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Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)
Remarks:
from MHRA (UK GLP Monitoring authority)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
482-140-6
EC Name:
-
Cas Number:
13641-96-8
Molecular formula:
Hill formula: C6 H7 N O3 CAS formula: C6 H7 N O3
IUPAC Name:
2-isocyanatoethyl prop-2-enoate

Study design

Buffers:
Preparation of buffer solutions
pH 4.0 : Potassium dihydrogen orthophosphate (3.00 g) and disodium hydrogen
orthophosphate dodecahydrate (6.40 g) were dissolved in purified water (950 ml)
and the pH was adjusted to 4.0 ± 0.05 with orthophosphoric acid. The volume was
then adjusted to 1000 ml with purified water.
pH 7.0 : Potassium dihydrogen orthophosphate (6.80 g) was dissolved in purified water
(950 ml), 1M sodium hydroxide (30 ml) was added and the pH was adjusted to
7.0 ± 0.05 with 1M hydrochloric acid. The volume was then adjusted to 1000 ml
with purified water.
pH 9.0 : Disodium tetraborate decahydrate (16.6 g) and potassium dihydrogen
orthophosphate (1.80 g) were dissolved in purified water (950 ml) and the pH was
adjusted to 9.0 ± 0.05 with 1M hydrochloric acid.. The volume was then adjusted
to 1000 ml with purified water.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Wheaton vials

GC CONDITIONS
Instrument: Hewlett Packard 5890 Gas Chromatograph
Column: HP-1 (25 m x 0.32 mm internal diameter x 0.52 μm film thickness)
Carrier gas: Helium
Flow: 1.6 ml/min
Oven temperature
Initial: 50°C
Ramp: 10°C/min to 150°C, then 50°C/min to 300°C
Final: 300°C (5 min)
Injection temperature: 250°C
Injection volume: 1 Hl (splitless)
Detector: FID
Detector gas flows
Air: Approximately 300 ml/min
Hydrogen: Approximately 30 ml/min
Auxiliary (helium) 29 ml/min
Detector temperature: 300°C
Retention time: Approximately 6.5 minutes

TEST MEDIUM
- Volume used/treatment
- Kind and purity of water:
- Preparation of test medium:
- Identity and concentration of co-solvent:

OTHER TEST CONDITIONS
- Adjustment of pH: yes
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
50% hydrolysis had occurred after 10 minutes, indicating a half-life of significantly less than 1 day under environmental conditions (25°C). The test substance was determined to be hydrolytically unstable under acidic, neutral and basic conditions.
Transformation products:
not specified
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
50 °C
DT50:
< 10 min
Type:
(pseudo-)first order (= half-life)
pH:
7
Temp.:
50 °C
DT50:
< 10 min
Type:
(pseudo-)first order (= half-life)
pH:
9
Temp.:
50 °C
DT50:
< 10 min

Any other information on results incl. tables

pH

  Ct (mg/l)       

t0min

 t10min

       

 Measured

 Mean

 Measured

 Mean

 

4

 76, 79

 78

 0.2, 0.1

 0.2

 

7

 71, 63

 67

 0.3, 0.3

 0.3

 

 9

 48, 54

51 

 1.4, 1.4

 1.4

 

  Where Ct is the concentration of AOI in solution at time tmin (in minutes)

pH change during preliminary hydrolysis test

 Nominal pH Initial buffer pH   Buffer pH after addition of test substance
4 3.9  4.2
7 7.0  7.0
9 9.0  9.0

Applicant's summary and conclusion