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EC number: 940-884-3
CAS number: -
PRELIMINARY SCREENING TEST
- Clinical observations, body weight and mortality data are given in
- Local skin irritation is given in Table 2
- Ear thickness measurements and mean ear thickness changes are given in
- There were no signs of systemic toxicity
- Clincial observations and mortality data are given in Table 5
- Individual body weights and body weight change are given in Table 6
- There were no deaths
- There were no signs of systemic toxicity in the test or control animals
- Body weight change of the test animals between Day 1 and Day 6 was
comparible to that observed in the corresponding control group animals
over the same period.
study was performed to assess the skin sensitization potential of the
test item in the CBA/Ca strain mouse following topical application to
the dorsal surface of the ear, according to the OECD Guideline 429 and
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay).
Following a preliminary screening test in
which no clinical signs of toxicity were noted at a concentration of 10%
w/w, this concentration was selected as the highest dose level to be
investigated in the main test of the Local Lymph Node Assay. Three
groups, each of four animals, were treated with 50 uL (25 uL per ear))
of the test item as a suspension in propylene glycol at concentrations
of 2.5, 5.0 and 10% w/w. A further group of four animals was treated
with propylene glycol .
mortality and no clinical signs were observed during the observation
period. Body weight of the animals was unaffected by the test item
treatment. The stimulation index for concentrations 2.5, 5.0 and 10%
were 1.16, 1.30 and 0.94, respectively. The positive control (5%v/v
phenylacetaldehyde) exhibited evidence of sensitisation (SI = 14.82)
indicating the validity of the study. In this study. The substance is
not a skin sensitizer in mice.
The test item was considered to be a
non-sensitizer under the conditions of the test.
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