Registration Dossier

Environmental fate & pathways

Hydrolysis

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Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline study Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
hydrolysis
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
It is considered appropriate to address data requirements for fatty acids, C14-22, 2-ethylhexyl esters, epoxidized via read-across to members of the epoxidised oils and derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is considered appropriate.
Reason / purpose:
read-across source
Transformation products:
not measured
Remarks on result:
not determinable because of methodological limitations
Remarks:
The attempted hydrolysis study (according to OECD 111) could not be performed due to the low and incomplete solubility of the test material. A quantitative result was therefore unable to be determined.
Conclusions:
No determination of hydrolysis was possible by the OECD 111 guideline due to the negligible solubility of soybean oil, epoxidised in water. Secondly and more critically, the test material found in solution during the water solubility study represented only the lower molecular weight range of the test material components. Therefore working at half this water solubility value, the maximum concentration permitted by the method guideline, was not applicable since the value does not address the more abundant, higher molecular weight fraction of the test material.
Executive summary:

A study was attempted on epoxidized soybean oil (ESBO) according to OECD guideline 111, however due to the low and incomplete solubility of the test material the test could not be performed.

Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is considered appropriate.

According to REACH guidelines a Stability study is not required, as Soybean Oil, epoxidised is considered to be readily biodegradable (Schulthess A.V., 1988).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot no. 396358
Radiolabelling:
no

Study design

Analytical monitoring:
not specified
Details on sampling:
Not applicable.

Results and discussion

Preliminary study:
Not applicable.
Transformation products:
not measured
Dissipation DT50 of parent compound
Remarks on result:
not determinable because of methodological limitations
Remarks:
The attempted hydrolysis study (according to OECD 111) could not be performed due to the low and incomplete solubility of the test material. A quantitative result was therefore unable to be determined.
Details on results:
No determination was possible by Method 111 of the OECD Guidelines for Testing of Chemicals, 12 May 1981 due to the negligible solubility of the test material in water, 1.36 x 10-3 g/l of solution. Secondly and more critically, the test material found in solution during the water solubility study represented only the lower molecular weight range of the test material components. Therefore working at half this water solubility value, the maximum concentration permitted by the method guideline, was not applicable since the value does not address the more abundant, higher molecular weight fraction of the test material.

Applicant's summary and conclusion

Conclusions:
A hydrolysis study according to OECD 111 was not possible due to the low and incomplete solubility of the test material.
Executive summary:

A study was attempted according to OECD guideline 111. However due to the low and incomplete solubility of the test material the test could not be performed.