Dienstag, 23. Februar 2016

Short-term toxicity to aquatic invertebrates.009 to 010

Short-term toxicity to aquatic invertebrates.009


Administrative data

Study result type:
read-across from supporting substance (structural analogue or surrogate)
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
Lacking data in all areas: not considered reliable.

Data source

Reference
Reference Type:
publication
Title:
Toxicity of selected chemicals to certain animals
Author:
Dowden, B.F. and Bennett H.J.
Year:
1965
Bibliographic source:
Water Pollut. Control Fed. 37(9):1308-1316.

Materials and methods

Principles of method if other than guideline:
Method: other: see freetext, based on Anderson, B.G. et al. The evaluation of aquatic invertebrates as assay organisms for the determination of the toxicity of industrial wastes. Report of the Ohio State University (1948)
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
Identifier:
EC name
Identity:
sodium sulphate
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Analytical monitoring:
no

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Limit test:
no

Results and discussion

Effect concentrations
Duration:
48 h
Endpoint:
EC50
Effect conc.:
2 564 mg/L
Any other information on results incl. tables:
RESULTS: EXPOSED 
- Nominal/measured concentrations: nominal 
- Effect data (Immobilisation): 
24 hours EC50 : 8384 mg/l 
72 hours EC50 : 725 mg/l 
96 hours EC50 : 630 mg/l 
- 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:
Not conducted to GLP , Not conducted to standard guidelines, No analysis or analysis certificate. Concluded unreliable.


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


Short-term toxicity to aquatic invertebrates.010


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:
Test was conducted to standard EPA guidelines with analysis. Lacking GLP and some detail expected of a modern report . Can be considered reliable however.

Iuclid 4 rationale:
Test performed according to standardized EPA guideline for testing of effluents, with determination of test concentrations. Test parameters pH and 
oxygen measured butnot all reported. No information about controls. Replicate test performance.

Data source

Reference
Reference Type:
publication
Title:
Statistical models to predict the toxicity of major ions to Ceriodaphnia dubia, Daphnia magna and Pimephales promelas
Author:
Mount, D.R., Gulley, D.D., Hockett, J.R., Garrison, T.D.,Evans, J.M.
Year:
1997
Bibliographic source:
Environmental Toxicology and Chemistry, Vol. 16, No. 10, pp. 2009-2019

Materials and methods

Principles of method if other than guideline:
Method: other: see freetext, based on EPA/600/4-90/027 (1991) guideline
GLP compliance:
no
Remarks:
Research project on modelling

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:
7757-82-6
Identifier:
EC number
Identity:
231-820-9
Identifier:
EC name
Identity:
sodium sulphate
Details on test material:
Test substances were all of reagent grade or higher supplied by Sigma Aldrich

Sodium Sulphate
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
Test solutions were prepared by dissolving 10,000 mg/l of the individual ion salts in moderately hard reconstituted water.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
All organisms used in testing were obtained from in-house cultures (ENSR, Fort Collins, CO. USA); daphnids were less than 24 h old at test initiation.
Ceriodaphnia dubia were cultured in either moderately hard reconstituted water (MHRW) or 20% mineral water at 25ºC. D. magna were cultured in 
hard reconstituted water 20°C.

Study design

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

Test conditions

Hardness:
moderately hard reconstituted water (MHRW)
Test temperature:
20 ºC
pH:
between pH 7.5 and 9.0
Dissolved oxygen:
Measured DO concentrations were always within an acceptable range (>40% saturation)
Nominal and measured concentrations:
Due to this study being a summary of many different tests and test substances nominal and measured values per test substance was not reported.
Details on test conditions:
All tests were conducted in 30-ml plastic beakers containing 10 ml of test solution and five organisms per chamber. 
Tests were conducted under a 16h : 8h light : dark photoperiod
Reference substance (positive control):
yes
Remarks:
NaCl

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Endpoint:
LC50
Effect conc.:
6 772 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Endpoint:
LC50
Effect conc.:
9 301 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Result suggest Sodium sulphate is not toxic to Daphnia species
Results with reference substance:
LC50 values were calculated for the reference toxicant tests from the first 11 test group. The variance calculated was used in the model to 
compensate for possible variation in the culture.
Reported statistics and error estimates:
STATISTICAL METHODS: logistic multiple regression.
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.

Applicant's summary and conclusion

Conclusions:
Study was carried out according to EPA guidelines and was reported in sufficient detail to be considered reliable with restrictions. It can be concluded that sodium sulphate is not a substance of concern for Daphnia magna.
Executive summary:
Lacking some detail expected of a substance specific report. Not conducted to GLP and certificate of analysis was not included. However this paper can be considered further reliable. Methods were reported clearly, guidelines were followed and analytical support for test substance conformation was carried out.
Validity criteria fulfilled:
yes

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