Short-term toxicity to aquatic invertebrates.001 to 005

Short-term toxicity to aquatic invertebrates.001

Administrative data

Purpose flag:

weight of evidence

Study result type:

experimental result

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report Date:

2005

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other guideline: EPA-600-R-95-136

GLP compliance:

no data

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):

yes

Test material identity

Identifier:

CAS number

Identity:

10049-04-4

Details on test material:

- Name of test material (as cited in study report): Chlorine dioxide
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Smiles notation (if other than submission substance): no data
- InChl (if other than submission substance): no data
- Structural formula attached as image file (if other than submission substance): no data
- Substance type: powder
- Physical state: solid dissolved in deionized water
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: none

Details on properties of test surrogate or analogue material:

No data

Analytical monitoring:

no

Details on sampling:

- Concentrations: 0, 0.156, 0.313, 0.625, 1.25, 2.5, and 5.0 mg/L
- Sampling method: test concentrations were verified at the beginning of the test using HACH DPD Method 10126
- Sample storage conditions before analysis: no data

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution was made from powered product supplied by Ecochlor. Two separate powders were mixed according to directions by dissolving them in deionized water and bringing the volume to one liter to obtain a target concentration of 3000 ppm chlorine dioxide.
- Eluate: deionized water
- Differential loading: 0.5 X dilution series
- Controls: only seawater
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data

Test organisms

Test organisms (species):

other aquatic mollusc: Mytilus edulis

Details on test organisms:

TEST ORGANISM
- Common name: blue mussel
- Strain: no data
- Source: Aquatic Research Organisms, NH
- Age at study initiation (mean and range, SD): < 4 h post fertilization
- Length at study initiation (length definition, mean, range and SD): no data
- Weight at study initiation (mean and range, SD): no data
- Method of breeding: no data
- Feeding during test NO
- Food type: none
- Amount: none
- Frequency: none

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions (same as test or not): no data
- Type and amount of food: no data
- Feeding frequency: no data
- Health during acclimation (any mortality observed): no data

QUARANTINE (wild caught)
- Duration: no data
- Health/mortality: no data

Study design

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

no data

Test conditions

Hardness:

no data

Test temperature:

15+-1°C

pH:

no data

Dissolved oxygen:

no data

Salinity:

30+-2 ppt

Nominal and measured concentrations:

- nominal conc.: 0, 0.156, 0.313, 0.625, 1.25, 2.5, 5.0 mg/L
- measured conc.: -, -, -, -, -, -, 1.5 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 30 mL glass beaker
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 10 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): none
- Renewal rate of test solution (frequency/flow rate): renewal at 48 h
- No. of organisms per vessel: 150-300
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 150-300
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Seawater from Seattle Aquarium ; filtered and UV sterilized
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: no data
- Conductivity: no data
- Culture medium different from test medium: not applicable
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16:8
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 0.5 X dilution
- Justification for using less concentrations than requested by guideline: no data
- Range finding study
- Test concentrations: 0, 0.156, 0.313, 0.625, 1.25, 2.5, 5.0 mg/L
- Results used to determine the conditions for the definitive study: no data

Reference substance (positive control):

yes

Remarks:

Copper chloride

Results and discussion

Effect concentrationsopen allclose all

Effect concentrations 1

Duration:

48 h

Endpoint:

EC50

Effect conc.:

ca. 0.23 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Duration:

48 h

Endpoint:

EC50

Effect conc.:

ca. 0.29 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

morphology

Details on results:

no data

Results with reference substance:

- Results with reference substance valid
- Mortality: EC50(96h) = 10.8 µg/L of Copper chloride

Reported statistics and error estimates:

no data

Any other information on results incl. tables:

Table: Results (mean +- standard deviation) of a larval development 48h acute test using M. edulis.

Chlorine dioxide (mg/L)			Surviving larvae (%)	Normal larvae (%)	Normal surviving larvae (%)
Nominal	Measured
0	-		90.1 ± 7.4	85.3 ± 14.2	81.0 ± 6.0
0.156	-		91.5 ± 8.5	84.8 ± 11.2	77.8 ± 4.3
0.313	-		94.0 ± 5.8	85.6 ± 35.6	80.5 ± 3.5
0.625	-		73.6 ± 6.6	80.4 ± 3.9	59.2 ± 5.5
1.25	-		3.2 ± 6.4	14.3 ± 0.0	0.5 ± 0.1
2.5	-		0	0	0
5	1.5		0	0	0

Applicant's summary and conclusion

Conclusions:

Toxicity of the substance has been tested on M. edulis, in a 48h acute test. The results demonstrated that a EC50(48h) = 0.23 mg/L.

