Registration Dossier

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): OS114454
- Molecular formula (if other than submission substance): C7H16N2O4S
- Molecular weight (if other than submission substance): 225.29
- Smiles notation (if other than submission substance): [NH4+].O=S(=O)(O)CC(C)(C)/N=C(\[O-])C=C
- InChl (if other than submission substance): 1/C7H13NO4S.H3N/c1-4-6(9)8-7(2,3)5-13(10,11)12;/h4H,1,5H2,2-3H3,(H,8,9)(H,10,11,12);1H3
- Substance type: organic
- Physical state: liquid
- Analytical purity: not specified
- Impurities (identity and concentrations): water (not specified)
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
METHOD OF ANALYSIS:
The test material concentration in the test samples was determined by high performance liquid chromatography (HPLC) using an external standard technique. The test samples were diluted with water to give a final theoretical test material concentration of approximately 200 mg/l.
VALIDATION:
A range of standard solutions was prepared covering 0 to 237% of the working concentration and analysed. The detector response was determined to be linear up to 473mg/l. The limits of quantification and detection were determined to be 40 and 10 mg/l, respectively.

Test organisms

Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Common name: green algae (Selenastrum capricornutum)
- Strain: CCAP 278/4
- Source (laboratory, culture collection): Culture Centre for Algae and Protozoa (CCAP), Institute of Freshwater Ecology, Ferry House, Ambleside, Cambia.
- Age of inoculum (at test initiation): not specified
- Method of cultivation: continuous illumination for 96 hours

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
Not specified
Test temperature:
24± 1°C
pH:
Dilution water: adjuted to pH 8.0 (pH ranged from 8.0 - 8.1 at 0-hour and 10.0 - 10.2 after 96 hours)
Dissolved oxygen:
Not specified
Salinity:
Not specified
Nominal and measured concentrations:
Measured test concentrations showed to be near nominal concentrations: 2000 mg/ml
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type : closed
- Material, size, headspace, fill volume: six 250-ml conical flasks containing 100-mL of solution. 3 flasks were used for the control
- Aeration: no.
- Initial cells density: 10 000 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Adjustment of pH: yes to pH 8.0
- Photoperiod:continuous illumination
- Light intensity and quality: cool-white fluorescent lights provided a light intensity of 7000 lux
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter]: daily cell counts were made concurrently with a hemocytometer
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
96 h
Dose descriptor:
IC50
Effect conc.:
> 2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate

Any other information on results incl. tables

The growth was monitored using absorbance values as they correlated well with cell density. The mean cell density and absorbance values in the control and absorbance values in the test concentration are shown below:

   0 hour  24 hour  48 hour  72 hour   96 hour
 Control (Cells/ml)  1.23 x 10 4  1.08 x 10 5  1.81 x 10 5  3.33 x 10 5   1.51 x 10 6
 Control Absorbance  0.022  0.100  0.220  0.529  1.074
 Test Conc (2000 mg/ml)  0.022  0.101  0.232  0;523  1.112

Measured concentration: Analysis of the test solutions at 0 and 96 hours showed the measured test concentration to be near nominal as shown below:

   0-hour (% of animal)   96 -hour (% of animal)
 Control (cells/ml)  < LOQ  < LOQ
 Treatment (R1 - R3)  96  100
 Treatment (R4 - R6)  97  102

Where LOQ is the limit of quantification

Unit: mg/L

There were statistically no significant differnces (p>0.05) between the control and 2000 mg/L test groups and therefore the no observed effect concentration (NOEC) is given as > 2000 mg/L

Other:

- Effect concentration based on nominal loading rates

- No insoluble material was noted

Control response was satisfactory

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No inhibition of algal growth or biomass were seen at the single test concentration of 2000 mg/L.