Registration Dossier
Registration Dossier
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EC number: 603-520-1 | CAS number: 131807-57-3
Stability: thermal, sunlight, metals
Administrative data
Link to relevant study record(s)
- Endpoint:
- stability: thermal, sunlight, metals, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.6313 (Stability to Sunlight, Normal and Elevated Temperature, Metals and Metal Ions)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Substance name: Famoxadone
Lot #: JE874-313
Purity: 99.4% - Test substance thermally stable:
- yes
- Key result
- Operating temp.:
- 54 °C
- Key result
- Operating temp.:
- 25 °C
- Test substance stable to metals / metal ions:
- yes
- Remarks:
- At 25°C or 54°C in the dark, solid famoxadone technical samples exposed to aluminum or iron metal are stable after 14 days.
- Conclusions:
- At normal (25°C) or elevated (54°C) temperatures in the dark, solid test substance samples were stable after 14 days.
- Executive summary:
The study was conducted according to OPPTS 830.6313
At normal (25°C) or elevated (54°C) temperatures in the dark, solid test substance samples were stable after 14 days.
At 25°C or 54°C in the dark, solid test substance samples exposed to aluminum or iron metal foil are stable after 14 days.
At 25°C in the dark, aqueous solutions of test substance containing 0.0005 M aluminum chloride or 0.0005 M ferric chloride are stable after 14 days.
Aqueous solutions of test substance demonstrated some degradation at 54°C after 14 days. The percent of Day 0 concentration (0.00003 M famoxadone) remaining in 0.0325 M aqueous potassium hydrogen phthalate control was 87%. In 0.0005 M aluminum chloride and in 0.0005 M ferric chloride, 89%, and 94% of the Day 0 concentration remained, indicating the slight change in concentration was not affected by the metal ions.
Reference
Description of key information
OPPTS 830.6313
Additional information
At normal (25°C) or elevated (54°C) temperatures in the dark, solid test substance samples were stable after 14 days.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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