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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-03-20 to 2002-03-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid
EC Number:
602-890-1
Cas Number:
122731-58-2
Molecular formula:
C11 H12 N2 O7
IUPAC Name:
rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Three test solutions, buffered to pH values of 4, 7 and 9, each with a ZK 39166 concentration of approx. 10 mg/L, were prepared by adding a stock solution of ZK 39166 in acetonitrile to the corresponding buffer solution which had been equilibrated at 50 °C for one hour followed by purging with nitrogen to remove dissolved oxygen. All experiments were conducted using sterilized equipment and buffer solutions.
Buffers:
-0.05 M acetate buffer solution pH 4
0.657 g =0.008 mol sodium acetate p.a. Merck Art. 106268 (M = 82.03 g/mol) and
2.4 mL =0.042 mol acetic acid 100 % p.a. Merck Art. 100063 E (M = 60.05 g/mol, density = 1.05 g/mL
were dissolved to 1000 mL with double distilled water. The pH value was adjusted to 4 by adding acetic acid (see above).
-0.05 M phosphate buffer solution pH 7
4.34 g=0.031 mol disodium hydrogen phosphate Merck Art. 106566 (M = 141.96 g/mol) and
2.64 g = 0.019 mol potassium dihydrogen phosphate Merck Art. 105108 (M = 136.09 g/mol) were dissolved to 1000 mL with double distilled water. The pH value was adjusted to by adding 0.1 M sodium hydroxide solution (Titrisol Merck Art. 109959)
-0.05 M borate buffer solution pH 9
2.52 g=0.0125 mol disodium tetraborate Merck Art. 106309 (M = 201.22 g/mol) and 46 mL=0.0046 mol hydrochloric acid Titrisol Merck Art. 109973 (0.1 M) were dissolved to 1000 mL with double distilled water. The pH value was adjusted to 9.20 by adding 0.1 M sodium hydroxide solution (Titrisol Merck Art. 109959) in order to take into account the temperature dependence of the pH of this buffer solution 2).
Duration of testopen allclose all
Duration:
119.2 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
10.15 mg/L
Duration:
118.9 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
10.18 mg/L
Duration:
119.8 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
10.22 mg/L
Number of replicates:
3 per pH

Results and discussion

Transformation products:
no
Dissipation DT50 of parent compoundopen allclose all
pH:
9
Temp.:
50
DT50:
> 1 yr
Key result
pH:
7
Temp.:
50
DT50:
> 1 yr
pH:
4
Temp.:
50
DT50:
> 1 yr

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

No hydrolytic degradation occured within five days at pH 4, 7 and 9 at 50 ± 0.1 °C. According to the EC test guideline, ZK 39166 can therefore be considered hydrolytically stable at pH 4, 7 and 9 (DT50 > 1 year at 25 °C).