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EC number: 201-877-4
CAS number: 89-04-3
RESULTS OF PILOT STUDY: no irritation at concentrations
of 100% test substance
RESULTS OF TEST
- Sensitization reaction: 0/20
- Clinical signs: Local reactions after intradermal
application (test and control animals after 1 and 24 hours): All FCA
treated injections sites showed severe erythema, edema and necrosis. The
animals treated with 10% test substance in maize germ oil showed well
defined erythema and edema.
Local reactions after patch test (48 hours): 1 hour after
patch removal, test and control animals: whole application area showed
erythema and edema, as well as inflamed or bloody lesions, restlessness
of the animals and scratching in the application area.
24 hours after patch removal: Some animals showed
erythema and eschar formation in the whole application area.
A structural analogue of the substance (1,2,4
-Benzenetricarboxylic acid, mixed decyl and octyl triesters) has been
tested for dermal sensitisation in guinea pigs by the Magnusson and
Kligman maximisation test according to OECD guideline 406. No response
was observed at challenge and, on the basis of these results, the
substance was regarded as having no sensitising effect on the skin of
of a structurally related substance, an ester of 1,2,4
-benzenetricarboxylic acid mixed octyl and decyl ester has been examined
in a maximisation test in guinea pigs. No evidence of skin sensitisation
was observed in any of the treated animals.
(Q)SAR modelling using
the OASIS database indicates that the substance itself is not predicted
to exhibit skin sensitisation based on the lack of functional groups in
the structure capable of protein binding.
Classification with regard to skin sensitisation is not justified based
on the observed lack of response in the relevant study(ies) and taking
into account the provisions laid down in Council Directive 67/548/EEC
and CLP (1272/2008/EC).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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