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EC number: 231-871-7 | CAS number: 7773-06-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 6 June 2011 and 15 July 2011.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- of Commission Regulation (EC) No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium sulphamate
- IUPAC Name:
- Sodium sulphamate
- Details on test material:
- Sponsor's identification: Sodium sulphamate
CAS No : 13845-18-6
Identifier : TIS I0442
Description : white solid
Purity : 99.67%
Batch number : LE12568
Date received : 6 May 2011
Expiry date : 6 May 2013
Storage conditions: room temperature in the dark over silica gel
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
SIngle concentration of 100 mg/l.
- Sampling method:
Water samples were taken from the control and each replicate test vessel at 0 (fresh media), 24 and 96 hours (old media) for quantitative analysis.
- Sample storage conditions before analysis:
Duplicate samples and samples at 24 (fresh media), 48 and 72 hours (fresh and old media) were taken and stored at approximately -20°C for further analysis if necessary.
The method of analysis, recovery and test preparation analyses are described in Appendix 3: Verification of Test Concentrations (see attached in background material section).
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Range-finding test:
The test concentration to be used in the definitive test was determined by a preliminary range-finding test.
In the range-finding test fish were exposed to a nominal test concentration of 100 mg/l. A single test concentration was used as results from the range-finding test for the Acute Toxicity to Daphnia magna study (Harlan Laboratories Ltd, Project Number: 41101646) indicated that toxicity was not expected at this concentration. The test item was dissolved directly in dechlorinated tap water.
An amount of test item (2000 mg) was dissolved in dechlorinated tap water and the volume adjusted to 500 ml to give a 4000 mg/l stock solution. The entire volume of this stock solution was diluted in a final volume of 20 litres of dechlorinated tap water, and stirred using a flat bladed mixer for approximately 1 minute, to give the 100 mg/l test concentration.
The stock solution was inverted several times to ensure adequate mixing and homogeneity.
In the range-finding test 3 fish were added to each 20 litre test and control vessel and maintained at approximately 20°C in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours under static test conditions.
The control group was maintained under identical conditions but not exposed to the test item.
Each vessel was covered to reduce evaporation. After 3, 6, 24, 48, 72 and 96 hours any mortalities or sub-lethal effects of exposure were determined by visual inspection of the test fish.
A sample of the 100 mg/l test concentration was taken for chemical analysis at 0 and 24 hours in order to determine the stability of the test item under test conditions. All samples were stored at approximately -20°C prior to analysis.
The range-finding test was conducted using common carp (Cyprinus carpio) as the test species. At the request of the Sponsor the species to be used for the definitive test was rainbow trout (Oncorhynchus mykiss). Given that toxicity was not observed in the range-finding test, and in the interests of animal welfare, it was considered unnecessary to repeat the range-finding test.
Definitive test:
Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100 mg/l to confirm that at the maximum concentration given in the OECD/EC Test Guidelines, no mortalities or sub-lethal effects of exposure were observed.
Experimental Preparation
For the purpose of the definitive test the test item was dissolved directly in dechlorinated tap water.
An amount of test item (4000 mg) was dissolved in dechlorinated tap water and the volume adjusted to 1 litre to give a 4000 mg/l stock solution.
An aliquot (500 ml) of this stock solution was diluted in a final volume of 20 litres of dechlorinated tap water, and stirred using a flat bladed mixer for approximately 1 minute, to give the 100 mg/l test concentration. This method of preparation was conducted in duplicate to give replicates R1 and R2.
The stock solution was inverted several times to ensure adequate mixing and homogeneity.
The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 (fresh media), 24 and 96 hours (old media).
Observations on test item solubility:
The test preparations were observed to be clear, colourless solutions throughout the duration of the test.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- Test Species
The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK and maintained in house since 5 May 2011. Fish were maintained in a glass fibre tank with a "single pass" water renewal system. Fish were acclimatised to test conditions from 29 June 2011 to 11 July 2011. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
The water temperature was controlled at approximately 14°C with a dissolved oxygen content of greater than or equal to 8.1 mg O2/l. These parameters were recorded daily. The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test. There was less than 1% mortality in the 7 days prior to the start of the test and the fish had a mean standard length of 5.5 cm
(sd = 0.2) and a mean weight of 1.85 g (sd = 0.13) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.65 g bodyweight/litre.
