Dienstag, 23. Februar 2016

Short-term toxicity to aquatic invertebrates.003 to 005

Short-term toxicity to aquatic invertebrates.003


Administrative data

Study result type:
read-across from supporting substance (structural analogue or surrogate)
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
Lacking to much critical information to be considered reliable.

Data source

Reference
Reference Type:
publication
Title:
Tech Info for Problem Spills: Sodium sulfate.
Author:
Environment Canada.
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to
Principles of method if other than guideline:
Method: E07-04
GLP compliance:
no

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):
no
Test material identityopen allclose all
Analytical monitoring:
no

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Limit test:
no

Results and discussion

Effect concentrations
Duration:
96 h
Endpoint:
EC50
Effect conc.:
4 547 mg/L
Any other information on results incl. tables:
RESULTS: EXPOSED 
- Nominal/measured concentrations: nominal 
- Effect data (Immobilisation):  
- Concentration / response curve: not described 
- Cumulative immobilisation: not described 
- Effect concentration vs. test substance solubility: not 
described  
- Other effects: not described

Applicant's summary and conclusion

Conclusions:
Lacking too much critical information
Validity criteria fulfilled:
no



*******************************************************************

Short-term toxicity to aquatic invertebrates.004


Administrative data

Purpose flag:
key study
Study result type:
read-across from supporting substance (structural analogue or surrogate)
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
Study well conducted with standard guidelines and chemical analysis. No GLP no analytical certificates and no raw data.

Data source

Reference
Reference Type:
publication
Title:
Importance of calcium in modifying the acute toxicity of sodium sulphate to hyalella azteca and Daphnia magna.
Author:
Davies, T.D. and Hall, K.J.
Year:
2007
Bibliographic source:
Environmental Toxicology and Chemistry, Vol. 26, No. 6, pp. 1243-1247

Materials and methods

Test guidelineopen allclose all
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
Identifier:
EC name
Identity:
sodium sulphate
Details on test material:
reagent grade or better
Fisher Scientific
Analytical monitoring:
yes
Details on sampling:
No details given
Vehicle:
no
Details on test solutions:
Reformulated deionized water was prepared following the general procedures and ion formulations recommended in US EPA procedures.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: Cantest Ltd. Vancouver, Canada
- Age at study initiation: less than 24h

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
standard hardness: 106 mg CaCO3/l, 
Several hardness levels were tested as well, namely 25, 50, 75 and 100 mg CaCO3/l.
Test temperature:
20 °C
pH:
7.5 - 8.1
Dissolved oxygen:
within 80% saturation
Nominal and measured concentrations:
No details given.
It is not known whether nominal or measured concentrations are use for the results. It is written that measured values would be used when the measured concentration would differ more than 10% from the nominal value, but no details are given in the publication whether or not this was the case.
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 250 ml Pyrex beakers with 200 ml test solution 


EXPOSURE REGIME
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 3
- Feeding regime: No feeding


TEST MEDIUM / WATER PARAMETERS
- Type of water: Reformulated deionized water
- K+: 2.6 mg/l
- Na+: 32.8 mg/l
- Ca2+: 17.4, 27.2 or 37.0 mg/l
- Mg2+: 15.1, 9.2 or 3.2 mg/l
- SO4 2-: 101.5 mg/l
- Cl-: 2.4 mg/l
- HCO3 -: 87.2 mg/l


OTHER TEST CONDITIONS
- Photoperiod: 16h


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, every 24h
Reference substance (positive control):
no data

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Endpoint:
LC50
Effect conc.:
1 766 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 25 mg CaCO3/l, Ca:Mg molar ratio is 0.7
Duration:
48 h
Endpoint:
LC50
Effect conc.:
2 311 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 25 mg CaCO3/l, Ca:Mg molar ratio is 1.8
Duration:
48 h
Endpoint:
LC50
Effect conc.:
2 935 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 25 mg CaCO3/l, Ca:Mg molar ratio is 7.0
Duration:
48 h
Endpoint:
LC50
Effect conc.:
2 293 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 50 mg CaCO3/l
Duration:
48 h
Endpoint:
LC50
Effect conc.:
4 942 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 75 mg CaCO3/l
Duration:
48 h
Endpoint:
LC50
Effect conc.:
4 736 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 100 mg CaCO3/l, Ca:Mg molar ratio is 0.7
Duration:
48 h
Endpoint:
LC50
Effect conc.:
5 631 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 100 mg CaCO3/l, Ca:Mg molar ratio is 1.8
Duration:
48 h
Endpoint:
LC50
Effect conc.:
6 499 mg/L
Nominal / measured:
no data
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks (e.g. 95% CL):
Test medium with 100 mg CaCO3/l, Ca:Mg molar ratio is 7.0
Details on results:
Regression analysis indicated a highly significant relationship between water hardness and sulfate concentration. Toxicity decreased with increasing water hardness. The same is valid for calcium concentrations; toxicity decreased with increasing calcium concentration.
Reported statistics and error estimates:
LC50 values were calculated using the trimmed Spearman-Karber method.
Any other information on results incl. tables:
The results in the publication are given as mg sulfate ion, these values were converted to mg sodium sulfate.
It is not known whether nominal or measured concentrations are use for the results. It is written that measured values would be used when the measured concentration would differ more than 10% from the nominal value, but no details are given in the publication whether or not this was the case.

