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EC number: 248-363-6
CAS number: 27247-96-7
Skin irritation / corrosion: not irritating upon one contact, but a repeat-dose DNEL can be set from the data of the 3-week dermal study in rabbits. For this purpose, a repeat-dose local NOAEC was derived as 0.22 mg/cm2/day.
Eye irritation: not irritating
The following concentration-response data are available for single
application in rabbits:
- study N° EB3413: highly irritant at an excessive concentration (vs
recommendation) of 0.5 mL over 2.5 cm2 skin (too small surface) over 4h
= 192 mg/cm2;
- study N° 3552 TAL: non irritant at the recommended level
of 0.5 mL over 6 cm2 skin over 4h = 0.962 * 0.5 / 6 g/cm2 = 80 mg/cm2;
a minimal erythema started at 48 or 72h and lasted for <1 week;
- study N° 80-2189A, on day 1: non-irritant (at most: one grade 2 edema
out of 3 animals, no other reaction) at 7.7 mg/cm2 (high-dose), applied
over 6h to non-abraded animals.
These data show that single application leads to concentration-dependent
results. The relevant conclusion is that of the test performed at the
recommended concentration. The importance and persistence of reactions
in the first (excessive concentration) study may also suggest an impact
The substance induced delayed atypical skin reactions (there is
no classification for such properties) as suggested by the standard
assay above, and largely confirmed by marked irritation and skin
cracking after repeated applications to rabbits (the same animals showed
no relevant effect within the first three applications). As indicated in
the sensitisation section (7.4), this was not attributable to
sensitisation in the absence of histological signs of immunological
reaction in Magnusson and Kligman assays. It seems possible that this
effect partly corresponds to vasodilation (2-ethylhexyl nitrate
being an organic nitrate so possibly a nitric oxide donor). However,
skin cracking was also observed in the repeated application study in
rabbits, and could also suggest interaction with skin lipids due
to the very high log Kow value. Last, an impact of impurities
could be suspected: the IUCLID4 file (see attached file) of the
synthesis precursor 2EH, which may be present as an impurity in some
studies (no data), is attached and shows that this substance is clearly
a skin irritant.
Minimally irritant (this is the minimal possible conclusion grade) in
vitro (BCOP). Non irritant in vivo in rabbits.
It is noteworthy that the IUCLID4 file of the synthesis precursor 2EH
(see attached file), which may be present as an impurity in some studies
(no data), shows that this substance induces some eye irritation but
apparently not of a level requiring classification.
No data. Based on absence of irritation for skin and eyes, no irritation
to respiratory tract is expected.
Effect level: empty Endpoint conclusion: Adverse effect observed
Non irritant to skin and eyes based on standard
single-application studies in rabbits.
NB: for the skin, this conclusion is only valid for a
sufficiently pure substance due to a possible impact of impurities (e.g.
EUH 066 and R66 are
applicable due to skin cracking and dryness after repeated dermal
No conclusion for respiratory tract.
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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