The diet and diluent water are considered not to contain any contaminant that would affect the integrity and outcome of the study.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure.
Test conditions
- Hardness:
- Total hardness of approximately 140 mg/l as CaCO3.
- Test temperature:
- The water temperature was recorded daily throughout the test and measured using a Hanna Instruments HI 93510 digital thermometer.
The test vessels were sealed and maintained at approximately 14ºC.
See results section for physico-chemical measurement results. - pH:
- The pH values were recorded daily throughout the test. The measurements at 0 hours, and after each test media renewal at 24, 48 and 72 hours, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the test after 96 hours, represent those of the used or 24-Hour old test preparations. The pH values were measured using a Hach HQ30d Flexi Handheld meter.
See results section for physico-chemical measurement results. - Dissolved oxygen:
- The dissolved oxygen concentrations were recorded daily throughout the test. The measurements at 0 hours, and after each test media renewal at 24, 48 and 72 hours, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the test after 96 hours, represent those of the used or 24-Hour old test preparations. The dissolved oxygen concentration were measured using a Hach HQ30d Flexi Handheld meter.
See results section for physico-chemical measurement results. - Salinity:
- Freshwater used.
- Nominal and measured concentrations:
- In the range-finding test fish were exposed to a nominal test concentration of 100 mg/l.
Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100 mg/l to confirm that at the maximum concentration given in the OECD/EC Test Guidelines, no mortalities or sub-lethal effects of exposure were observed. - Details on test conditions:
- EXPOSURE CONDITIONS:
As in the range-finding test 20 litre glass exposure vessels were used for each test concentration. At the start of the test seven fish were placed in each test vessel at random, in the test preparations. The test vessels were then covered to reduce evaporation and maintained at approximately 14ºC in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours. The test vessels were aerated via narrow bore glass tubes. The fish were not individually identified and received no food during exposure.
The control group was maintained under identical conditions but not exposed to the test item. Data from the control group was shared with similar concurrent studies.
A semi-static test regime was employed in the test involving a daily renewal of the test preparations to ensure that the concentrations of the test item remained near nominal and to prevent the build up of nitrogenous waste products
TEST WATER:
The test water used for both the range-finding and definitive tests was the same as that used to maintain the stock fish.
Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener) giving water with a total hardness of approximately 140 mg/l as CaCO3. After dechlorination and softening the water was passed through a series of computer controlled plate heat exchangers to achieve the required temperature.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.
TEST CONCENTRATIONS
Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100 mg/l. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% confidence limits not stated
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: CL not stated
- Details on results:
- Range-finding Test:
Cumulative mortality data from the exposure of common carp to the test item during the range-finding test are given in Table 1. There were no sub-lethal effects of exposure during the range-finding test.
The results showed no mortalities at the test concentration of 100 mg/l.
Based on this information, a single test concentration, in duplicate, of 100 mg/l was selected for the definitive test. This experimental design conforms to a "Limit test" to confirm that at the maximum test concentration given in the OECD/EC Test Guidelines, no mortalities or sub lethal effects of exposure were observed.
Chemical analysis of the 100 mg/l test preparation at 0 and 24 hours (see Appendix 3: Verification of Test Concentrations - attached in background material section) showed measured concentrations to be 98% and 97% respectively indicating that the test item was stable under test conditions.
Definitive Test:
Mortality data:
Cumulative mortality data from the exposure of rainbow trout to the test item during the definitive test are given in Table 2.
There were no mortalities in 14 fish exposed to a test concentration of 100 mg/l for a period of 96 hours. Inspection of the mortality data gave the following results:
Time (h) LC50 (mg/l)
3 >100
6 >100
24 >100
48 >100
72 >100
96 >100
The results of the definitive test showed the No Observed Effect Concentration (NOEC) to be 100 mg/l. The No Observed Effect Concentration is based upon zero mortalities and the absence of any sub-lethal effects of exposure at this concentration .
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/l.
A single mortality was observed in the control after approximately 72 hours. This was considered to be due to natural causes and/or handling stress rather than a toxic effect given that no further mortality was observed.
