Quaternary ammonium compounds, benzyl-C16-18-alkyldimethyl, chlorides

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July - September 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: ISO 6341 (second edition; 1989)

GLP compliance:

not specified

Analytical monitoring:

no

Details on sampling:

2 replicates of 10 animals/dose.

Vehicle:

yes

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Daphnia magna Straus
-Souce: Elf Atochom S.A.
- Age at study initiation: <24 hours
- Feeding during study: none
- Control: Potassium dichloride

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

room temperature range from 19 to 21°C

pH:

7.7

Dissolved oxygen:

8.6

Nominal and measured concentrations:

Nominal concentration: 0; 0.006; 0.0095; 0.0153; 0.0244; 0.0391; 0.0625; 0.1 mg/L

Details on test conditions:

Test medium (25 mL of each solution):
- 11.76 g of Cacl2, 2H2O per liter of ultrapure water
- 4.93 g of MgSO4, 7H2O per liter of ultrapure water
- 2.59 g of NaHCO3 per liter of ultrapure water
- 0.23 g of KCl per liter of ultrapure water
Medium saturated in oxygen.
The nominal concentration of the eluate was 100 mg/L. By diluting this eluate with the medium the following nominal concentrations were prepared: 0; 0.006; 0.0095; 0.0153; 0.0244; 0.0391; 0.0625; 0.1 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichlorate

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 0.094 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: equivalent to 0.080 mg a.i./L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 0.059 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: equivalent to 0.050 mg a.i./L

Details on results:

OXYGEN CONTENT
At each concentration, the dissolved oxygen content, measured at the end of the test, was greater than OR equal to 2 mg/L

IMMOBILIZATION OF WITNESSES
Immobilization after 48 hours in the control series is 5%. The clause requiring a mortality lower OR equal to 10% at the end of the test has therefore been respected.

SENSITIVITY OF BIOLOGICAL REAGENT
The last control of the sensitivity of daphnia to potassium dichromate was carried out on 6/9/95. The EC (I) 50 - 24 h of this reference substance, evaluated at 0.94 mg/L, was between 0.9 mg/L and 2.4 mg/L which is the acceptable range (ISO 6341 standard).

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

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 48 h EC50 of the test substance to Daphnia was determined to be 0.059 mg/L (equivalent to 0.050 mg a.i./L).

Executive summary:

A study was conducted to determine the short-term toxicity of the test substance, C16 -18 ADBAC (85% active in isopropanol) to aquatic invertebrates, according to ISO 6341 Method. Daphnia magna (2 replicates of 10 animals/dose) were exposed to the test substance at nominal concentrations of 0, 0.006, 0.0095, 0.0153, 0.0244, 0.0391, 0.0625 and 0.1 mg/L for 48 hours under static conditions at 20°C. Animals were observed for immobilisation after 24 and 48 h. Potassium dichlorate was used as the positive control. No analytical determination of the test substance was performed. At each concentration, the dissolved oxygen content, measured at the end of the test, was greater than or equal to 2 mg/L. Immobilization after 48 hours in the control series was 5%. The last control of the sensitivity of daphnia to potassium dichromate was carried out on 6/9/95. The EC50 (24 h) of the reference substance was determined to be 0.94 mg/L (between 0.9 mg/L and 2.4 mg/L which is the acceptable range of ISO 6341 standard). Under the study conditions, the 48 h EC50 of the test substance to Daphnia was determined to be 0.059 mg/L (equivalent to 0.050 mg a.i./L) nominal (Thiébaud, 1995).

Reference 2

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 May 09, 2003 to May 16, 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Justification for type of information:

Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: ISO/CD14669: "Determination of Acute Lethal Toxicity to Marine Copepods"

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: PARCOM ring test Protocol: "Acute Toxicity to the Marine Capepod Acartia tansa"

Deviations:

no

GLP compliance:

yes

Remarks:

GLP number: 41849

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Preparation and application of test solution:
- Method: The test substance was soluble in water, so the sample preparation method for water soluble test substances was followed.
The test substance was dissolved in filtered and aerated seawater to prepare a stock solution with concentration corresponding to the highest test concentration. The stock solution was mixed in a 1L Erlenmeyer flask on a magnetic stirrer (~100 rpm) for 2-4h after covering the top to minimise the volatilization. Required concentrations were prepared form the stock solution.
- Controls: 4
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): water

