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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:
1999-09-27 to 1999-11-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

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
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
17 July, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
31 July, 1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-methylenebis[methacrylamide]
EC Number:
219-102-3
EC Name:
N,N'-methylenebis[methacrylamide]
Cas Number:
2359-15-1
Molecular formula:
C9H14N2O2
IUPAC Name:
N,N'-methylenebis(2-methylacrylamide)

Sampling and analysis

Analytical monitoring:
yes
Remarks:
HPLC; HPLC analyses of the test substance concentration were conducted at the beginning and at the end of every 24 h cycle.
Details on sampling:
The samples were filtered (<0.45 pM) and stored at 4 °C until analysis.

Test solutions

Vehicle:
no
Details on test solutions:
At least 2 h before the test the test vessels were filled with the medium to allow equilibration of pH, oxygen and temperature. The pH was not adjusted. The nominal test concentration of 100 mg/L was prepared with tap water. A blank with tap water served as a control.

Test organisms

Test organisms (species):
Poecilia reticulata
Details on test organisms:
TEST ORGANISM
- Common name: Guppy
- Strain: Poecilia reticulata
- Length at study initiation (length definition, mean, range and SD): 1-3 cm
- Method of breeding: Parental and young fish population was held in two 250 L glass aquaria


Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
Observations of the fish were made after 2, 24, 48, 72 and 96 h of exposure.

Test conditions

Hardness:
2.4 -4.1 °F
Test temperature:
21 ± 1 °C
pH:
8.4 - 8.8
Dissolved oxygen:
7.5 - 8.0 mg/L
Nominal and measured concentrations:
preliminary test: 1, 10, 100 mg/L
definitive test: 0 and 100 mg/L nominal/measured
Details on test conditions:
TEST SYSTEM
- Test vessel: 1 L aquaria
- Material, size, headspace, fill volume: all-glass
- Aeration: Tap water from Schlieren, aerated
- Renewal rate of test solution (frequency/flow rate): renewal every 24 h
- 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: Tap water from Schlieren
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14 h photoperiod a day, supplied by overhead white fluorescent tubes


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality of the fish was recorded at the same time intervals.
Dead fish were removed immediately from the test medium and weight and length recorded.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No effects up to 100 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: No adverse effects observed
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: No adverse effects observed
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: No adverse effects observed

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the present 96 h toxicity to fish study the NOEC is considered to be > 100 mg/L. No adverse effects were observed up to the limit concentration of 100 mg/L.
Executive summary:

In a 96 h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, Guppy (Poecilia reticulata) were exposed to N,N'-Methylenebisacrylamide at nominal concentrations of 0 (control) and 100 mg/L under semi-static conditions in tap water. The added test material as determined by HPLC was 100 ± 5 % at all medium renewals. These concentrations remained stable during both renewal periods. Given these results, effect parameters can be based on the nominal test concentrations.

No mortality or other clinical effect was observed at the limit concentration and the control during the 96-hour test period. The 96 h LC50 was >100 mg a.i./L. 

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with Poecilia reticulata.

 

Results Synopsis

Test organism size/age (mean wet weight or length): Guppy (Poecilia reticulata) (1 - 3 cm)

Test Type: Static Renewal

LC50:  >100 mg a.i./L

Endpoint(s) Effected: mortality