Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Stability in organic solvents and identity of relevant degradation products
Administrative data
Link to relevant study record(s)
- 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
- Reason / purpose for cross-reference:
- read-across source
- Test substance stable:
- yes
- Transformation products:
- no
- Conclusions:
- The test material is stable for at least 21 days as a solution in Arachis oil BP.
- Executive summary:
Arachis oil BP is a vehicle used for a repeated dose oral toxicity range-finding study. The stability of the test material in Arachis oil BP was determined by comparing the chromatograms of freshly prepared solutions of the test material in the oil to oil solutions stored for 21 days. Data obtained from the analysis showed the test substance is stable in Arachis oil BP for at least 21 days. Concentrations of the test material after 21 days storage in the oil were 101 - 103 % of the initial concentration.
Reference
The stability of the test material was determined by comparing peak areas obtained for freshly prepared solutions to solutions stored for 21 days at 4 0C in the dark. Data is summarized in Table 3. Example chromatograms of a standard and the test material at 250 mg/mL are attached as Figure 2.
Table 3: Stability of Test Material After 21 Days
Nominal Concentration (mg/mL) |
Initial Concentration Found – Day 0 (mg/mL) |
Concentration Found – Day 21 |
|
mg/mL |
% of initial |
||
3.75 |
3.69 |
3.79 |
103 |
250 |
257 |
261 |
101 |
Description of key information
The test material is stable for at least 21 days as a solution in Arachis oil BP.
Additional information
Arachis oil BP is a vehicle used for a repeated dose oral toxicity range-finding study. The stability of the test material in Arachis oil BP was determined by comparing the chromatograms of freshly prepared solutions of the test material in the oil to oil solutions stored for 21 days. Data obtained from the analysis showed the test substance is stable in Arachis oil BP for at least 21 days. Concentrations of the test material after 21 days storage in the oil were 101 - 103 % of the initial concentration.
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