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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
March 21st, 1990 to April 14th, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment it is considered appropriate to read across from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)]


In this study Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1) was subjected to a short term toxicity to fish study according to the OECD 203 protocol.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Arquad 2C-75
- Physical state: Clear yellow liquid
- Analytical purity: 76.4 % activity
- Impurities (identity and concentrations):
- Composition of test material, percentage of components: Activity 76.4%, solids: 75.0%, amine hydrochloride: 0.3%, free amine : 1.1%, colour Gardner: 1-2
- Lot/batch No.: L00963, CoA (Nov 1988)
- Stability under test conditions: Stable
- Storage condition of test material: at room temperature in the dark
- Other:
- Water solubility : Forms stable dispersions
- CRL code : T 90-2-1.10
Analytical monitoring:
no
Details on sampling:
Concentrations: 0.18, 0.23,0.3, 0.4 and 0.51 mg/L
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test substance formed a stable, homogeneous dispersion in water. The stock solution used contained 1 g of the test substance/L of deionized water. The test concentrations were prepared by addition of the respective amounts of stock dispersion to the dilution water (DSW), a synthetic water having a pH of approx 8.2 and a hardness of 13 dH.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Source: Local aquarium retailer (batch 15-03-90)
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 2.9 cm
- Weight at study initiation (mean and range, SD): 0.3 g( wet weight)
- Feeding during test: No

ACCLIMATION
- Acclimation period: atleast 12 d
- Acclimation conditions (same as test or not): Yes
- Feeding frequency: Fed one to three times each day for 6 d a wk
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No post observation period.
Hardness:
13 degrees of hardness
Test temperature:
21.7 to 22.3 °C
pH:
7.4 - 8.1
Dissolved oxygen:
Fresh solutions: 8.8 mgO2/L, decreasing to 6.0 mgO2/L at 96h.
Salinity:
DSW:
100 mg of NaHCO3/L
20 mg of KHCO3/L
200 mg of CaCl2.2H2O/L
180 mg of MgSO4.7H2O/L

The deionized water which was used to prepare the DSW contained less than 10 μg of copper/L and a conductivity of less than 5 μS/cm. The TOC content was less than 2 mg/L
Conductivity:
The deionized water which was used to prepare the DSW contained less than 10 μg of copper/L and a conductivity of less than 5 μS/cm. The TOC content was less than 2 mg/L
Nominal and measured concentrations:
0 (control), 0.18, 0.23, 0.3, 0.4 and 0.51 mg/L Nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: 5 L glass aquaria
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 5 L glass aquaria were filled with 3 L of test solution covered with glass plate
- Aeration: During the test the test media were not aerated
- Biomass loading rate: 0.7 g/L

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 12 hours of ambient light per day, provided by fluorescent tubes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
0.32 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 0.29-0.35 mg/L CL
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
0.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 0.27-0.32 mg/L CL
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
0.26 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 0.24-0.29 mg/L CL
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.26 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 0.24-0.29 mg/L CL
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.23 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
- The highest concentration causing no mortality after 96 h was 0.23 mg/L.
- The lowest concentration causing 100 % mortality already after 72 h was 0.3 mg/L
- At 0.4 and 0.51 mg/L 100 % mortality was observed after 22 h.
- No other effects, such as deviations in the behaviour or appearance of the fish, were observed, except for the fish at the concentrations of 0.3 mg/L after 22 h and at 0.4 and 0.51 mg/L after 6 and 4 h, respectively, which showed a reduced activity.
The results observed in the definitive study are in good agreement with the results observed in the two preliminary tests.
Results with reference substance (positive control):
The LC50 values for the reference substance are: 215 mg/L at 23 h, 183 mg/L after 48 h, 183 mg/L after 72 h and 183 mg/L after 96 h. The results obtained are in accordance with previous test results generated in an EEC report.
Reported statistics and error estimates:
The LC50 was determined using a statistical program of Griffioen (RIZA) based on a model of Kooyman (1981)
Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96 h LC50 and NOEC value of the test material (76.4 % dicocodimethylammonium chloride) were 0.26 mg/L ( 95 % CL.: 0.24 - 0.29 mg/L) and 0.23 mg/L respectively
Executive summary:
A study was conducted to evaluate the acute toxic effects of test material (76.4 % dicocodimethylammonium chloride) to Brachydanio rerio (zebra fish) under semi-static conditions in accordance with EEC method C.1 and OECD guideline 203.

No chemical analyses of the test concentrations were performed during the test and all concentrations mentioned are nominal concentrations of the test material. On the basis of preliminary tests, the following concentrations were used in the definitive test: 0.18, 0.23, 0.3, 0.4 and 0.51 mg/L. Seven fish were used per test concentration and control. The concentration causing 100% mortality was observed within 72 h at 0.3 mg/L. Sub lethal effects were observed in all groups which also showed mortality.

Under the test conditions, the 96 h LC50 and NOEC value of the test material (76.4 % dicocodimethylammonium chloride) were 0.26 mg/L ( 95 % CL.: 0.24 - 0.29 mg/L) and 0.23 mg/L respectively.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
February 27th 1998 to March 6 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted according to OECD guideline 203 in compliance with GLP
Justification for type of information:
Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment it is considered appropriate to read across from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites


Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)]


In this study Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1) was subjected to a short term toxicity to fish study according to the OECD 203 protocol and the PARCOM Protocols on methods for the testing of chemicals used in the off-shore industry, part B: protocol for a fish acute toxicity test.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
other guideline: PARCOM Protocols on methods for the testing of chemicals used in the off-shore industry, part B: protocol for a fish acute toxicity test
Deviations:
yes
Remarks:
Study conducterd in saltwater
Principles of method if other than guideline:
PARCOM Protocols on methods for the testing of chemicals used in the off-shore industry, part B: protocol for a fish acute toxicity test.
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Lilaflot 1590 (project sample code T98003)
- Physical state: Yellowish liquid
- Composition of test material, percentage of components: Dicocodimethyl quaternary ammonium compound chloride 60 %, amines tallowalkyl ethoxylate 18%, propan-2-ol 13 % and water 9 %
- Batch No.: 98-01-22
- Stability under test conditions: assumed to be stable at test and storage conditions
- Storage condition of test material: At room temperature in the dark
- Other:
- Water solubility : Dispersable
Analytical monitoring:
no
Details on sampling:
No sampling performed
Vehicle:
no
Details on test solutions:
The test material was dispersible in water. A stock solution containing approximately 1 g/L of test substance was prepared as follows: to an accurately measured amount of approximately 1 g of test substance 80 mL of deionized water was added. The test substance dispersed well at room temperature when stirring. Thereafter, deionized water was added up to a final volume of 1000 mL. A homogeneous, clear, foaming stock solution was obtained. This was used for the preparation of the test solutions at the start of the test. For the refreshening of the test solutions on Day 2, a fresh stock solution of approximately 1 g/L was prepared as described above.

