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EC number: 287-476-5
CAS number: 85535-84-8
In well reported studies (Hoechst AG, 1986, 1983) conducted according to modern standards, C10-13 chlorinated paraffins (59 and 70% chlorination) have the potential to produce, at most, mild irritation when applied under a semi-occlusive dressing to the shaven skin of rabbits for 4 h. More pronounced irritation can occur following repeated exposure, and is probably due to a defatting mechanism. Limited information in humans indicates that SCCPs do not cause skin irritation. No corrosion has been reported. There is no information from humans on the potential for SCCPs to cause eye irritation. However, the information from animals indicates that C10-13 chlorinated paraffins (40 to 63% chlorination) produce only mild eye irritation in rabbits.
In well reported, unpublished studies
(Hoechst AG, 1986, 1983) conducted according to modern standards, three
rabbits were treated, dermally, with 0.5 ml of undiluted SCCPs applied
under a semi-occlusive dressing to the shaven skin for 4 h. In the later
study, no signs of skin irritation were seen for up to 72 h after
removal of the C10-13 chlorinated paraffin (59% chlorination) (Hoecsht
AG, 1986). In the earlier study, very slight oedema (grade 1) was noted
in two of the animals for up to 24 h following skin application of a
C10-13 chlorinated paraffin (70% chlorination). One rabbit showed
clearly defined erythema (grade 2 on a scale of 0-4) at 48 and 72 h,
while "slightly noticeable" erythema (grade 1) was seen in the other two
animals. All signs of irritation were completely resolved by day 7
(Hoechst AG, 1983).
SCCPs were also investigated in several
other unpublished studies, although (according to the final RAR (EU,
2000)) these were not conducted according to modern protocols and were
less well, and often only briefly reported. All studies were conducted
using rats. In most studies, six 24
hour applications of 0.1 or 0.2 mL of
chlorinated paraffin was applied to shaven skin, under occlusive
dressings. Treatment periods were separated by 24-hour treatment-free
periods. The samples of chlorinated paraffin were usually undiluted but
contained low percentages of epoxy
stabilisers and/or various additives. Two
studies investigated C10-13, 70% chlorinated paraffin. In the more
recent study, no signs of irritation were noted throughout the study
following repeated application of the chlorinated paraffin which
contained 0.1 or 2% benzoyl peroxide initiator. In the earlier study the
chlorinated paraffin contained 1 or 2% of an epoxised vegetable oil
stabiliser with and without additives (0.1% oxalic acid or 0.05%
benzotriazole). Very mild to mild desquamation was only noted following
the applications of chlorinated paraffins which contained the additives.
The reactions were described as occasional, transient and inconsistent.
It was not stated how many applications were made before these reactions
were seen. Another two studies investigated the effects of three C10-13,
63% chlorinated paraffins, containing up to 3% epoxy soya oil
stabilisers or other unspecified additives. Erythema was usually noted
following 2 to 4 applications of all three paraffins, although on one
occasion erythema was noted in 1/3 animals after only one application.
The severity of the reactions were not described. Desquamation was also
noted following 3 or 4 applications and increased in severity with
further treatments. In theolder study (with 0.7% epoxy carboxylate
stabiliser) the desquamation was described as severe following the
fourth application when the study was terminated.
Several studies have been conducted using
C10-13 paraffins which were 48, 50, 52 or 55% chlorinated. In most
studies the paraffins contained 0.2 or 2% epoxy stabilisers. In one
study with 48 or 55% chlorinated paraffins, containing 0.2% epoxy octyl
stearate stabiliser, no signs of irritation
were noted throughout the study (unpublished
reference, 52, 1969). In the other studies results were as above with
mild or slight erythema to erythema and mild desquamation usually being
noted following the second or third application. In one study, testing a
paraffin with 2% epoxised octyl oleate
stabiliser, erythema was noted following the first application, although
the severity of the reactions were not discussed. It was noted in 4/5 of
the studies that the reactions did not worsen following further
applications, although in one study (testing a 52% chlorinated paraffin
with unspecified additives), slight erythema, noted after the second
application worsened to severe erythema
with slight necrosis after the third, when
the study was terminated. An unspecified volume of a C10-13, 40%
chlorinated paraffin, containing 1% epoxy soya oil stabiliser, produced
slight desquamation following the second application and mild erythema
after the third (unpublished reference 57, 1966). This condition
persisted throughout the remaining applications until the end of the
study when small scattered ulcers developed.
Several or all of the above studies have
been summarised in less detail in a published report (Birtley et al.,
Two unpublished studies in rats have also
been conducted to investigate the potential for skin irritation of two
C10-11 chlorinated paraffins which were 49 and 60% chlorinated. The
protocols were as above except that single application tests were also
conducted. No signs of irritation were noted following a single
application of the higher chlorinated paraffin, although slight
desquamation was noted in 2/6 rats, three to six hours after the
treatment with the lower chlorinated paraffin. As above, both
chlorinated paraffins produced slight erythema and/or slight
desquamation with repeated applications, although neither study stated
when such signs were first observed.