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

Test organism
- Common name: Calanoid copepod
- Source: Eggs of test organisms were obtained from University of Copenhagen, Laboratory of marine biology, Helsingør, Denmark
- Date of arrival of eggs: January 22, 2003
- Eggs were stored in refrigerator. Synchronious culture was used. The animals were cultivated in small batches.
- Age at study initiation: 14d

Test type:

not specified

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20.0 - 21.1°C

Dissolved oxygen:

7.2 mg/L

Nominal and measured concentrations:

- Based on the results from the Skeletonema costatum range finding study, the following test concentrations (nominal whole product) were used for the definitive test: 0.05; 0.2; 0.8; and 3.2 mg/L.
- Reference substance (3,5-dichlorophenol) concentrations (nominal): 1.0 mg/L.

Details on test conditions:

Test system
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

Effect parameters measured: Mortality

Test concentrations:
- Range finding study: Dose levels selection was based on Skeletonema costatum range finding study
- Test concentrations: 0.05; 0.2; 0.8; and 3.2 mg/L.

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 0.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Calculated

Remarks:

equivalent to 0.16 mg a.i./L

Key result

Duration:

48 h

Dose descriptor:

LC10

Effect conc.:

ca. 0.37 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Calculated

Remarks:

equivalent to 0.296 mg a.i./L

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

ca. 0.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Calculated

Remarks:

equivalent to 0.32 mg a.i./L

Key result

Duration:

48 h

Dose descriptor:

other: LC90

Effect conc.:

ca. 0.43 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Calculated

Remarks:

equivalent to 0.34 mg a.i./L

Details on results:

- Mortality of control: 0
- Mortality with test substance: Refer to Table 1

Results with reference substance (positive control):

- Reference substance study dates: May 14, 2003 to the May 16, 2003
- Results with reference substance valid? Yes
- Mortality: 55% after 48 h

Reported statistics and error estimates:

The LC50-value and 95% confidence intervals were calculated based from a Logistic regression model using JMP Program, version 3, 1998.

Test substance:

Results of the control and test substance groups are given below under tables:

Table 1. Test substance concentrations and mortality after 24 and 48h

Test concentration (mg/L)	Parallel	Number of organisms per vessel	Mortality (24 h)	Mortality (48 h)
Control	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
0.05	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
0.2	1	5	0	0
	2	5	0	0
	3	5	0	0
	4	5	0	0
0.8	1	5	5	5
	2	5	5	5
	3	5	5	5
	4	5	5	5
3.2	1	5	5	5
	2	5	5	5
	3	5	5	5
	4	5	5	5

 

Table 2. Calculation of LC₁₀, LC₅₀and LC₉₀-values after 24 and 48h (The 95% confidence range could not be calculated)

24 and 48h
Effect level	mean (log)
LC10	-0.43
LC50	-0.40
LC90	-0.37
Effect level	mean (inverse log)
LC10	0.37
LC50	0.40
LC90	0.43

 

Summary of the results:

The LC₅₀-value for the test substance was found to be 0.40 mg/L after 24 and 48 h. The 95% confidence range could not be calculated.

The NOEC-, LC₁₀- and LC₉₀-values after 24 and 48h were 0.2, 0.37 and 0.43 mg/L, respectively.

Reference substance:

The lethality with 1.0 mg/L 3,5-dichlorophenol was 55% after 48 h.

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of the read across study, the 48 h NOEC, LC10, LC50 and LC90 values were considered to be 0.2, 0.37, 0.40 and 0.43 mg/L (equivalent to 0.16, 0.296, 0.32 and 0.34 mg a.i./L), respectively.