The test solutions were prepared by addition of the required amounts of stock solution to the dilution water. The following concentrations were tested: 0.05, 0.11, 0.24, 0.53 and 1.17 mg/L. A control containing only dilution water was included in the test.
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: Sheepshead minnow
- Source: Bio international, Roemond, The Netherlands
- Length at study initiation (length definition, mean, range and SD): 2.4 cm
- Weight at study initiation (mean and range, SD): 0.29 g (wet weight of 5 fish).
- Feeding during test: No, 24 h or longer before the test

ACCLIMATION
- Type and amount of food: Dried or deep-frozen fish food
- Feeding frequency: Once a day
- Health during acclimation (any mortality observed):
Test type:
semi-static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
No data
Test temperature:
21.0 to 21.5 degrees C
pH:
7.8- 8.1
Dissolved oxygen:
6.6 - 7.5 mgO2/L
Salinity:
31.2 to 33.4 g/L
Nominal and measured concentrations:
Nominal: 0.05, 0.11, 0.24, 0.53 and 1.17 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 5L aquariums
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 5 L in size and contained 3 L of test solution covered with glass plates
- Renewal rate of test solution (frequency/flow rate): once in 48 h
- No of fishes/dose: 7



OTHER TEST CONDITIONS
- Photoperiod: 16 h of ambient light/d provided by fluorescent tubes


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline:
- Range finding study: No
- Test concentrations: 0.05, 0.11, 0.24, 0.53 and 1.17 mg/L
Reference substance (positive control):
no
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
0.787 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.530- 1.170 mg/L
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
0.787 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.530- 1.170 mg/L
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
0.787 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.530- 1.170 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.787 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.530- 1.170 mg/L
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.53 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
- Dose groups of 1.17 mg/L caused 100 % mortality within 19 h.
- The NOEC was 0.53 mg/L.
- 96h LC50 was 0.787 mg/L.
- Reduced activity was only observed at the concentrations at which mortality occurred. Other sublethal effects such as deviations in the behaviour or the appearance of the fish were not observed.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
The LC50 was calculated with a computer program (Akzo program SKBT, version 1.0) according to SOP L2, using both the trimmed Spearman-Karber method and the binomial test method.
Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96 h NOEC and 19 h LC100 of the test material (containing 60 % dicocodimethyl quaternary ammonium compound chloride, 18 % amines tallow alkyl ethoxylate, 13 % isopropanol and 9 % water 9 %) was determined to be 0.53 mg/L and 1.17 mg/L respectively. The 96 h LC50 of the test material was determined to be 0.787 mg/L ( at 98% CL: 0.470 and 1.170 mg/L).
Executive summary:

A study was conducted to evaluate the acute toxicity of test material (containing dicocodimethyl quaternary ammonium compound chloride 60 %, amines tallow alkyl ethoxylate 18%, isopropanol 13 % and water 9 %) with the salt water fish, Cyprinodon variegates (sheepshead minnow) under semi-static conditions in accordance with OECD guideline 203 and the Parcom protocol on methods of the testing of chemicals used in the offshore oil industry in compliance with GLP.

Test fish were exposed to the test material for 96 h in the concentrations of 0.05, 0.11, 0.24, 0.53 and 1.17 mg/L.

Reduced activity was only observed at the concentrations at which mortality occurred. Other sub lethal effects such as deviations in the behaviour and appearance of the fish were not observed.

Under the test conditions, the 96 h NOEC and 19 h LC100 of the test material (containing 60 % dicocodimethyl quaternary ammonium compound chloride, 18 % amines tallow alkyl ethoxylate, 13 % isopropanol and 9 % water 9 %) was determined to be 0.53 mg/L and 1.17 mg/L respectively. The 96 h LC50 of the test material was determined to be 0.787 mg/L(98% CL: 0.470 and 1.170 mg/L).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
February 27th, 1998 to March 6th, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment it is considered appropriate to read across from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)]


In this study Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1) was subjected to a short term toxicity to fish study according to the OECD 203 protocol and the PARCOM Protocols on methods for the testing of chemicals used in the off-shore industry, part B: protocol for a fish acute toxicity test.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
other guideline: PARCOM Protocols on methods for the testing of chemicals used in the off-shore industry, part B: protocol for a fish acute toxicity test
Deviations:
yes
Remarks:
Study conducted in saltwater
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Arquad 2C-75 (project sample code T98001)
- Physical state: Clear yellow liquid
- Composition of test material, percentage of components: Dicocodimethylammonium chloride (75%)
- Batch No.: 98-01-22
- Stability under test conditions: Assumed to be stable at test and storage conditions
- Storage condition of test material: At room temperature in the dark
- Other:
- Water solubility : Dispersable
Analytical monitoring:
no
Details on sampling:
No sampling performed
Vehicle:
no
Details on test solutions:
The test material was dispersible in water. A stock solution containing approximately 1 g/L of test substance was prepared as follows: to an accurately measured amount of approximately 1 g of test substance 80 mL of deionized water was added. The test substance dispersed well at room temperature when stirring. Thereafter, deionized water was added up to a final volume of 1000 mL. A homogeneous, clear, foaming stock solution was obtained. This was used for the preparation of the test solutions at the start of the test. For the refreshening of the test solutions on Day 2, a fresh stock solution of approximately 1 g/L was prepared as described above.

