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:
July 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with appropriate OECD test guideline and the report includes a statement of GLP compliance.

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
Details on test material:
- Name of test material (as cited in study report): Polyol TD
- Physical state: Clear, colourless liquid

- Composition of test material, percentage of components:
5-ethyl-5-hydroymethyl-1,3-dioaxane (CAS number 5187-23-5, EINECS number 225-967-8): 25 - 60%
1,3-Propandiol, 2-ethyl (CAS number 2612-29-5, EINECS number 220-08-3): 20 - 50%
2-ethyl-2-hydroxymethyl-1,3-propanediol (CAS number 77-99-6, EINECS number 201-074-9): 15 - 25%


- Lot/batch No.: 3777937
- Expiration date of the lot/batch: 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 and 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:
In order to prepare a stock solution, 10 015,3 mg of the test item was solved in 1 000 mL reconstituted test water (dilution water) by magnetic stirring. Since the pH of the stock solution (pH=5.3) was not in the range of 6-9, the solution was adjusted with NaOH to the pH of the dilution water
according to OECD TG 202. The test solutions were made by dilution of the stock solution (10 000 mg/L) with reconstituted test water. Nominal test
concentrations were 125, 250, 500, 1000, 2000, and 4000 mg/L.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
- Common name: Daphnia Magna
- Source: Animals taken from Toxicon's continuous culture of Daphnia Magna. The culture originates from NIVA, Denmark.
- 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
Test temperature:
21±1ºC
pH:
Measured 7.69 - 8.06
Dissolved oxygen:
Measured 99.6 - 102.6%
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal: 125, 250, 500, 1000, 2000, and 4000 mg/L.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 25 mL fill volume in 50 mL Petri dish (i.e. 25 mL headspace).
- 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 reconstituted test water was prepared according to OECD test guideline 202.


OTHER TEST CONDITIONS
- Adjustment of pH: pH of stock solution was not in the range 6 - 9 as described in OECD TG 202 (pH = 5.3) so solution was adjusted using NaOH.
- Photoperiod:16 hours light, 8 hours darkness per day.
- Light intensity:Not reported.


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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
Reference substance (positive control):
yes
Remarks:
Substance used not stated

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1 090 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: calculated by means of graphic interpolation
Results with reference substance (positive control):
A qualification test on the Daphnia magna culture was amde on 15 may 2008 to assure the quality of the test animals. EC50 was 1.1 mg/L whcih confirmed that the culutre was suitable as a est organisms according to OECD TG 202.
Reported statistics and error estimates:
The 48 hour EC50 was determined by graphical interpolation.

Any other information on results incl. tables

Cumulative % immobility over the 48 hour observation period

Nominal concentration (mg/L)

Cumulative % immobility

24 hours

48 hours

Control

0

0

125

5

5

250

10

15

500

5

10

1000

20

45

2000

90

100

4000

100

100

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
A static 48 hour definitive test was performed exposing Daphnia magnato a range of concentrations (125 - 4000 mg/L) of Polyol TD. The study was performed in accordance with the OECD guideline 202 and according to GLP. The 48 hour EC50 was calculated to be 1090 mg/L (based on nominal concentrations), the corresponding no-observed effect concentration was observed to be <125 mg/L.
Executive summary:

A static 48 hour definitive test was performed exposing Daphnia magnato a range of concentrations (125 - 4000 mg/L) of Polyol TD. The study was performed in accordance with the OECD guideline 202 and according to GLP. The 48 hour EC50 was calculated to be 1090 mg/L (based on nominal concentrations), the corresponding no-observed effect concentration was observed to be <125 mg/L.