Executive summary:

A study was conducted to determine the short-term toxicity of the read across substance, C12-14 ADBAC (60 -100% active) to aquatic invertebrates, according to ISO/CD14669 and PARCOM ring test Protocol, in compliance with GLP. Acartia tonsa were exposed for 48 h at nominal concentrations of 0, 0.05, 0.2, 0.8 and 3.2 mg/L, equivalent to 0, 0.04, 0.16, 0.64 and 2.56 mg a.i./L considering 80% as mean active. Analytical dose verification was not performed. The test was performed on 14 d old organisms under static conditions. The percent lethality was recorded after 24 and 48 h and the LC50-value along with 95% confidence intervals were calculated based from a Logistic regression model using JMP Program. To ensure reproducibility, a single concentration 1 mg/L of reference substance 3,5-dichlorophenol was included in the study, which indicated 55% mortality after 48 h. All validity criteria were fulfilled. Under the study conditions, the 48 h NOEC, LC10, LC50 and LC90 values were considered to be 0.2, 0.37, 0.40 and 0.43 mg/L (equivalent to 0.16, 0.296, 0.32 and 0.34 mg a.i./L), respectively (Haug, 2003). Based on the results of the read across study, similar effect levels can be expected for the test substance.

Description of key information

Based on the available information, the freshwater 48 h EC50 value of the test substance for effects on mobility ofDaphnia magnawas determined to be 0.05 mg a.i./L (nominal). Further, based on the results of the read across study with C12-14 ADBAC, the marine water 48 h EC50 value of the test substance for acute toxicity in Acartia tonsais considered to be 0.32 mg a.i. /L (nominal). These respective EC50 values in fresh and marine water have been considered further for hazard/risk assessment.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

0.5 mg/L

Marine water invertebrates

Marine water invertebrates

Dose descriptor:

EC50

Effect concentration:

0.32 mg/L

Additional information

Freshwater

A study was conducted to determine the short-term toxicity of the test substance, C16 -18 ADBAC (85% active in isopropanol) to aquatic invertebrates, according to ISO 6341 Method. Daphnia magna (2 replicates of 10 animals/dose) were exposed to the test substance at nominal concentrations of 0, 0.006, 0.0095, 0.0153, 0.0244, 0.0391, 0.0625 and 0.1 mg/L for 48 hours under static conditions at 20°C. Animals were observed for immobilisation after 24 and 48 h. Potassium dichlorate was used as the positive control. No analytical determination of the test substance was performed. At each concentration, the dissolved oxygen content, measured at the end of the test, was greater than or equal to 2 mg/L. Immobilization after 48 hours in the control series was 5%. The last control of the sensitivity of daphnia to potassium dichromate was carried out on 6/9/95. The EC50 (24 h) of the reference substance was determined to be 0.94 mg/L (between 0.9 mg/L and 2.4 mg/L which is the acceptable range of ISO 6341 standard). Under the study conditions, the 48 h EC50 of the test substance to Daphnia was determined to be 0.059 mg/L (equivalent to 0.050 mg a.i./L; nominal) (Thiébaud, 1995).

Marinewater

A study was conducted to determine the short-term toxicity of the read across substance, C12-14 ADBAC (60 -100% active) to aquatic invertebrates, according to ISO/CD14669 and PARCOM ring test Protocol, in compliance with GLP. Acartia tonsa were exposed for 48 h at nominal concentrations of 0, 0.05, 0.2, 0.8 and 3.2 mg/L, equivalent to 0, 0.04, 0.16, 0.64 and 2.56 mg a.i./L considering 80% as mean active. Analytical dose verification was not performed. The test was performed on 14 d old organisms under static conditions. The percent lethality was recorded after 24 and 48 h and the LC50-value along with 95% confidence intervals were calculated based from a Logistic regression model using JMP Program. To ensure reproducibility, a single concentration 1 mg/L of reference substance 3,5-dichlorophenol was included in the study, which indicated 55% mortality after 48 h. All validity criteria were fulfilled. Under the study conditions, the 48 h NOEC, LC10, LC50 and LC90 values were considered to be 0.2, 0.37, 0.40 and 0.43 mg/L (equivalent to 0.16, 0.296, 0.32 and 0.34 mg a.i./L), respectively (Haug, 2003). Based on the results of the read across study, similar effect levels can be expected for the test substance.

Based on the available information, the freshwater 48 h EC50 value of the test substance for effects on mobility of Daphnia magna was determined to be 0.05 mg a.i./L (nominal). Further, based on the results of the read across study with C12-14 ADBAC, the marine water 48 h EC50 value of the test substance for acute toxicity in Acartia tonsa is considered to be 0.32 mg a.i. /L (nominal).