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

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:

From 1st April 2014 to 28th November 2014

Reliability:

1 (reliable without restriction)

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:

yes

Remarks:

Temperature in the treatments was partially >21°C exceeding the range 20 ± 1°C indicated in the study plan. This represents a deviation of the study plan which is not considered to have an influence.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

279-482-1

EC Name:

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

Cas Number:

80480-24-6

Molecular formula:

C13H26O2

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Troenan
- Physical state: colourless liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

A sample of the test item will be archived according to the actually legal German GLP regulatives. After this period the test item will be disposed of in the correct way.

Test solutions

Vehicle:

not specified

Details on test solutions:

The daphnia are exposed to different concentrations (aqueous eluates from different amounts of the partially poorly water soluble test item) of the test item for 48 h at 21.2 – 21.8 ºCC1) (measured values in the treatments, main test) with a light-dark cycle (16h of light and 8h of darkness). After 24h and 48h the number of immobilised daphnia at each concentration of the test item is recorded. If possible the concentration at which 50% of the daphnia are immobilised after the incubation period (EC50) should be determined.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna STRAUS (clone 5) of a laboratory breed (derived from Dr. M. Bergtold, BASF, D-67117 Limburgerhof; the strain originally derived from the Institut National de Recherche Chimique Appliquee, France in 1978 and cultivated since then at BASF using medium M4 acc. Elendt) was used for the test.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

21.8

pH:

8.87

Dissolved oxygen:

8.8 mg O2/L

Nominal and measured concentrations:

Nominal concentrations of 0.1 mg/L, 1.0 mg/L and 10 mg/L.

Details on test conditions:

Preparation of the 1st Main Test (open Vessels)
The 1st main test was performed using the “WAFs” from 1.4 mg / 1400 mL, 3.0 mg / 1500 mL, 6.0 mg / 1500 mL, 12.0 mg / 1500 mL, and 15.1 mg / 1510 mL dilution water, in the same way as in the 1st and 2nd screening test described above. Further steps were the same as for the treatments within the screening test. The test solutions were filled into four test vessels (beakers) using 5 animals each parallel. The daphnids were not fed during the test.

Preparation of the 2nd Main Test (closed Vessels)
The 2nd main test was performed in closed bottles (100 mL carboys) in order to avoid loss of test item due to evaporation. For this purpose the flasks were filled up to the bottle neck and stoppered with glass stoppers. Further steps were the same as for the treatments within the 3rd screening test. The nominal concentrations were 0.625 mg/L, 1.25 mg/L, 2.5 mg/L, 5.0 mg/L and 10 mg/L.
During the 1st main test it became obvious that the volatility of the test item was too high, and thus, an additional screening and main test using closed flasks as the test vessels were performed accordingly.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

2.787 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 2.343-3.318

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.807 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 1.527-2.035

Any other information on results incl. tables

	Basis: Nominal Concentrations [mg/L]
	t24hr	t48hr
NOEL	5.00	1.25
LOEL	10.00	2.50
EL10	4.737 [n.d.]	1.818 [1.239 – 2.193]
EL20	5.000 [n.d.]	2.105 [1.571 – 2.481]
EL50	5.546 [n.d.]	2.787 [2.343 – 3.318]
	Basis: Measured Concentrations [mg/L]
	t24hr	t48hr
NOEC	2.680	0.760
LOEC	5.320	1.700
EC10	2.555 [n.d.]	1.331 [0.824 – 1.561]
EC20	2.680 [n.d.]	1.478 [1.031 – 1.688]
EC50	2.937 [n.d.]	1.807 [1.527 – 2.035]

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

As a conclusion of the analytical part of this study, recoveries of the concentrations determined after 48hr were all at ≥ 80% of those determined at time t0 but the measured concentrations of the treatments deviated partially more than 20 % from the nominal values. Based on this, the reported effect concentrations refer to the measured concentrations tested.

Executive summary:

“TROENAN” was tested for acute toxicity towards daphnia according to OECD-Test Guideline 202 (version dated 13-Apr-2004). In order to in¬vestigate the influence of the test item towards the daphnias, the swimming behaviour of the animals was recorded. Under the conditions used for the test, immobilisa¬tion of the daphnias was observed at concentrations representing the water soluble part (hereafter abbreviated “WAF”, water accommodated fraction) of the test item at concentrations up to 1000 mg/L (screening test). As a conclusion of the analytical part of this study, recoveries of the concentrations determined after 48hr were all at ≥ 80% of those determined at time t0 but the measured concentrations of the treatments deviated partially more than 20 % from the nominal values. Based on this, the reported effect concentrations refer to the measured concentrations tested.