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EC number: 226-394-6
CAS number: 5392-40-5
Skin irritation /
Skin irritation of the
test substance was assessed in several internal BASF tests:
of citral for 1 min, 15 min, and 2 hours on 2 Vienna White rabbits led
to increasing irritation scores for erythema and edema, depending on the
application duration. The individual mean scores (including 24 h and 48
h observation time points) ranged from 2 to 3 for erythema and edema in
both animals and persisted until the end of the observation period (8
days). In addition, all animals show desquamation at the end of the
observation period. After
occlusive application for 20 hours on two rabbits, individual mean
erythema and edema scores (including 24 h and 48 h observation time
points) increased to 4 and 3, respectively, and did marginally decline
over the 8 day observation period. Furthermore, both animals show soft
and parchment-like necroses indicating a severe skin irritating
potential (BASF 1978a).
In line, occlusive
application of citral for 1 hour on 2 rabbits showed individual
irritation scores (mean including 24 h and 48 h observation time points)
above 2.3 for erythema and above 2 for edema. Inflammatory reactions
persisted until the end of the observation period, i.e. 8 days, and
desquamation was observed (BASF 1978b).
of citral on 6 Vienna White rabbits for 4 hours resulted in erythema and
edema scores (mean scores including 24 h and 48 h observation time
points and all animals) of 2.3 and 2.4, respectively, and signs of
dermal inflammation were still observed at the end of the observation
period (8 days). Furthermore, desquamation in all animals,
parchment-like necrosis in one animal and hard but slidable necrosis in
2 of 6 animals was observed at the end of the observation period (BASF
Studies cited from
secondary sources with limited information on test design and results
(reliability: not assignable) reported citral to be corrosive
in rabbits after
dermal application for 24 hours (Monsanto 1992) or moderately to
markedly irritating in
dermal occlusive application for 24 hours (Moreno 1974).
Since no test is
available, which meets current standart procedures, the available
relevant studies are assessed in a weight of evidence approach.
Taken together, the
studies have been performed mainly occlusive, representing a worst case
exposure scenario. In the BASF studies, severe necrosis was observed in
2 rabbits after a 4 hour occlusive application, however a more stringent
treatment, i.e. 20 hour occlusive application did not result in a severe
tissue destruction. The majority of studies, reported from secondary
sources, identified citral to be irritating to the skin.
the chosen key study (BASF, 1978), 50 µl citral was applied to the
conjunctival sac of one eye of two White Vienna rabbits (no eye wash
after 24 hours). The saline-treated second eye served as control.
Readings of eye scores were made on the day of treatment after 1 and 3
hrs, and after 24 hrs, 48 hrs, 5 days, 7 days and 8 days .This study was
comparable to OECD Guideline 405 with several deviations (reduced test
substance volume, 2 test animals, no reading after 72 hrs, observation
period shortened to 8 days). Mean scores of 24 and 48 h readings for
animal 1/animal 2 were for corneal opacity 1/1, iritis 0/0, conjunctiva
redness 1/1.5, and chemosis 1/1.5. Corneal opacity and chemosis were
fully reversible within 7 days, whereas
the conjunctival redness declined but not completely resolved during the
study period (score 1/1
after 8 days).
a weight of evidence approach the test material fulfils the criteria
under 67/548/EEC and CLP to be classified as irritating to the skin (R38
and Category 2).
According to the the
mean scores observed for corneal opacity, and the lack of reversibility
for conjunctival redness within 7 days, the substance is considered to
be irritating to the eyes (Cat 2) according to 1272/2008/EEC, whereas a
non-classification is warranted according to criteria laid down in
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