Executive summary:

Toxicity of the substance has been tested on Mytilus edulis, in a 48 h acute test. A control and six different concentrations (0.156, 0.313, 0.625, 1.25, 2.5, and 5.0 mg/L) were tested in 4 replicates, each replicate containing 150 -300 individuals. The results demonstrated a EC50(48h) = 0.23 mg/L of chlorine dioxide.

Validity criteria fulfilled:

no data

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Short-term toxicity to aquatic invertebrates.002

Administrative data

Purpose flag:

weight of evidence

Study result type:

experimental result

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report Date:

2008

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other guideline: EPA-821-R-02-014

GLP compliance:

no

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):

no

Test material identity

Identifier:

CAS number

Identity:

7758-19-2

Details on test material:

- Name of test material (as cited in study report): Sodium chlorite
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Smiles notation (if other than submission substance): no data
- InChl (if other than submission substance): no data
- Structural formula attached as image file (if other than submission substance): no data
- Substance type: solution
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: none

Details on properties of test surrogate or analogue material:

no data

Analytical monitoring:

no

Details on sampling:

no data

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test concentrations for chlorite were prepared volumetrically from a 5000 mg/L stock solution of chlorite, which was prepared by addition of sodium chlorite to deionized water.
- Eluate: deionized water
- Differential loading: 0.5 X dilution series
- Controls: only seawater
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data

Test organisms

Test organisms (species):

Mysidopsis bahia (new name: Americamysis bahia)

Details on test organisms:

TEST ORGANISM
- Common name: Mysid shrimp
- Strain: no data
- Source: Aquatic BioSystems; Fort Collins, CO
- Age at study initiation (mean and range, SD): 7 days post hatch
- Length at study initiation (length definition, mean, range and SD): no data
- Weight at study initiation (mean and range, SD): no data
- Method of breeding: no data
- Feeding during test
- Food type: Artemia nauplii during holding time
- Amount: no data
- Frequency: 2 times per day

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions (same as test or not): no data
- Type and amount of food: no data
- Feeding frequency: no data
- Health during acclimation (any mortality observed): no data

QUARANTINE (wild caught)
- Duration: no data
- Health/mortality: no data

Study design

Test type:

other: static with renewal

Water media type:

saltwater

Limit test:

no

Total exposure duration:

7 d

Post exposure observation period:

no data

Test conditions

Hardness:

no data

Test temperature:

26+-1°C

pH:

no data

Dissolved oxygen:

no data

Salinity:

30+-2 ppt

Nominal and measured concentrations:

- nominal conc.: 0, 0.25, 0.5, 1.0, 2.0, 4.0 mg/L
- measured conc.: -, 0.18, -, 0.75, -, 3.7 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL HDPE cup
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 200 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): no data
- Renewal rate of test solution (frequency/flow rate): Daily solution renewal
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 8
- No. of vessels per control (replicates): 8
- No. of vessels per vehicle control (replicates): 5
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: 40 Fathoms artificial seawater
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data no data
- Alkalinity: no data
- Ca/mg ratio: no data
- Conductivity: no data
- Culture medium different from test medium: no data
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16:8
- Light intensity: no data

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: not applicable
- Range finding study
- Test concentrations: 0, 0.25, 0.5, 1.0, 2.0, 4.0 mg/L
- Results used to determine the conditions for the definitive study: no data

Reference substance (positive control):

yes

Remarks:

Copper chloride

Results and discussion

Effect concentrationsopen allclose all

Effect concentrations 1

Duration:

7 d

Endpoint:

NOEC

Effect conc.:

ca. 0.18 mg/L

Basis for effect:

mortality

Effect concentrations 2

Duration:

7 d

Endpoint:

LOEC

Effect conc.:

ca. 0.36 mg/L

Basis for effect:

mortality

Effect concentrations 3

Duration:

7 d

Endpoint:

EC50

Effect conc.:

ca. 0.26 mg/L

Basis for effect:

mortality

Effect concentrations 4

Duration:

