Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites

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:

weight of evidence

Study period:

1988

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-alkyldimethyl, chlorides to the 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 didecyldimethylammonium chloride (CAS Number 7173-51-5, EC Number 230-525-2) was subjected to a short term toxicity to aquatic invertebrates study according to OECD Guideline 202 (Daphnia sp. Acute Immoblisation Test) in compliance with GLP protocol.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Composition: ca. 50% Didecyldimethylammonium chloride (CASno.: 7173-51-5) and 20% isopropanol (CAS no.: 67-63-0) in water.

Analytical monitoring:

no

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Test type:

static

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.057 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Calculated

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.029 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

48hr-EC50 = 0.057 mg/l, with 95% confidence limit 0.046-0.071 mg/L.
The highest dose at which 100% immobilisation was observed was 0.32 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria can be considered as fulfilled.

The highest dose at which 100% immobilisation was observed was 0.32 mg/L of the test substance (0.16 mg/L of DDAC). The 48 h EC50 of the test substance based on mobility was determined to be 0.057 mg/L, with 95% confidence limits of 0.046 - 0.071 mg/L. The 48 h EC50 based on DDAC was determined to be 0.029 mg/L.

Executive summary:

The acute toxicity to aquatic invertebrates of the test substance, didecyldimethylammonium chloride (CAS Number 7173-51-5, EC Number 230-525-2) was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immoblisation Test) in compliance with GLP protocol.

The study was assigned a reliability score of 1 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 it is considered appropriate to read across from didecyldimethylammonium chloride to the structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites.

Twenty daphnids per concentration were exposed for 48 h to 0.0032, 0.0056, 0.010, 0.018, 0.032, 0.056, 0.20 or 0.32 mg/L of the test substance (containing 50% DDAC). The test was carried out under static conditions. No chemical analysis of the test media was conducted. The results are therefore expressed as nominal concentrations.

The 48 h EC50 was found to be 0.057 mg/L of test substance with 95% confidence limits of 0.046 - 0.071 mg/L, i.e. 0.029 mg DDAC/L. The highest dose at which 100% immobilisation was observed was 0.32 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

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-alkyldimethyl, chlorides to the 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)]


This publication reports a study entitled "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009 on dimethyldioctadecylammonium chloride (CAS Number 107-64-2, EC Number 203-508-2).

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009

Deviations:

no

Remarks:

This publication is referenced in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride.

GLP compliance:

not specified

Specific details on test material used for the study:

Radiolabelled 14C Distearyldimethylammonium chloride was used.

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

Related to exposure comment: dilution water was river water (White River). The test solution was prepared with either ethanol or isopropanol.

Test organisms (species):

Daphnia magna

Details on test organisms:

No additional detail on test organisms avaialble

Test type:

semi-static

pH:

8.4 - 8.6

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

3.1 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mobility

Remarks on result:

other: Study conducted at a pH of 8.4 - 8.6

Conclusions:

A semistatic aquatic acute toxicity study entitled "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009 on dapnia magna was conducted with 14C radiolabelled Distearyldimethylammonium chloride. The study was conducted at a pH of 8.4 - 8.6. The LC50 (48 h) was found to be 3.1 mg/L.

Executive summary:

The acute toxicity to aquatic invertebrates of the test substance, dimethyldioctadecylammonium chloride (CAS Number 107 -64 -2, EC Number 203 -508 -2), was investigated in a study conducted according "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009. Compliance with GLP is not specified.

This study is reported in a publication by Lewis and Wee; Environmental Toxicology and Chemistry, 2, 105-118, (1983) and is assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al (1997).

This publication is also referenced in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioactadecylammonium chloride.

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 dimethyldioactdecylammonium chloride to the structurally analogous quaternary ammonium compounds, di-C12 -18- alkyldimethyl, nitrites.

The study was conducted at a pH of 8.4 - 8.6 using river water (White River) as the dilution water.

Under the conditions of the study (using 14C radiolabelled distearyldimethylammonium chloride) the 48 h LC50 was found to be 3.1 mg/L.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009

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-alkyldimethyl, chlorides to the 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)]


This publication reports a study entitled "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009 on dimethyldioctadecylammonium chloride (CAS Number 107-64-2, EC Number 203-508-2).

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009

Deviations:

no

Remarks:

This publication is referenced in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride.

GLP compliance:

not specified

Specific details on test material used for the study:

Radiolabelled 14C Distearyldimethylammonium chloride was used.

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

Related to exposure comment: dilution water was reconstituted water. The test solution was prepared with either ethanol or isopropanol.

