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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
2-acrylamido-2-methylpropanesulfonic acid
IUPAC Name:
2-acrylamido-2-methylpropanesulfonic acid
Constituent 2
Chemical structure
Reference substance name:
ammonium (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidate
EC Number:
611-646-3
Cas Number:
58374-69-9
Molecular formula:
C7H12NO4S.H4N
IUPAC Name:
ammonium (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidate
Details on test material:
- Name of test material (as cited in study report): OS 114454
- Substance type: organic
- Physical state: very pale brown clear liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 50%
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: oom temperature

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 200 mg/l
- Sampling method: no data
- Sample storage conditions before analysis: no data

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow
- Strain:
- Source: Neil Hardy Aquatica Carshalton, UK,
- Age at study initiation (mean and range, SD): juvenile
- Length at study initiation: 3.8 cm (SD 0.4)
- Weight at study initiation: 0.54 g (SD 0.12)
- Feeding during test: no
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Type and amount of food: Tetramin flake food
- Feeding frequency: no data
- Health during acclimation: 3% mortality in 7 days prior to test

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No

Test conditions

Hardness:
100 mgll as CaC03
Test temperature:
21±1°C
Dissolved oxygen:
>7.6 mg O2/l
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal: 200, 360, 640, 1120 and 2000 mg/l
Measured: 200, 367, 648, 1133 and 2066 mg/l at study initiation
Details on test conditions:
TEST SYSTEM
- Test vessel: glass
- Type: closed
- Fill volume: 20 l
- Aeration: yes
- 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: dechloinated laboratory tap water
- Total organic carbon: 1 mg/l
- Particulate matter: no data
- Metals: all below the prescribed concentration
- Pesticides: <0.08 µg/l (all below the prescribed concentration)
- Chlorine: 0.22 mg/l
- Alkalinity: 80 mg/l
- Ca/mg ratio: 5:1
- Conductivity: 382 MICSM
- Intervals of water quality measurement: initially and every 24 hours for temerature, pH and dissolved oxygen
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours light/8 hours darkness
- Light intensity: no data
EFFECT PARAMETERS MEASURED: mortality and behavioural effects
TEST CONCENTRATIONS
- Spacing factor for test concentrations: no data
- Justification for using less concentrations than requested by guideline: based on range-finding study
- Range finding study
- Test concentrations: 200 and 2000 mg/l
- Results used to determine the conditions for the definitive study: yes

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
640 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
other: mortality and behaviour
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1 400 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 1300-1600 mg/l
Details on results:
- Behavioural abnormalities: yes, loss of equilibrium at concentrations greater than 640 mg/l
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: none

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute LC50 at 96 hours exposure of the test article to the freshwater fish Fathead Minnow (Pimephales promelas) was determined to be1400 mg/l with 95% confidence limits of 1300-1600 mg/l. The No Observed Effect Concentration (NOEC) was 640 mg/l.