7 d

Endpoint:

NOEC

Effect conc.:

ca. 0.18 mg/L

Basis for effect:

weight

Effect concentrations 5

Duration:

7 d

Endpoint:

LOEC

Effect conc.:

ca. 0.36 mg/L

Basis for effect:

weight

Effect concentrations 6

Duration:

7 d

Endpoint:

EC50

Effect conc.:

ca. 0.28 mg/L

Basis for effect:

weight

Details on results:

no data

Results with reference substance:

- Results with reference substance valid
- Mortality: 246.1 µg/L
- LC50: 227.1 µg/L (growth)
- Other: none

Reported statistics and error estimates:

Statistical analyses were calculated based on the measured value.

Any other information on results incl. tables:

Table: Results (means +- standard deviation) of the 7-d toxicity test using M. bahia.

Chlorine dioxide (mg/L)			Survival (%)	Biomass (mg)
Nominal	Measured
0	-		97.5 ± 7.1	0.34 ± 0.05
0.25	0.18		92.5 ± 10.47.1	0.34 ± 0.04
0.5	-		7.5 ± 14.9	0.02 ± 0.05
1	0.75		0	0
2	-		0	0
4	3.7		0	0

Applicant's summary and conclusion

Conclusions:

Toxicity of the substance has been tested on M. bahia, in a 7d acute test. The results demonstrated a NOEC of 0.18 mg/L of chlorite for mortality and biomass criteria; an EC50(7d) = 0.26 mg/L for mortality, and an EC50(7d) = 0.28 mg/L for biomass criterion.

Executive summary:

Toxicity of the substance has been tested on Mysidopsis bahia, in a 7d acute-renewal test, following US EPA Guideline EPA-821 -R-02-014. A control and five different concentrations (0.01, 0.1, 1, 10, and 100 mg/L) were tested in 8 replicates, each replicate containing 5 individuals. The solution was completely changed every days of the experiment. The results demonstrated a NOEC of 0.18 mg/L of chlorite for mortality and biomass criteria; an EC50(7d) = 0.26 mg/L for mortality, and an EC50(7d) = 0.28 mg/L for biomass criterion.

Validity criteria fulfilled:

no data

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a r

Short-term toxicity to aquatic invertebrates.003

Administrative data

Purpose flag:

key study

Study result type:

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

No standard protocol was used, but the test method was described in enough detail. No chemical analyses on the test concentrations were perfored, only the stock solution was analyzed. From results in chronic tests it can be assumed that the test substance was stable during the test and animals were exposed properly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report Date:

1991

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other guideline: protocol developed for EnviroSystems Study Number 90117-DE.

Principles of method if other than guideline:

It is not known if the protocol used is equal to a standard guideline.

Twenty mysids were randomly and equally distributed among two replicates of each treatment. The test was performed in 19.6 liter glass aquaria that contained 15 liters of test solution (water depth was approximately 20 cm). Test vessels were randomly arranged in a water bath during the 96 h test (a random numbers table was used to select the location of each vessel). The test substance was supplied to the test vessels under flow through conditions by an intermittent flow proportional diluter. The diluter, which was constructed at EnviroSystems, allowed test media to contact only glass or Teflon-coated surfaces. The diluter was calibrated before and after the test. During the test the diluter was activated 812 times, resulting in an average of 6.8 media exchanges per 24 hours in each test vessel.

The number of surviving organisms and the occurrence of sublethal effects (loss of equilibrium, erratic swimming, loss of reflex, excitability, discoloration, or change in behavior) were determined visually and recorded after 24, 48, 72, and 96 hours.

GLP compliance:

yes

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):

no

Test material identityopen allclose all

Test material identity 1

Identifier:

CAS number

Identity:

7775-09-9

Test material identity 2

Identifier:

EC number

Identity:

231-887-4

Test material identity 3

Identifier:

IUPAC name

Identity:

sodium chlorate

Details on test material:

- Purity: >99%
- lot no.: 29-A/PAL A-113.

Analytical monitoring:

yes

Details on sampling:

The concentration of sodium chlorate in test media could not be determined because of naturally occurring interference in the dilution water. The available analytical methods were effective in deionized water used to prepare toxicant stock solutions but not in the dilution water. A subsample of the 600,000 mg/L primary stock solution (prepared in deionized water) was withdrawn from the toxicant reservoir placed into 40 ml VOA vial, and stored in 2-4°C prior to analysis.