Test organisms (species):

Daphnia magna

Details on test organisms:

No additional detail on test organisms avaialble

Test type:

semi-static

pH:

6.5 - 7.3

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

0.16 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mobility

Conclusions:

A semistatic aquatic acute toxicity study entitled "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009 on dapnia magna was conducted with 14C radiolabelled Distearyldimethylammonium chloride. The study was conducted at a pH of 6.5 - 7.3. The LC50 (48 h) was found to be 0.16 mg/L.

Executive summary:

The acute toxicity to aquatic invertebrates of the test substance, dimethyldioctadecylammonium chloride (CAS Number 107 -64 -2, EC Number 203 -508 -2), was investigated in a study conducted according "Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians" - Ecological Research Service EPA 660/13-75-009. Compliance with GLP is not specified.

This study is reported in a publication by Lewis and Wee; Environmental Toxicology and Chemistry, 2, 105-118, (1983) and is assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al (1997).

This publication is also referenced in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride.

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 dimethyldioactdecylammonium chloride to the structurally analogous quaternary ammonium compounds, di-C12 -18- alkyldimethyl, nitrites.

The study was conducted at a pH of 6.5 - 7.3 using reconstitued water as the dilution water.

Under the conditions of the study (using 14C radiolabelled distearyldimethylammonium chloride) the 48 h LC50 was found to be 0.16 mg/L.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1993

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:

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-alkyldimethyl, chlorides to the 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)]


This study referenced in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride reports an acute aquatic toxicity laboratory test of dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] complexed with Linear alkyl benzene sulphonate (LAS) 1 : 1.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

no guideline followed

Principles of method if other than guideline:

Acute Aquatic Toxicity Laboratory Tests of Dihydrogenated tallow dimethyl ammonium chloride (DHTDMAC) complexed with Linear alkyl benzene sulphonate (LAS) 1 : 1.

GLP compliance:

not specified

Specific details on test material used for the study:

Dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] complexed with Linear alkyl benzene sulphonate (LAS) 1 : 1.

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Test type:

not specified

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.72 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

not specified

Remarks on result:

other: Similar result (concentration) obtained when the test was repeated for the same molar ratio. EC50 or LC50, for 48 hours = 1.6 mg/L.

Validity criteria fulfilled:

not specified

Conclusions:

The OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride reports an acute aquatic toxicity laboratory test of dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] complexed with Linear alkyl benzene sulphonate (LAS) 1 : 1. The EC50 (48 h) was determined to be 0.72 mg/L.

Executive summary:

The acute toxicity to aquatic invertebrates of the test substance, dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] complexed with Linear alkyl benzene sulphonate (LAS) 1 : 1, was investigated in a study described as "Acute Aquatic Toxicity Laboratory Tests of DHTDMAC complexed with LAS" reported in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride.

This study is 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 it is considered appropriate to read across from dimethyldioactdecylammonium chloride to the structurally analogous quaternary ammonium compounds, di-C12 -18- alkyldimethyl, nitrites.

Under the conditions of the study the EC50 (48 h) was deternied to be 0.72 mg/L.

Reference 5

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Comparison between acute aquatic toxicity laboratory results of dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] in the presence and absence of linerar alkyl benzene sulphonate (LAS).

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-alkyldimethyl, chlorides to the 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)]


This study referenced in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride is a comparison between acute aquatic toxicity laboratory results of dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] in the presence and absence of linerar alkyl benzene sulphonate (LAS).

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

no guideline followed

Principles of method if other than guideline:

Comparison between acute aquatic toxicity laboratory results of DHTDMAC, [technical product of distearyldimethylammonium chloride {DSDMAC}] in the presence and absence of linear alkyl benzene sulphonate (LAS).

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Test type:

not specified

Water media type:

freshwater

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.36 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

not specified

Remarks on result:

other: In the absence of linear alkjyl benzene sulphonate (LAS)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.97 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

not specified

Remarks on result:

other: In the presence on linear alkyl benzene sulphonate (LAS) 1:1.

Details on results:

As shown in several tests in daphnia, the presence of LAS causes a reduction in toxicity. Complexes with anionics are formed, which have less bioavailability than the pure substance.

Validity criteria fulfilled:

not specified

Conclusions:

A study described as a comparison between acute aquatic toxicity laboratory results of dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] in the presence and absence of linerar alkyl benzene sulphonate (LAS) was conducted. In the absence of LAS the EC50 was determined to be 0.36 mg/L. In the presence of LAS the EC50 was determined to be 0.97 mg/L.

