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EC number: 203-652-6
CAS number: 109-16-0
In a primary dermal irritation study similar
to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally
exposed to 0.5 mL of TREGDMA (according to supplier's information:
purity ca. 95%) to approximately 2.5 cm² skin area. Two application
sites per animal were treated, one site was left intact, the other was
abraded. Test sites were covered with an occlusive dressing for 24
hours. Animals were observed for 72 hours. Irritation was scored similar
to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar
to OECD guideline 404.
No dermal irritation response was observed
on intact skin. 1/6 animals showed very slight edema (score 1) after 24
h on abraded skin; this effect was fully reversible within 72 h.
study, TREGDMA is not a dermal irritant.
performance does not comply with requirements of the relevant recent EU
and OECD guidelines, where a less vigorous application regime with
semi-occlusive dressing, an exposure period of 4 hours, treatment of
only intact skin is stipulated.
can be assumed, that a substance which shows no irritating activity
under the application regime of guideline US FHSA Federal regulation: 16
CFR 1500.41 will also be non irritating under the application regimes of
the relevant recent EU and OECD guidelines. Therefore the study is
adequate for C&L purposes.
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