Registration Dossier

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:
28-02-2012 to 24-03-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conform guideline and under GLP, the test was performed as WAF

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Principles of method if other than guideline:
The test was perfomed on a water accomodated fraction (WAF)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: extremely viscous liquid
Details on test material:
- Name of test material (as cited in study report): Fatty acids, tall oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and methylhydrogen maleate
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: at 0 and 48 h; in the pre-test at 0, 10 and 100 mg/L, in the final test at 0 and 100 mg/L
- Sample storage conditions before analysis: at -20 °C

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stirring for 23 hours, standing 1 hour and transfer via tube by mid depth syphoning
- Differential loading: pre-test 10 and 100 mg/L; final test 100 mg/L
- Controls: untreated
- Evidence of undissolved material: microscopic evaluation did not show any undissolved material in the WAF

The mixing time was validated in a separate test where extension of the mixing period to 96 hours did not improve the final measured concentrations (at 100 mg/L loading rate : 24 h 32.38 mg/L, 96 h 43.52 mg/L)

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation: < 24 hours
- Feeding in culture: algae suspension and tetramin flake food suspension

Study design

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

Test conditions

Hardness:
250 mg/L as CaCO3
Test temperature:
22 °C
pH:
7.9-8.1
Dissolved oxygen:
8.7-9.0 mg/L (100-103% of saturation)
Nominal and measured concentrations:
nominal: 0, 100 mg/L (loading rate)
measured
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL
- Type: covered
- Fill volume: 200 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (according to guidance)
- Alkalinity: pH 7.8 ± 0.2
- Ca/mg ratio: 4/1
- Conductivity: 5 uS
- Culture medium different from test medium: Elendt M7
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16/8
- Light intensity: 611-653 Lux

EFFECT PARAMETERS MEASURED : immobilization

TEST CONCENTRATIONS
- Range finding study: 0, 10, 100 mg/L as loading rate
- Test concentrations: 0, 100 mg/L as loading rate
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 other: mg/L as loading rate
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The analysed concentration was < LOQ for all test concentrations
Results with reference substance (positive control):
48h EC50 1.1 mg/L within expected range

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test substance did not induce immobility in Daphnia magna at a loading rate of 100 mg/L
Executive summary:

Daphnids were exposed to 0 and 100 mg/L test substance during 48 hours. No immobility was found. The analyses for accuracy of preparation at the maximum concentration attainable showed that the actual concentration was below the LOQ (0.054 mg/L).