Sub-lethal effects:
There were no sub-lethal effects of exposure observed in 14 fish exposed to a test concentration of 100 mg/l for a period of 96 hours.
Physico-chemical measurements:
The results of the physico-chemical measurements are given in the tables below. Temperature was maintained at approximately 14ºC throughout the test, while there were no treatment related differences for oxygen concentration or pH.
Verification of test concentrations:
Analysis of the test preparations at 0, 24 and 96 hours (see Appendix 3: Verification of Test Concentrations - attached in background material section) showed measured test concentrations to range from 96% to 101% of nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only
Validation Criteria
In the control, a single mortality was observed after 96 hours exposure. Thus the validity criterion was met.
The oxygen content was ≥ 90% ASV in the control and test vessels at the end of the test. Thus the validity criterion was met. - Results with reference substance (positive control):
- Not applicable.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Table 1 Cumulative Mortality Data in the Range-finding Test
Nominal
Concentration
(mg/l)
Cumulative Mortality
(Initial Population = 3)
3 Hours
6 Hours
24 Hours
48 Hours
72 Hours
96 Hours
Control
0
0
0
0
0
0
100
0
0
0
0
0
0
Table 2 Cumulative Mortality Data in the Definitive Test
Nominal
Concentration
(mg/l)
Cumulative Mortality
(Initial Population = 7)%
Mortality
3 Hours
6 Hours
24 Hours
48 Hours
72 Hours
96 Hours
96 Hours
Control
0
0
0
0
1*
1*
14*
100 R1
0
0
0
0
0
0
0
100 R2
0
0
0
0
0
0
0
R1and R2= Replicates 1 and 2
* Single mortality considered to be due to natural causes and/or handling stress rather than a toxic effect given that no further mortality was observed
Physico-Chemical Measurements
Nominal
Concentration
(mg/l)
Time (Hours)
0 Hours (Fresh Media)
24 Hours (Old Media)
24 Hours (Fresh Media)
pH
mg O2/l
%ASV*
TºC
pH
mg O2/l
%ASV*
T°C
pH
mg O2/l
%ASV*
T°C
Control
7.1
9.4
91
14
7.9
9.9
96
14
7.2
9.4
91
14
100 R1
7.5
9.4
91
14
7.9
9.5
92
14
7.8
9.5
92
14
100 R2
7.5
9.4
91
14
7.9
9.7
94
14
7.7
9.6
93
14
Nominal
Concentration
(mg/l)
Time (Hours)
48 Hours (Old Media)
48 Hours (Fresh Media)
72 Hours (Old Media)
pH
mg O2/l
%ASV*
TºC
pH
mg O2/l
%ASV*
T°C
pH
mg O2/l
%ASV*
T°C
Control
8.0
9.9
96
14
7.1
9.8
95
14
8.1
10.3
100
14
100 R1
8.0
9.9
96
14
7.8
9.9
96
14
8.0
10.0
97
14
100 R2
7.9
10.0
97
14
7.8
9.7
94
14
8.0
10.1
98
14
Nominal
Concentration
(mg/l)
Time (Hours)
72 Hours (Fresh Media)
96 Hours (Old Media)
pH
mg O2/l
%ASV*
TºC
pH
mg O2/l
%ASV*
T°C
Control
7.9
9.5
92
14
7.8
10.1
98
14
100 R1
8.0
9.4
91
14
7.9
9.9
96
14
100 R2
7.9
9.3
90
14
8.0
9.9
96
14
*ASV= Dissolved oxygen concentration expressed as a percentage of Air Saturation Value
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LC50 of greater than 100 mg/l. Correspondingly the No Observed Effect Concentration was 100 mg/l.
- Executive summary:
Introduction.
A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.
Methods.
Following a preliminary range-finding test fish were exposed, in two groups of seven, to an aqueous solution of the test item, at a single concentration of 100 mg/l for a period of 96 hours at a temperature of approximately 14ºC under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.
Results
The 96-Hour LC50 based on nominal test concentrations was greater than100 mg/l. The No Observed Effect Concentration was 100 mg/l.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/l.
Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 96% to 101% of nominal and so the results are based on nominal test concentrations only.
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