Reaction mass of cyclododecanol and cyclododecanone

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:

2010-02-11 to 2010-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of cyclododecanol and cyclododecanone

EC Number:

909-034-9

Molecular formula:

C12H24O (Cyclododecanol) C12H22O (Cyclododecanone)

IUPAC Name:

Reaction mass of cyclododecanol and cyclododecanone

Details on test material:

- Name of test material (as cited in study report): Cyclododecanol tel quel
- Physical state: solid
- Composition of test material, percentage of components: 65 % - 85 % cyclododecanol; 15 % - 35 % cyclododecanone
- Lot/batch No.: 3347-27129
- Expiration date of the lot/batch: 2010-10-05
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 1.0 (below detection limit), 2.2 (2.0), 4.84 (4.0), 10.65 (9.1), 23.43 (22.3) mg/L nominal (measured)
- Sampling method: samples drawn from additional beakers without daphnia, kept under the same experimental conditions
- Sample storage conditions before analysis: samples were drawn, immediately transferred to the analytical laboratory and analyzed on the same day

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance concentrations were individually prepared in M4 medium, stirred for 24 h, and afterwards the preparations were filtered .
- Controls: were preparations without test substance treated otherwise the same way
- Evidence of undissolved material (e.g. precipitate, surface film, etc): precipitate removed by filtration

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna, water flea
- Source: Landesumweltamt NRW, Düsseldorf, Germany
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: The daphnids were held in beakers with a nominal capacity of 2000 mL. Each beaker was filled with approximately 1400 mL M4 medium (Elendt-Schneider). Between 15 and 20 adult organisms were held in one beaker in order to get a high reproduction rate and viable offspring. The breeding beakers were kept at an additional artificial light-dark cycle of 16 to 8 hours. Breeding beakers were placed in a temperature controlled laboratory at 20 +/- 2°C. The breeding medium was renewed three times a week.
- Feeding during test: no feeding during experimental period


ACCLIMATION
- Acclimation period: culture of daphnids permanently kept at the test facility
- Acclimation conditions (same as test or not): no acclimation necessary
- Type and amount of food: singel cell green algae (Desmodesmus subspicatus)
- Feeding frequency: daily

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

2.2 - 3.2 mmol/L

Test temperature:

20.5 - 21.8 °C

pH:

7.87 - 8.06

Dissolved oxygen:

5.5 - 5.9 mg/L

Nominal and measured concentrations:

1.0 (below detection limit), 2.2 (2.0), 4.84 (4.0), 10.65 (9.1), 23.43 (22.3) mg/L nominal (measured)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glas test beakers (50 mL), filled with 30 mL
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 5
- Biomass loading rate: 1 daphnid per 6 mL test solution



TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: 0.5 mg/L
- Particulate matter: none
- Alkalinity: 0.5 - 1.5 mmol/L
- Conductivity: 536 µS/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 h / 8 h light / dark cycle
- Light intensity: 700 +/- 50 Lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: 0.1 mg/L, 1 mg/L, 10 mg/L, 100 mg/L
- Results used to determine the conditions for the definitive study: immobility values of pre-test

Reference substance (positive control):

yes

Remarks:

reference substance potassium dichromate was tested in an independent experiment in august 2009 and adequate sensitivity of the culture was demonstrated

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.87 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

5.77 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no immobility observed in the control group
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: immobility
- EC50/LC50: EC50 (24h) = 0.99 mg/L; in the required range of 0.6 - 2.1 mg/L
- Other:

Reported statistics and error estimates:

EC values were calculated using ToxRat Professional (ToxRat Solutions GmbH, Alsdorf, Germany)

Any other information on results incl. tables

Table:EC values (probit analysis using linear max. likelihood regression) and NOEC values (Fisher`s Exact Binomial Test with Bonferroni correction)after 48 hours exposure of Daphnia magna to different concentrations of test substance Cyclododecanol tel quel

 

	Effective concentration after 48 hours [mg/L]
	nominal	analytically measured
EC50	5.77	4.87
95 % Confidence interval	0.84 – 96.25	n.d.
NOEC	1.00	-

 

n.d.: not determined due to mathematical reasons or inappropriate data

Vessel No.		Concentration of test substance (mg/L)	Immobilized daphnia per test vessel
			24 hours					48 hours
1 - 5		0 (Control)	0	0	0	0	0	0	0	0	0	0
6 - 10		1	0	0	0	0	0	0	0	1	0	0
11 - 15		2.2	0	0	0	0	0	1	1	2	2	1
16 - 20		4.84	0	0	0	0	0	3	2	2	3	2
21 - 25		10.65	0	0	0	0	0	2	3	2	2	3
26 - 30		23.43	5	5	5	5	5	5	5	5	5	5

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50 (48h), based on measured concentrations, was determined as 4.87 mg/L, indicating that the test substance may be toxic to aquatic invertebrates.

Executive summary:

The test substance Cyclododecanol tel quel was tested in the Acute Daphnia Toxicity Test according to the OECD Guideline for the Testing of Chemicals No. 202 (April 2004) using Daphnia magna (Straus) as test organism. The experiment was carried out as a static test, i.e. the test substance preparations were not exchanged for the whole exposure period of 48 hours. The test was performed with test substance preparations of nominal 1*; 2.2; 4.84; 10.65; 23.43 mg test substance/L M4 medium. Geometric mean values for analytically determined concentrations were 2.0, 4.0, 9.1, and 22.3 mg/L . The EC₅₀value after 48 hours of exposure was 5.77 mg/L and the NOEC was 1 mg/L, based on nominal concentrations. Based on analytically determined concentrations, the EC₅₀value was 4.87 mg/L.

*1.0 mg/L was excluded from analysis because the concentration was in the range of the limit of quantification (LOQ: 1.0 mg/L) as shown in a NON-GLP pre-test at the test site AQura GmbH.