Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Details on test material:
Polyol TD, batch no. 3977901, was described as a clear liquid, and stored at ambient temperature in the dark. Stability purity and identity were confirmed by the sponsor in a material safety data sheet (not available).
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:
Portions of the test solution were sampled before the test and after 24 hours for analysis in the Sponsor's laboratory.

Test solutions

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

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.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not specified.

Test conditions

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

Results and discussion

Effect concentrationsopen allclose all
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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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:

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).