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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Aug - 2 Sep 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Circular on Test Methods of New Chemical Substances (Japan), fish acute toxicity test
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloroacetic acid
EC Number:
201-178-4
EC Name:
Chloroacetic acid
Cas Number:
79-11-8
Molecular formula:
C2H3ClO2
IUPAC Name:
chloroacetic acid
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Chloroacetic acid
- Physical state: non colored crystalline
- Analytical purity: 100%
_ Vapour pressure: 1 hPa at 20°C
-Water solubility: 45% at 20 °C
- Lot/batch No.: 610C2140
- Stability under test conditions: stable, verified by IR.
- Storage condition of test material: in the cool and dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0, 20, 30, 45, 67, and 100 mg/L, dilution factor: 1.5
- Sampling method: test water was sampled at the study initiation, 24 hours before water change, 48 hours after water change and 72 hours before water exchange.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution was prepared by dissolving 500 mg test substance in dilution water. The nominal concentration of the stock solution was 100 mg/l. Following this, appropriate volumes of the stirring stock solution were added respectively into the test vessels containing 5 Liter test dilution water to obtain the desired test concentrations, no vehicle was applied.

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Medaka (Japanes rice fish)
- Strain: Oryzias latipes
- Source: Amishima Fishing, Yokohama, Japan
- Age at study initiation (mean and range, SD): ca 6 months.
- Length at study initiation (length definition, mean, range and SD): 2.33 cm (2.12 - 2.52 cm), n=10
- Weight at study initiation (mean and range, SD): 0.068 g (0.054 - 0.079 g), n=10
- Feeding during test: no food

ACCLIMATION
- Acclimation period: 7 days
- Type and amount of food: Tetramine, 2% of body weight
- Health during acclimation (any mortality observed): Mortality of 7 days before exposure was <5%.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
55 mg/L (as CaCO3)
Test temperature:
23.7 - 24.0 °C, measured every 24 hours at the change of test solutions
pH:
3.2 - 7.5, measured every 24 hours at the change of test solutions
Dissolved oxygen:
6.4 - 8.3 mg/L, measured every 24 hours at the change of test solutions
Nominal and measured concentrations:
Nominal concentration: 0, 20, 30, 45, 67, 100 mg/L
Measured concentration (TWA): 0, 19.2, 29.8, 43.5, 65.1, 99.1 mg/L

Recovery of test substance is > 80%
Details on test conditions:
TEST SYSTEM
- Test vessel: glass vessel
- Type (delete if not applicable): close, covered with teflon film
- Material, size, headspace, fill volume: Glass, 5.0 L
- Renewal rate of test solution (frequency/flow rate): every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water in Yokohama-city was treated with active charcoal to remove residual chlorine and aerated.
- Alkalinity: 44 mg/L
- Ca/mg ratio: 14/4.2
- Culture medium different from test medium: same medium
- Intervals of water quality measurement: every 6 months

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours in light/8 hours in dark
- Light intensity: < 1000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
LC50, highest concentration in 0% mortality, lowest concentration in 100% mortality

TEST CONCENTRATIONS
- Range finding study: performed
- Test concentrations: 10, 30, 100 mg/L
- Results used to determine the conditions for the definitive study: In 10 mg/L, 0% mortality after 96 hours and no toxicological effect was observed. In 30 mg/L, mortality after 96 hours was 0% but toxicological effect was observed. In 100 mg/L, mortality after 96 hours was 100%.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
71.7 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Remarks:
without pH adjustment
Basis for effect:
mortality (fish)
Remarks on result:
other: 43.5 - 99.1 mg/L
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
43.5 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Remarks:
without pH adjustment
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
99.1 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Remarks:
without pH adjustment
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
72.5 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Remarks:
with pH adjustment
Basis for effect:
mortality (fish)
Remarks on result:
other: 44.1 - 98.9 mg/L
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
44.1 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Remarks:
with pH adjustment
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
98.9 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Remarks:
with pH adjustment
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: No abnormalities were observed in 0, 20, 30 and 45 mg/L. In 67 mg/L, one animal showed paralyzation and dead, thereafter. In 100 mg/L, all animals were dead after 24 hours.
- Mortality of control: 0%
- Other adverse effects control: No adverse effects
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test water was always colorless during test in all concentrations.
Reported statistics and error estimates:
Either Probit test, moving average test or binomial test was applied for LC 50.

Any other information on results incl. tables

Sublethal observations / clinical signs:

There was no significant effect of pH change on the toxiicty to fish observed.

Applicant's summary and conclusion