Reaction products of furan-2,5-dione and octadec-1-ene

Stability in organic solvents and identity of relevant degradation products

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

stability in organic solvents and identity of relevant degradation products

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Analytical assessment as part of a GLP Guideline study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard analytical procedures

GLP compliance:

yes

Test substance stable:

yes

Transformation products:

not measured

Conclusions:

The stability and homogeneity of the test item formulation in arachis oil were determined by Harlan Laboratories Ltd., Shardlow, UK, Analytical Services.  Results show the formulations to be stable for at least twenty one days.  Formulations were therefore prepared weekly and stored at approximately 4 °C in the dark.

Reference 2

Endpoint:

stability in organic solvents and identity of relevant degradation products

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This study was conducted on 2,5-furandione, dihydro-, mono-C15- 20-alkenyl derivatives (CAS 68784-12-3), an analogue substance used as the source of information for the assessment of the target substance through read-across. Therefore, this study is informative for evaluation of the environmental fate and toxicity of the target substance, Reaction products of furan-2,5-dione and octadec-1-ene (known here as n-ODSA EC 701-338-8; no CASRN available), and it is adequate for classification and risk assessment.

Reason / purpose for cross-reference:

read-across source

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard analytical procedures

GLP compliance:

yes

Test substance stable:

yes

Transformation products:

not measured

Conclusions:

The stability and homogeneity of the analogue test item formulation (C15-20 ASA in arachis oil) were determined by Harlan Laboratories Ltd., Shardlow, UK, Analytical Services.  Results show the formulations to be stable for at least twenty one days.  Formulations were prepared weekly and stored at approximately 4 °C in the dark. This study is relevant for the registered substance, n-ODSA EC 701-338-8, which is a close structural analogue, and is adequate for filling the data requirement for the registration of this substance.

Description of key information

Stable for 21 days

Additional information

The analogue C15 -20 ASA test substance was found to be stable in arachis oil for 21 days. It is expected that the registered substance, n-ODSA EC 701-338 -8, would behave similarly.

This information is from the substance 2,5-furandione, dihydro-,mono-C15-20-alkenylderivatives (CAS 68784-12-3, a mixture of a hexadecenyl- and octadecenyl succinic anhydrides), an analogue used for the assessment of several endpoints through read-across. The hypothesis for read-across between the substance being registered (Reaction products of furan-2,5-dione and octadec-1-ene; known here asn-ODSA EC 701-338-8; no CASRN available), and the analogue substance is a common functional group: a 2,5-furandione, dihydro- structure, also known as a succinic anhydride, to which is attached a long-chain monounsaturated olefin. In the environment, the anhydride moiety is quickly hydrolysed to form a dioic acid.  When the substance to be registered and the analogue substance are compared, changes in the purity of the starting olefin stock, or small differences in the length (between sixteen and twenty) or arrangement (linear or branched) of the carbon chain are not anticipated to significantly affect the environmental fate properties or the toxicity of the substances. For each endpoint study based upon read-across, the analogue approach is substantiated by an evaluation provided in the Analogue Approach Report Format (AARF) attached to the endpoint study summary file. The AARF allows the read-across information to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.