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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 January 2009 - 30 January 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to an OECD guideline and a statment of GLP compliance is included in the report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity 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: N/A
- Final preparation of a solid: 100 g of Polyol TD was dissolved per 1 l of aerated dilution water as a stock solution

Analytical monitoring:

yes

Details on sampling:

Portions of the test solution were sampled before the test and after 24 hours for analysis in the Sponsor's laboratory.

Vehicle:

no

Details on test solutions:

Test media were prepared daily, 100g of POLYOL TD was dissolved per one litre of aerated dilution water as a stock solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish (i.e. Brachydanio rerio) noted in report (page 8), but no explicit details of test organisms provided.


ACCLIMATION
- Acclimation period: Fish were placed in an internal quarantine for 14 days prior to the commencement of the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not specified.

Hardness:

Equivalent to 250 ± 25 mg calcium carbonate/L.

Test temperature:

24±1ºC

pH:

actual values recorded: pH 7.4 - 8.1.

Dissolved oxygen:

actual values recorded: 100 - 103 % in fresh solutions; 66 - 94 % in used solutions.

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations 0, 500, 1000, 2000, 4000, 8000 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Fill volume 5L.
- Aeration: water aerated prior to use.
- Renewal rate of test solution (frequency/flow rate): Solutions exchanged every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Dilution water
The composition ofthe dilution water:
1. Calcium chloride
Dissolve 11.76 g CaCl2x 2H2Oin water and dilute to 1 litre.
2. Magnesium sulphate
Dissolve 4.93 g MgS04 x 7H2Oin water and dilute to 1 litre.
3. Sodium bicarbonate
Dissolve 2.59 g NaHC03 in water and dilute to 1 litre.
4. Potassium chloride
Dissolve 0.23 g KCI in water and dilute to 1 litre.
Mix 1-4 in water and dilute to 40 litres.

Before use the water should be oxygenated with an air pump, a plastic tube with sintered end. The pH value may be adjusted with HCI or NaOH.
Adjusted water should not be aerated again. The dilution water should allow survival of zebra fish for at least 96 hrs, Reverse osmosis (RO) water was used to prepare the dilution water.


OTHER TEST CONDITIONS
- Adjustment of pH: performed using NaOH or HCl solutions as appropriate.
- Photoperiod: light:dark 16:8 hours daily.
- Light intensity: Not specified / normal laboratory illumination.

Reference substance (positive control):

yes

Remarks:

Disodium heptachromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1 250 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: Not reported
- Observations on body length and weight: at the end of the study surviving fish had a mean body weight of 0.22 g (range - 0.12 - 0.33) and a mean length of 28 mm (range 25 - 30 mm).
- Other biological observations: visible abnormalities (e.g. darker pigmentation, loss of equilibrium, disturbance in swimming behaviour or increased respiration rate) were observed in each fish in the 1000 mg/L group.
- Mortality of control: None.

Results with reference substance (positive control):

The fish batch was qualified for testing purposes with disodium heptachromate. The 24 hour LC50 value fulfilled the aceptable criterion of 200-400 mg/L (SS 028162).

Reported statistics and error estimates:

No details reported.

Sublethal observations / clinical signs:

Mortality in the test and control group during the 96 hours of exposure.

Group	Concentration (mg/L)	0	3	24	48	72	96	Total
Control	0	0	0	0	0	0	0	0
Test	500	0	0	0	0	0	0	0
Test	1000	0	1	2	2	2	2	2
Test	2000	0	7	7	7	7	7	7
Test	4000	0	7	7	7	7	7	7
Test	8000	0	7	7	7	7	7	7

 

Validity criteria fulfilled:

yes

Conclusions:

A 96 hour acute semi-static toxicity study in zebra fish (Brachydanio rerio) was performed to assess the toxicity of Polyol TD. The study was performed according to GLP and the OECD 203 Test Guideline. The 96 hour LC50 was calculated to be 1250 mg/L (based nominal exposure concentrations), the corresponding NOEC was 500 mg/L (nominal concentration).

Executive summary:

In a 96-h acute toxicity study, zebra fish (Brachydanio rerio) was exposed to Polyol TD at nominal concentrations of 0 (control), 500, 1000, 2000, 4000, 8000 mg Polyol TD/L under semi-static conditions.

The 96-h LC₅₀ was 1250 mg Polyol TD/L.  The NOEC value, based on mortality was 500 mg Polyol TD/L, respectively. Visible abnormalities (e.g. darker pigmentation, loss of equilibrium, disturbance in swimming behaviour or increased respiration rate) were observed in each fish in the 1000 mg/L group.

 

Results Synopsis

 

Test organism: zebra fish (Brachydanio rerio)

Test Type (Flowthrough, Static, Static Renewal): semi-static

LC₅₀: 1250 mg Polyol TD/L                      95% C.I.: N/A

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

Endpoint(s) Effected: mortality

Description of key information

One short-term toxicity test with zebra fish (Brachydanio rerio) was conducted. In this 96-h acute toxicity study, zebra fish (Brachydanio rerio) was exposed to Polyol TD at nominal concentrations of0(control), 500, 1000, 2000, 4000, 8000 mg Polyol TD/L under semi-static conditions.

The 96-h LC₅₀ was 1250 mg Polyol TD/L.  The NOEC value, based on mortality was 500 mg Polyol TD/L, respectively. Visible abnormalities (e.g. darker pigmentation, loss of equilibrium, disturbance in swimming behaviour or increased respiration rate) were observed in each fish in the 1000 mg/L group.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

1 250 mg/L