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EC number: 946-382-0
CAS number: -
A guinea pig maximisation study conducted according to OECD/EC
guidelines (1981) and GLP principles is available (Klimisch 1). The test
substance was found to have skin sensitising properties.
One test animal was found dead on day 1 with unknown cause of death. One
test animal was killed for humane reasons on day 21 (no further details
Observations after topical induction:
One hour after removal of dressing, scattered mild redness was seen in
11/19 animals, and 7/19 had moderate and diffuse redness.
In one animal, the adverse reactions prevented accurate evaluation of
the skin effects. Furthermore, 8/19 animals had scratched and bleeding
test sites. after 24 hours, skin evaluation was not possible in 7/19
guinea pigs, related to dried blood and presence of hardened,
dark-brown/ black-colored scabs. No skin reactions were seen in the
Observations after challenge:
Scattered mild redness and moderate and diffuse redness were elicited by
the test material after challenge with 100% and 75% test substance after
24 hours. One animal (challenged with 75% test substance) was observed
to have small superficial scattered scabs. In almost all challenged
animals, the skin reactions extended beyond treatment site. At 48 hours,
adverse reactions prevented accurate evaluation of the skin reactions.
In these animals, desquamation was seen, accompanied by slight or
well-defined oedema. For most animals, skin reactions extended beyond
treatment site (these animals were regarded to give a positive reaction
to the test substance).
No skin reactions were seen after treatment of induced animals with
Body weight gains of the guinea pigs in the test group during the study
were comparable to those observed in the control group.
A guinea pig maximisation study was conducted according to OECD/EC
guidelines (1981) and GLP principles. Based on preliminary testing, the
concentrations of test material were choosen as follows: 1% (w/v) in
arachis oil B.P. (intradermal induction), undiluted (topical induction)
and undiluted and 75% (topical challenge). One animal was found dead at
day 1 (unknown cause) and one was killed in extremis on day 21. The test
material gave a positive response in 12/18 (100%) and 13/18 (75%)
animals after 24 hours. At 48 hours, adverse reactions (including
desquamination and oedema) prevented accurate evaluation in many animals.
Based on the results of this study, the test substance was found to have
skin sensitising properties.
Based on the available data, PEMP is classified for skin sensitization
according to CLP Regulation (EC) No. 1272/2008.
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