Vehicle:

no

Details on test solutions:

- Dilution water: Water used for acclimation of test organisms and for all toxicity testing was unfiltered seawater collected from the Atlantic
Ocean at EnviroSystems in Hampton, New Hampshire. Water, which had a salinity of 11 to 17 ppt (parts per thousand) and a pH of 7.7, was stored in 500-gallon
polyethylene tanks where it was aerated.

- Stock solution: An initial 600,000 mg/L stock solution was prepared by combining 1,200.0 g of test substance and deionized water and adjusting the
volume to approximately 1,800 ml in a 2 liter glass class A volumetric flask. The stock solution was mixed on a magnetic stir plate until the test substance dissolved and the total volume was adjusted to 2.0 L with deionized water. This procedure was repeated twice and all stock solution was transferred to a 6.0 L Erlenmeyer flask. 

Test solutions: Appropriate amounts of the stock solution were added directly to dilution water by a proportional diluter (5.0 ml of test substance was combined with 3,000 ml of water during each diluter cycle) and this diluter toxicant cell solution was mixed by a high shear pump equipped with a Teflon
head.

Test organisms

Test organisms (species):

Mysidopsis bahia (new name: Americamysis bahia)

Details on test organisms:

Juvenile mysids (less than 24 hours old) were identified using an appropriate taxonomic key. They were produced from in-house cultures
at EnviroSystems in Hampton, New Hampshire. Mysids were not treated for disease and they were free of apparent sickness, injuries,and abnormalities at the beginning of the test. Mysids were fed newly hatched Artemia salina nauplii once or twice daily before the test.

Study design

Test type:

flow-through

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

21.4 to 23.0 °C

pH:

7.6 to 7.8

Dissolved oxygen:

7.4 to 8.9 mg/L

Salinity:

16 to 17 parts per thousand

Nominal and measured concentrations:

Mean nominal concentrations: 0 (control), 130, 220, 360, 590, and 1,000 mg/L sodium chlorate.
The 600,000 mg/L (nominal) stock solution had a measured concentration of 650,000 mg/L sodium chlorate.

Details on test conditions:

- Photoperiod: A 16 hour light and 8 hour dark photoperiod was automatically maintained
- Light intensity: cool-white fluorescent lights that provided a light intensity of 10 pEs-1/m2
- Aeration: Aeration was not required to maintain dissolved oxygen concentrations above acceptable levels. 
- Feeding: Mysids were fed newly hatched Artemia salina nauplii once per day during the test.

Reference substance (positive control):

no

Results and discussion

Effect concentrationsopen allclose all

Effect concentrations 1

Duration:

96 h

Endpoint:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Duration:

96 h

Endpoint:

NOEC

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

One hundred percent survival occurred in the control and no sublethal effects were noted during the exposure period. Control mysids had an average wet weight (blotted dry) of 0.0001 g, resulting in a loading rate during the toxicity test of approximaJely 0.0001 g/L.
One animal died in 590 mg/l and 3 died in 100 mg/l, but this was not significant.

Reported statistics and error estimates:

Results of the toxicity test could not be interpreted by standard statistical techniques (Stephan, 1983) because greater than 50% survival occurred at all tested concentrations.

Applicant's summary and conclusion

Conclusions:

The test substance did not give significant effects at the highest test concentration of 1000 mg/l, therefore LC50 is greater than 1000 mg/l.
Sodium chlorate is not toxic to Mysid shrimp.

Executive summary:

