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EC number: 220-479-1
CAS number: 2781-00-2
From the read across with 1, (3) 4-bis(tert-butylperoxyisopropyl)benzene: 1,4-di-(2-t-butylperoxyisolpropyl)benzene is not irritating to skin and is very slightly irritating to eyes.
MEASURED ENDPOINT/INDEX (i.e. LD50, PII): Test material
produced very slight erythema and was not considered a
primary dermal irritation.
There was not dermal irritation after 4 hours of contact.
After 28 hours there was very slight erythema (grade 1) on
abraded sites, but cleared by 52 hours. There was no edema
and no irritation observed on intact skin sites.
The acute dermal irritation of the peroxide was evaluated in rabbits
according to OECD 404 guideline.
The substance was applied undiluted and not pre-moistened to the skin of
6 New-Zealand White albino rabbits and held in contact for 4 hours by
means of an occlusive dressing.
No irritation was observed.
Under the experimental conditions,the substance was considered as non
irritant when applied topically in rabits.
The scores recorded for cornea and iris were zero (0) in all
rabbits at all reading times. A maximum score of 2 (slight
to moderate) for redness and 2 (slight to moderate swelling)
for chemosis were observed in 2/3 rabbits after 1 hour. At
24 hours only 1/3 rabbits still had a score of 2 for
redness, all other scores were 1 or 0. 2/3animals had a
score of 1 for redness, and 1/3 had a score of 1 for
chemosis at 48 hours. At 72 hours all scores were zero (0).
The laboratory stated that the test material was not an eye
irritant based upon the EEC standards for evaluation.
The potential of the
peroxide to induce ocular irritation was evaluated in rabbits according
to OECD405 guideline.
The substance was
administered to three male New Zealand White rabbits.
A single dose of 0.1 g
of the substance was instilled into the left/right conjunctival sac. The
right/left eye was not treated and served as control. The eyes were not
rinsed after administration of the test item.
Ocular reactions were
observed approximately 1 hour, 24, 48 and 72 hours after the
administration of the test substance. The mean values of the scores for
chemosis, redness of the conjunctiva, iris lesions and corneal opacity
were calculated for each animal.
After one hour, the
eyes effects observed in all rabbits consisted of slight or moderate
redness and slight or moderate swelling of the consjunctivae. All these
clinical signs were fully reversible within 72 hours.
Mean scores calculated
for each animal over 24, 48 and 72 hours were (0) (0.6) and (0) for
chemosis, (0.3) (1) and (0.6) for redness of the conjunctiva, (0) (0)
and (0) for iris lesions and (0) (0) and (0) for corneal opacity.
experimental conditions, the test item was considered as sligh irritant
when administered by ocular route to rabbits.
There is no data on 1,4-bis(tert-butylperoxyisopropyl)benzene.
A read across approach is proposed with 1, (3
The acute dermal irritation of 1,
was evaluated in rabbits according to OECD 404 guideline (TNO, 1986).
The substance was applied undiluted (purity 40%) and not pre-moistened
to the skin of New-Zealand White albino rabbits and held in contact for
4 hours by means of an occlusive dressing. No irritation was observed.
Even if the purity was only 40% and even if
the substance was not pre-moistened, data available from an acute dermal
toxicity study (CIT, 1999) where no dermal signs were observed at high
doses (2000 mg/kg) strengthen that the pure substance is not irritant.
In addition, an
in vitro skin irritation test (performed according to the OECD 439
guideline) on the pure meta isomer (CAS 2212-81-9) is currently
available (Warren, 2012). In this test, the relative mean viability of
the test item was 99.5 % of the negative control item. Therefore there
was no skin irritation potential for the pure meta isomer. It can be
anticipated there is neither no skin irritation potential for the para
potential of 1,(3)
ocular irritation was evaluated in rabbits (TNO, 1986) according to OECD
405 guideline (Klimish 2 study). In this test, three
male New Zealand White rabbits were used. A quantity of 0.1
g of the substance (purity: 40%) was instilled in the conjunctival sac,
and the eyes were not rinsed. After
one hour, the eyes effects observed in all rabbits consisted of slight
or moderate redness and slight or moderate swelling of the conjunctivae.
All these clinical signs were fully reversible within 72 hours.
All the mean
scores calculated for each animal over 24, 48 and 72 hours were less
than 1 (for chemosis, redness of the conjunctiva, iris lesions and
corneal opacity). The purity of the substance was only 40 %;
nevertheless, as only minimal signs of eye irritation were observed (
all scores were between 0 and 1, and as all clinical signs were fully
reversible within 3 days), it is foreseeable that the substance with a
higher purity is neither an eye irritant.
The substance 1,(3)
as non-irritant for skin and slight irritant when administered by ocular
route to rabbits.
According to the directive 67/548/EEC and according to EU
Regulation (EC) N0. 1272/2008 (CLP): 1,4-bis(tert-butylperoxyisopropyl)benzene
is not classified as an eye irritant (even slight eye irritation was
observed, all mean scores < 1) or as a skin irritant (no skin irritation
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