The test solutions were prepared by addition of the required amounts of stock solution to the dilution water. The following concentrations were tested: 0.21, 0.47, 1.03, 2.27 and 5.00 mg/L. A control containing only dilution water was included in the test.

The test was performed as a semi-static test with the test media replaced after 48 h.
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: Sheepshead minnow
- Source: Bio international, Roemond, The Netherlands
- Length at study initiation (length definition, mean, range and SD): 2.4 cm
- Weight at study initiation (mean and range, SD): 0.29 g (wet weight of 5 fish).
- Feeding during test: No, 24 h or longer before the test

ACCLIMATION
- Type and amount of food: Dried or deep-frozen fish food
- Feeding frequency: Once a day
- Health during acclimation (any mortality observed):
Test type:
semi-static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
No data
Test temperature:
21.5 to 22.5 degrees C
pH:
7.8- 8.0
Dissolved oxygen:
6.5 - 7.5 mgO2/L
Salinity:
31.2 to 33.4 g/L
Nominal and measured concentrations:
Nominal: 0.21, 0.47, 1.03, 2.27, 5.00 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 5L aquariums
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 5 L in size and contained 3 L of test solution covered with glass plates
- Renewal rate of test solution (frequency/flow rate): once in 48 h
- No of fishes/dose: 7



OTHER TEST CONDITIONS
- Photoperiod: 16 h of ambient light/d provided by fluorescent tubes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline:
- Range finding study: No
- Test concentrations: 0.21, 0.47, 1.03, 2.27, 5.00 mg/L
Reference substance (positive control):
no
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
0.696 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.470-1.030 mg/L
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
0.696 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.470-1.030 mg/L
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
0.696 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.470-1.030 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.696 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 98 % CL: 0.470-1.030 mg/L
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.47 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
- Dose groups of 1.03, 2.27 and 5.00 mg/L caused 100 % mortality within 19 h.
- The NOEC was 0.47 mg/L.
- 96h LC50 was 0.696 mg/L.
- Reduced activity was only observed at the concentrations at which mortality occurred. Other sublethal effects, such as deviations in the behaviour or the appearance of the fish, were not observed.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
The LC50 was calculated with a computer program (Akzo program SKBT, version 1.0) according to SOP L2, using both the trimmed Spearman-Karber method and the binomial test method.
Sublethal observations / clinical signs:

Number of surviving animals

Conc (mg/L)

0h

1h

2h

19h

24h

26h

44h

48h

51h

68h

72h

74h

91h

96h

Control

7

7

7

7

7

7

7

7

7

7

7

7

7

7

0.21

7

7

7

7

7

7

7

7

7

7

7

7

7

7

0.47

7

7

7

7

7

7

7

7

7

7

7

7

7

7

1.03

7

7

7

0

-

-

-

-

-

-

-

-

-

-

2.27

7

7

7

0

-

-

-

-

-

-

-

-

-

-

5.00

7

5

0

-

-

-

-

-

-

-

-

-

-

-

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96 h NOEC and 19 h LC100 value of the test material (75 % dicocodimethylammonium chloride) was determined to be 0.47 mg/L and 1.03 mg/L respectively. The 96 h LC50 of the test material was determined to be 0.696 mg/L at 98% confidence limits of 0.470 and 1.030 mg/L.
Executive summary:

A study was conducted to evaluate the acute toxicity of test material (75 % dicocodimethylammonium chloride) with the salt water fish, Cyprinodon variegatus (sheepshead minnow) under semi-static conditions in accordance with OECD guideline 203 and the Parcom protocol on methods of the testing of chemicals used in the offshore oil industry in compliance with GLP.

Test fish were exposed to the test material for 96 h in the concentrations of 0.21, 0.47, 1.03, 2.27 and 5.00 mg/L. Reduced activity was only observed at the concentrations at which mortality occurred. Other sub lethal effects such as deviations in the behaviour and appearance of the fish were not observed.

Under the test conditions, the 96 h NOEC and 19 h LC100 value of the test material (75 % dicocodimethylammonium chloride) was determined to be 0.47 mg/L and 1.03 mg/L respectively. The 96 h LC50 of the test material was determined to be 0.696 mg/L at 98% confidence limits of 0.470 and 1.030 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment it is considered appropriate to read across from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)]


In this study Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1) was subjected to a short term toxicity to fish study according to the OECD 203 protocol.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dodigen 1490
- Substance type: Surfactant
- Physical state: Light yellowish liquid
- Impurities (identity and concentrations): Water and isopropanol
- Lot/batch No.: E 06142685
- Expiration date of the lot/batch: 02-09-1989
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Others:
- Density: 0.89 g/cm3
- pH value at 10 g/L = 4 - 6
- miscible with water
Analytical monitoring:
no
Details on sampling:
Sampling not performed
Vehicle:
no
Details on test solutions:
Stock solution: 20 mg/L
0, 0.05, 0.1, 0.25, 0.5 and 1 mg/L. Dilutions were prepared with tapwater.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Source: Zoo Stumpe Hildesheim
- Length at study initiation (length definition, mean, range and SD): 3.2 cm
- Weight at study initiation (mean and range, SD): 0.42 g
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observation period.
Hardness:
7.6-7.8 mg/L
Test temperature:
23 +/- 2 degrees C
pH:
7.9 - 8.2
Dissolved oxygen:
7.6 - 8.9
Nominal and measured concentrations:
Nominal: 0, 0.05, 0.1, 0.25, 0.5 and 1 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 16 L aquarium
- Material, size, headspace, fill volume: 16 L aquarium
- No. of organisms per vessel: 10 fish/tank
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.66 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 0.57 - 0.77 CL
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.25 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- The % mortality was determined at 24, 48 , 72 and 96 h. The data shows that the mortality rate was the same from 24 to 96 h.
- Death caused by the test substance must occur in the first 24 h.
-The LC50 at 24 h was 0.63 mg/L. At 48, 72 and 96 h the LC50 was 0.66 mg/L
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not reported
Sublethal observations / clinical signs:

Table 1: Mortality rates

Concentration mg/l

% Mortality

24 h

48 h

72 h

96 h

1

100

100

100

100

0.50

10

20

20

20

0.25

0

0

0

0

0.10

10

10

10

10

0.05

0

0

0

0

control

0

0

0

0

Table 2: Estimated LC50 values.