Executive summary:

The comparison between the acute aquatic toxicity laboratory results to aquatic invertebrates of dihydrogenated tallow dimethyl ammonium chloride, CAS number 61789-80-8, EC number 263-090-2, (DHTDMAC), [technical product of distearyldimethylammonium chloride {DSDMAC}] in the presence and absence of linerar alkyl benzene sulphonate (LAS) was investigated.

This study is reported in the OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) for dimethyldioctadecylammonium chloride and is 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 it is considered appropriate to read across from dimethyldioactdecylammonium chloride to the structurally analogous quaternary ammonium compounds, di-C12 -18- alkyldimethyl, nitrites.

In the absence of LAS the EC50 was determined to be 0.36 mg/L. In the presence of LAS the EC50 was determined to be 0.97 mg/L.

Reference 6

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

February 11th, 1998 to February 20th, 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 the 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 aquatic invertebrates study according to ISO/CD 14669 and the PARCOM ring test protocol in compliance with GLP protocol.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: ISO/CD 14669 and the PARCOM ring test protocol

Deviations:

yes

Remarks:

pH and O2 measurement frequency slightly altered

Principles of method if other than guideline:

Study conducted according to ISO/CD 14669 and the PARCOM ring test protocol in compliance with GLP

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Arquat 2C-75
- Physical state: Clear yellow liquid
- Lot/batch No.: FP96221
- Storage condition of test material: At room temperature in closed cupboard.
- Other:
- Product full label: Arquad 2C-75,98-01-22 order 335781 batch FP96221

Report states that sponsor provided information on the composition and properties of the test substance, but data not given in report, except for the content of the active ingredient = 75%

Analytical monitoring:

no

Details on sampling:

Sampling not performed

Vehicle:

no

Details on test solutions:

- Dilution water used was natural seawater from the Eastern Scheldt. This water was checked for contaminants (volatile organics, organochlorine compounds and oil) before use.
- The water was also filtered and recirculated over a carbon filter before use. 0.0030 g of the test substance was dissolved directly in 3L of diluted natural seawater. From this 1mg/L stock the test concentrations were prepared.
- The substance was dispersable in water

Test organisms (species):

other aquatic crustacea: Acartia tonsa

Details on test organisms:

- The test animal was the marine crustacean Acartia tonsa cultured in the laboratory under standard conditions.
- The animals used in the test were copepodites (subadults) between 6 and 8 days old.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

No, during the test only.

Hardness:

No data

Test temperature:

The temperature as measured in the control medium was 19.6 ⁰C at the start of the test and 19.4 ⁰C at the end

pH:

8.0-8.2

Dissolved oxygen:

7.3 - 7.7 mgO2/l

Salinity:

(32% diluted to) 29%

Nominal and measured concentrations:

Nominal: 0, 0.056, 0.10, 0.18, 0.32, 0.56, 1.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 small glass vessels
- Type (delete if not applicable): Closed
- No. of organisms per vessel: 1
- Material, size, headspace, fill volume: 10 mL


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Sea water
- Diluted seawater at 29% salinity was used in the control

OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h dark

Reference substance (positive control):

no

Key result

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

0.397 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 0.318 - 0.495 mg/L (95% CL)

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

0.295 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 0.237 - 0.367 mg/L (95% CL)

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Mortality and behaviour

Details on results:

- Mortality and condition have been recorded in the test. Immobile, sluggish or drugged animals were not observed and no mortality in the controls.
- The LC50 and NOEC 48h were 0.295 and 0.10 mg/L respectively.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Maximum likelihood estimates of the LC50 values were calculated assuming a log-logistic dose-effect relationship. Likelihood-ratio confidence intervals were derived from the confidence intervals.

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 24 and 48h LC50 of test material (containing 75% dicocodimethylammonium chloride) to Acartia tonsa in diluted natural seawater were 0.397 and 0.295 mg/L respectively. The 48 h NOEC was determined to be 0.10 mg/L

Executive summary:

The acute toxicity of test material, Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides (containing 75% dicocodimethylammonium chloride) to Acartia tonsa (Copepod: Crustacea) was investigated according to the draft International Standard ISO/CD 14669 and a PARCOM ring-test protocol in compliance with 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 it is considered appropriate to read across from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to the structurally analogous quaternary dialkyldimethylammonium nitrites.

The test was conducted in static conditions without replacement of the test media, with exposure period of 48 h. 10 individual replicate scintillation vials, each containing one Acartia tonsa were used for each control and test concentration. , The nominal concentrations tested in this test were 0.056, 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L.

