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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 30, 2001 till December 6, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline 202 (Daphnia sp. Acute Immobilisation Test) under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identity: ZP-TIX 1014
Batch no.: NW-01-028
Purity: >99%
Expiration date: 30.12. 2001
Stability under test conditions: Not stable in test water, the degradation products were tested
Aggregate state/physical form at roomtemperature: Solid
Color: White (visually determined at RCC)
Storage condition of test material: At room temperature at about 20°C, in the dark

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain: Clone 5
- Source: University of Sheffield/UK in 1992
- Age at study initiation (mean and range, SD): 6-24 hours (nott first brood progeny)
- Feeding during test: no feeding during test

Study design

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

Test conditions

Hardness:
Before start of the test: 2.5 mmol/L (= 250 mg/L) as CaCO3
During test: no data
Test temperature:
Between 21 °C and 22 °C
pH:
Between 7.8 and 7.9
Dissolved oxygen:
Between 7.9 mg/L and 8.3 mg/L
Salinity:
CaCl2 x 2H2O 2.0 mmol/L (= 294 mg/L)
MgSO4 x 7H20 0.5 mmol/L (= 123 mg/L)
NaHCO3 0.75 mmol/L (= 65 mg/L)
KCl 0.075 mmol/L (= 5.8 mg/L)
Nominal and measured concentrations:
100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 ml glas beaker
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 50 ml test medium
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 1 daphnia per 2.0 ml test solution

TEST MEDIUM / WATER PARAMETERS
Reconstituted water: analytical grade salts were dissolved in deionized water to obtain the following nominal concentrations
- Alkalinity: 0.8 mmol/L
- Ca/Mg ratio: 4:1 (based on mortality)
- Na/K ratio: 10:1 (based on mortality)
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: A 16-hour light to 8-hour darkness photoperiod with a 30 minute transition period
- Light intensity: within the range of 370 to 670 LUX

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Daphnia: observed for mobility after 24 and 48 hours
- Water: measurements of temperature, pH-values, dissolved oxigen concentrations at the start and at the end of the test
- Appearance of the test medium: at the start off the test and after 24 and 48 houres of test duration

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none (only one concentration)
- Test concentrations: 100 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: none
- Other biological observations: no abnormalities of mobility during the whole test
- Mortality of control: 0
- Other adverse effects control: no

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In the control and at the loading rate of 100 mg/L no immobilized or dead test organism s were observed during the test period of 48 hours.
Executive summary:

The acute toxicity of the test item ZP-TIX 1014 to Daphnia magnawas determined in a 48-hour static test aeeording to the EU Commission Directive 92/69/EEC, Part C.2 (1992), and the OECD Guideline for Testing of Chemieals, No. 202, Part I (1984). The test method is also based on the OECD Guidance Document on Aquatie Toxicity Testing of Difficult Substances and Mixtures, 2000.

In order to assess the toxicity of ZP-TIX 1014 to daphnids, a water accommodated fraction (WAF) with a loading rate of 100mg/L was tested. Additionally, a control (test water without test item) was tested in parallel. Thus, a limit test was performed in accordance with the EU Commission Directive 92/69/EEC to demonstrate that the test item has no toxic effect on the daphnids up to the loading rate of 100 mg/L.

The W AF with a loading rate of 100 mg/L was prepared by dispersing the test item in test water by stirring for 96 hours. Then, the dispersion of the test item was filtered through a membrane filter (pore size 0.45 ~m). The undiluted filtrate of the dispersion was used as test medium.

Since the test item is not stable in test water, the degradation products were tested. Therefore, a long stirring period of 96 hours was chosen to enrich the test water with the maximum concentration of degradation products within a practically acceptable time period.

The test item is a poorly soluble mixture of isocyanates and it is generally known. that these compounds degrade fast in water. Due to this characteristics, the test item could not be analytically measured in the test medium. Furthermore, the verification of the test item could not be based on its degradation products, since none could be defined during the analytical pre-experiments. For this reasons, no analytical work was performed.

The biological test results after 48 hours test duration:

In the control and at the loading rate of 100 mg/L no immobilized or dead test organisms or other signs of intoxication were determined during the test period.

The 48-hour NOEC (highest eoncentration tested without toxie effeets after the exposure period of 48 hours), and the 48-hour ECO of the test item ZP-TIX1014 and its degradation products, respectively,to Daphnia magna were determined to be at least at the loading rate of 100 mg/L. These values might even be higher, but loading rates in excess of 100 mg/L have not been tested, according to the EU Commission Directive. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of ZP- TIX 1014 at the loading rate of 100 mg/L.