Two studies have also been conducted using
rabbits and were reported in very brief unpublished summaries. A C10-13,
61% chlorinated paraffin and a 50% chlorinated short chain paraffin
(Cereclor 50 HS), of unspecified carbon chain length, produced mild or a
mild to moderate skin irritation, following a single occlusive
application to intact and abraded skin. It was stated that "varying
degrees of erythema persisted for 72
hours". No other information was available.
In contrast to the above studies, another
two unpublished studies report more severe findings. One of these
studies is a very brief summary which states that repeated occlusive
application with a 50% chlorinated short chain paraffin (Cereclor 50
HS), of unspecified carbon chain length, resulted in moderately severe
irritation with erythema, desquamation, thickening, cracking and
scabbing of the skin being observed in rats. The second study reported
slight erythema and desquamation after one 24-h application of the test
substance applied under occlusive dressings. Following the third
application, moderately severe desquamation, intracutaneous oedema with
"extensive scratching" were reported and the study was terminated.
However it was unclear if the test substance was a chlorinated paraffin
or a solvent used in chlorinated paraffin formulations. Overall, due to
uncertainties in the identification of the test substances and
considering the weight of evidence, neither of these studies is
considered to be reliable when assessing the skin irritation potential
of the chlorinated paraffins under consideration
humans, Cereclor 50 LV and 63 L (C10-13 chlorinated paraffins; 50 and
63% chlorination, respectively) were mildly irritating following 48 h
occluded application to the upper arm of 26 healthy volunteers
(MacDonald, 1975) [ICI, 1975], whereas Chlorowax
500C (a C12 chlorinated paraffin; 59% chlorination) did not produce
local irritation when applied to the skin of 200 male and female
volunteers (Howard et al. 1975). [See IUCLID Chapter 7.10.3 for further
details of human data].
relevant human data are currently available.
an assessment of its potential to induce eye irritation, a drop of
undiluted C10-13 chlorinated paraffin (40% chlorinatation) was placed
into the right eye of each of three rabbits and observations were made
over a 3-day period. Mild congestion was evident after 1 h, but this had
completely resolved within 24 h (McElligott, 1966) [ICI, 1966].
eye irritation potential of C10-13, 40 to 52% chlorinated paraffins has
been reported in a published study (Birtley et al., 1980). Three
different C10-13 paraffins which were 63% chlorinated and which
contained either 2.5 or 2% of two different additives or 0.7% of an
epoxy stabiliser were tested in 2 studies. Both studies were conducted
according to modern protocols with either 0.1 mL or "one drop" of the
paraffin being instilled into one conjunctival sac of groups of three
rabbits. Similar results were reported for all three formulations:
"practically no" initial pain (2 on a 6 point scale) was noted. Slight
irritation (3 on an 8 point scale), evidenced by redness and chemosis
(only noted in the formulation containing the epoxy stabiliser) of the
conjunctiva with some discharge, lasted for 24 hours. One drop of a 52%
chlorinated paraffin, containing unspecified additives, was also tested
as above, and slight, immediate irritation was followed by slight
redness of the conjunctiva which, as above, lasted for 24 hours.
to an expert review, citing a personal communication with industry, a
single application of Chlorowax 500C (a C12 chlorinated paraffin; 58%
chlorination) apparently produced a mild redness in the eyes of 4/6
rabbits (Howard et al., 1975). Similar results were obtained with
another two chlorinated paraffins (Cereclor 50 HS, Hoechst 64 flussig),
although the carbon chain length and/or percentage chlorination of these
short chain paraffins was not identified. Although little information
was provided, the earlier study apparently indicated the severity of the
reactions observed did not increase with up to 5 daily instillations of
the chlorinated paraffin (Hoechst AG, 1966; ICI, 1974).
studies in animals and humans (summarised above) indicate that SCCPs are
not corrosive to the skin and eyes.
are no data in relation to respiratory irritation in humans or animals.
However, the lack of any reports relating to this endpoint given the
widespread use of these substances, suggests that they lack the
potential to cause such an effect. The low skin and eye irritation
potential, and generally unreactive nature of this group of substances,
lends further support to this view.
(for which a ESR has not been created - please move to reference list in
AG (1966). 66.0053 (cited in EU, 2000).
(1974). ICI Study Number CTL Z0548, 03.12.74 (cited in EU, 2000).
Under the conditions of these studies,
C10-13 chlorinated paraffins would not be classified as skin, eye or respiratory
tract irritants according to EU CLP or DSD regulations.
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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