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EC number: 444-810-6
CAS number: -
CLINICAL SIGNS No signs of ill health or toxicity were recorded.
Bodyweight increases were recorded for all guinea-pigs over the period
of the study. There were no remarkable findings.
Necrosis was recorded at most sites receiving Freund's Complete Adjuvant
in test and control animals. Slight to well-defined irritation was seen
in test animals at sites receiving CP-163,625-BV, 1% w/v in Alembicol D
and slight irritation was observed in control animals receiving
Slight to well-defined erythema was observed in test animals following
topical application with CP-163,625-BV, 50% w/v in Alembicol D. Slight
erythema was seen in the control guinea-pigs.
There were no dermal reactions seen in any of the test or control
animals that were considered to be related to treatment, therefore all
ten test animals gave negative responses. Dryness and sloughing of the
epidermis was noted for one control and two test animals, however, this
was considered to represent background irritation.
This study was performed to assess the skin sensitization potential of
CP-163,625-BV using the guinea-pig. The method followed was that
EEC Methods for the determination of toxicity, Annex to Directive
96/54/EEC (Official Journal No. L248, 30.9.96), Part B, Method B.6. Skin
OECD Guideline for Testing of Chemicals No. 406 "Skin Sensitization".
Adopted: 17 July 1992.
MAGNUSSON, B. And KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in
the Guinea-pig: Identification of contact allergens, Thomas, C.C.,
Springfield, Illinois, U.S.A.
The guinea pigs were dosed by intradermal injection and topical
application as these are the routes of exposure required by the test
guideline and method. Based on the results of a preliminary study and in
compliance with the guideline, the following dose levels were selected:
Intradermal injection: 1% w/v in Alembicol D
Topical application: 50% w/v in Alembicol D
Challenge application: 50 and 25% w/v in Alembicol D
Ten test and five control guinea-pigs were used in this study. In this
study CP-163,625-BV did not produce evidence of skin sensitization
(delayed contact hypersensitivity) in any of the ten test animals.
CP-163,625-BV does not require labelling with the risk phrase R43 "May
cause sensitization by skin contact" in accordance with Commission
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