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Long-term toxicity to fish

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Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
other: Heteropneustes fossilis
Details on test organisms:
SPECIES #
(NAME): 352 Heteropneustes fossilis (Indian Catfish)
AGE: NR
LIFE STAGE: not reported, unknown
COMMENT: NR
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
40 d
Hardness:
200 mg/L CaCO3
Test temperature:
20 0C
pH:
7.5 to 8.2
Dissolved oxygen:
NR
Salinity:
NR
Nominal and measured concentrations:
TYPE VALUE RANGES STANDARD CONC (ug/L) IONCIC FRACTION
F 2000000 NR TO NR 2000000 ug/L NR
Details on test conditions:
TEST CONDITIONS
STUDY TYPE:
MEDIA: FW (Fresh water)
LOCATION: LAB (Laboratory, indoor)
CONTROL: K ( control)
EXPOSURE TYPE: F ( flow-through)
APPLICATION FREQ.: NR CON
EXPOSURE DUR.: 40 day(s)
STAND DUR. (D): 40 day(s)
TEST CONCENTRATION
CHEM ANAL. METHOD: unmeasured
UNIT OF MEASURE: ug/L micrograms per liter

TYPE VALUE RANGES STANDARD CONC (ug/L) IONCIC FRACTION
F 2000000 NR TO NR 2000000 ug/L NR

WATER QUALITY VALUE RANGE (UNIT)
TEMPERATURE: 20 NR TO NR C
pH: NR 7.5 TO 8.2
HARDNESS: 200 NR TO NR mg/L CaCO3
SALINITY: NR NR TO NR
ALKALINITY: NR NR TO NR mg/L CaCO3
CONDUCTIVITY: NR NR TO NR NR
DISSOLVED OXYGEN: NR NR TO NR mg/l
ORGANIC CARBON (NR): NR NR TO NR NR
Reference substance (positive control):
no
Duration:
40 d
Dose descriptor:
NOEC
Effect conc.:
2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Biochemistry
Duration:
40 d
Dose descriptor:
LOEC
Effect conc.:
2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Biochemistry
Details on results:
Under the conditions of the present test Potassium oxide induced no Biochemistry effect in Heteropneustes fossilis (Indian Catfish) below 2000 mg/l (NOEC).
EFFECT RESULTS
EFFECT: Biochemistry
TREND: NR
RESPONSE SITE:BL
% EFFECT: NR
EFFECT MEASUREMENT: Glucose

ENDPOINT: No-observable-effect-concentration
ENDPOINT ASSIGN.: R
SIGNIFICANCE: ANOSIG
LEVEL: <0.05
BCF Value (T):
BCF Value ():
Validity criteria fulfilled:
not specified
Conclusions:
Under the conditions of the present test Potassium oxide induced no Biochemistry effect in Heteropneustes fossilis (Indian Catfish) below 2000 mg/l (NOEC).
Executive summary:

Under the conditions of the present test Potassium oxide induced no Biochemistry effect in Heteropneustes fossilis (Indian Catfish) below 2000 mg/l (NOEC).

Endpoint:
fish life cycle toxicity
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
QSAR prediction: US EPA accepted QSAR method for chemicals properties assessment.
Qualifier:
according to
Guideline:
other: QSAR
Principles of method if other than guideline:
ECOSAR Program (v1.00)
GLP compliance:
no
Remarks:
not applicable to QSAR models
Analytical monitoring:
not required
Vehicle:
not specified
Test organisms (species):
other: Fish species
Details on test organisms:
no further information
Test type:
other: QSAR model
Water media type:
freshwater
Limit test:
no
Total exposure duration:
30 d
Hardness:
not applicable. QSAR model
Test temperature:
not applicable. QSAR model
pH:
not applicable. QSAR model
Dissolved oxygen:
not applicable. QSAR model
Salinity:
not applicable. QSAR model
Details on test conditions:
-Name of test material (as cited in study report:Potassium oxide
CAS Number: 12136-45-7
SMILES : KOK
CHEM : Potash (potassium oxide)
MOL FOR: O1 K2
MOL WT : 94.20
Values used to Generate ECOSAR Profile

Log Kow: -1.380 (EPISuite Kowwin v1.68 Estimate)
Wat Sol: 1E+006 (mg/L, EPISuite WSKowwin v1.43 Estimate)






Reference substance (positive control):
no
Duration:
30 d
Dose descriptor:
NOEC
Effect conc.:
1 086.545 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Remarks on result:
other: cited as a ChV value
Details on results:
Using the EPIWIN ECOSAR QSAR model, a 30-day NOEC , cited as a ChV (chronic value) for fresh water fish of 1086.545 mg/l was established.
Fish 30-day ChV =1085.545 mg/L (ppm)


Overview of QSARs estimations on long-term aquatic toxicity of Dipotassium oxide/Potassium oxide to fish

 

Method

 

Results

Remarks

Reference

QSAR

estimate

 Fish 30-day ChV =1086.545 mg/L (ppm)

 

Reliable with restrictions,

QSAR estimated data

ECOSAR Program (v1.00)

 

 Using the EPIWIN ECOSAR QSAR model, a 30-day NOEC , cited as a ChV (chronic value) for fresh water fish of 1086.545 mg/l was established.

 

 

Validity criteria fulfilled:
yes
Remarks:
US EPA accepted QSAR method for chemicals properties assessment.
Conclusions:
Using the EPIWIN ECOSAR QSAR model, a 30-day NOEC , cited as a ChV (chronic value) for fresh water fish of 1086.545 mg/l was established.
 




Executive summary:

Using the EPIWIN ECOSAR QSAR model, a 30-day NOEC , cited as a ChV (chronic value) for fresh water fish of 1086.545 mg/l was established.

