3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

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:

Between 1999-10-19 and 1999-10-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to 92/69/EEC C.2 and OECD test guideline 202

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

EC Number:

251-090-5

EC Name:

3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

Cas Number:

32539-83-6

Molecular formula:

C15H26O1

IUPAC Name:

2H,3H,4H,5H,6H,7H,8H,9H,10H,11H,12H,13H,14H-cyclododeca[b]pyran

Details on test material:

- Name of test material (as cited in study report): DDP
- Substance type: active substance
- Physical state: viscous liquid
- Isomers composition: no isomers
- Purity test date: 1999.02.17
- Lot/batch No.: 9020015
- Expiration date of the lot/batch: 2000.07

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Analysis of all test concentrations plus a control at test start and after 48h of exposure (in the nominal concentration 0.25 mg/L, after 24h of exposure because of early 100% immobilization rates)

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: STRAUS, parthenogenetic females
- Source: cloned at the Federal Health Office (BGA) in Berlin
- Age at study initiation (mean and range, SD): 1 - 24hrs

Study design

Test type:

static

Limit test:

no

Total exposure duration:

24 h

Post exposure observation period:

24 hours

Test conditions

Hardness:

15.5 °dH (M4-Medium)

Test temperature:

20.0 - 20.1°C, at 48h

pH:

87.9 - 8.9 at 48h

Dissolved oxygen:

8.2 - 8.7 mg/L at 48h

Nominal and measured concentrations:

0 hours, nominal vs measured concentrations in mg/L : control < 0.01, 0.03 vs<0.018, 0.06 vs 0.037, 0.13 vs 0.10, 0.25 vs 0.22
48 hours: nominal vs measured concentrations in mg/L: control < 0.01, 0.03 vs<0.013, 0.06 vs 0.030, 0.13 vs 0.061, 0.25 vs 0.15

Details on test conditions:

TEST SYSTEM
- Test vessel: "Karlsruher bottles"
- Material, size, headspace, fill volume: bottles with stoppers, 250-300 ml test medium, headspace
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Solubilizer or other auxiliaries: ultra-turrax magnetic stirrer folded filter
Control: M4- Medium according to Elendt and BGA (1992)


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4- Medium according to Elendt and BGA (1992), used also as control


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours light/ 8hours dark

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

ca. 0.06 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

ca. 0.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

ca. 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

ca. 0.08 mg/L

Nominal / measured:

meas. (arithm. mean)

Reported statistics and error estimates:

Geometric mean after 24 hours: EC0/EC100: 0.12 mg/L
Geometric mean after 48 hours: EC0/EC100: 0.04 mg/L

Any other information on results incl. tables

	Immobile daphnids absolute %				Oxygen	pH	Temperature
Nominal Concentration test substance (mg/l)	24h	48h	24h	48h	48 h (mg/L)	48h	48 h (°C)
control	0	0	0	0	8.7	8.0	20.1
0.03	0	0	0	0	8.6	8.0	20.0
0.06	0	5	0	25	8.2	7.9	20 .0
0.13	18	20	90	100	8.3	7.9	20.1
0.25	20	20	100	100	8.5 *	7.9 *	20.3 *

To accelerate the solution procedure a thirty fold amount of the maximum water solubility under exposure conditions was taken (10 mg/l). To produce the stock solution the test substance was weighed into water, treated for 60 seconds at 8000 rpm. with an ultra-turrax and afterwards stirred for 24 hours on a magnetic stirrer. To remove undissolved particles, the resulting suspension was filtered using a folded filter of the pore size 7-12 microm. Deviating from the above test guideline and considering the decrease of the test concentrations during the preliminary experiment, the main test was conducted under closed-bottle conditions in so-called "Karlsruher bottles".

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

1. In the control , 0% of the daphnids was immobilised (<10% required in the guidance). 2.The dissolved oxygen concentration at the end of the test is 8 mg/l in control and test vessels (>=32 mg/L required in the guidance)

Conclusions:

EC50 at 48 hours for the test material determined by geometric mean is 0.04 mg/l.

Executive summary:

The test material has been tested following the procedure "Acute Toxicity for Daphnia" of 92/69/EEC C.2. Four defined concentrations of the test material plus a control will lead to a certain percentage proportion of immobile daphnids at the end of the study period. The EC0 and EC100 have been determined directly from the study, while the EC50 has been calculated by the geometric average. The study lasted for 48hours. The test material has a EC50 of 0.04 mg/l. The study report fulfill sthe criteria of validity of the followed procedure.