2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

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:

August 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD test guidelines, and a statement of GLP compliance was included in the test report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

EC Number:

245-509-0

EC Name:

2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

Cas Number:

23235-61-2

Molecular formula:

C12H26O5

IUPAC Name:

2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol

Constituent 2

Reference substance name:

Di-Trimethylolpropane

IUPAC Name:

Di-Trimethylolpropane

Constituent 3

Reference substance name:

Di-TMP

IUPAC Name:

Di-TMP

Details on test material:

- Name of test material (as cited in study report): Di-Trimethylolpropane flakes (Di-TMP flakes) (reported as ditrimethylolpropane in this summary)
- Physical state: White flakes
- Analytical purity: 98% (3,3,7,7-Tetrahydroxymethyl-5-oxanone)
- Impurities (identity and concentrations): <2%, 2-Ethyl-2-hydroxymethyl-1,3-propanediol (CAS 77-99-6)
Ash, as sodium - 8 ppm.
Water content 0.2%
- Lot/batch No.: 3774335
- Expiration date of the lot/batch: Not specified. Material stable for at least 6 months.
- Storage condition of test material: Sealed containers, room temperature, dark.

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples of the stock solution (equal to the highest tested concentration) at 0h and 48h were collected and stored in the freezer until analysed by the sponsor.

Test solutions

Vehicle:

no

Details on test solutions:

5g of test substance were dissolved in 1 L dilution water by magnetic stirring on the day of the test start. The test solutions were made by
dilution of the stock solution (approximately 5000 mg/L) with reconstituted test water.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Animals were taken from Toxicon's continuous culture of Daphnia Magna, which originates from NIVA, Norway.
Age at study initiation (mean and range, SD): 6 to 24 hours old.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

Not applicable

Test conditions

Hardness:

250 ± 25 mg/L (expressed as CaCO3)

Test temperature:

21 ± 1 ºC

pH:

Measures values - 7.93 - 8.07

Dissolved oxygen:

98.9 - 102.3% (Measured values).

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal - 0 (control), 1000, 2000, 3000, 4000, and 5000 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Glass petri dishes, 50 mL capacity, 25 mL fill volume.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water was prepared acording to OECD test guideline 202.


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light (subdued light), 8 hours darkness.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Number of immobilised animals - observed at 24 and 48 hours.

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

2 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3 560 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

No control animals were found to have been immobilised after 48 hours.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

The 48 hour EC50 was determined by graphical interpolation.

Any other information on results incl. tables

Daphnia immobilisation during the toxicity study

Nominal concentration (mg/L)	% immobilisation
	24 hours	48 hours
Control	0	0
1000	0	0
2000	0	5
3000	15	25
4000	40	70
5000	75	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

A static 48 hour definitive test was performed exposing Daphnia magna to a range of conentrations (1000 - 5000 mg/L) of ditrimethylolpropane. The study was performed in accordance with the OECD guideline 202 and according to GLP. The 48 hour EC50 was calculated to be 3560 mg/L (based on nominal concentrations).