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Short-term toxicity to aquatic invertebrates

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Reference
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 11 March 1988 to 13 March 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
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:
equivalent or similar to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
no
Details on sampling:
A clear stock solution of 3.03 mg/mL was prepared by diluting 0.0303 g of the test substance with distilled water in a 10 mL flask. The test solutions were prepared by adding the appropriate volume of stock solution to dilution water to total 1,000 mL. Each solution was mixed on a magnetic stirrer for 30 seconds and then divided into 4 beakers to provide replicate exposure treatments, each containing 200 mL. The remaining 200 mL of test solution were used for 0 h water quality measurement.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Name of vehicle: Water
- Concentration of vehicle in test medium (stock solution): Stock solution of 3.03 mg/mL was prepared by diluting 0.0303 g of the test substance with distilled water in a 10 mL flask
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Species: Daphnia magna
- Source: Springborn Life sciences, Inc., Wareham, Massachusetts
- Age at study initiation (mean and range, SD): ≤24 h
- Feeding during test: No

ACCLIMATION
- Acclimation period: Cultures of the test organism over many generation has been continuously maintained at the lab
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: Solution of green algae and yeast suspension daily
- Feeding frequency: Daily
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
180 mg/L as CaCO3
Test temperature:
20-21⁰C
pH:
7.9-8.3
Dissolved oxygen:
98-99%
Nominal and measured concentrations:
0, 236, 394, 667, 1,091, 1,818 and 3,030 µg/L as nominal concentration
Details on test conditions:
The test was conducted in 250 mL glass beaker. A clear stock solution of 3.03 mg/mL was prepared by diluting 0.0303 g of the test substance with distilled water in a 10 mL flask. The test solution was prepared by adding the appropiate volume of stock solution to dilution water to a total volume of 1 L. Each solution was mixed on a magnectic stirrer for 30 seconds and then divided into 4 beakers to provide replicate exposure treatments, each containing 200 mL. The remaining 200 mL of test solution was used for 0 hour water quality measurement and then discarded. One set of 4 control beakers was prepared containing the same dilution water and maintained under the same conditions as the exposure concentration, but without the test subsatnce. The ambient air temperature was controlled in order to maintain test solution temperature at 20 ± 1⁰C. The test solution was not aerated. The test area was illuminated with Sylvania GRO-LUX and cool white fluorescent lights at an intensity of 70 footcandles at the solution surface.

See below tables for detials.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
550 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
280 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: i.e., equivalent to 92.4 µg a.i. /L)
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
< 236 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, behavioural and physical abnormalities
Remarks on result:
other: i.e., equivalent to 78 µg a.i. /L)
Details on results:
The 48 h EC50 and 95% confidence interval (calculated by probit analysis) was 280 (i.e. 92.4 ug a.i./L). The NOEC was <236 µg/L (<78 ug a.i./L), the lowest tested concentration.



Table 1: Immobilisation data

Test­-Substance

Concentration
(nominal)

[µg a.i./l]

 

ImmobileDaphnia

 

 

 

Number

 

   24 h         48 h    

Percentage

 

    24 h        48 h

Oxygen

[mg/l]

48 h

pH

 

48 h

Tempera­ture [°C]

48 h

0

0

0

0

0

8.4

8.4

not known

79

0

4

0

20

8.9

8.5

 

131

1

19

5

95

9.0

8.5

 

222

17

20

85

100

9.0

8.5

 

364

20

20

100

100

-

-

 

606

20

20

100

100

-

-

 

1010

20

20

100

100

-

-

 

 

Table 2: Effect data

 

EC501

95 % c.l.

