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Environmental fate & pathways

Hydrolysis

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Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in a facility operating to Good Laboratory Practice (GLP) within the national GLP monitoring programme. However, no experimental testing was carried out.
Principles of method if other than guideline:
Determined using QSAR.
GLP compliance:
no
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice (GLP) within the national GLP monitoring programme. However, no experimental testing was carried out. Therefore, a formal claim of GLP compliance cannot be made.
Specific details on test material used for the study:
Identification: FAT #: 93580/A
Description: White-yellowish waxy solid
Batch: 0022357000
Purity: 94.3 %
Expiry / Retest Date: 15 December 2015
Storage Conditions: Room temperature in the dark
Radiolabelling:
no
Analytical monitoring:
no
Details on sampling:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Buffers:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Estimation method (if used):
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Details on test conditions:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Number of replicates:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Positive controls:
no
Negative controls:
no
Statistical methods:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Preliminary study:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Test performance:
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
Not applicable: The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation
software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.
pH:
4
Temp.:
20 °C
Remarks on result:
other: stable towards hydrolysis
pH:
7
Temp.:
20 °C
Remarks on result:
other: stable towards hydrolysis
pH:
9
Temp.:
20 °C
Remarks on result:
other: stable towards hydrolysis
Other kinetic parameters:
None
Details on results:
Using HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency, all nine potentially hydrolysable components of the test item were considered to be stable towards hydrolysis at pH 4, 7 and 9.
Validity criteria fulfilled:
not applicable
Conclusions:
It was concluded that the test item would be stable towards hydrolysis at pH 4, 7 and 9.
Executive summary:

FAT 93580/A was evaluated for hydrolytic stability. Due to the complex nature and low solubility of the test item in water, it was considered that determination of the hydrolytic stability according to Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 was not feasible.

A preliminary scientific assessment of the main constituent (ten components) of the test item indicated that nine of these components contained at least one potentially hydrolysable functional group; whereas, the remaining component did not contain any hydrolysable functional groups, and thus, would be stable towards hydrolysis.

The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.

Using HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency, all nine potentially hydrolysable components of the test item were considered to be stable towards hydrolysis at pH 4, 7 and 9.

Hence; it was concluded that the test item would be stable towards hydrolysis at pH 4, 7 and 9.

Description of key information

FAT 93580/A was evaluated for hydrolytic stability. Due to the complex nature and low solubility of the test item in water, it was considered that determination of the hydrolytic stability according to Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 was not feasible.

A preliminary scientific assessment of the main constituent (ten components) of the test item indicated that nine of these components contained at least one potentially hydrolysable functional group; whereas, the remaining component did not contain any hydrolysable functional groups, and thus, would be stable towards hydrolysis.

The hydrolytic stability of each of the nine, potentially hydrolysable components was estimated using the specialist estimation software, HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency.

Using HYDROWIN v2.00 (September 2010), © 2000 U.S. Environmental Protection Agency, all nine potentially hydrolysable components of the test item were considered to be stable towards hydrolysis at pH 4, 7 and 9.

Hence; it was concluded that the test item would be stable towards hydrolysis at pH 4, 7 and 9.

Key value for chemical safety assessment

Additional information