Time (h)

LC50 (mg/L)

P 95%

24

0.63

0.25-1.00

48

0.66

0.57-0.77

72

0.66

0.57-0.77

96

0.66

0.57-0.77

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96 h LC50 of the test material (containing dicocodimethylammonium chloride, isopropanol and water) was 0.66 mg/L. The lowest concentration which caused 100 % mortality was 1.00 mg/L. The lowest concentration without mortalities was 0.25 mg/L.
Executive summary:

A study was conducted to test the acute toxic effects of the test material (containing dicocodimethylammonium chloride, Isopropanol and water) to the fresh water fish, Brachydanio rerio (new name: Danio rerio) under static conditions in accordance with OECD guideline 203 in compliance with GLP.

Test fish were exposed to the test material for 96 h in the concentrations of 0, 0.05, 0.1, 0.25, 0.5 and 1 mg/L.

Under the test conditions, the 96 h LC50 of the test material (containing dicocodimethylammonium chloride, Isopropanol and water) was 0.66 mg/L. The lowest concentration which caused 100 % mortality was 1.00 mg/L. The lowest concentration without mortalities was 0.25 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion.

In the case of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites that anion will be "nitrite" (NO2−) which will associate with other cations in solution. It is therefore prudent to consider read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Four series of 96h bioassays were conducted using rainbow trout. Series 1 (12 tests) and Series II (22 tests) were conducted over the pH range 6.4 - 9.0. The two series were conducted on two different size ranges of fish and in two different years. Series III (six tests) was conducted at pH 7 using three different acids (H2SO4, H3PO4 and HNO3) for pH reduction. Series IV (four tests) was conducted over the pH range 7.5 - 8.6 at chloride concentrations above background.
GLP compliance:
no
Specific details on test material used for the study:
Constituent
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM- Common name: rainbow trout
- Source: Fish Cultural Development Center, US Fish and Wildlife Service, Bozeman, Montana, USA
- Age at study initiation (mean and range, SD): no data
- Length at study initiation: (see tables)
- Weight at study initiation: (see tables)

ACCLIMATION- Acclimation period: fish were acclimated to the test pH by gradually adjusting the dilution water pH over a 24-hour period to the desired value and maintaining that value for 48 hours before addition of sodium nitrite.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
See below under "Details on test conditions".
Test temperature:
See below under "Details on test conditions".
pH:
See below under "Details on test conditions".
Dissolved oxygen:
See below under "Details on test conditions".
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 62 L plastic tanks or 350 L circular glassfibre tanks
- Aeration: no
- Renewal rate of test solution: Approximately 5 hours for 62 L tank and 1.3 hours for 350 L tank.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Ground spring water

CASE A-1 to 12:
- Temperature; 9.0 - 10.7 degree C
- Hardness (mg/L CaC03); 185 - 208
- Alkalinity (mg/L CaC03); (see Table 1)
- Dissolved O2 (mg/L); 7.6 - 9.3
- pH; (see Table 1)

- CASE B-1 to 22:
- Temperature; 8.9 - 14.7 degree C
- Hardness (mg/L CaC03); 178 - 209
- Alkalinity (mg/L CaC03); (see Table 2)
- Dissolved O2 (mg/L); 6.6 - 9.3 - pH; (see Table 2)

CASE C-1 to 6:
- Temperature; 9.4 - 14.0 degree C - Hardness (mg/L CaC03); 192 - 201
- Alkalinity (mg/L CaC03); (see Table 3)
- Dissolved O2 (mg/L); 6.6 - 6.8 - pH; (see Table 3)

CASE D-1 to 4:
- Temperature; 9.9 - 10.7 degree C
- Hardness (mg/L CaC03); 199 - 206
- Alkalinity (mg/L CaC03); (see Table 4)
- Dissolved O2 (mg/L); 7.2 - 9.6 - pH; (see Table 4)

OTHER TEST CONDITIONS

- Photoperiod: no data
- Light intensity:Room light
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.54 - < 26.3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Values were converted from NO2-N into Na-NO2
Details on results:
The lowest 96-h LC50 was 0.11 mg/L NO2-N (equivalent to 0.54 mg/L NaNO2).

The highest 96-h LC50 was 5.35 mg/L NO2-N (equivalent to 26.3 mg/L NaNO2), in the presence of 10 mg/L chloride.
Sublethal observations / clinical signs:

Table 1: Acute toxicity of nitrite at different pH values to rainbow trout (Series I)

Avg fish wt (g)

Mean size length (cm)

Fish per tank

Acid or base

Alkalinity mg/L CaCO3

pH

96h-LC50NO2-N

285

28.1

5

H3PO4

109

6.44

0.21

171

23.2

10

H3PO4

171

7.50

0.20

46.7

15.3

20

H3PO4

174

7.52

0.32

53.1

15.7

20

None

176

7.68

0.27

387

29.7

5

None

159

7.74

0.24

60.5

16.6

20

None

177

7.76

0.27

188

23.6

10

None

172

7.81

0.19

24.3

12.3

20

None

179

8.10

0.28

121

20.5

10

NaOH

176

8.15

0.41

74.8

17.4

10

NaOH

180

8.23

0.38

69.8

17.0

10

NaOH

182

8.24

0.39

341

28.4

5

NaOH

190

9.00

1.67

 

The range of other water chemistry variables (in mg/L) for all tanks at time of tests were: dissolved oxygen 7.6-9.3; NH3-N 0.00-0.11; Cl- 0.00-1.71; Ca2+ 54.9-65.7; hardness (as CaCO3) 185-208. Temperature range for all tanks was 9.0-10.7°C

Table 2: Acute toxicity of nitrite at different pH values to rainbow trout (Series II)

Avg fish wt (g)

Mean size length (cm)

