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EC number: 203-733-6
CAS number: 110-05-4
Di-tert-butyl peroxide has been tested for skin irritation in vivo and eye irritation in vitro and in vivo. It is not irritating to skin or eyes in any of these studies.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and
1.7 for erythema and 0.0, 0.0 and 0.0 for oedema.
The potential of the test substance PEROXYDE
DE DI-t-BUTYLE (batch No. 990-9801-124) to induce skin irritation was
evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC
(92/69/EEC, B.4, 31st July 1992) guidelines. After a 3 -minute exposure
(one animal), no cutaneous reactions were observed. After a 4-hour
exposure (three animals), a very slight erythema (grade 1) was observed
in one animal on day 1. A well-defined erythema (grade 2) was observed
in the second animal between days 1 and 3, then a very slight erythema
(grade 1) was noted on day 4. It was replaced by dryness of the skin
from day 5 up to day 8. No cutaneous reactions were observed in the
third animal. Under our experimental conditions, the test substance
PEROXYDE DE DI-t-BUTYLE (batch No. 990-9801-124) is non-irritant when
applied topically to rabbits.
Viability / Mortality: No intercurrent
deaths occurred during the course of the study.
Clinical Signs: No clinical signs were
recorded throughout the entire observation period.
Body Weights: The body weight of the animals
was within the range commonly recorded for this strain and age.
The primary eye irritation potential of
di-tert-butyl peroxide (CAS# 110-05-4) was investigated according to
OECD test guideline no. 405. The test item was applied by instillation
of 0.1 mL into the left eye of each of three young adult New Zealand
White rabbits. Scoring of irritation effects was performed approximately
1, 24, 48 and 72 hours after test item instillation.
The mean score was calculated across 3
scoring times (24, 48 and 72 hours after instillation) for each animal
for corneal opacity, iris light reflex and redness and chemosis of the
conjunctivae. The individual mean scores for corneal opacity and iris
light reflex were 0.00 for all three animals. The individual mean scores
for the conjunctivae were 1.00, 0.33 and 0.33 for reddening and 0.00,
0.00 and 0.00 for chemosis, respectively.
The instillation of di-tert-butyl peroxide
(CAS# 110-05-4) into the eye resulted in mild, early onset and transient
ocular changes, such as reddening and swelling of the conjunctivae and
reddening of the sclerae. These effects were reversible and were no
longer evident 72 hours after treatment, the end of the observation
period for all animals. No abnormal findings were observed in the cornea
or for the iris light reflex of any animal at any of the examinations.
No corrosion was observed at any of the measuring intervals. No staining
of the treated eyes by the test item was observed and no clinical signs
Thus, the test item did not induce
significant or irreversible damage to the rabbit eye.
Based upon the referred classification
criteria (Regulation (EC) No 1272/2008), di-tert-butyl peroxide (CAS#
110-05-4) is not classified with respect to eye irritation in rabbits.
This in vitro study was performed to assess the corneal irritation and
damage potential of ditert- butyl peroxide (CAS No. 110-05-4) by means
of the BCOP assay using fresh bovine corneae. After a first opacity
measurement of the fresh bovine corneae (t0), the neat test item
di-tertbutyl peroxide (CAS No. 110-05-4), the positive, and the negative
controls were applied to corneae and incubated for 10 minutes at 32 ± 2
°C. After the incubation phase the test item, the positive, and the
negative controls were each rinsed from the corneae and opacity was
measured again (t10). Further, the corneae were incubated for another
120 minutes at 32 ± 2 °C in complete medium, and opacity was measured a
third time (t130). After the opacity measurements permeability of the
corneae was determined while application of 1 mL of a fluorescein
solution for 90 minutes at 32 ± 2 °C in a horizontal position. The
liquid coming out was measured spectrophotometrically. With the negative
control (0.9% NaCl solution) neither an increase of opacity nor
permeability of the corneae could be observed. The positive control
(2-Ethoxyethanol) showed clear opacity and distinctive permeability of
the corneae and therefore, is classified as very severe eye irritant.
The test item di-tert-butyl peroxide (CAS No. 110-05-4) did not cause
any opacity or permeability of the corneae compared with the results of
the negative control. The calculated in vitro score was 0.81 and
therefore, the test item was classified as non eye irritant. In
conclusion, it can be stated that in this study and under the
experimental conditions reported, the test item di-tert-butyl peroxide
(CAS No. 110-05-4) is not considered to be an eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
Apparently well conducted GLP study.
Justification for selection of eye irritation endpoint:
Apparently well conducted GLP study.
Di- tert- butyl peroxide does not cause
irritation when tested using in vitro or in vivo methods; therefore, it
is not classified for either skin or eye irritation.
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