 μg/L (geometric mean: 17.5 μg/L) in Southwest well water, 16.3 and 8.8 μg/L (geometric mean: 12.6 μg/L) in blended water and 98.9 μg a.i./L (initial) in rive water respectively. In the initial acute toxicity tests, little difference existed between LC50 values for blended and well waters. The river water LC50, however, was 5 to 11 times higher, possibly related to the presence of solids causing test substance adsorption and reduced bioavailability. An additional factor may have been that the river water contained endogenous nutritional sources perhaps enhancing daphnid resistance to the effects of the test substance. Under the test conditions, the 48 h LC50 measured concentration were 17.5 μg a.i./L in Southwest well water, 12.6 μg a.i./L in blended water and 98.9 μg a.i./L in river water (TRS-HPV, 2001).

Description of key information

Given that the read across to C16-18 TMAC can be justified for the test substance based on a category approach, the lower 48-h EC50 value of 0.0091 mg/L (nominal) for effects on mobility in Daphnia magna, has been considered further for hazard/risk assessment of the test substance. 

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
9.1 µg/L

Additional information

Study 1: A study was conducted to determine the short-term toxicity of the read across substance, C16-18 TMAC (46.5% active in isopropanol and water) to Daphnia magna under static conditions according to OECD Guideline 202, in compliance with GLP. Ten daphnids per group were exposed to the read across substance at nominal concentrations of 0.0010, 0.0018, 0.0032, 0.0056, 0.010, 0.018, 0.032, 0.056 and 0.10 mg/L for 48 h followed by determination of immobilisation. No analytical determination of the read across substance was performed. The 24 and 48 h EC50 value were calculated as 0.035 (95% confidence limits (CL): 0.027-0.044) and 0.019 mg/L (95% CL: 0.015-0.025) respectively, which was equivalent to 0.016 (95% CL: 0013-0.021) and 0.0091 (95% CL: 0.0072-0.012) mg a.i./L respectively. The 24 and 48 h NOEC values were determined to be 0.010 (i.e., 0.0047) and 0.0056 mg/L (i.e., 0.0026 mg a.i./L) respectively. Under the study conditions, the 48-h EC50 and NOEC were 0.0091 and 0.0026 mg a.i./L, respectively (Handley and Wetton, 1990).

Study 2: A study was conducted to determine the short-term toxicity of the test substance, C16-18 and C18-unsatd. TMAC (48.4% active in water, radiochemical purity: 98%) to Daphnia magna according to a method similar to OECD Guideline 202, under static conditions. Twenty Daphnids were exposed to seven nominal concentrations of the test substance in three different water types (i.e., laboratory blended water, Southwest well water and river water). The nominal concentration in Southwest well and blended water were 11.5, 15.5, 21.0, 28.0, 37.0, 49.0 and 65.0 µg/L and 115, 155, 210, 280, 370, 490 and 650 µg/L in river water. The tests were repeated to ensure reproducibility. The same procedures were utilized in the repeat tests with the exception of testing a more recently collected batch of river water. Mortality was recorded daily and water chemistry measurements were made at the beginning and end of the test period for control waters only. Each test substance concentration was verified by radiochemical counting of triplicate 10 mL samples collected from the fresh stock solution (0 hour) and from a randomly selected beaker after 24 and 48 h. Because of the very rapid removal of the test substance from the water column, the geometric mean of the 0, 24 and 48-hour concentrations was considered to be the overall exposure concentration in the acute toxicity tests. The initial and repeat 48-h LC50s values of the test substance based on the measured concentrations were determined to be 19.8 and 15.3 μg/L (geometric mean: 17.5 μg/L) in Southwest well water, 16.3 and 8.8 μg/L (geometric mean: 12.6 μg/L) in blended water and 98.9 μg a.i./L (initial) in rive water respectively. In the initial acute toxicity tests, little difference existed between LC50 values for blended and well waters. The river water LC50, however, was 5 to 11 times higher, possibly related to the presence of solids causing test substance adsorption and reduced bioavailability. An additional factor may have been that the river water contained endogenous nutritional sources perhaps enhancing daphnid resistance to the effects of the test substance. Under the test conditions, the 48 h LC50 measured concentration were 17.5 μg a.i./L in Southwest well water, 12.6 μg a.i./L in blended water and 98.9 μg a.i./L in river water (TRS-HPV, 2001).

Given that the read across to C16-18 TMAC can be justified for the test substance based on a category approach, the lower 48-h EC50 value of 0.0091 mg/L (nominal) for effects on mobility in Daphnia magna, has been considered further for hazard/risk assessment of the test substance.