Fish per tank

Acid or base

Alkalinity mg/L CaCO3

pH

96h-LC50 NO2-N

12.8

10.4

10

H2SO4

12

6.99

0.14

15.3

10.2

10

H2SO4

128

7.02

0.11

10.4

10.0

10

H2SO4

135

7.24

0.15

10.0

9.4

10

H2SO4

150

7.37

0.19

9.3

9.2

10

H2SO4

160

7.59

0.18

7.0

9.1

10

None

188

7.83

0.40

12.8

10.3

10

None

173

7.86

0.21

13.2

10.3

10

None

177

7.87

0.22

8.0

8.6

10

None

170

7.88

0.36

10.0

9.3

10

None

172

7.90

0.21

8.2

8.7

10

None

170

7.91

0.30

3.1

6.3

10

None

165

7.94

0.25

10.4

9.2

10

None

174

7.95

0.17

8.4

8.9

10

NaOH

178

8.27

0.54

12.8

10.2

10

NaOH

185

8.41

0.46

15.5

10.9

10

NaOH

188

8.49

0.45

15.3

10.0

10

NaOH

186

8.61

0.50

8.2

8.8

10

NaOH

181

8.70

0.71

9.3

9.4

10

NaOH

188

8.83

1.17

10.5

9.6

10

NaOH

191

8.83

0.61

7.0

8.7

10

NaOH

202

9.03

1.10

8.0

8.8

10

NaOH

190

9.04

1.12

 

The range of other water chemistry variables (in mg/L) for all tanks at time of tests were: dissolved oxygen 6.6-9.3; NH3-N 0.00-0.06; Cl- 0.00-0.47; Ca2+ 46.8-61.3; hardness (as CaCO3) 178-209. Temperature range for all tanks was 8.9-14.7°C

 

Table 3: Acute toxicity of nitrite at pH 7 to rainbow trout using different acids (Series III)

Avg fish wt (g)

Mean size length (cm)

Fish per tank

Acid or base

Alkalinity mg/L CaCO3

pH

96h-LC50 NO2-N

15.3

10.2

10

H2SO4

128

7.02

0.11

12.8

10.4

10

H2SO4

120

6.99

0.14

13.2

10.7

10

H3PO4

152

6.99

0.18

13.7

10.8

10

H3PO4

150

6.98

0.18

13.7

10.6

10

HNO3

137

7.01

0.29

18.2

11.8

10

HNO3

136

7.01

0.26

 

The range of other water chemistry variables (in mg/L) for all tanks at time of tests were: dissolved oxygen 6.6-6.8; NH3-N 0.00-0.06; Cl- 0.10-0.63; Ca2+ 48.9-52.9; hardness (as CaCO3) 192-201. Temperature range for all tanks was 9.4-14.0°C

 

Table 4: Acute toxicity of nitrite at 10 mg/L chloride over different pH values to rainbow trout (Series IV)

Avg fish wt (g)

Mean size length (cm)

Fish per tank

Acid or base

Alkalinity mg/L CaCO3

pH

96h-LC50 NO2-N

28.2

12.9

10

HCl

174

7.50

3.74

79.0

17.6

10

None

177

7.90

3.54

147

22.0

10

NaOH

188

8.47

4.35

244

26.1

10

NaOH

184

8.59

5.34

 

The range of other water chemistry variables (in mg/L) for all tanks at time of tests were: dissolved oxygen 7.2-9.6; NH3-N 0.00-0.06; hardness (as CaCO3) 199-206. Temperature range for all tanks was 9.9-10.7°C

 

Validity criteria fulfilled:
not specified
Conclusions:
A publication from 1981, "Nitrite to Rainbow Trout (Salmo gairdneri): Effects of pH, Nitrite Species, and Anion Species", (Russo, R.C., Thurston, R.V. and Emerson, K. : Can. J. Fish. Aquatic. Sci 38, 387-393, which is also referenced in the OECD Screening Information DataSet (SIDS) for Sodium Nitrite [2006], UNEP publications, reports an LC50 range for sodium nitrite to be 0.54 - 26.3 mg/L.



Executive summary:

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9 was investigated in a publication entitled "Nitrite to Rainbow Trout (Salmo gairdneri): Effects of pH, Nitrite Species, and Anion Species", (Russo, R.C., Thurston, R.V. and Emerson, K. : Can. J. Fish. Aquatic. Sci 38, 387-393, 1981. This study was also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications, No guideline was followed and the study was not conducted to GLP.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion, the counter anion in this case being "nitrite" (NO2−), it is considered prudent to read across from sodium nitrite  (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

The study reported in this publication determined an LC50 (96 h) range for sodium nitrite to be 0.54 - 26.3 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion.

In the case of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites that anion will be "nitrite" (NO2−) which will associate with other cations in solution. It is therefore prudent to consider read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Common eel were exposed over 96 h in a semistatic system
GLP compliance:
no
Specific details on test material used for the study:
Constituent
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
Anguilla anguilla
Details on test organisms:
TEST ORGANISM
- Common name: common eel- Weight at study initiation (mean and range, SD): 21.9 ±5.6 g

ACCLIMATION
- Acclimation period: 2 weeks
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
21.2 degrees C
pH:
8.36
Dissolved oxygen:
8.7 mg/L
Nominal and measured concentrations:
Test concentrations (nominal): 0, 120, 192, 307, 492 and 786 g/m³ NO2-N
Test concentrations (measured): 0, 121, 193, 318, 488 and 823 g/m³ NO2-N
Details on test conditions:
TEST SYSTEM
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: IJmuiden (The Netherlands) tap water
- Na: 69 g/m³- K: 12 g/m³
- Ca: 76 g/m³
- Mg: 15 g/m³
- HCO3: 134 g/m³
- Cl: 117 g/m³- SO4: 106 g/m³
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
708.2 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Value was converted from NO2-N into NaNO2
Validity criteria fulfilled:
not specified
Conclusions:
A publication from 1996, "The Acute Toxicity and Sublethal Effects of Nitrite on Growth and Feed Utilization of European Eel, Anguilla anguilla (L.)." (Kamstra A, Span JA, van Weerd JH : Aquacult. Res. 27, 903-911, which is also referenced in the OECD Screening Information DataSet (SIDS) for Sodium Nitrite [2006], UNEP publications, {http://www.inchem.org/documents/sids/sids/7632000.pdf}) reports an LC50 of 708.2 mg/L.
Executive summary:

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9) was investigated in a publication entitled "The Acute Toxicity and Sublethal Effects of Nitrite on Growth and Feed Utilization of European Eel, Anguilla anguilla (L.).", : (Kamstra A, Span JA, van Weerd JH : Aquacult. Res. 27, 903-911, 1996). This study is also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications. No guideline was followed and the study was not conducted to GLP.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion, the counter anion in this case being "nitrite" (NO2−), it is considered prudent to read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

The study reported in this publication determined an LC50 (96 h) for sodium nitrite to be 708.2 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion.

