Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2011
Reliability:
1 (reliable without restriction)
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. certificate)
Remarks:
Staatliches Gewerbeaussichtsamt, Hildesheim, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Wacker Catalyst 41, Ch. UL03475
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Estimation method (if used):
Samples were taken at test start (0 min) and until plateau phase
was reached. All samples were analysed immediately (max. 3 min
until start of analyses) via GC-SPME-FID for the transformation
product ethanol.
Duration of testopen allclose all
Duration:
3 min
pH:
4
Temp.:
20
Initial conc. measured:
ca. 0.2 other: v/v %
Duration:
3 min
pH:
7
Temp.:
20
Initial conc. measured:
ca. 0.2 other: v/v %
Duration:
3 min
pH:
9
Temp.:
20
Initial conc. measured:
ca. 0.2 other: v/v %

Results and discussion

Transformation products:
yes
Identity of transformation products
No.:
#1
Reference
Reference substance name:
Unnamed
Inventory number:
InventoryMultipleMappingImpl [inventoryEntryValue=EC 200-578-6]
IUPAC name:
ethanol
CAS number:
64-17-5
Total recovery of test substance (in %)open allclose all
% Recovery:
> 70 - < 110
St. dev.:
20
pH:
4
Temp.:
20 °C
Duration:
ca. 3 min
% Recovery:
> 70 - < 110
St. dev.:
20
pH:
7
Temp.:
20 °C
Duration:
ca. 3 min
% Recovery:
> 70 - < 110
St. dev.:
20
pH:
9
Temp.:
20 °C
Duration:
ca. 3 min

Any other information on results incl. tables

Reaction rate constants and half lives for all tested conditions could not be assessed, as the

hydrolysis reaction was completed before (or within) the first analysis.

Hydrolysis Time

[min]

 

Ethanol content

[%, v/v]

pH 4

pH 7

pH 9

 

0

(0.5371)

(1.1523)

(0.5344)

10

0.2536

0.3023

0.3053

20

0.2574

0.2569

0.1569

30

0.3148

0.2301

0.1753

40

0.1834

0.2453

0.1793

50

0.1845

n.a.

n.a.

60

0.1796

n.a.

n.a.

MV

0.183

0.244

0.171

SD

0.00210

0.0110

0.00975

RSD [%]

(plateau phase)

1.15

4.51

5.70

 

 

Bold= plateau phase

n.a. = not applicable (not sampled as plateau phase was reached)

() = out of calibration range

MV = mean value of the last three samples

SD = standard deviation

RSD [%] = relative standard deviation

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Reaction rate constants and half lives for all tested conditions could not be assessed, as the
hydrolysis reaction was completed before (or within) the first analysis. Taking the visual
observation of the immediate precipitation into account, it could be assumed that the
hydrolytical half life is significantly lower than the analysis time (15 minutes at 40 °C) needed
for the measurement of the samples.
WACKER Katalysator 41 is highly hydrolytically unstable. The hydrolytically half life of the test
item was below the scope of the employed methodology and could not be assessed following
the principles of OECD Guideline 111 for all tested conditions