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EC number: 235-935-5
CAS number: 13052-09-0
The dose descriptor of 1000 mg/kg/day was selected from an OECD 422 oral study with rats. See the discussion for route to route extrapolation calculation.
bis(2-ethylperoxyhexanoate) CAS# 13052-09-0
Initial Dose Descriptor
administration of 1,1,4,4-tetramethylbutane-1,4-diylbis(2-
(CAS 13052-09-0) to rats by gavage, at dose levels of 30, 300
mg/kg bw/day, resulted in treatment related findings in animals of
with 30, 300 and 1000 mg/kg bw/day. The effects detected in females were
confined to adaptive microscopic thyroid changes and there were no
that were considered to represent an adverse effect of treatment. The ‘No
Adverse Effect Level' (NOAEL) for females was considered to be 1000 mg/kg
detected in males were mainly confined to adaptive microscopic liver and
changes and hyaline droplet nephropathy at 300 and 1000 mg/kg bw/day. The
droplet nephropathy of the kidney consisted of increased incidence and
droplets, tubular degeneration, granulated tubular casts and interstitial
infiltrate. This nephropathy was deemed to be related to treatment and to
an adverse effect of treatment to the rat. Hyaline droplets were also
at 30 mg/kg bw/day but these occurred in the absence of any degenerative
the No Observed Adverse Effect Level' (NOAEL) for males was therefore
to be 30 mg/kg bw/day. However, the hyaline droplets nephropathy at
were consistent with well documented changes that are peculiar to the
to treatment with some hydrocarbons. This effect is, therefore, not
of a hazard
to human health. In the context of this study, the remaining kidney
of tubular and/or degeneration, tubular dilation/vacuolation, granulated
interstitial inflammatory infiltrate detected in males are more likely
to the same condition as hyaline droplet accumulation and are, therefore,
to represent limited relevance to humans.
evaluation of reproduction for this study did not indicate any effect of
on reproduction including litter size and offspring survival, growth and
at dosages up to 1000 mg/kg bw/day. The ‘No Observed Effect Level’
reproductive toxicity was considered to be 1000 mg/kg bw/day.
the NOAEL, for DNEL calculation, was set a 1000 mg/kg/day.
descriptor of 1000 mg/kg/day, was selected from an OECD 422 oral study
absorption rat – oral/dermal absorption human: Assume 10% absorption
based on the physical-chemical properties, in accordance with Endpoint
Specific Guidance Chapter 8 and 7c (R.7.12).
mg/kg/day/0.10 mg/kg/day = 10000 = dermal dose descriptor
assessment factors in accordance with Endpoint Specific Guidance Chapter
for interspecies differences (apply factor for allometric scaling 4 for
rat x 2.5 for additional factors): 10
mg/kg/day/10 = 1000 mg/kg/day
for intraspecies difference: 5
mg/kg/day/5 = 200 mg/kg/day
for duration: 4
mg/kg/day/4 = 50 mg/kg/day
for dose-response: 1 due to NOAEL
mg/kg/day/1 = 50
for whole database: 1 due to quality of study
mg/kg/day/1 = 50 mg/kg/day
Total AF =
mg/kg/day DNEL dermal-worker-systemic
ABSoral-rat/ABSinh-human is 1 based on phys-chem properties and Endpoint
Specific Guidance chapters 8 and 7c (R.7.12).
inhalatory NOAEC from oral NOAEL
x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x (sRVhuman/wRV)
absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory
NOAEC = 1000 mg/kg/day x (1/0.38 m3/kg/day) x (1.0) x 6.7 m3/10m3
remaining assessment factors in accordance with Endpoint Specific
Guidance Chapter 8:
for interspecies differences: 2.5
= 705 mg/m3
for intraspecies differences: 5
= 141 mg/m3
= 35 mg/m3
for dose-response: 1
= 35 mg/m3
Total AF =
are no consumer uses of this substance. Human exposure, via the
environment, is unlikely due to the instability of the peroxide. Only
DNELs for the relevant populations will have to be derived (Guidance on
information requirements and chemical safety assessment R.22.214.171.124).
Considered for DNEL Derivation
1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate) CAS# 13052-09-0
>6.5 (7.1 extrapolated)
The VP of the test substance at 25 deg C is well below 0.01 Pa
y (based on log P and tox data)
n (perhaps 10% max)
n (based on WS and VP)
* per ECHA
Guidance on information requirements and chemical safety assessment Ch 7C
below 100 Pa are likely to be well absorbed and the amount absorbed
dermally may be more than 10% of the amount that would be absorbed by
the rate of transfer between the stratum corneum and the epidermis will
be slow and will limit absorption across the skis. Uptake
into the stratum corneum itself may be slow.
lipophilic compoud may be taken up by micellular solubilization but this
mechanism may be of particular importance for highly lipophillic
compounds (log P >4) particularly those that are poorly soluble in water
(1 mg/L or less) that would otherwise be poorly absorbed.
water solubility, like small particle size enhances penetration to the
lower respiratory tract. For
absorption of deposited material similar criteria as for GI absorption
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