5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-10-25 to 1994-07-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study conducted under GLP and accordîng to EU Guidance 92/69/EWG. The following information was not given or only given to limited extent: characterisation of the test water, specifications of the sampling method. Due to the low water solubility, a semi-static test design was used. The test concentrations were measured by DOC-analysis which gave results difficult to interpret. Given that the portions of dissolved and unsdissolved poertions of the test substance did not change during 24 hours of exposure interval, the dose-dependent effetcs are caused by the dissolved portion of the test item and nominal concentrations can be used as worst case assumption (the analysed DOC-values were always greater that the nominal), the NOEC was determined to be 20 mg/L.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

EU Method Version 1992-07-31

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Troenan (S 521)

IUPAC Name:

Troenan (S 521)

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Troenan (S 521)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 10, 40, 80, 160 and 320 mg/L
- Sampling method: not reported
- Sample storage conditions before analysis: not reported

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct weighing (appropriate amount of test item weight and mixed into test water for 10 seconds using ultraturrax)
- Controls: one water control
- Evidence of undissolved material (e.g. precipitate, surface film, etc): not reported

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Strain: not applicable
- Source: company Westaquarium
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): not reported
- Weight at study initiation (mean and range, SD): not reported
- Method of breeding: not applicable
- Feeding during test: yes
- Food type: Altromin N1324 spezial 161293 1500 (pre-test), Altromin N1324 spezial 140694 0825 (definitive test)
- Amount: not reported
- Frequency: not reported

ACCLIMATION
- Acclimation period: not reported
- Acclimation conditions (same as test or not): not reported
- Type and amount of food: Altromin, amount not reported
- Feeding frequency: not reported
- Health during acclimation (any mortality observed): < 0.1 % one week before test start

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no

Test conditions

Hardness:

not reported

Test temperature:

21.4-23.8 °C
Variability of temperature > ± 1 °C. This devaition from the guideline is not considered to be critical, since the recommended range of temperature for zebrafish (i.e. 20-24 °C) was not left.

pH:

7.8-8.1, measured in all treatments

Dissolved oxygen:

70-106 % of saturation

Salinity:

not applicable

Nominal and measured concentrations:

nominal: 10, 20, 40, 80, 160, 320 mg/L, corresponding to 0.63, 1.25, 2.5, 5.1, 10.2, 20.4 mg DOC/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 1 per treatment
- Type: open
- Material, size, headspace, fill volume: not reported, nor reported, not applicable, 5 L
- Aeration: not reported
- Renewal rate of test solution: semistatic test design (preparation of new test systems each day and transfer of test organisms)
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: not reported

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water
- Total organic carbon: not reported
- Particulate matter: not reported
- Metals: not reported
- Pesticides: not reported
- Chlorine: not reported
- Alkalinity: not reported
- Ca/mg ratio: not reported
- Conductivity: not reported
- Culture medium different from test medium: not reported
- Intervals of water quality measurement: not reported

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: not reported
- Light intensity: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and symptoms of toxicity 0, 4-6, 24, 48, 72 and 96 hours of exposure

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: yes
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: not reported

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

40 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

80 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: sublethal effects (i.e. imbalances) after 4-6 hours at 80, 160 and 320 mg/l and after 48 hours at 40 mg/L
- Observations on body length and weight: not reported
- Other biological observations: not reported
- Mortality of control: 0 %
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: due to the low water solubility of the test item, effects of the not-dissolved portion of the test item cannot be excluded.

Reported statistics and error estimates:

Calculation of LC50 according to Stephan (i.e. square root of (LC0 x LC100))

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1 Analytical results

target concentration		Measured concentrations
mg product/L	mg/DOC/L	mg DOC/L
		0 h (13.06.)	24 h (14.06.)	0 h (15.06.)	24 h (16.06.)
10	0.63	2.6	1.4	2.3	2.9
40	2.5	--	--	2.8	2.6
80	5.1	5.4	8.9	--	--

Table 2 Biological results

Treatment	Hours of exposure
mg/L	0	4.6	24	48	72	96
0	0	0	0	0	0	0
10	0	0	0	0	0	0
20	0	0	0	0	0	0
40	0	10	10	40	70	70
80	0	20	80	100	100	100
160	0	50	90	100	100	100
320	0	0	80	100	100	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In a valid and reliable study, the acute toxicity of the test substance Troenan (S521) under semi-static condictions was determined according to EU Method 92/96/EWG. The NOEC was nominal 20 mg/L.

Executive summary:

In a valid and reliable study, the acute toxicity of the test substance Troenan (S521) was determined according to EU Method 92/96/EWG.

In a semi-static design with 24 hour renewal, the test organisms were exposed to 10, 20, 40, 80, 160 and 320 mg/L. For the analytical verfication of the test concentrations, analysis of the dissolved carbon concentration (DOC) was conducted considering an DOC of 63.4 mg/g product. However, the analytical results are difficult to interpret since the DOC in the test media was composed of an unknown portion of dissolved test item and an unknown portion of undissolved test item not removed by filtration. Given that these portions did not change during 24 hours, the dose-dependent effetcs are caused by the dissolved portion of the test item and nominal concentrations can be used as worst case assumption (the analyses DOC-values were always greater that the nominal), the NOEC was determined to be 20 mg/L.