The acute toxicity of sodium chlorate to the mysid Mysidopsis bahia, is described in this final report. The test was conducted for Albright and Wilson Americas for 96 hours during February 15 to 19, 1991, at the EnviroSystems Division of Resource Analysts Inc. in Hampton, New Hampshire. It was conducted by Peter Kowalski, Ellen Stanford, Jeanne Magazu, Robert Boeri and Timothy Ward according to the protocol developed for EnviroSystems Study Number 90117-DE. The analytical portion of this study was conducted under the supervision of Gloria Switalski. Sodium chlorate (reported purity >99\ active ingredient) was supplied by the sponsor. The test was performed under flow-through conditions with five concentrations of test substance and a dilution water control at a temperature of 22 ± 1°C. The dilution water was unfiltered natural seawater collected at Hampton, New Hampshire. Nominal concentrations of sodium Chlorate were: 0 mg/L (control), 130, 220, 360, 590, and 1,000 mg/L. Nominal concentrations were used for all calculations. Mysids used in the test were less than 24 hours old at the start of the test. They were produced from in-house cultures at EnviroSystems in Hampton, New Hampshire. After 96 hours of exposure the control organisms had an average wet weight (blotted dry) of 0.0001 g. All animals were in good condition at the beginning of the study. Exposure of mysids to the test substance resulted in a 96 hour LC50 greater than 1,000 mg/L sodium chlorate. The 96 hour no observed effect concentration was 1,000 mg/L sodium chlorate, the highest tested concentration.

Validity criteria fulfilled:

no data

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation).

Short-term toxicity to aquatic invertebrates.003

Administrative data

Purpose flag:

key study

Study result type:

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

No standard protocol was used, but the test method was described in enough detail. No chemical analyses on the test concentrations were perfored, only the stock solution was analyzed. From results in chronic tests it can be assumed that the test substance was stable during the test and animals were exposed properly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report Date:

1991

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other guideline: protocol developed for EnviroSystems Study Number 90117-DE.

Principles of method if other than guideline:

It is not known if the protocol used is equal to a standard guideline.

Twenty mysids were randomly and equally distributed among two replicates of each treatment. The test was performed in 19.6 liter glass aquaria that contained 15 liters of test solution (water depth was approximately 20 cm). Test vessels were randomly arranged in a water bath during the 96 h test (a random numbers table was used to select the location of each vessel). The test substance was supplied to the test vessels under flow through conditions by an intermittent flow proportional diluter. The diluter, which was constructed at EnviroSystems, allowed test media to contact only glass or Teflon-coated surfaces. The diluter was calibrated before and after the test. During the test the diluter was activated 812 times, resulting in an average of 6.8 media exchanges per 24 hours in each test vessel.

The number of surviving organisms and the occurrence of sublethal effects (loss of equilibrium, erratic swimming, loss of reflex, excitability, discoloration, or change in behavior) were determined visually and recorded after 24, 48, 72, and 96 hours.

GLP compliance:

yes

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):

no

Test material identityopen allclose all

Test material identity 1

Identifier:

CAS number

Identity:

7775-09-9

Test material identity 2

Identifier:

EC number

Identity:

231-887-4

Test material identity 3

Identifier:

IUPAC name

Identity:

sodium chlorate

Details on test material:

- Purity: >99%
- lot no.: 29-A/PAL A-113.

Analytical monitoring:

yes

Details on sampling:

The concentration of sodium chlorate in test media could not be determined because of naturally occurring interference in the dilution water. The available analytical methods were effective in deionized water used to prepare toxicant stock solutions but not in the dilution water. A subsample of the 600,000 mg/L primary stock solution (prepared in deionized water) was withdrawn from the toxicant reservoir placed into 40 ml VOA vial, and stored in 2-4°C prior to analysis.

Vehicle:

no

Details on test solutions:

- Dilution water: Water used for acclimation of test organisms and for all toxicity testing was unfiltered seawater collected from the Atlantic
Ocean at EnviroSystems in Hampton, New Hampshire. Water, which had a salinity of 11 to 17 ppt (parts per thousand) and a pH of 7.7, was stored in 500-gallon
polyethylene tanks where it was aerated.

- Stock solution: An initial 600,000 mg/L stock solution was prepared by combining 1,200.0 g of test substance and deionized water and adjusting the
volume to approximately 1,800 ml in a 2 liter glass class A volumetric flask. The stock solution was mixed on a magnetic stir plate until the test substance dissolved and the total volume was adjusted to 2.0 L with deionized water. This procedure was repeated twice and all stock solution was transferred to a 6.0 L Erlenmeyer flask. 

Test solutions: Appropriate amounts of the stock solution were added directly to dilution water by a proportional diluter (5.0 ml of test substance was combined with 3,000 ml of water during each diluter cycle) and this diluter toxicant cell solution was mixed by a high shear pump equipped with a Teflon
head.