 

Endpoint:
fish early-life stage toxicity
Type of information:
other: Published data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Principles of method if other than guideline:
- The materials, methods, and quality assurance practices were those of the U.S. EPA with the method being that of fathead minnows, larval survival and growth test method 1000.0. This method is used to estimate the effects of effluents and toxicants on the survival and growth of fathead minnow larvae in a 7-d static-renewal test. In order to evaluate the effect of age on survival and growth, all tests were initiated with side-by-side exposure of 1-, 4-, and 7-d larvae.
- Method according to: U.S. Environmental Protection Agency (1989): Short-term chronic methods for estimating the chronic toxicity of effluents and receiving waters to freshwater organisms, 2nd ed. EPA 600/4-89-001. Cinncinati, OH.
- Both methods are equivalent or similar to OECD 210
GLP compliance:
not specified
Analytical monitoring:
yes
Details on sampling:
Grab samples of initial and final concentrations were taken. The samples were collected in plastic containers, acidified to pH of 2 or less, and stored in glass in the refrigerator for later analysis.
Vehicle:
not specified
Test organisms (species):
Pimephales promelas
Details on test organisms:
The larvae from all tests were from the fathead minnow culture unit at the EPA Newtown Facility.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
7 d
Remarks on exposure duration:
1-, 4-, and 7-d old larvae were exposed in parallel
Hardness:
Culture water nominal hardness: 200 mg/L CaCO3.
Test temperature:
25 +/- 1 °C
pH:
Initial: 8.1 to 8.4, mean 8.2
Final: 7.24 to 7.81, mean 7.5
Dissolved oxygen:
Dilution water was aerated vigorously for about 24 hours. Dissolved oxygen was about 100 % of saturation.
4.4 to 7.2 mg/L
Nominal and measured concentrations:
Nominal concentrations: 2000, 1000, 500, 250 and 125 mg/L
Reference substance (positive control):
not specified
Duration:
7 d
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 1 day old larvae
Duration:
7 d
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 4 day old larvae
Duration:
7 d
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 7 day old larvae
Duration:
7 d
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 1 day old larvae
Duration:
7 d
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 4 day old larvae
Duration:
7 d
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 7 day old larvae
Details on results:
Results are based on two replicates.

- Mean measured concentration of daily final grab samples was 104 % of nominal concentration in the first set and 103 % of nominal concentration in the second set.

Validity criteria fulfilled:
yes
Remarks:
Dissolved oxygen concentration: about 100 %, Temperature: 25 +/- 1 °C, Test item concentration: 103% and 104%, Control survival: 96 % to 99.2%, Solubilising agent: not used
Conclusions:
The study is valid and fulfills the requirements demanded by OECD method 210 for fish early-life-stage toxicity test except for that the test duration is too short with 7 days of exposure. 1-, 4- and 7-day old larvae were exposed in parallel each for a total of 7 days. Thus, effects of 7 day exposure on fish early-life-stages of different age to potassium chloride were determined and LOEC = 1000 mg/L as well as NOECs = 500 mg/L were determined.
Potassium chloride is an inorganic salt which is highly water soluble, does not bioaccumulate and which is not subject to hydrolytical reactions. The salt is dissolved at any environmental relevant pH. Thus, effects of the inorganic salt on fish larvae may be expected to be most critical on a short-term scale and the results of this study should be reliable and meaningful although exposure was shorter than demanded by REACH Guidance and OECD test method 210.
Executive summary:

A fish early-life-stage test was conducted according to U.S.-EPA methods that are equivalent or similar to OECD 210 with the test organism fathead minnow (Pimephales promelas) and gives a 7 d-NOEC = 500 mg/L

Description of key information

Under the conditions of the study of Srivastava,P.N., and A.S. Narain,1985, Potassium oxide induced no Biochemistry effect  in  Heteropneustes fossilis  (Indian Catfish) below 2000 mg/l (NOEC).
Using the EPIWIN ECOSAR QSAR model, a 30-day NOEC, cited as a ChV (chronic value) for fresh water fish of 1086.545 mg/l was established.
The available data for saltwater fishes are limited and to obtaine the value for PNECs for saltwaters is taken account a assesment factor 10 to extrapolate to NOEC following the “Guidance on Information Requirement and Chemical Safety Assessment R.10: Characterisation of dose [concentration]- response for environment”and “Table R.10-5 Assessment factors proposed for deriving PNEC water for saltwater for different data sets”, to account for the possibility that greater taxonomic diversity in the marine environment makes it likely that some marine taxa may be more sensitive than the most sensitive freshwater taxa

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
2 000 mg/L
EC10, LC10 or NOEC for marine water fish:
200 mg/L

Additional information

Under the conditions of thestudy of Srivastava,P.N., and A.S. Narain,1985, Potassium oxide induced no Biochemistry effect in Heteropneustes fossilis (Indian Catfish) below 2000 mg/l (NOEC).

Using the EPIWIN ECOSAR QSAR model, a 30-day NOEC, cited as a ChV (chronic value) for fresh water fish of 1086.545 mg/l was established.

The available data for saltwater fishes are limited and to obtaine the value for PNECs for saltwaters is taken account a assesment factor 10 to extrapolate to NOEC following the “Guidance on Information Requirement and Chemical Safety Assessment R.10: Characterisation of dose [concentration]- response for environment”and “Table R.10-5 Assessment factors proposed for deriving PNEC water for saltwater for different data sets”, to account for the possibility that greater taxonomic diversity in the marine environment makes it likely that some marine taxa may be more sensitive than the most sensitive freshwater taxa