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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
18 Jan - 20 Jan 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (ECHA, 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.”

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters
EC Number:
500-204-4
EC Name:
Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters
Cas Number:
68334-05-4
Molecular formula:
C44H80O4
Details on test material:
- Name of test material: Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters
- Physical state: liquid
- Analytical purity: no data
- Storage condition of test material: in the dark, at ambient temperature, in the container in which it was received until required for testing.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples for analysis were taken from the centre of the test solutions at start of the test period (0 h).

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water Accommodated Fractions (WAF) with a loading rate of 100 mg/L were prepared based on ASTM D6081-98 for this test. The test concentration was prepared by the addition of a known amount of the test substance to dilution water. This solution was stirred for 24 hours in the dark using a PTFE coated magnetic stirring bar and then allowed to settle for > 1 hour. The resultant solution was clear and colourless with an oily surface film visible. A portion of the sub-surface liquid was siphoned off for use in the study. The control consisted of dilution water only.
Dissolved organic carbon analysis of the nominal 100 mg/L WAF gave essentially the same values as the dilution water control, which had been similarly treated.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Source: from own continuous laboratory cultures. The culture was originally obtained from IRCHA, France and the Daphnia were subsequently characterised by Sheffield University, UK as Clone 5.
- Age at study initiation: Daphnia < 24 hours old (first instar), obtained from a single culture vessel, were used for testing. The parent animals were 29 ± 1 days old.
- Method of breeding: Daphnia reproduction by diploid parthenogenesis
- Feeding during test: none

ACCLIMATION
- Acclimation conditions: The stock cultures of Daphnia were maintained in a reconstituted water medium (M4 medium), identical to the test dilution water, at a temperature of 20 ± 1 °C. The cultures were maintained in 2 L glass vessels. A photoperiod of 16 hours light: 8 hours dark, with 20 minute dusk and dawn transition periods was provided.
- Type and amount of food: The Daphnia cultures were fed a defined diet of algae Chlorella vulgaris, strain CCAP 211/12 and a commercially available fish food.
- Health during acclimation: No evidence of disease was observed.

Study design

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

Test conditions

Hardness:
216 mg /L as CaCO3
Test temperature:
20 ± 1 °C
pH:
7.9 - 8.2
Dissolved oxygen:
8.2 to 9.2 mg/L (> 60% oxygen saturation)
Nominal and measured concentrations:
Nominal: 100 mg/L loading rate WAF
Details on test conditions:
TEST SYSTEM
- Test vessel: narrow necked borosilicate glass bottles of 60 mL nominal capacity. The bottles were covered with silicon lids and clamp sealed.
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water, M4 Medium according to Elendt and Bias
- Total organic carbon: 0.75 mg/L
- Conductivity: 586 µS/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: After 0 and 48 hours

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light : 8 hours dark, with 20 minute dusk and dawn transition periods

EFFECT PARAMETERS MEASURED: Immobility were recorded after 24 and 48 hours test duration.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test as WAF were prepared.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: WAF
Basis for effect:
mobility
Details on results:
No immobilised daphnia were observed within this study - neither in the test concentrations nor in the controls. No symptoms of toxicity were observed in this study.

Any other information on results incl. tables

Due to the low water solubility of the test substance (< 1 mg/L) Water Accommodated Fractions were prepared for the test. No effects up to the limit of the water solubility of the test substance were observed under conditions tested. Thus, the test substance has only a low toxicity for Daphnia magna.

The test report mentions a NOEC of 100 mg/L, but due to the fact that WAFs were prepared a NOELR has to be reported instead.

Applicant's summary and conclusion