Test organisms

Test organisms (species):

Mysidopsis bahia (new name: Americamysis bahia)

Details on test organisms:

Juvenile mysids (less than 24 hours old) were identified using an appropriate taxonomic key. They were produced from in-house cultures
at EnviroSystems in Hampton, New Hampshire. Mysids were not treated for disease and they were free of apparent sickness, injuries,and abnormalities at the beginning of the test. Mysids were fed newly hatched Artemia salina nauplii once or twice daily before the test.

Study design

Test type:

flow-through

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

21.4 to 23.0 °C

pH:

7.6 to 7.8

Dissolved oxygen:

7.4 to 8.9 mg/L

Salinity:

16 to 17 parts per thousand

Nominal and measured concentrations:

Mean nominal concentrations: 0 (control), 130, 220, 360, 590, and 1,000 mg/L sodium chlorate.
The 600,000 mg/L (nominal) stock solution had a measured concentration of 650,000 mg/L sodium chlorate.

Details on test conditions:

- Photoperiod: A 16 hour light and 8 hour dark photoperiod was automatically maintained
- Light intensity: cool-white fluorescent lights that provided a light intensity of 10 pEs-1/m2
- Aeration: Aeration was not required to maintain dissolved oxygen concentrations above acceptable levels. 
- Feeding: Mysids were fed newly hatched Artemia salina nauplii once per day during the test.

Reference substance (positive control):

no

Results and discussion

Effect concentrationsopen allclose all

Effect concentrations 1

Duration:

96 h

Endpoint:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Duration:

96 h

Endpoint:

NOEC

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

One hundred percent survival occurred in the control and no sublethal effects were noted during the exposure period. Control mysids had an average wet weight (blotted dry) of 0.0001 g, resulting in a loading rate during the toxicity test of approximaJely 0.0001 g/L.
One animal died in 590 mg/l and 3 died in 100 mg/l, but this was not significant.

Reported statistics and error estimates:

Results of the toxicity test could not be interpreted by standard statistical techniques (Stephan, 1983) because greater than 50% survival occurred at all tested concentrations.

Applicant's summary and conclusion

Conclusions:

The test substance did not give significant effects at the highest test concentration of 1000 mg/l, therefore LC50 is greater than 1000 mg/l.
Sodium chlorate is not toxic to Mysid shrimp.

Executive summary:

The acute toxicity of sodium chlorate to the mysid Mysidopsis bahia, is described in this final report. The test was conducted for Albright and Wilson Americas for 96 hours during February 15 to 19, 1991, at the EnviroSystems Division of Resource Analysts Inc. in Hampton, New Hampshire. It was conducted by Peter Kowalski, Ellen Stanford, Jeanne Magazu, Robert Boeri and Timothy Ward according to the protocol developed for EnviroSystems Study Number 90117-DE. The analytical portion of this study was conducted under the supervision of Gloria Switalski. Sodium chlorate (reported purity >99\ active ingredient) was supplied by the sponsor. The test was performed under flow-through conditions with five concentrations of test substance and a dilution water control at a temperature of 22 ± 1°C. The dilution water was unfiltered natural seawater collected at Hampton, New Hampshire. Nominal concentrations of sodium Chlorate were: 0 mg/L (control), 130, 220, 360, 590, and 1,000 mg/L. Nominal concentrations were used for all calculations. Mysids used in the test were less than 24 hours old at the start of the test. They were produced from in-house cultures at EnviroSystems in Hampton, New Hampshire. After 96 hours of exposure the control organisms had an average wet weight (blotted dry) of 0.0001 g. All animals were in good condition at the beginning of the study. Exposure of mysids to the test substance resulted in a 96 hour LC50 greater than 1,000 mg/L sodium chlorate. The 96 hour no observed effect concentration was 1,000 mg/L sodium chlorate, the highest tested concentration.

Validity criteria fulfilled:

no data

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation).

