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EC number: 248-130-9
CAS number: 26952-13-6
Six key skin irritation studies (OECD 404) were identified for isomerised olefins; alpha, internal, linear and branched - multiple carbon number. The available data indicate that C6-8 to C20-24 isomerised olefins, including alkenes, C11/C13/C14, do not meet the quantitative criteria for classification as skin irritants.One key eye irritation study (OECD 405) was identified in which the test material was not irritating to the eyes of rabbits.
skin irritation studies were identified for isomerised olefins; alpha,
internal, linear and branched-multiple carbon number. For the purpose of
hazard identification, only six of these were considered key (Klimisch
scores =1) because they adhered to the current OECD 404 guidelines (4
hour exposure, semi-occlusive conditions) with mean scores for erythema
and oedema averaged over 24, 48, and 72 hours. These six studies were
conducted with the following substances: alkenes, C6-8, alkenes,
C10/C11/C12/C13, alkenes, C11/C13/C14, alkenes, C16-18, and alkenes, C20
-24. The remaining studies, using occlusive methods and/or skin contact
times exceeding 4 hours duration, were considered less reliable since
the exposure conditions were more stringent than guideline and likely
therefore to yield unrepresentative results.
application of alkenes, C6-8 as SHOP C68 internal olefin, to rabbit skin
produced very slight to slight erythema, which sometimes extended beyond
the test site, and occasionally very slight oedema for the first 72
hours post exposure. The
mean erythema and oedema scores were 1.55 and 0, respectively (Rees,
of rabbit skin with alkenes, C10 /C11/C12/C13, applied as SHOP olefin
103, produced slight-to-moderate reversible irritation in a majority of
animals, with more pronounced responses present in two of six rabbits at
day 7 which then fully resolved by day 16 (flaking skin at test site)
The mean erythema score was 1.7 over 72 hours and the mean oedema score
was 0.5 (Price, 1985).
slight to slight erythema and very slight oedema was observed in rabbits
treated with SHOP C134 (alkenes, C11/C13/C14). Very slight oedema was
still apparent in one animal 7 days post-exposure. Irritant effects were
fully reversible in all animals by day 13 (Rees, 1996(b)).
treated with alkenes, C16-18 exhibited
reversible, well-defined erythema and very slight to slight oedema. The
average erythema score was 1.56 over 72 hours and the average oedema
score was 0.22 (Morris, 1994).
studies were identified for alkenes, C20-24. In the first study,
application of alkenes, C20-24 to rabbit skin produced no
signs of dermal irritation in any of the treated animals; mean
irritation scores erythema and oedema were 0 at all time points(Driscoll,
1998). In the second study by Sanders (2008), the mean erythema and
oedema scores averaged over the 24, 48, and 72-hour observation points,
were 0.33 and 0.0, respectively, when rabbit skin was exposed to
recorded in the aforementioned studies were generally slight to moderate
or occasionally moderate to severe irritation, however the magnitude of
the responses obtained was not such that it would trigger classification
as “irritating to skin” (mean erythema or oedema scores =2 or = 2.3,
respectively, as described in EU Dangerous Substances Directive
67/548/EEC and CLP EU Regulation 1272/2008 (GHS aligned)). Based on a
weight of evidence analysis, the available data indicate that C6 to C24
isomerised olefins are only mildly irritating to skin. Prolonged or
occluded exposures in non-guideline studies (not discussed above) were
in some instances associated with erythema and/or oedema suggesting that
irritation may be triggered following prolonged or repeated skin
contact. Precautionary classification with R66 (Repeated exposure may
cause skin dryness or cracking) under the Dangerous Substances Directive
or H066 (Repeated exposure may cause skin dryness or cracking) under the
CLP Regulation would therefore seem reasonable.
was no evidence of corrosive effects in any of these investigations.
key irritation study was identified, in which three New Zealand White
rabbits (sex note specified) were instilled with 0.1mL of Shop 134
(i.e., alkenes, C11/C13/C14) in the right eye (Rees, 1996). The left eye
served as control. Very slight to slight conjunctivitis was observed in
all animals one hour after exposure. Very
slight conjunctival redness persisted in one animal and was observed at
the 24- and 48-hour examinations. Iritis
was observed in one animal at the 1-hour examination. At
the 72-hour examination, there were no signs of ocular irritation. None
of the animals exhibited a pain response to administration of the test
on these results, SHOP C134 was considered to be a non-irritant to the
olefins; alpha, internal, linear and branched - multiple carbon number,
including alkenes, C11/C13/C14 do not meet the criteria for
classification and labelling as skin irritants under EU Dangerous
Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008 (GHS
aligned) based on evaluation of the overall mean erythema and oedema
scores from skin irritation studies with these substances. Precautionary
classification with R66 (Repeated exposure may cause skin dryness or
cracking) under the Dangerous Substances Directive or H066 (Repeated
exposure may cause skin dryness or cracking) under the CLP Regulation is
C11/C13/C14 do not meet the criteria for classification as an eye
irritant as defined by EU Dangerous Substances Directive 67/548/EEC or
CLP EU Regulation 1272/2008 (GHS aligned).
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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