Montag, 22. Februar 2016

Chlorine Dioxide-Dossier: Sodium Chlorite Short-term toxicity to fish.014

http://www.qsartoolbox.org/de/web/guest/registration-dossier/-/registered-dossier/15450/6/2/2/?documentUUID=7a5d5b47-3312-4adc-a425-7ce70680ef5e

Chlorine Dioxide-Dossier: Sodium Chlorite

Short-term toxicity to fish.014


Administrative data

Purpose flag:
key study
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:
not applicable
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
Identifier:
CAS number
Identity:
7758-19-2
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.
In the analytical report given in the test report 81.41% sodium chlorite was found.
- Lot/batch No.: 5064
- Storage condition of test material: in the dark at ambient temperature
Details on properties of test surrogate or analogue material:
no data
Analytical monitoring:
yes
Details on sampling:
Samples were collected from the B-replicate of the control and each test concentration on day 0 and from the A-replicate of each on 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
Details on test solutions:
no data

Test organisms

Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: Sheepshead minnow
- Source: Aquatox Inc., Hot Springs, Arkansas on February 15, 1994
- Length at study initiation (length definition, mean, range and SD): average 21.8 mm (ranging from 20 to 25)
- Weight at study initiation (mean and range, SD): average 0.19 g (ranging from 0.11 to 0.31 g)
- Feeding during test: No


ACCLIMATION
- Acclimation period: 48 hours
- Acclimation conditions: same as test
- Type and amount of food: Brine shrimp
- Feeding frequency: 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
Post exposure observation period:
no data

Test conditions

Hardness:
no data
Test temperature:
21.8 – 22.7 °C
pH:
8.1 – 8.4
Dissolved oxygen:
7.3 – 8.2 mg O2/l
Salinity:
20 ‰
Nominal and measured concentrations:
Nominal: 0, 13.8, 27.6, 55.3, 111 and 221 mg/l
Mean measured: 0, 13.9, 30.0, 59.5, 112 and 229 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: 10.5 l rectangular glass chambers
- Type (delete if not applicable): open
- Aeration: No
- Type of flow-through: proportional diluter system
- Renewal rate of test solution (frequency/flow rate): A test solution volume of approx. 250 ml was delivered to each test chamber during every cycle. The diluter cycled at a rate of 5.1 cycles per hour providing approx. 6.1 volume additions every 24 hours. Diluter function including stock delivery, stock usage, and cycle time were checked and recorded daily throughout the test.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.38 g/l


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. 20‰, with well water from a well located at the test site. Chemical analyses of 20‰, filtered sea water are performed semi-annually.
- Total organic carbon: 2.3 mg/l
- Particulate matter: 27 mg/l suspended solids
- Alkalinity: 171 mg/l (CaCO3)
- Culture medium different from test medium: no information
- Intervals of water quality measurement: semi-annually


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours
- Light intensity: 616 lux on average


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, observed daily


TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, 10, 100, 500 and 100 mg/l
- Results used to determine the conditions for the definitive study: 80% survival in the control, 100% survival in the lowest test concentration, 60% survival in 100 mg/l and 0% in the two highest concentrations.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Details on results:
- Behavioural abnormalities: At 48 hours 1 fish was lethargic in 59.5 mg/l and 4 fish in 112 mg/l. At 96 hours 2 fish were lethargic in 112 mg/l.
- Mortality of control: No mortalities
Reported statistics and error estimates:
Mortality data for the test organisms and the mean measured concentrations of the test material were used to compute the 24-, 48-, 72- and 96-hour LC50-values and their 95% confidence limits, using a statistical computer program (Stephan, 1982). The method of statistical analysis selected by the program was determined by characteristics of the data. A 96 hour no-observed effect concentration (NOEC) of the test substance was defined as the highest test concentration where no mortality or other toxic signs occurred.
For 48h-LC50 and 96h-LC50 probit analyses was used.

Applicant's summary and conclusion

Conclusions:
The 96-hour LC50 for sodium chlorite in the sheepshead minnow (Cyprinodon variegatus) was determined to be 75.0 mg/L (equivalent to 55.9 mg chlorite/L) with 95% confidence limits of 62.6 and 89.8 mg/L. The 96-hour NOEC of the test substance was estimated to be 13.9 mg/L (equivalent to 10.4 mg chlorite/L).
Executive summary:
Data requirement: section 72 -3 of the EPA Pesticide Assessment Guidelines, Subdivision E
Test substance: Sodium Chlorite, Batch No. 5064 CA RN. 7758 -19 -2, purity 79.0%
Test organism and source: Sheepshead Minnow (Cyprinodon variegatus) , juveniles, obtained from Aquatox Inc., Hot Springs, Arkansas
Test Conditions: Dilution water: filtered sea water adjusted to approximately 20 ‰, salinity with well water from a well located at test. site; photoperiod: 16-h light and 8 -h dark with 3 minute dawn/dusk transition; temperature: 22 ± 2 °C
Test Results: 96 hour LC50: 75.0 mg/L Sodium chlorite (equivalent to 55.9 mg chlorite/L) with 95% confidence limits of 62.6 and 89.8 mg/L. The 96-hour NOEC of the test substance was estimated to be 13.9 mg/L (equivalent to 10.4 mg chlorite/L).
Validity criteria fulfilled:
yes

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