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EC number: 403-030-6 | CAS number: 137398-54-0
The numerical scores awarded to the dermal reactions elicited by the challenge application are shown in Table 1 (see attached background material)
The dermal reactions seen in all twenty test animals were more marked than those seen in the controls.
Dryness and sloughing of the epidermis, thickening, dryness and sloughing of the epidermis partially obscuring erythema, necrotic edge, necrotic patch, necrosis.
The experimental procedure used followed the recommendations of Annex V Part B Method B6 of the EEC Directive 79/831/EEC and OECD Guideline for Testing of Chemicals No.406 "Skin sensitisation".
Thirty female albino guinea pigs of the Hartley/Dunkin strain were used in the study, 20 as test animals and 10 as control animals.
The following concentrations of DIXT were selected for the study.
Intradermal injection: 1% v/v in liquid paraffin
Topical application: Neat substance as supplied
During the induction period the control animals wwere treated similarly to the test animals with the exception that the test substance was omitted from the interdermal injections and topical application.
Neat substance as 50% v/v in liquid paraffin.
The test and control animals were challenged topically two weeks after the induction period using DlXT., as supplied and 50% v/v in liquid paraffin.
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches.
Dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
Clinical observations observed in test group animals included:
In this screening test, performed in twenty albino guinea-pigs, DIXT produced evidence of delayed contact hypersensitivity in all twenty animals and therefore requires labelling as a skin sensitiser.
During the induction period the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the interdermal injections and topical application.
No experimental study data is available. However, as the substance is a skin sensitiser, it can be presumed that it may also cause respiratory sensitisation if repeated inhalation of the substance occurred.
In a skin sensitisation test, performed in twenty test group albino guinea-pigs, DIXT produced evidence of delayed contact hypersensitivity in all twenty animals and therefore requires labelling as a skin sensitiser.
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