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EC number: 205-055-6
CAS number: 132-27-4
Skin sensitisation (OECD 406): not sensitising
A Guinea pig maximisation test was performed with the test
substance according to OECD guideline 406 and under GLP conditions (The
Toxicological Research Laboratory, 1994). A range-finding study was
performed to establish suitable dose levels for the induction and
challenge treatments. In the main study, 10 male Hartley guinea pigs
received three dermal applications each of a 0.5% suspension of the test
substance in distilled water for 6 hours under occlusive conditions
during the three-week induction period. Two weeks thereafter, the
challenge treatment was performed by topical application of the test
substance as a 0.1% suspension in distilled water for 6 hours under
occlusive conditions. Observations were made 24 and 48 hours after
challenge treatment. Ten naïve male guinea pigs served as control, 5
from those received a 0.1% solution of the test substance in distilled
water and 5 received the positive control. Challenge application with
the positive control caused slight to moderate erythema, considered to
reflect a hypersensitivity response, at the test site on nine of ten
animals, with no effect noted in the corresponding naïve control
animals. Examination of the application sites at challenge
reading time points 24 and 48 h revealed no skin reaction in any of the
10 animals tested; thus, the test substance was not a skin sensitizer
under the test conditions used.
The available data on skin sensitisation with the test substance sodium
2-biphenylate (CAS 132-27-4) do not meet the criteria for classification
according to Regulation (EC) No. 1272/2008, and are therefore conclusive
but not sufficient for classification.
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