Short-term toxicity to aquatic invertebrates.004

Administrative data

Purpose flag:

weight of evidence

Study result type:

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

Study period:

1994-03-28 until 1994-04-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

Guideline study performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report Date:

1994

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other guideline: US-EPA-FIFRA 40 CFR series 72-3

Deviations:

no data

Principles of method if other than guideline:

Six days prior to test start, the periphery of the shell margin of each oyster was ground (approximately 1-2 mm) with a fine grit grinder in order to establish a baseline for new shell growth. To begin the test, any new shell growth was removed to the baseline and 20 oysters were indiscriminately distributed to each of the test and control vessels. There was one test vessel for each test concentration, loaded so that 0.5 liters of test solution was delivered per hour per oyster.
The definitive test was conducted under flow-through conditions in a continuous flow diluter system.
Test organisms were observed daily for mortality and any physical or behavioral changes. Mortality was defined as the inability to close the shell on gentle prodding. A definitive determination of mortality was made at test termination, when oysters were removed from the test system. New shell growth, the effect criterion, was measured with vernier calipers at test termination. New shell growth was defined as the length of the longest finger of growth on the peripheral shell margin.

GLP compliance:

yes

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):

no

Test material identityopen allclose all

Test material identity 1

Identifier:

CAS number

Identity:

7758-19-2

Test material identity 2

Identifier:

EC number

Identity:

231-836-6

Details on test material:

- Analytical purity: 79.0% specified by the sponsor. No Certificate of Analysis is attached to the report.
- Lot/batch No.: 5064

Analytical monitoring:

yes

Details on sampling:

Samples were collected from the control and each test concentration on day 0 and day 4 for chemical analysis. Test solutions were sampled from the approximate center of the test vessel using a serological pipette, and transported in scintillation vials to analytical services for analyses.

Vehicle:

no

Test organisms

Test organisms (species):

other aquatic mollusc: Crassostrea virginica

Details on test organisms:

TEST ORGANISM
- Common name: Eastern oyster
- Source: P. Cummins Oyster Company,Pasadena, CA on March 18, 1994
- Method of breeding: No information
- Size: 25-50 mm valve height
- Feeding during test: yes
- Food type: A natural algal diet supplement (Diet A; Coast Oyster Co., Seattle, WA)
- Amount: No information
- Frequency: at least once daily


ACCLIMATION
- Acclimation period: 48 hours
- Acclimation conditions: same as test
- Type and amount of food: A natural algal diet supplement (Diet A; Coast Oyster Co., Seattle, WA)
- Feeding frequency: at least once daily
- Health during acclimation: no mortality observed

Study design

Test type:

flow-through

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

22.4-24.0 °C

pH:

7.7-8.1

Dissolved oxygen:

7.0-7.6 mg O2/l

Salinity:

28 ± 1‰

Nominal and measured concentrations:

Nominal concentrations: 0, 12.5, 25.0, 50.0, 100 and 200 mg/l
Mean measured concentrations: 0,14.29, 27.13, 54.12, 101.1 and 210.5 mg/l
These concentrations are used for calculation of the EC50.

Details on test conditions:

Test vessel: 16.3 l rectangular glass chambers
- Type: open
- Aeration: No information
- Type of flow-through: proportional diluter system 
- Renewal rate of test solution (frequency/flow rate): 0.5 liters of test solution per hour per oyster
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Sand filtered Atlantic Ocean water was obtained from Laboratory, Marineland, FL and was diluted to a salinity of approx. 28‰, with well water from a well located at the test site.
The following parameters were measured in undiluted seawater 
- Total organic carbon: 11.5 mg/l
- Particulate matter: 40 mg/l suspended solids
- Alkalinity: 180 mg/l (CaCO3)
- Culture medium different from test medium: no information


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours
- Light intensity: 200 lux on average


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Test organisms were observed daily for mortality and any physical or behavioral changes. Mortality was defined as the inability to close the shell on gentle prodding. A definitive determination of mortality was made at test termination, when oysters were removed from the test system. New shell growth, the effect criterion, was measured with vernier calipers at test termination. New shell growth was defined as the length of the longest finger of growth on the peripheral shell margin.

Reference substance (positive control):

no

Results and discussion

Effect concentrationsopen allclose all

Effect concentrations 1

Duration:

96 h

Endpoint:

EC50

Effect conc.:

21.4 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

other: new shell growth

Remarks (e.g. 95% CL):

14.3 – 27.1 mg/l

Effect concentrations 2

Duration:

96 h

Endpoint:

EC50

Effect conc.:

16 other: mg chlorite/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: New shell growth

Details on results:

In 211 mg/l at 48 h 1 oyster died, at 72 h 7 oysters died and at 96 h again 7 died

Results with reference substance:

not applicable

Reported statistics and error estimates:

Statistical analyses of the new shell growth data were performed using the mean measured concentrations of the test substance. A 96-hour EC50-value and its 95% confidence limits, using a statistical computer program (Stephan, 1982) using the following statistical method: moving average angle, Probit, and non-linear interpolation. Prior to statistical analysis, new shell growth data for each treatment were converted to a percentage reduction of new shell growth as compared control new shell growth. To determine a NOEC, statistical significance (p ≤ 0.05) between the control and treatment new shell growth data was evaluated using Steel's Many-One Rank test.

