(1S)-1-{(2R)-3,4-bis[(2-hexyldecanoyl)oxy]-5-oxo-2,5-dihydrofuran-2-yl}ethane-1,2-diyl bis(2-hexyldecanoate)

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:

July 16 - November 02, 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and EC guidelines and according to GLP principles. Study performed without analytical support.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Principles of method if other than guideline:

ISO 6341 15 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Nikkol VC-IP
- Substance type: Colourless liquid (determined at NOTOX)
- Physical state: Liquid
- Stability under test conditions: stability in water unknown
- Storage condition of test material: At room temperature in the dark

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable.

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

Not applicable.

Test solutions

Vehicle:

no

Details on test solutions:

Preparation of test solutions started with a loading rate of 100 mg/l. This solution was stirred for 24 hours, which resulted in a slightly hazy
dispersion containing undissolved material and an oily-like floating layer on the surface. The dispersion was consequently left to stabilise for ~ 30
minutes after which the middle fraction was collected and, in order to remove the majority of non-dissolved material, filtered through a glass-filter
(Schleicher & Schuell GF92; in the final combined limit/range-finding test). The lower test concentrations were prepared by subsequent dilution of the filtrate in test medium. The final test solutions were all clear and colourless.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: In-house laboratory culture with a known history.
- Age at study initiation (mean and range, SD): < 24 hours
- Method of breeding: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture
vessel.
- Feeding during test: no feeding

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

No post exposure observations.

Test conditions

Hardness:

180 mg/l expressed as CaCO3

Test temperature:

19.4 - 20.7 °C

pH:

7.9 - 8.1 (measured)

Dissolved oxygen:

8.8-9.0 (measured) mg/l

Nominal and measured concentrations:

Nominal 1.0, 10 and 100% of a glass-filter filtered solution prepared at a nominal loading rate of 100 mg/l.

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 ml, all-glass
- Aeration: No aeration of the test solutions
- No. of organisms per vessel: 5 per vessel containing 80 ml of test solution
- No. of vessels per concentration (replicates): 4 for the highest concentration; 2 each for the lower concentrations
- No. of vessels per control (replicates): 4 each for the control

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium
- Total organic carbon: Unknown
- Culture medium different from test medium: yes, for culturing M7 medium is used

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : EC50 based on immobility (including mortality) daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Range finding study: study was a combined limit/range finding test
- Test concentrations: Nominal 1.0, 10 and 100% of a glass-filter filtered solution prepared at a nominal loading rate of 100 mg/l.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

other: > solubility in testmedium

Nominal / measured:

nominal

Basis for effect:

mobility

Remarks on result:

other: Solubility in medium is unknown and solubility in water is < 0.09 mg/l.

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

< 0.09 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Remarks on result:

other: Solubility in medium is unknown and solubility in water is < 0.09 mg/l.

Details on results:

Under the conditions of the present study NIKKOL VC-IP caused no immobilisation of daphnids after 24 hours of exposure. After 48 hours of
exposure 75% of daphnids were immobilized in the filtered solution prepared at a loading rate of 100 mg/l. In the lower treatments (1 and 10 % dilutions of a filtered solution prepared at a loading rate of 100 mg/L) no daphnids were immobilised.

Results with reference substance (positive control):

- Results with reference substance valid: Yes
- Immobility after 48h: 0% at 0.10 mg/l; 0% at 0.18 mg/l; 5% at 0.32 mg/l; 15% at 0.56 mg/l; 100% at 1.0 and 1.8 mg/l
- EC50/LC50: 48h-EC50 was 0.62 mg/l with a 95% confidence interval between 0.53 and 0.77 mg/l.

Reported statistics and error estimates:

No data.

Any other information on results incl. tables

Table   Incidence of immobility in the final combined limit/range-finding test

Test group Nikkol VC-IP (% filtrate)^1	Vessel number	Number Daphnia exposed	Response at 24 h		Response at 48 h
			number	Total %	number	Total %
control	A B C D	5 5 5 5	0 0 0 0	0	0 0 0 0	0
1.0	A B	5 5	0 0	0	0 0	0
10	A B	5 5	0 0	0	0 0	0
100	A B C D	5 5 5 5	0 0 0 0	0	3 4 4 4	75

1.    Test groups represent dilutions of a glass-filter filtered loading rate of 100 mg/l.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study NIKKOL VC-IP caused no immobilisation of daphnids after 24 hours of exposure. After 48 hours of
exposure 75% of daphnids were immobilized in the filtered solution prepared at a loading rate of 100 mg/l. In the lower treatments no daphnids were
immobilised. The 24-hour EC50 is expected to be higher than the maximum solubility and the 48-hour EC50 is < 0.09 mg/l.