Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
Test material
- Test material form:
- solid: flakes
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Technically not Feasible.
- Executive summary:
Analytical monitoring of the test tem in the aqueous puffer solutions used for tha hydrolysis studie according to the guideline OECD 111 is not possible due to the low water solubility of the test item and high analytical detection limit / low sensitivity of the analytical method.
No test item could be detected in aqueous samples of aquatoxicity studies (Noack ID: 180706CM / DAI18315 and SPO18315) when test samples were prepared as water accommodated fractions (WAF). Only approximately 0.1 to 1 mg test item/L can be detected though a LC-MS/MS system, known as analytical device enabling the implementation of analytical methods with highest sensitivity. Furthermore, no stock solutions of the test item, for application into an aqueous phases, in concentrations adequate for analytical monitoring can be prepared. Only 50 mg test item/L can be dissolved in toluene under heating (Noack ID: 180706CM / CAD18315N) and this solution is unsuitable for aqueous spiking.
In combination, these facts impair the accurate deduction of the study endpoints required by the guideline OECD111, as a reliable and sensitive quantitation of the test item in the aqueous buffer solutions during the experiments is mandatory for their calculation. The low water solubility, the low sensitivity of the analytical method and the the lack of suitable solvents for the praparation of stock solutions for spiking of aqueous solutions, led to the assessmet, that a hydrolysis study according to OECD guideline 111 is technically not feasible.
The experimental determination of the hydrolysis as a function of pH of
LICOCARE RBW 300 FL TP
according to the OECD guideline OECD 111 isTechnically not Feasible.
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