Reaction mass of sodium chloride and potassium chloride and trisodium hexafluoroaluminate

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Remarks:

One GLP-compliant guideline study (OECD 201) in which the concentrations were analytically verified is available for toxicity in algae. (Solvay, 2008b). It was a static test and analytical monitoring has been performed.

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other:

Remarks:

GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Justification for type of information:

The read-across can be performed because trisodium hexafluoroaluminate is component parts of ADS 2-5, and is the only component with possible negative effects on the aquatic environment. In view of this fact, we will detail its effect, based on published studies.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Remarks:

In the following is the data from the study available to determine the short-term toxicity of trisodium hexafluoroaluminate on aquatic algae.

Reference

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

One GLP-compliant guideline study (OECD 201) in which the concentrations were analytically verified is available for toxicity in algae. (Solvay, 2008b). It was a static test and analytical monitoring has been performed

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

available as unpublished report, no restrictions, fully adequate for assessment

Justification for type of information:

The read-across can be performed because trisodium hexafluoroaluminate is component parts of ADS 2-5, and is the only component with possible negative effects on the aquatic environment. In view of this fact, we will detail its effect, based on published studies

Reason / purpose for cross-reference:

read-across source

Remarks:

In the following is the data from the study available to determine the short-term toxicity of trisodium hexafluoroaluminate to aquatic algae.

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material: Cryolite
- Supplier: Solvay Fluor
- Substance type: slightly coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6% and F 53.5%
- Storage condition of test material: room temperature

Analytical monitoring:

yes

Details on sampling:

On day 0 samples were taken in duplicate from all bulk solutions. On day 3 samples were taken from all test solutions. The samples (day 3) were left for one hour to settle down the algae. The test solutions with concentrations of 5, 11 and 25 mg/l were diluted 2, 5 and 10 times respectively with algae medium before analysis

Vehicle:

no

Details on test solutions:

Four days before test initiation a stock solution of 100 mg/l cryolite was prepared in algal medium by dissolving 50.5 mg in 500 ml algal medium. This stock solution was continuously stirred at 20°C.
On the day of test initiation the solution was filtered with filter paper (S&S 595 1/2) to remove undissolved particles.

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

Organism: Selenastrum capricornutum (strain ATCC 22662)
Source: Culture Collection of Algae and Protoza, Ambleside, Cumbria, UK
Culturing: Inhouse in 100-ml erlenmeyer flasks with 50 ml filter sterilised medium. Each week a volume of 0.5-2 ml of this culture was transferred into fresh algal medium. The preculture used for this study was transferred into fresh algal medium 4 days prior to the start of the test. The culture chamber is illuminated 24 hours a day with fluorescent lamps.
Initial cell density: 1.0 x 10E4 cells/ml

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Hardness:

Not measured

Test temperature:

21 - 23 °C

pH:

7.6 - 7.7

Dissolved oxygen:

not measured

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 0, 1.0, 2.2, 5.0, 11 and 25 mg/l
Measured: 0, 1.1, 2.2, 5.1, 11.6 and 25 mg/l

Details on test conditions:

Algae were exposed for three days using 250 ml sterile erlenmeyer flasks containing 100 ml test solution. During the test, the erlenmeyer flasks were placed in a shaking incubator. The shaking speed in the incubator was 90-110 rotations per minute.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

ca. 8.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Key result

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

ca. 3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Details on results:

The 72-h EC50 for biomass integral and growth rate were 3.2 and 8.8 mg/l, respectively. The no observed effect concentration (NOEC), based on biomass integral and growth rate at test termination, was 1.0 mg/l. Based on the certificate of analysis cryolite contains 53.3% fluoride. Based on these results, the difference between the nominal and the mean measured concentrations was <20% and for this reason the endpoints of the test were based on nominal concentrations.

Results with reference substance (positive control):

The results of the test revealed a 72-h EC50 of 0.48 mg/l for biomass and 0.85 mg/l for growth rate.
The results were in agreement with the results of an interlaboratory test. The EC50 for biomass should be in the range of 0.28 to 1.1 mg/l. The EC50 for growth rate should be in the range of 0.174 to 1.6 mg/l

Reported statistics and error estimates:

Linear interpolation, with concentration on a logarithmic scale, was used tot determine the EC50 values for biomass integral and growth rate inhibition. The NOEC was determined with the Williams test.

Conclusions:

Trisodium hexafluoroaluminate is toxic to aquatic life with long lasting effects. But in the composition
ADS 2-5 Trisodium hexafluoroaluminate is present in a proportion below 10%. Therefore ADS 2-5 may be harmful to aquatic life. Under normal conditions of production, storage, transport and use ADS 2-5 does not affect the environment. Requires only a warning to avoid dispersion in water.