The results of the tests based on nominal concentrations were 24h LC50 0.397 (0.318-0.495) mg/L, 48h LC50 0.295 (0.237-0.367) mg/L, 48h NOEC (mortality and behaviour) 0.10 mg/L. At the start of the test all test media were clear and colorless (visually assessed). No mortality was observed among the control population following a 48h exposure.

Under the test conditions, the 24 and 48h LC50 of test material (containing 75% dicocodimethylammonium chloride) to Acartia tonsa in diluted natural seawater were 0.397 and 0.295 mg/L respectively. The 48 h NOEC was determined to be 0.10 mg/L.

Reference 7

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1995

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:

according to guideline

Guideline:

other: AHPA 1980

Deviations:

not specified

Principles of method if other than guideline:

Method: APHA, American Water Works Association and Water Pollution Control Federation (1980). Standard Methods for the Examination of Water and Wastewater. 15th edn. APHA, Washington, DC.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): Sodium nitrite

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

other: Cherax quadricarinatus

Details on test organisms:

- Age: Hatchlings- Pretreatment: Feed withheld 24h prior to transfer to treatment tanks- Supplier: redclaw broodstock produced at the Aubum University Agricultural Experiment Station, Auburn Alabama

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

54 mg/L

Test temperature:

28 ±1 °C

pH:

8.3

Dissolved oxygen:

7.4 mg/L

Nominal and measured concentrations:

Test concentrations (nominal): 0, 0.5-3.5 mg/L NO2-N at 0.5 mg/L intervalsStability of the test chemical solutions: Final nitrite concentrations varied less than 7% from the original concentration.

Details on test conditions:

TEST SYSTEM-
Test vessel:
- Material, size, headspace, fill volume: 4 L plastic jars filled with 3L of culture water
- Aeration: gentle to maintain dissolved oxygen levels at saturation
- No. of organisms per vessel: 4
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Feeding: no

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Alkalinity: 20 mg/L-
Renewal of test solution: Static test, but nitrite concentrations adjusted to initial levels if necessary every 24h

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.93 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality

Expressed as sodium nitrite: 

LC50 (96h) = 4.93 mg/L 

LC50 (mg/L NO2-N) values in mg/L for hatchling reclaw crayfish. pH 8.3, temperature 28 degree C 

24-h LC50 = 1.4

48-h LC50 = 1.1

72-h LC50 = 1.1

96-h LC50 = 1.0

Conclusions:

The LC50 of sodium nitrite in a toxicity study to Hatchling Redclaw Crayfish, Cherax quadricarinatus was found to be 4.93 mg/L.

Executive summary:

In a publication entitled "Toxicity of Ammonia and Nitrite to Hatchling Redclaw Crayfish, Cherax quadricarinatus" (Rouse. DB, Kastner. RJ, Reddy. KS, Freshw. Crayfish 10, 298 -303, 1995) the toxicity of sodium nitrite was investigated in a study conducted according to APHA, 1980 as a primary source. GLP compliance is not specified.

This publication is also referenced in :-

The Screening Information DataSet (SIDS) for sodium nitrite as a secondary source

and in the disseminated REACH registration dossier for sodium nitrite.

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

Under the conditions of this study the LC50 of sodium nitrite in a toxicity study to Hatchling Redclaw Crayfish, Cherax quadricarinatus was found to be 4.93 mg/L.

Reference 8

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1991

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: Toxicity tests were conducted according to Hubert (1980) and APHA (1985). Different larvae and post-larvae stages of saltwater crustacea Metapenaeus ensis were exposed to sodium nitrite over 120 h in a semi-static system.

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

other aquatic crustacea: Metapenaeus ensis

Details on test organisms:

- Source: Fertilized eggs released from a single brood were hatched and reared to different stages in the laboratory.
- Method of breeding: The larvae used in the study were third nauplius substage (N3), second zoea substage (Z2), second mysis substage (M2), and first postlarva substage (PL 1).
- Feeding during test: During the experiments, shrimp were fed artificial plankton BP (Nippai Co. Ltd., Tokyo, Japan) for zoea, mysis and postlarvae three times a day. However, nauplius larvae were no fed (American Public Health Associations 1985).

