N,N'-methylenediacrylamide

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Test tank temperature was outside recommended range, but was considered acceptable & without influence on test results since differences from the right temperature were not considerable (the gap from acceptable range was 0.4°C) & all organisms were alive.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-methylenediacrylamide

EC Number:

203-750-9

EC Name:

N,N'-methylenediacrylamide

Cas Number:

110-26-9

Molecular formula:

C7H10N2O2

IUPAC Name:

N,N'-methylenediacrylamide

Test material form:

solid: crystalline

Details on test material:

Purity: >99.9%

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

10 - 250 mg/L as CaCO3

Test temperature:

Temperature (°C)

Negative Control

Min 22.1 ; Max 24.1 ; Mean 23.0 ; S.D. 0.5

100.0 mg/L

Min = 21.1 ; Max = 23.8 ; Mean = 22.6 ; S.D. = 0.7

The temperature range provided by OECD No. 203 (1992) is 22.0 ± 2.0 °C, this range was corrected according to the probe precision (therefore the range to be considered for the test was 21.5 – 24.5 °C ), while temperature values were corrected according to the correction factor (cw) of each probe

pH:

Negative control tank: 7.21 – 7.44
Test item tank: 7.49 – 7.64

Dissolved oxygen:

Negative control tank: 66.1 – 70.1 %
Test item tank: 65.5 – 76.0 %

Nominal and measured concentrations:

In fresh solution the analytical recovery was 93.9% of the nominal concentration while in the spent solution (after 96 hours of exposure) the analytical recovery of the concentration was 106.6% of the nominal value.

Since the analytical recoveries of N,N'-Methylenediacrylamide were in the range 80 % - 120 %, the toxic end-points were calculated in terms of nominal test item concentration (100 mg/L).

Details on test conditions:

Monitoring of test medium quality: At the start and at the end of the test, in the negative control and in the test item solution.

Light intensity: 225 - 279 Lux
Light Regime: 12 hours light and 12 hours dark
Test temperature: 21.1 – 24.1 °C
pH of test medium: Negative control tank: 7.21 – 7.44
test item tank: 7.49 – 7.64
Oxygen Concentration: Negative control tank: 66.1 – 70.1 %
test item tank: 65.5 – 76.0 %

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

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)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Since the analytical recoveries of N,N'-Methylenediacrylamide were in the range 80 % - 120 %, the toxic end-points were calculated in terms of nominal test item concentration, as recommended by OECD Guidance Document on testing of difficult substances No. 23 (2000).

The obtained experimental results allowed to determine LC0, the LC50 , the LC100 and the NOEC at 24, 48, 72 and 96 hours (mortality as endpoint).

The LC0 and LC100 values at each observation time were directly extracted from the Raw Data, while the NOEC was calculated by comparison with the negative control performed by CETIS software v.1.8.7.7 with Fisher Exact Test.

The LC0 and NOEC at all time points was 100 mg/l. The LC50 and LC100 at all time ppoints was greater than 100 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of N,N'-Methylenediacrylamide was tested in a GLP guideline study on zebra fish under static conditions. The NOEC at 96 hours 100 mg/L (single concentration).