In the case of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites that anion will be "nitrite" (NO2−) which will associate with other cations in solution. It is therefore prudent to consider read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: According to the frequent seasonal extremes of temperature and salinity of the estuarine and coastal water where flatfishes were captured, two experimental conditions were established: the 'winter condition' (0% salinity and 12°C) and the 'summer condition' (30% salinity and 25°C).
GLP compliance:
no
Specific details on test material used for the study:
Constituent
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
other: Paralichthys orbignyanus
Details on test organisms:
TEST ORGANISM
- Common name: flatfish
- Source: Wild fish captured at the Cassino beach or at the estuary of the Patos Lagoon in Southern Brazil.
- Age at study initiation: juveniles
- Weight at study initiation: 88 ±17 g
- Feeding during test: no food

ACCLIMATION
- Acclimation period: Fish were acclimated in 1000 L tanks to 30% salinity and 20°C for 15 days. Water was continuously aerated
- Acclimation conditions (same as test or not):
- Type and amount of food: fry of mullet Mugil platanus or silverside Odonthestes sp. and small crustaceans like the shrimps Penaeus paulensis and Artemesia longinaris (ad libitum)
- Feeding frequency: daily
Test type:
semi-static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
Winter conditions: 12 °C; Summer conditions: 25 °C
Salinity:
Winter conditions: 0 %; Summer conditions: 30 %
Nominal and measured concentrations:
Test concentration ('winter conditions''; nominal): 0, 15, 20, 25, 30, 40, 60, 90 and 120 mg NO2-N/L.
Test concentration ('summer conditions''; nominal): 0, 10, 20, 25, 30, 40, 50 and 60 mg NO2-N/L
Details on test conditions:
TEST SYSTEM
- Test vessel: - Material, size, headspace, fill volume: 30 L plastic tanks
- Aeration: continuous
- Renewal rate of test solution: 100 % renewal daily
- No. of organisms per vessel: 10

OTHER TEST CONDITIONS
- Photoperiod: 12 h light and 12 h darkness
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
118.3 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Winter conditions. Values were converted from NO2-N into Na-NO2
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
150.7 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Summer conditions. Values were converted from NO2-N into Na-NO2.
Sublethal observations / clinical signs:

LC50 (96 hr) of NO2-N for juveniles of the flatfish Paralichthys orbignyanus in "winter" and "summer" conditions. Data are expressed in mg/L. Data in brackets represent the 95% confidence limits of the LC50.

Time

Experimental conditions

Winter

Summer

24 h

107.86

55.78

(89.3 – 130.4)

(51.8 – 60.0)

48 h

52.98

38.52

(44.5 – 63.1)

(34.9 – 42.5)

72 h

33.69

31.30

(27.8 – 40.8)

(28.0 – 34.9

96 h

24.01

30.57

(21.3 – 27.1)

(27.3 – 34.2)

Validity criteria fulfilled:
not specified
Conclusions:
A publication from 1996, "Toxicity of Nitrogenous Compounds to Juveniles of Flatfish Paralichthys orbignyanus." (Bianchini A, Wasielesky W Jr, Miranda Filho KC : Bull. Environ. Contam.Toxicol. 56, 453-459, which is also referenced in the OECD Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications, {http://www.inchem.org/documents/sids/sids/7632000.pdf}) reports LC50 values of 118.3 mg/L (Winter conditions) and 150.7 mg/L (Summer conditions).
Executive summary:

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9) was investigated in a publication entitled " Toxicity of Nitrogenous Compounds to Juveniles of Flatfish Paralichthys orbignyanus", : (Bianchini A, Wasielesky W Jr, Miranda Filho KC : Bull. Environ. Contam.Toxicol. 56, 453-459, 1996). This study is also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications. No guideline was followed and the study was not conducted to GLP.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion, the counter anion in this case being "nitrite" (NO2−), it is considered prudent to read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

The study reported in this publication determined LC50 values (96 h) for sodium nitrite to be 118.3 mg/L (Winter conditions) and 150.7 mg/L (Summer conditions).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion.

In the case of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites that anion will be "nitrite" (NO2−) which will associate with other cations in solution. It is therefore prudent to consider read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Three different freswater fish species (Ictalurus punctatus, Tilapia aurea, Micropterus salmoides) were exposed over 96 hours in a static test system.
GLP compliance:
no
Specific details on test material used for the study:
Constituent
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
other: Ictalurus punctatus (Channel Catfish), Tilapia aurea (Tilapia), Micropterus salmoides (Largemouth Bass)
Details on test organisms:
TEST ORGANISM
Largemouth Bass:
- Source: National Fish Hatchery and Technology Center, San Marcos, Texas
- Age at study initiation: no data
- Weight at study initiation (mean and range, SD): 2.8 g Channel Catfish:- Source: Texas Parks and Wildlife Department, San Marcos Fish Hatchery
- Age at study initiation: no data
- Weight at study initiation (mean and range, SD): 3.0 ±0.1 gTilapia:- Source: Texas Parks and Wildlife Department, San Marcos Fish Hatchery
- Age at study initiation: no data
- Weight at study initiation (mean and range, SD): 3.0 ±0.1 g

