Reaction mass of propylidynetrimethanol and 2-ethylpropane-1,3-diol and 5-ethyl-1,3-dioxane-5-methanol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: N/A, lot no. 3777937
- Purity, including information on contaminants, isomers, etc.:
N/A
- Composition: 5-ethyl-5-hydroxymethyl-1,3-dioaxane (CAS no. 5187-23-5) (25-60 %), 1,3-Propandiol, 2-ethyl (CAS no. 2612-29-5) (20-50 %), 2-ethyl-2-hydroxymethyl-1,3-propanediol (CAS no. 77-99-6) (15-25 %)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: sealed containers, room temperature, dark
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: stable for at least 6 months
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: N/A
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: soluble
- Reactivity of the test material with the incubation material used (e.g. plastic ware): N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): N/A
- Final concentration of a dissolved solid, stock liquid or gel: 10,000 mg/L
- Final preparation of a solid: 10,015.3 mg of Polyol TD was dissolved in 1 l of reconstituted water (dilution water) by magnetic stirring; pH adjustment with NaOH from 5.3 to range 6-9

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.

Vehicle:

no

Details on test solutions:

In order to prepare a stock solution 10 015.3 mg of the test item was solved in 1000 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 (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.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

Not applicable

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.
- Testing period: 24 h and 48 h

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

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

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 made on 15 May 2008 to assure the quality of the test animals. The EC50 was 1.1 mg/L which confirmed that the culture 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.

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

Validity criteria fulfilled:

yes

Conclusions:

A static 48 hour definitive test was performed exposing Daphnia magna to 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:

The 48–hr-acute toxicity of Polyol TD to Daphnia magna was studied under static conditions.  Test species were exposed to control,  and test chemical at (nominal) concentration of 125, 250, 500, 1000, 2000, and 4000 mg Polyol TD/L for 24 and 48 hr.  Immobilisation was observed at test termination.  The 48-hour EC50 was 1090 mg Polyol/L.  The 48-hr NOEC based on immobilization was 500 mg Polyol TD/L.

Results Synopsis

Test Organism Age (e.g. 1st instar): 6-24 hours old

Test Type (flow-through, static, static renewal): static

NOEC:  500 mg Polyol TD/L                        Probit Slope: N/A

EC50:  1090 mg Polyol TD/L                  

Endpoint(s) Effected:  Immobilisation

Description of key information

One acute immobilisation test was conducted with Daphnia magna. The 48–hr-acute toxicity of Polyol TD to Daphnia magna was studied under static conditions.  Test species were exposed to control,  and test chemical at (nominal) concentration of 125, 250, 500, 1000, 2000, and 4000 mg Polyol TD/L for 24 and 48 hr.  Immobilisation was observed at test termination.  The 48 hour EC50 was 1090 mg Polyol TD/L.  The 48–hr NOEC based on immobilization was 500 mg Polyol TD/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

1 090 mg/L