Toxicology


Test
Product Method Result
Cytotoxicity amalian I expert premium amalian III expert volume In vitro cell proliferation assay, L929 cells, BCA staining;agarose overlay, L929 cells non-cytotoxic
Sensitisation amalian I expert premium
amalian III expert volume

Murine local lymph node assay (MLLA) non-sensitizing
Irritation amalian I expert premium amalian III expert volume Subcutaneous reactivity non-irritant
Systemic (acute) toxicity
amalian I expert premium
amalian III expert volume

Injection test for detection of acute systemic reactions
non-toxic, no loss of weight
Subacute / subchronic toxicity
amalian I expert premium
amalian III expert volume

4-week biocompatibility + toxicity
non-toxic
Genotoxicity
amalian I expert premium
amalian III expert volume

In vitro mouse lymphoma assay, L5178Y
no induced mutagenic / clastogenic cell response

Mutagenicity
amalian I expert premium
amalian III expert volume

Ames assay, 5 Salmonella strains
In vivo mouse micronucleus assay (bone marrow)
non-mutagenic
non-mutagenic
Implantation
amalian I expert premium
amalian III expert volume

Intramuscular implantation test (rabbit):
non-irritating