ACCLIMATION
- Acclimation period: min. 4 weeks
- Acclimation conditions (same as test or not): All fish were acclimatized in 252 L fiberglass tanks supplied by well water at a flow rate of seven turnovers per hour.
- Type and amount of food: commercial fish food (40% protein) ad libitum
- Feeding frequency: every 48 hours.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
202.4 4 mg/L as CaCO3
Test temperature:
23 °C
pH:
7.7 (max. 8.2)
Dissolved oxygen:
8.1 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: - Material, size, headspace, fill volume: 30 L glass aquaria.
- Aeration: Constant aeration to maintain dissolved oxygen levels near saturation.
- No. of organisms per vessel: 10 fish per dose (largemouth bass and channel catfish), 5 fish per dose (Tilapia).
- No. of vessels per concentration (replicates): three or more

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ground spring water
- Alkalinity: 165.5 mg/L as CaCO3- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Light intensity: room light
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
35 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Test organism: Channel Catfish; Value was converted from NO2-N into NaNO2
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
79.8 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Test organism: Tilapia; Value was converted from NO2-N into NaNO2
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
691 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Test organism: Largemouth Bass; Value was converted from NO2-N into NaNO2
Sublethal observations / clinical signs:

Stability of the test chemical solutions: Measured nitrite concentrations ranged from 99.7+/-1.1% of nominal to 102.0+/-2.3% of nominal throughout the study.

Method of calculation: Median lethal concentrations were estimated using the method of Thompson (1947)

Analytical methods: Nitrite concentration determined using the method described by EPA (1974).

 

Determination of methemoglobin and plasma nitrite levels: Methemoglobin and plasma nitrite concentrations were determined using five fish per aquarium exposed to nitrite concentrations ranging from 1.5 to 194.9 mg/L. After 24 hours of exposure, fish were weighed, the caudal peduncle was severed, and blood was collected into capillary tubes from the haemal arch. Methemoglobin levels were determined spectrophotometrically (Evelyn & Malloy, 1938) after blood samples were lysed and centrifuged to remove turbidity. Total hemoglobin was determined according to Hainline (1958). Plasma nitrite levels were determined by a modification of the azo dye method (EPA 1974).

 

Analysis of variance followed by a student-Newman-keuls multiple range test was employed to test for difference among species.

Validity criteria fulfilled:
not specified
Conclusions:
The toxicity of nitrite varies considerably among species tested under similar water quality conditions. These differences are related to the the extent to which nitrite is concentrated in the plasma and the associated blood methemoglobin levels. Therefore, channel catfish have a lower resistance to nitrite than tilapia or largemouth bass because nitrite is more concentrated in catfish plasma. among the three species, largemouth bass has the greatest resistance to environmental nitrite as well as the lowest methemoglobin levels due to lower plasma nitrite concentrations. The low plasma nitrite levels may be indicative of a more selective chloride uptake cell located in the gills, resulting in exclusion of nitrite.
Executive summary:

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9) was investigated in a publication entitled "Toxicity of Nitrite to Channel Catfish (Ictalurus punctatus), Tilapia (Tilapia aurea), and Largemouth Bass (Micropterus salmoides)", : ( Palachek & Tomasso : Can. J. Fish. Aquat. Sci. 41, 1739-1744, 1984). This study is also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications. No guideline was followed and the study was not conducted to GLP.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations in the aquatic environment and the counter anion, the counter anion in this case being "nitrite" (NO2−), it is considered prudent to read across from sodium nitrite (CAS Number 7632-00-0, EC Number 231-555-9) in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

The study reported in this publication determined LC50 values (96 h) for sodium nitrite to be 35 mg/L (Channel Catfish; Value was converted from NO2 -N into NaNO2), 79.8 mg/L

(Tilapia; Value was converted from NO2 -N into NaNO2) and 691 mg/L (Largemouth Bass; Value was converted from NO2 -N into NaNO2).

Description of key information

Read across data is presented in order to demonstrate short term aquatic toxicity to fish of quaternary ammonium compounds, di-C12 -18 -alkyldimethyl nitrites.

The read across data is taken from Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 and from sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9. These substances were selected since quaternary ammonium substances are to be expected to dissociate into their quaternary ammonium cations and their counter anions in the aquatic environment.

Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)]

Therefore, it is considered appropriate to read across from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to the structurally analogous quaternary dialkyldimethylammonium nitrites. In addition to this the counter anion is "nitrite" (NO2−) which will associate with other cations in solution. It is therefore prudent to consider read across from sodium nitrite in order to realise a fuller impression of the environmental properties of Quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. (Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)

Therefore, four study endpoints are reported for Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 and four study endpoints are reported for from sodium nitite, CAS Number 7632-00-0, EC Number 231-555-9.

Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1

1.

A study was conducted to evaluate the acute toxicity of test material (containing dicocodimethyl quaternary ammonium compound chloride 60 %, amines tallow alkyl ethoxylate 18%, isopropanol 13 % and water 9 %) with the salt water fish, Cyprinodon variegates (sheepshead minnow) under semi-static conditions in accordance with OECD guideline 203 and the Parcom protocol on methods of the testing of chemicals used in the offshore oil industry in compliance with GLP.

Under the test conditions, the 96 h NOEC and 19 h LC100 of the test material (containing 60 % dicocodimethyl quaternary ammonium compound chloride, 18 % amines tallow alkyl ethoxylate, 13 % isopropanol and 9 % water 9 %) was determined to be 0.53 mg/L and 1.17 mg/L respectively. The 96 h LC50 of the test material was determined to be 0.787 mg/L(98% CL: 0.470 and 1.170 mg/L).

2.

A study was conducted to evaluate the acute toxic effects of test material (76.4 % dicocodimethylammonium chloride) to Brachydanio rerio (zebra fish) under semi-static conditions in accordance with EEC method C.1 and OECD guideline 203.

Under the test conditions, the 96 h LC50 and NOEC value of the test material (76.4 % dicocodimethylammonium chloride) were 0.26 mg/L ( 95 % CL.: 0.24 - 0.29 mg/L) and 0.23 mg/L respectively.

3.

A study was conducted to evaluate the acute toxicity of test material (75 % dicocodimethylammonium chloride) with the salt water fish, Cyprinodon variegatus (sheepshead minnow) under semi-static conditions in accordance with OECD guideline 203 and the Parcom protocol on methods of the testing of chemicals used in the offshore oil industry in compliance with GLP.

