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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GPL guideline study without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-methylprop-2-en-1-yl)cyclododecan-1-one
EC Number:
691-657-8
Cas Number:
62599-49-9
Molecular formula:
C16 H28 O
IUPAC Name:
2-(2-methylprop-2-en-1-yl)cyclododecan-1-one
Details on test material:
- Name of test material (as cited in study report): 2-(2-Methylallyl)-cyclododecanon-Rein
- Physical state: colorless, clear liquid
- Analytical purity: 99.3 area % (not corrected with the water content)
- Expiration date of the lot/batch: October, 2014
- Stability under test conditions: stable
- Water solubility: 1.4 mg/L at 20 °C.
- Storage condition of test material: at ambient temperature without exposure to light in a tightly sealed container

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations : 1.4, 0.7, 0.35, 0.18, 0.09 mg/L and control (nominal)
- Sampling method: The aim of the analytical part of the definitive test was to determine the concentrations of 2-(2-
Methylallyl)-cyclododecanon-Rein using a validated gas chromatography method with FID detection
[SOP/C/289]. In the definitive test, the samples at exposure initiation and at exposure termination collected from
each test item concentration and the control were analyzed [SOP/W/83].
- Sample storage conditions before analysis: The sample of the test item was stored at ambient temperature without exposure to light in a tightly
sealed container [SOP/W/3, SOP/PB/1].

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
In the definitive test following test item concentrations were used: 1.4, 0.7, 0.35, 0.18 and 0.09 mg/L
plus the control (with a spacing factor of 2.0). The 3 μL of the test item was added into 200 mL of
Elendt M7 medium in glass flask with a capacity of 250 mL using a glass syringe (Hamilton, 10 μL,
Switzerland). The content of flask was thoroughly mixed and, then content of flask was transferred into
glass flask with a capacity of 5 L by multiple washing with Elendt M7 medium. The glass flask was
filled up to 2 L of Elendt M7 medium. The content of flask was ultarsonicated for 5 minutes
[SOP/W78]. After that the test item concentration of 1.4 mg/L was visually transparent and
homogeneous. The test item was visually dissolved. The lower test item concentrations were prepared
by sequential dilutions with the Elendt M7 medium in a ratio of 1 : 1 (volume per volume).
The control (550 mL of Elendt M7 medium) was ultarsonicated for 5 minutes [SOP/W78].

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Source: Institute of Industrial Organic Chemistry, Branch Pszczyna, Department of Ecotoxicology, Laboratory of Aquatic Toxicology.
- Age at study initiation (mean and range, SD): < 24 h old at exposure initiation); not first brood progeny.
- Method of breeding: Daphnia magna was cultured in glass beakers with a capacity of 150 mL (one parent per vessel)
containing 100 mL of Elend M7 medium, at room temperature ranging from 18 to 22°C with daily cycle 16 h light : 8 h dark.
- Feeding during test: no feeding.

ACCLIMATION
- Type and amount of food: suspension of algae; mixture of two species Pseudokirchneriella subcapitata: Desmodesmus subspicatus (in 2:1 ratio) Group B vitamins and micronutrients necessary for proper growth were supplied with the lyophilized suspension of Spirulina sp.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
20.0 – 21.0 ºC
pH:
7.52 – 7.53
Dissolved oxygen:
8.9 – 9.6 mg/L
Nominal and measured concentrations:
Nominal concentrations: 1.4, 0.7, 0.35, 0.18, 0.09 mg/L and control.
Measured concentrations: 1.3, 0.6, 0.32, 1.17, 0.08 and control.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers of 150 mL (with transparent lids)
- Type : closed
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
The Elendt M7 medium recommended by the OECD Guideline No. 202 (2004) was used to culture the test organism and as a diluent/solvent of the test item.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: daily cycle 16 h light : 8 h dark; fluorescent light source

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Daphnia magna was observed for immobilization after 24 and 48 h of exposure. The Daphnia magna
was considered immobile if they showed no ability to swim within 15 seconds after swirling the test
vessel.
- The temperature was continuously recorded.
- The pH values and the dissolved oxygen concentrations were measured at exposure initiation, i.e.
before the split up into replicates, and at exposure termination in pooled replicates

TEST CONCENTRATIONS
- Range finding study: preliminary test
- Results used to determine the conditions for the definitive study: were determined on the basis of the preliminary tests results

Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.48 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% confidence limits: 0.41 – 0.56 mg/L).
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
0.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
- EC50: 0.60 mg/L
Reported statistics and error estimates:
- Statistical analysis: Probit method calculations and analysis by Fisher’s Exact Binomial Test with Bonferroni Correction.

Any other information on results incl. tables

S ince the analytically determined concentrations of the test substance in the test solutions were within +20% of the nominal concentrations, the effect concentration can be expressed relative to the nominal concentration.

Applicant's summary and conclusion