Registration Dossier

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
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:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
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).