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

120 h

Test temperature:

30 °C

pH:

8.1 - 8.3

Dissolved oxygen:

5.4 - 5.6 mg/L

Salinity:

33 %

Nominal and measured concentrations:

Test concentration (Naplius third substage):
- Nominal: 1, 2, 4, 8, 16, 32, 64 and 96 mg/L
- Measured: 0.92, 1.96, 3.87, 7.62, 14.25, 30.18, 62.44 and 93.56 mg/LTest concentration (Zoea second substage):
- Nominal: 2, 4, 8, 12, 16, 24, 32, 64 and 96 mg/L
- Measured: 1.87, 3.79, 7.76, 11.23, 14.37, 22.67, 31.10, 63.10 and 93.45 mg/LTest concentration (Mysis second substage):
- Nominal: : 2, 4, 8, 16, 24, 32, 64 and 96 mg/L
- Measured: 1.87, 3.79, 7.79, 14.75, 23.42, 30.18, 62.32 and 92.14 mg/LTest concentration (Postlarva first substage)
- Nominal: 2, 4, 8, 16, 24, 32, 64, 96 and 128 mg/L
- Measured: 1.93, 3.84, 7.72, 14.62, 22.79, 30.03, 62.79, 93.77 and 124.65 mg/L

Details on test conditions:

TEST SYSTEM
-Test vessel:
- Material, size, headspace, fill volume: 1 L polyethylene beakers
- Aeration: air stone- Renewal rate of test solution (frequency/flow rate): 100% of the test solution was renewed daily
- No. of organisms per vessel: 15- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: seawater pumped from the KKlung coast adjacent to the National Taiwan Ocean University was filtered through sand and gravel filters and aerated three days before use.
- COD: 1.22 mg/L- Alkalinity: 108 mg/L as CaCO3- Ca/Mg ratio: 1:4
- Ammonia 41 µg/L- Nitrite: 14 µg/L
- Nitrate: 32 µg/L- Phosphate: 19 µg/L- Silica: 0.79 mg/L as SiO2- Ca: 310 mg/L
- Mg: 1,320 mg/L
- Culture medium different from test medium: no

Key result

Duration:

120 h

Dose descriptor:

LC50

Effect conc.:

34.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Stage of development: PL1. Value was converted from NO2-N into NaNO2.

Key result

Duration:

120 h

Dose descriptor:

NOEC

Effect conc.:

3.5 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Stage of development: PL1. Value was converted from NO2-N into NaNO2.

Details on results of NO2-N (95% confidence limits in parentheses):

Nauplius third substage (N3):

LC50 (12h) = 40.36 (21.91-75.90) mg/L

LC50 (24h) = 31.29 (16.16-61.25) mg/L

Zoea second substage (Z2):

LC50 (12h) = 33.66 (25.10-45.53) mg/L

LC50 (24h) = 16.05 (10.77-23.95) mg/L

 

Mysis second substage (M2):

LC50 (12h) = 110.77 (48.17-262.59) mg/L

LC50 (24h) = 47.60 (36.68-57.12) mg/L

LC50 (48h) = 20.67 (16.14-26.61) mg/L

 

Postiarvae first substage (PL 1):

LC50 (12h) = 132.60 (80.33-226.68) mg/L

LC50 (24h) = 70.06 (57.17-85) mg/L

LC50 (48h) = 27.10 (18.16-40.81) mg/L

LC50 (96h) = 9.13 (5.16-16.30) mg/L

LC50 (120h) = 7.06 (4.39-11.47) mg/L

 

A "safe level" for M. ensis larvae was estimated to be 0.71 mg/L nitrite-N in the hatchery.

Conclusions:

The LC50 (120h) of sodium nitrite in a toxicity study to the aquatic crustacea: Metapenaeus ensis was found to be 34.8 mg/L and the NOEC was 3.5 mg/L.

Executive summary:

In a publication entitled "Lethal Effect of Nitrite on Metapenaeus ensis Larvae" (Chen J-C & Nan F-H, J. World Aquacult. Soc. 22, 51-56., 1991) the toxicity of sodium nitrite was investigated in a study conducted according to Hubert (1980) and APHA (1985)APHA, 1980 as a primary source. The study was not conducted according to GLP.

This publication is also referenced in :-

The Screening Information DataSet (SIDS) for sodium nitrite as a secondary source

and in the disseminated REACH registration dossier for sodium nitrite.

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

Under the conditions of this study the LC50 (120h) of sodium nitrite to the aquatic crustacea: Metapenaeus ensis was found to be 34.8 mg/L and the NOEC was 3.5 mg/L.

Description of key information

A number of studies are available on the read across substances Quaternary ammonium compounds, di-C12 -18 -alkyldimethyl chlorides, didecyldimethylammonium chloride, dimethyldioctadecylammonium chloride and sodium nitrite.

As a consequence the following values are presented :-

EC50 (freshwater invertebrates) = 0.029 mg/l

EC50 (marine water invertebrates) = 0.295 mg/l

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.029 mg/L

Marine water invertebrates

Marine water invertebrates

Effect concentration:

0.295 mg/L