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EC number: 701-122-3
CAS number: 106185-75-5
Intradermal sighting test - summary of results
Time of observation
Concentration of test material in arachis oil (% w/v)
Evidence of necrosis
Evidence of systemic toxicity
Conclusion: The concentration of the test
material selected for the intradermal induction stage of the main study
was 10% w/v in arachis oil BP
Topical sighting test: Evaluation of reactions
Concentration of test material in absolute alcohol (% v/v)
Evaluation of application sites (hours after removal of patches)
Conclusion: The undiluted test material and
75% (v/v) in absolute ethanol were selected for the main study topical
induction and challenger, respectively.
Main test: Topical induction - evaluation of reactions in test animals
No. of animals
Skin reaction (immediately after removal of dressings)
Test material: HR 87/600001
Control: Blank patch only
In a Magnusson & Kligman maximisation study
(GPMT) performed according to OECD guideline 406 and in compliance with
GLP, groups of 20 female albino Dunkin-Hartley guinea pigs were
intradermally induced with three injections of 0.1 mL of FCA, 10% w/v of
test item in arachis oil and 10% w/v of test item emulsion in FCA on Day
0 on shoulder region on each side of mid-line. Control group of 10
animals was induced with FCA, arachis oil and 50% w/v arachis oil in FCA
intradermal injections. After one week the same area was topically
induced with 0.2-0.3 mL of undiluted test material via occluded filter
paper patch for 48 hours for the treated group. Control group was
patched with nothing applied to the filter paper. After 2 weeks of rest
period, a challenge patch of 0 or 75% v/v test material in absolute
ethanol was applied to left or right shorn flank of all animals,
respectively. The test concentrations for the main study were determined
from a sighting study using one or two animals.
Intradermal and topical induction indicated
evidence of dermal irritation. No skin reactions were noted at the
challenge sites of the test or control group animals at the 24 or
48-hour observations. The test item produced a 0% (0/20) sensitisation
rate and was considered to be a nonsensitiser to guinea pig skin.
Historical data on positive control (40% formaldehyde) exhibited
evidence of sensitisation.
Therefore, the test item is not classified
according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.
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