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Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 24-30, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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: particulate/powder
Details on test material:
Purity: 9 9.8% w/w

Identification: N, N’-methylene-bis-acrylamide
Batch: LQ27A1696
Manufacturing date: 13 January 2016
Expiry date: 12 January 2018
Supplier: SNF SAS
Appearance: White powder
Packaging: White opaque PE flask
Quantity received: 2 x 800 g
Date of receipt 08 February 2016

Storage In darkness at room temperature

Identification number of the test item 16-033
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Autosampler: Varian Prostar 410
Buffers:
Sodium hydroxide 0.1N
A quantity 4.0 g (to the nearest 0.01 g) of sodium hydroxide was weighed into a 1000-mL volumetric flask and the volume was made up with water. The solution was magnetically stirred until complete dissolution.

Buffer pH 4.0
Quantities of 2.96 g of citric acid and 2.73 g of dibasic sodium phosphate (to the nearest 0.01 g) were weighed into a 500-mL volumetric flask.
The volume was made up with water and the solution was magnetically stirred until complete dissolution then the pH was verified.

Buffer pH 7.0
A quantity of 6.8 g (to the nearest 0.01 g) of potassium dihydrogen phosphate was weighed into a 1000-mL volumetric flask.
A volume of 296 mL of the sodium hydroxide 0.1N solution was added and the volume was made up with water. The solution was magnetically stirred until complete dissolution then the pH was verified.

Buffer pH 9.0
Quantities of 3.8 g of potassium chloride and 3.1 g (to the nearest 0.01 g) of boric acid were weighed into a 1000-mL volumetric flask.
A volume 213 mL of the sodium hydroxide 0.1N solution was added and the volume was made up with water. The solution was magnetically stirred until complete dissolution then the pH was verified.
Details on test conditions:
The preliminary test is performed at 50 °C ± 0.5 °C and pH 4.0, 7.0 and 9.0.
Duplicate assays are conducted. The resulting number of samples analysed is 12 (six at T = 0 and six at 5 days).
If less than 10% of hydrolysis is observed after 5 days, the test item is considered hydrolytically stable and the study will be stopped.
In all other cases and at the pH values for which the above condition is not satisfied, an advanced assay is conducted.
Duration of testopen allclose all
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
49.4 mg/L
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
49.26 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
50.96 mg/L
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
52.06 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
51.5 mg/L
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
51.03 mg/L
Number of replicates:
2 replicates per pH
Positive controls:
no
Negative controls:
no
Statistical methods:
No statistical analysis performed.

Results and discussion

Transformation products:
not measured
Total recovery of test substance (in %)open allclose all
% Recovery:
99.1
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
99.6
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
98.4
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
96.9
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
97.9
pH:
9
Temp.:
50 °C
Duration:
5 d
% Recovery:
90.1
pH:
9
Temp.:
50 °C
Duration:
5 d
Dissipation DT50 of parent compound
Key result
Remarks on result:
hydrolytically stable based on preliminary test

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The results of the abiotic degradation are summarised as following:

At pH 4, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.

At pH 7, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.

At pH 9, less than 10% of degradation was observed after 5 days. The test item was considered hydrolytically stable and no additional assay was done.