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EC number: 274-570-6
CAS number: 70321-86-7
In the key study, 0 out of 20 guinea pigs
gave positive results after challenge exposures with the test article.
Based on the evaluation criteria of Annex VI of the Commission Directive
67/548/EEC, the evaluation "sensitizing" is warranted when at least 30 %
of the test animals exhibit positive skin reactions in an adjuvant test.
Therefore, in line with the above argument, the test article is
considered not sensitizing after skin contact.
Body weights were taken before the start of
the treatment and at termination.
- At start: Mean (n = 20) = 380.7 +/- 36.66
- At termination: Mean (n = 20) = 528.4 +/-
Test group animals
- At start: Mean (n = 20) = 383.3 +/- 31.65
- At termination: Mean (n = 20) = 532.1 +/-
In the key study, the potential of the
test article (technical grade) to cause "delayed contact
hypersensitivity" after dermal contact was appraised in
Pirbright-Hartley Guinea Pigs pursuant to OECD TG 406 (Skin
Sensitisation, GPMT). Intradermal inductions were performed with 1% of
the test substance in sesame oil. Topical induction (occlusive; 48
hours) and as well as challenge exposures (epicutaneous occlusive; 24
hours) were performed with 30% of the test substance in vaseline. The
control and test groups consisted of 20 animals each. Evaluation of the
skin reactions were performed 24 and 48 hours after challenge according
to the Draize method. After challenge, 0 out of 20 guinea pigs exhibited
evidence of "delayed contact hypersensitivity". All animals of the
control group did not show evidence of "delayed contact
hypersentisation" (0/20). The sensitivity and reliability of the
experimental technique was ascertained every 6 months using p -
Classification, Labeling, and
Packaging Regulation (EC) No. 1272/2008
The available experimental test data
are reliable and suitable for the purpose of classification under
Regulation 1272/2008. Based on the criteria laid down in Regulation (EC)
No. 1272/2008, as amended for the fifth
time in Directive EC 944/2013, classification as a skin
sensitizer is not warranted.
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