Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
other: Expert statement
Adequacy of study:
key study
Study period:
25-Mar-2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No GLP test was performed. Only an Expert Statement was issued.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: Oxirane, mono[(C12-14-alkyloxy)methyl] derivs. / ERC Nr 17
Batch Number: AA82003300
Purity: C-12 MGE 60%, C-14 MGE 20%
Appearance: Clear liquid
Expiry Date: November 2013
Expiry Date
(handled at Harlan Laboratories): November 30, 2013
Storage Conditions: At room temperature at about 20 °C
Radiolabelling:
no

Study design

Analytical monitoring:
not specified
Details on sampling:
Not applicable
Positive controls:
no
Negative controls:
no

Results and discussion

Transformation products:
not specified
Total recovery of test substance (in %)
Remarks on result:
other: Please see remarks.
Remarks:
The solubility of the test item in water is fairly low. In study C81364 it was determined to be < 0.5 mg/L. It is outlined in the EC guideline C.7 as well as in the OECD guideline 111, that the hydrolysis test is only applicable to water soluble substances.
Dissipation DT50 of parent compound
Remarks on result:
not determinable

Any other information on results incl. tables

In study C81375 Harlan Laboratories was supposed to perform the testing for abiotic degradation (hydrolysis) of Oxirane, mono[(C12-14-alkyloxy)methyl] derivs. / ERC Nr 17.Due to the special properties of the test item, it was decided not to perform the experimental hydrolysis test.

 

The solubility of the test item in water is fairly low. In study C81364 it was determined to be < 0.5 mg/L. It is outlined in the EC guideline C.7 as well as in the OECD guideline 111, that the hydrolysis test is only applicable to water soluble substances.

 

 

Therefore it was suggested not to perform the hydrolysis test with Oxirane, mono[(C12-14-alkyloxy)methyl] derivs. / ERC Nr 17.

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Executive summary:

In study C81375 Harlan Laboratories was supposed to perform the testing for abiotic degradation (hydrolysis) of Oxirane, mono[(C12-14-alkyloxy)methyl] derivs. / ERC Nr 17.Due to the special properties of the test item, it was decided not to perform the experimental hydrolysis test.

 

The solubility of the test item in water is fairly low. In study C81364 it was determined to be < 0.5 mg/L. It is outlined in the EC guideline C.7 as well as in the OECD guideline 111, that the hydrolysis test is only applicable to water soluble substances.

 

 

Therefore it was suggested not to perform the hydrolysis test with Oxirane, mono[(C12-14-alkyloxy)methyl] derivs. / ERC Nr 17.