Under the test conditions, the 96 h NOEC and 19 h LC100 value of the test material (75 % dicocodimethylammonium chloride) was determined to be 0.47 mg/L and 1.03 mg/L respectively. The 96 h LC50 of the test material was determined to be 0.696 mg/L at 98% confidence limits of 0.470 and 1.030 mg/L.

4.

A study was conducted to test the acute toxic effects of the test material (containing dicocodimethylammonium chloride, Isopropanol and water) to the fresh water fish, Brachydanio rerio(new name: Danio rerio) under static conditions in accordance with OECD guideline 203 in compliance with GLP.

Under the test conditions, the 96 h LC50 of the test material (containing dicocodimethylammonium chloride, Isopropanol and water) was 0.66 mg/L. The lowest concentration which caused 100 % mortality was 1.00 mg/L. The lowest concentration without mortalities was 0.25 mg/L.

Therefore, the lowest NOEC and LC50 values available are :-

NOEC = 0.23 mg/L (freshwater) and LC50 = 0.26 mg/L (freshwater)

NOEC = 0.47 mg/L (seawater) and LC50 = 0.696 mg/L (seawater)

Sodium nitite, CAS Number 7632-00-0, EC Number 231-555-9

1.

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9 was investigated in a publication entitled "Nitrite to Rainbow Trout (Salmo gairdneri): Effects of pH, Nitrite Species, and Anion Species", (Russo, R.C., Thurston, R.V. and Emerson, K. : Can. J. Fish. Aquatic. Sci 38, 387-393, 1981. This study was also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary sorce. No guideline was followed and the study was not conducted to GLP.

The study reported in this publication determined an LC50 (96 h) range for sodium nitrite to be 0.54 - 26.3 mg/L.

2.

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9) was investigated in a publication entitled "The Acute Toxicity and Sublethal Effects of Nitrite on Growth and Feed Utilization of European Eel, Anguilla anguilla (L.).", : (Kamstra A, Span JA, van Weerd JH : Aquacult. Res. 27, 903-911, 1996). This study is also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications. No guideline was followed and the study was not conducted to GLP.

The study reported in this publication determined an LC50 (96 h) for sodium nitrite to be 708.2 mg/L.

3.

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9) was investigated in a publication entitled " Toxicity of Nitrogenous Compounds to Juveniles of Flatfish Paralichthys orbignyanus", : (Bianchini A, Wasielesky W Jr, Miranda Filho KC : Bull. Environ. Contam.Toxicol. 56, 453-459, 1996). This study is also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications. No guideline was followed and the study was not conducted to GLP.

The study reported in this publication determined LC50 values (96 h) for sodium nitrite to be 118.3 mg/L (Winter conditions) and 150.7 mg/L (Summer conditions).

4.

The short-term toxicity to fish of sodium nitite (CAS Number 7632-00-0, EC Number 231-555-9) was investigated in a publication entitled "Toxicity of Nitrite to Channel Catfish (Ictalurus punctatus), Tilapia (Tilapia aurea), and Largemouth Bass (Micropterus salmoides)", : ( Palachek & Tomasso : Can. J. Fish. Aquat. Sci. 41, 1739-1744, 1984). This study is also referenced in the OECD  Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publications. No guideline was followed and the study was not conducted to GLP.

The study reported in this publication determined LC50 values (96 h) for sodium nitrite to be 35 mg/L(Channel Catfish; Value was converted from NO2 -N into NaNO2), 79.8 mg/L

(Tilapia; Value was converted from NO2 -N into NaNO2) and 691 mg/L (Largemouth Bass; Value was converted from NO2 -N into NaNO2).

Therefore, the lowest LC50 values available are :-

0.54 mg/L (freshwater)

118.3 mg/L (saltwater)

The study endpoints reported above for sodium nitrite are all referenced in the Screening Information DataSet (SIDS) for Sodium Nitrite [2006] as a secondary source, UNEP publication. In addition to these fish toxicity studies summarised as follows :

The LC50 values for the acute toxicity of sodium nitrite to fish reported in the literature vary widely between the species tested; LC50 (96h) = 0.54 mg NaNO2/L for Oncorhynchus mykiss; LC50 (96h) = 35 mg NaNO2/L for Ictalurus punctatus; LC50 (96h) = 691.0 mg NaNO2/L for Micropterus salmoides; and LC50 (96h) = 1010.4 mg NaNO2/L for

Anguilla japonica, for example. This difference has been attributed to the ability of certain species, such as eels, bass and sunfish to prevent nitrite from crossing the gill membrane and entering the blood, whilst other species such as rainbow trout concentrate nitrite in their blood. The range of toxicity values reported for some species of fish varies widely and is believed to be dependant on the quality of the water used in the test with pH, chloride and calcium ion oncentration all having an influence. In particular, chloride ion concentration has been shown to be important, with increasing concentrations leading to a decrease in the toxicity of nitrite.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.26 mg/L

Marine water fish

Marine water fish
Effect concentration:
0.696 mg/L

Additional information

In addition to the data summarised for Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1

above an OECD  Screening Information DataSet (SIDS) for Dimethyldioctadecylammonium  chloride, (CAS no.: 107-64-2, EC Number 203 -508 -2) has been published, UNEP publications, 1996.

This report references a number of fish toxicity studies on this substance summarised as follows :-

LC50 4.08 mg/l (Fathead minnow); SIDS Report (p 299); LC50 (48 h) 1.04 mg/l (Bluegill sunfish); SIDS Report (p 300); LC50 (96 h) 6.49 (Fathead minnow; SIDS Report (p 304); LC50s (96 h) 17.6 mg/l, 7.1 mg/l, 113.5 mg/l - substance complexed with LAS (Bluegill sunfish); SIDS Report (p 305 / 306); LC50 0.56 - 3.2 mg/l (Bluegill sunfish); SIDS Report (p 307); LC50 0.29 - 0.558 (Fathead minnow); SIDS Report (p 308); OECD 203, LC50 (96 h) 1.48 mg/l (Zebra fish); SIDS REport (p 327); DIN 38412 Part 15, 1986), LC50 (48 h) 0.1 - 0.37 mg/l (Zebra fish); SIDS Report (p 328); see also EU Risk Assessment report (p 34).

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