Applicant's summary and conclusion

Conclusions:
Sodium sulfate is not toxic to D. magna, the lowest LC50 found in a water hardness of 25 mg CaCO3/l and Ca:Mg ration of 0.7 is 1766 mg/l. Under standard test conditions sodium sulfate is even less toxic, LC50 found there is 4736 mg/l. .
The test was found to be valid with restrictions because the study was well conducted with standard guidelines and chemical analysis. No GLP no analytical certificates and no raw data were documented. It is not known whether nominal or measured concentrations were used for the results. Sodium sulfate is stable in water over a period of 48h, therefore it is considered not to have an impact on the outcome and the conclusions of the test.
Executive summary:
The test was performed according to standard EPA methods. Daphnia magna was exposed to sodium sulfate for 48h in test medium with several different water hardness levels, namely 25, 50, 75 and 100 mg CaCO3/l.
For a water hardness of 25 and 100 mg CaCO3/l three different Ca:Mg molar ratios of 0.7, 1.8 and 7.0 were tested as well.
Sodium sulfate is not toxic to D. magna, the lowest LC50 found in water with the lowest hardness and a Ca:Mg ratio of 0.7 is 1766 mg/l. Under standard test conditions of 100 mg CaCO3/l and Ca:Mg ratio of 0.7 the LC50 is 4736 mg/l.




***********************************************************************

Short-term toxicity to aquatic invertebrates.005


Administrative data

Purpose flag:
supporting study
Study result type:
read-across from supporting substance (structural analogue or surrogate)
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
Study well conducted with standard guidelines and chemical analysis. No GLP no analytical certificates and no raw data.

Data source

Reference
Reference Type:
publication
Title:
Comparison of hardness and chloride regulated acute effects of sodium sulfate on two freshwater crustaceans.
Author:
Soucek, D.J.
Year:
2007
Bibliographic source:
Environmental Toxicology and Chemistry, Vol. 26, No. 4, pp. 773–779

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other guideline: American Society for testing and materials E72996
Principles of method if other than guideline:
Tests conducted were to standardised guidelines conducted in a scientifically sound manner.
GLP compliance:
no

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):
no
Test material identityopen allclose all
Details on test material:
99% pure anhydrous sodium sulfate was tested CAS 7757-82-6 obtained from Fisher Scientific.
Analytical monitoring:
yes
Vehicle:
no

Test organisms

Test organisms (species):
Ceriodaphnia dubia

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Results and discussion

Effect concentrationsopen allclose all
Any other information on results incl. tables:
The results in the publication are given as mg sulfate ion, the values above were converted to mg sodium sulfate.
Results reported are concerning the correlation between sodium sulfate toxicity and water hardness and sodium sulfate toxicity and chloride concentration. Actual toxicity results and raw data are not reported. Results are all represented graphically depicting the relationships observed. Data points used for generating these graphs are not reported. These values are therefore estimated from the published graphical representations and are not the exact values generated.
Toxicity ranged from an LC50 of approximately 2000 mg SO4 2-/L for C.dubia at a hardness of 100 mg/L (as CaCO3) to between 3500 - 4000 mg SO4 2 -/L LC50 at a hardness of 500 mg/L (as CaCO3). A strong linear trend was therefore observed of decreased sulfate toxicity with increased hardness.
Chloride had variable effects of sodium sulfate toxicity. Two different linear trends were observed depending on the chloride concentration. from 5 mg/L - 25 mg/L chloride the LC50 ranged from approximately 2000 -2250 mg SO4 2-/L for C. dubia. For chloride concentrations of 100 - 500 mg/L the LC50 decreased from 2250 -1500 mg SO4 2-/L .

Applicant's summary and conclusion

Conclusions:
Provides additional ecotoxicity data for sodium sulfate with varying hardness and chloride concentrations. 
No raw data was presented, No GLP accreditation, Certificate of analysis, or analytical methods were reported. Studies were however carried out under standard conditions with sufficient physical chemical and analytical measurements and can be considered reliable with restrictions.
Executive summary:
No raw data was presented, No GLP accreditation,Certificate of analysis, or analytical methods were reported. Studies were however carried out under standard conditions with sufficient physical chemical and analytical measurements and can be considered reliable with r





Keine Kommentare:

Kommentar veröffentlichen