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EC number: 268-074-9
CAS number: 68002-61-9
This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl trimethyl ammonium chloride and SDA Reporting Number: 11-045-00.
28-day study was conducted to determine the repeated dose dermal
toxicity of the test substance, C16 TMAC (
54.5% active in aqueous isopropanol),
in New Zealand albino rabbits (both sexes) according to a method similar
to OECD Guideline 410. The purity was not specified and the study
included a lower than recommended number of animals (i.e., 10/group
rather than 20/group as per guideline) and histopathology was performed
only on limited organs. The test substance (0 and 10 mg/kg bw/day) was
applied to the shaved, intact skin of groups of 5 New Zealand albino
rabbits/sex/group for 6.5 to 7 h, 5 days/week for 4 weeks. Dermal
irritation readings were recorded daily. The animals were weighed weekly
during the exposure period. Blood was collected for haematology
measurements before initiation of dosing and prior to termination. Liver
and kidneys weights were recorded at necropsy and limited histopathology
was conducted. There were no systemic treatment-related effects on body
weights, haematology, organ weights, gross necropsy findings or
histopathology. Treated areas of the skin showed mild to marked
acanthosis with active mitosis, hyperkeratosis, and partial to extensive
necrosis of the epidermis and hair follicles, partly with encrustation
and exudate. Under the study conditions, the 28d NOAEL for male and
female rabbits were determined to be 10 mg/kg bw/day (TRS-HPV, 2001).
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