Registration Dossier
Registration Dossier
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EC number: 936-023-6 | CAS number: 950782-86-2
Storage stability and reactivity towards container material
Administrative data
Link to relevant study record(s)
- Endpoint:
- storage stability and reactivity towards container material
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.6313 (Storage Stability)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.6320 (Corrosion Characteristics)
- Deviations:
- no
- Principles of method if other than guideline:
- EPA OPPTS 830.6313 (Storage Stability): A two weeks storage stability study at ambient and elevated temperature (54°C) in the presence of metals and metal
ions was conducted (Part A).
EPA OPPTS 830.6320 (Corrosion Characteristics): An accelerated two weeks storage stability study at elevated temperature (54°C) in the presence of six test
material stripes (steel, stainless steel, aluminium, brass, HDPE, PP) representing commercial packing materials to investigate the corrosion characteristics and
stability was conducted (Part B). - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- accelerated testing
- Transformation products:
- no
- Conclusions:
- - stable at ambient and elevated temperature (54 °C) in the presence of the tested metals and metal ions (Iron powder extra pure, Ferric citrate Monohydrate p.a., Aluminium gritty, Aluminium acetate
- chemically and stereo-chemically stable in the presence of the used packaging materials steel, stainless steel, aluminium, brass, HDPE and PP represented by test material stripes
- There is no evidence of either pitting or corrosion of the test material stripes (steel, aluminium, brass, HDPE and PP).
Reference
Part A:A stability study has been completed on AE 1170437 technical grade active
ingredient following the EPA guideline OPPTS 830.6313. A two weeks storage stability study
at ambient and elevated temperature (54°C) in the presence of metals and metal ions shows
no reduction of the AE 1170437 content (sum of all stereoisomeres, chemical purity) and no
change of the relative area ratio of the stereoisomeres of AE 1170437. No isomerisation of
the stereoisomeres is observed (stereo-chemical purity). No colour changes or clumping of
the test item is observed. The appearance of the test item is unchanged. AE 1170437 is
chemically and stereo-chemically stable at ambient and elevated temperature in the
presence of the tested metals and metal ions.
Part B: An accelerated two weeks storage stability study of AE 1170437 technical grade
active ingredient following the EPA guideline OPPTS 830.6320 at elevated temperature
(54°C) in the presence of six test material stripes (steel, stainless steel, aluminium, brass,
HDPE, PP) representing commercial packing materials to investigate the corrosion
characteristics and stability of AE 1170437 has been completed. The results show that
AE 1170437 is chemically and stereo-chemically stable in the presence of the used
packaging materials steel, stainless steel, aluminium, brass, HDPE and PP represented by
test material stripes. No isomerisation of the stereoisomeres (stereo-chemical purity) is
observed. No change of the active substance occurs in terms of physical appearance, active
ingredient content (sum of all stereoisomeres, chemical purity) and distribution of the area
ratio of the stereoisomeres of AE 1170437.
AE 1170437 does not show any effects on the tested packing materials. There is no
evidence of either pitting or corrosion of the test material stripes. Their appearance is
unchanged. All materials tested can be used for the storage of AE 1170437 active ingredient.
AE 1170437 is chemically and stereo-chemically stable in the presence of the test material
stripes.
Description of key information
no effects on packing materials (steel, aluminium, brass, HDPE and PP)
Additional information
The substance does not show any effects on the tested packing materials (steel, aluminium, brass, HDPE and PP). There is no evidence of either pitting or corrosion of the test material stripes. Their appearance is unchanged. All materials tested can be used for the storage of the substance The substance is chemically and stereo-chemically stable in the presence of the test material stripes.
The substance is chemically and stereo-chemically stable at ambient and elevated temperature (54 °C) in the presence of the tested metals and metal ions (Iron powder extra pure, Ferric citrate Monohydrate p.a., Aluminium gritty, Aluminium acetate.)
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