Executive summary:

One GLP-compliant guideline study (OECD 201) in which the concentrations were analytically verified is available for toxicity in algae. The 72-h EC50 for biomass integral and growth rate were 3.2 and 8.8 mg/L, respectively, in the freshwater species Pseudokirchneriella subcapitata (tested as: Selenastrum capricornutum). The 72-h NOEC, based on biomass integral and growth rate were both 1.0 mg/L
(Solvay, 2008b). It was a static test and analytical monitoring has been performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

impurity 1

Reference substance name:

Trisodium hexafluoroaluminate

EC Number:

237-410-6

EC Name:

Trisodium hexafluoroaluminate

Cas Number:

13775-53-6

Molecular formula:

AlF6Na3

IUPAC Name:

trisodium hexafluoroalumanetriuide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature

Specific details on test material used for the study:

Name of test material: Cryolite
- Supplier: Solvay Fluor
- Substance type: slightly coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6% and F 53.5%
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

On day 0 samples were taken in duplicate from all bulk solutions. On day 3 samples were taken from all test solutions. The samples (day 3) were left for one hour to settle down the algae. The test solutions with concentrations of 5, 11 and 25 mg/l were diluted 2, 5 and 10 times respectively with algal medium before analysis

Test solutions

Vehicle:

no

Details on test solutions:

Four days before test initiation a stock solution of 100 mg/l cryolite was prepared in algal medium by dissolving 50.5 mg in 500 ml algal medium. This stock solution was continuously stirred at 20°C.
On the day of test initiation the solution was filtered with filter paper (S&S 595 1/2) to remove un dissolved particles.

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

Organism: Selenastrum capricornutum (strain ATCC 22662)
Source: Culture Collection of Algae and Protoza, Ambleside, Cumbria, UK
Culturing: Inhouse in 100-ml erlenmeyer flasks with 50 ml filter sterilised medium. Each week a volume of 0.5-2 ml of this culture was transferred into fresh algal medium. The preculture used for this study was transferred into fresh algal medium 4 days prior to the start of the test. The culture chamber is illuminated 24 hours a day with fluorescent lamps.
Initial cell density: 1.0 x 10E4 cells/ml

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Test conditions

Hardness:

Not measured

Test temperature:

21 - 23 °C

pH:

7.6 - 7.7

Dissolved oxygen:

not measured

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 0, 1.0, 2.2, 5.0, 11 and 25 mg/l
Measured: 0, 1.1, 2.2, 5.1, 11.6 and 25 mg/l

Details on test conditions:

Algae were exposed for three days using 250 ml sterile erlenmeyer flasks containing 100 ml test solution. During the test, the erlenmeyer flasks were placed in a shaking incubator. The shaking speed in the incubator was 90-110 rotations per minute.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

8.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Key result

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Details on results:

The 72-h EC50 for biomass integral and growth rate were 3.2 and 8.8 mg/l, respectively. The no observed effect concentration (NOEC), based on biomass integral and growth rate at test termination, was 1.0 mg/l. Based on the certificate of analysis cryolite contains 53.3% fluoride. Based on these results, the difference between the nominal and the mean measured concentrations was <20% and for this reason the endpoints of the test were based on nominal concentrations.

Results with reference substance (positive control):

The results of the test revealed a 72-h EC50 of 0.48 mg/l for biomass and 0.85 mg/l for growth rate.
The results were in agreement with the results of an interlaboratory test. The EC50 for biomass should be in the range of 0.28 to 1.1 mg/l. The EC50 for growth rate should be in the range of 0.174 to 1.6 mg/l

Reported statistics and error estimates:

Linear interpolation, with concentration on a logarithmic scale, was used tot determine the EC50 values for biomass integral and growth rate inhibition. The NOEC was determined with the Williams test

Applicant's summary and conclusion

Conclusions:

Trisodium hexafluoroaluminate is toxic to aquatic life with long lasting effects. But in the composition
ADS 2-5 Trisodium hexafluoroaluminate is present in a proportion below 10%. Therefore ADS 2-5 may be harmful to aquatic life. Under normal conditions of production, storage, transport and use ADS 2-5 does not affect the environment. Requires only a warning to avoid dispersion in water.

Executive summary:

One GLP-compliant guideline study (OECD 201) in which the concentrations were analytically verified is available for toxicity in algae. The 72-h EC50 for biomass integral and growth rate were 3.2 and 8.8 mg/L, respectively, in the freshwater species Pseudokirchneriella subcapitata (tested as: Selenastrum capricornutum). The 72-h NOEC, based on biomass integral and growth rate were both 1.0 mg/L
(Solvay, 2008b). It was a static test and analytical monitoring has been performed.