EC01

EC1001

24 h [µg a.i./l]

183 (n)

130-223

-

-

48 h [µg a.i./l]

93 (n)

83-100

< 79 (n)

-

1indicate if effect data are based on nominal (n) or measured (m) concentrations

 

Table 3: Validity criteria for acute daphnia immobilistaion test according to OECD Guideline 202

 

fulfilled

Not fullfilled

Immobilisation of control animals <10%

YES

 

Control animals not staying at the surface

YES

 

Concentration of dissolved oxygen in all test vessels >3 mg/l

YES

 

Concentration of test substance³80% of initial concentration during test

*

 

* Not known for no analyses were performed

Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the read across study, the 48 h EC50 and NOEC for the test substance are considered to be at 280 and <236 µg/L, (i.e., equivalent to 0.09 and <0.08 mg a.i./L), respectively
Executive summary:

A study was conducted to determine the acute toxicity study of the read across substance, Coco TMAC (33% active in water), to the Daphnia magna according to a method similar to OECD Guideline 202, in compliance with GLP. Daphnia magna (10 per dose) were exposed to the read across substance at nominal concentrations of 0, 236, 394, 667, 1,091, 1,818 and 3,030 µg/L for 48 h under static conditions and mortalities were determined. No analytical determination of the read across substance was performed. Throughout the test period no visible sign of undissolved material was observed in the exposure solutions. Immobilisation was determined after 24 and 48 h. Through-out the 48-h exposure all organisms which were not immobilized appeared normal as compared to the control daphnids i.e., behavior and physical appearance. The 48 h EC50 and 95% confidence interval were calculated by probit analysis as 280 (250 - 300) µg/L. The NOEC was < 236 µg/L, the lowest tested concentration. Under the study conditions, the 48 h EC50 and NOEC were 280 and <236 µg/L, (i.e., equivalent to 0.093 and <0.08 mg a.i./L), respectively (Surprenant, 1988). Based on the results of the read across study, similar effect levels are considered for the test substance.

Description of key information

Therefore, in line with the biocides assessment report and as a conservative approach, the same 48 h EC50 value of 0.012 mg a.i./L (nominal) based on read across to C12 -16 ADBAC has been considered further for hazard/risk assessment.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
12 µg/L

Additional information

A study was conducted to determine the acute toxicity study of the read across substance, Coco TMAC (33% active in water), to theDaphniamagna according to a method similar to OECD Guideline 202, in compliance with GLP.Daphniamagna (10 per dose) were exposed to the read across substance at nominal concentrations of 0, 236, 394, 667, 1,091, 1,818 and 3,030 µg/L for 48 h under static conditions and mortalities were determined. No analytical determination of the read across substance was performed. Throughout the test period no visible sign of undissolved material was observed in the exposure solutions. Immobilisation was determined after 24 and 48 h. Through-out the 48-h exposure all organisms which were not immobilized appeared normal as compared to the control daphnids i.e., behavior and physical appearance. The 48 h EC50 and 95% confidence interval were calculated by probit analysis as 280 (250 - 300) µg/L. The NOEC was < 236 µg/L, the lowest tested concentration. Under the study conditions, the 48 h EC50 and NOEC were 280 and <236 µg/L (nominal; i.e., equivalent to 0.093 and <0.08 mg a.i./L), respectively (Surprenant, 1988). 

The biocide assessment report available from RMS Italy on Coco TMAC (ECHA assessment report, 2016), considered the above study to be supportive because the endpoints were based on nominal concentrations, which could underestimate the toxicity. However, similar to the fish endpoint, several available reliable read across studies with DDAC and BKC, also indicated toxicity in the same range. Therefore, as a final endpoint for Coco TMAC, the RMS selected the read across data to C12-16 ADBAC (also known as BKC) with the lowest 48 h EC50 = 0.016 mg a.i./L, as the worst case and calculated the 48 h EC50 for Coco TMAC at 0.012 mg a.i./L by applying correction for MW.   

Therefore, in line with the biocides assessment report and as a conservative approach, the same 48 h EC50 value of 0.012 mg a.i./L based on read across to C12-16 ADBAC has been considered further for hazard/risk assessment.