Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
15 - 19 Mar 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom (date of inspection 23 Mar 1998)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given- Physical state: straw coloured liquid- Analytical purity: no data - Storage condition of test material: room temperature, in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: Water samples were taken from the control and each replicate test vessel at 0, 24 and 48 hours.- Sample storage conditions before analysis: Duplicate samples and samples at 24, 48 and 72 hours were taken and stored frozen (approximately -20 °C) for further analysis if necessary.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Prior to addition of the test material, the dechlorinated tap water was stirred by magnetic stirrer such that a vortex depth of approximately 25% of the overall height of the water column was achieved. An amount of test material (2.0 g) was added to the vortex of 20 litres of dechlorinated tap water and stirred for 23 hours to give the 100 mg/L loading rate. The stirring was stopped after 23 hours and the mixture allowed to stand for 1 hour. The WSF was the removed by filtration through 0.45 µm filters.- Controls: yes, dechlorinated tap water

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM- Common name: rainbow trout- Source: Donnington Fish Farm, Upper Swell, Gloucestershire, UK (in-house since 23 Feb 1999)- Length at the end of the definitive study (mean and SD): 4.1 cm (SD = 0.1)- Weight at the end of the definitive study (mean and SD): 0.88 g (SD = 0.14)- Feeding during test: NoneACCLIMATION- Acclimation period: from 3 - 15 Mar 1999- Acclimation conditions (same as test or not): Same as test (14 °C, lighting cycle: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods)- Type and amount of food: commercial trout pellets- Feeding frequency: The fish were not fed for 24 h prior to the start of the test.- Health during acclimation (any mortality observed): No mortality in the 7 days prior to the start of the test

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
approximately 100 mg/L CaCO3
Test temperature:
14 °C
pH:
7.5 - 7.8
Dissolved oxygen:
8.6 - 9.8 mg/L
Nominal and measured concentrations:
Nominal: 0 and 100 mg/Lmeasured: < Limit of quantification (0.02 mg/L)
Details on test conditions:
TEST SYSTEM- Test vessel: - Material, size: 20 L glass vessels - Aeration: gentle aeration via narrow bore glass tubes- Renewal rate of test solution (frequency): every 24 hours- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener). It was then passed through a series of computer controlled plate heat exchanges to achieve the required temperature (14 °C).- Alkalinity: approximately 100 mg/L as CaCO3- Intervals of water quality measurement: Daily for pH, dissolved oxygen and temperature.OTHER TEST CONDITIONS- Photoperiod: 16 h light/ 8 h dark with 20 minutes dawn and dusk transition periodsEFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities and symptoms of toxicity at 3, 6, 24, 48, 72 and 96 hours. The fish from the control were weighted and measured at the end of the exposure period.
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Observations on body length and weight: Control at the end of the exposure period: mean standard length of 41 mm (SD = 0.1), mean weight of 0.88 g (SD = 0.14)- Mortality of control: No- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: At the start of each mixing period the test material was observed to form pale straw coloured oily globules within the vortex and also throughout the water column. After 23 hours of stirring and 1 hour of standing the test material was observed to form an oily slick at the water surface with globules throughout the water column. After filtering and during testing the 100 mg/L loading rate WSFs were observed to be clear, colourless solutions.

Any other information on results incl. tables

Table 1: Cumulative mortality data in the definitive study

Nominal loading rate
(mg/L)

Cumulative mortality (initial population)

% mortality

3 h

6 h

24 h

48 h

72 h

96 h

96 h

Control

0

0

0

0

0

0

0

100 R1

0

0

0

0

0

0

0

100 R2

0

0

0

0

0

0

0

h = hours

R = replicate

Applicant's summary and conclusion