Any other information on results incl. tables:

No other informations

Applicant's summary and conclusion

Conclusions:

The 96-hour EC50 for sodium chlorite for the eastern oyster (Crassostrea virqinica), based on new shell growth was determined to be 21.4 mg/L (equivalent to 16.0 mg chlorite/L) with 95% confidence limits of 14.3 and 27.1 mg/L. The NOEC of sodium chlorite was determined to be 14.3 mg/L (equivalent to 10.7 mg chlorite/L).

Executive summary:

Data Requirement: Section 72-3 of the EPA Pesticide Assessment Guidelines, Subdivision E

Test Organism and Source: Eastern Oyster (Crassostrea virainica) , 25 to 50 mm valve height, obtained m P. Cummings Oyster Company

Test substance: Sodium Chlorite, Batch No. 5064, CAS NO. 7758-19-2, purity 79.0%

Test Conditions: Dilution water: filtered sea water adjusted to approximately 28‰ salinity with well water from a well located at test site; photoperiod 16 -h light and 8-b dark with 30-minute dawn/dusk transition; temperature 23 ± 2 °C

Test results: 96hr EC50: 21.4 mg/L Sodium Chlorite (equivalent to 16.0 mg chlorite/L); 95% confidence limits: 14.3 and 27.1 mg/L; NOEC: 14.3 mg/L (equivalent to 10.7 mg chlorite/L).

Validity criteria fulfilled:

yes

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registr

Short-term toxicity to aquatic invertebrates.005

Administrative data

Purpose flag:

weight of evidence

Study result type:

experimental result

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

2006

Materials and methods

Principles of method if other than guideline:

A number of studies performed using sodium chlorite of purity ≥79 % have been reviewed by the US EPA in order to establish their acceptability for use in the reregistration eligibility decision (RED) for chlorine dioxide and sodium chlorite. The results from those studies considered acceptable by EPA are summarised.

GLP compliance:

no data

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):

no

Test material identityopen allclose all

Test material identity 1

Test material identity 2

Test material identity 3

Details on test material:

Purity: 79 % or 80 %

Test organisms

Test organisms (species):

Daphnia magna

Study design

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Duration:

48 h

Endpoint:

EC50

Effect conc.:

ca. 0.064 mg/L

Details on results:

EC50 = 0.39 mg/L (0.31 mg/L corrected for purity); Hoberg and Surprenant, 1984
EC50 = 0.29 mg/L (0.23 mg/L corrected for purity); Vilkas, 1976
EC50 = 0.08 mg/L (0.064 mg/L corrected for purity); Larkin, 1984
EC50 = 0.146 mg/L (0.117 mg/L corrected for purity); Nachrord, 1984

Hoberg JR and Surprenant DC (1984) Acute toxicity of AC-66 to Daphnids (Daphnia magna). Unpublished data. Conducted by Springborn Bionomics, Inc. for Calgon Corporation.

Vilkas AG (1976) Acute toxicity of textone to the water flea Daphnia magna Strauss. Unpublished data. Conducted by Aquatic Environmental Sciences for Olin Corporation.

Larkin J (1984) Acute toxicity of sodium chlorite to Daphnia magna Strauss. Unpublished data. Conducted by Biospherics Incorporated for TR America Chemicals, Inc.

Nachrord S (1984) Daphnia LC50 bioassay. Unpublished data. Conducted by Anater Tesconi Circle for Rio Linder Chemical Company, Inc.

Applicant's summary and conclusion

Conclusions:

48-h EC50 = 0.064 - 0.31 mg/L (corrected for purity) (equivalent to 0.048 – 0.23 mg chlorite/L)

These studies all provide EC50 values which are significantly higher than the value of 0.0206 mg/L (equivalent to 0.015 mg /L as chlorite) from the study available to the applicant reported in Doc IIIA Section A7.4.1.2(2).