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EC number: 237-438-9
CAS number: 13784-51-5
The NOAEL of 250 mg/kg/day from a 90-day
repeat dose oral study with rats was used.
Assuming an oral/inhalation rate of
absorption of 0.5, a dose descriptor of 220.4 mg/m3 was derived as the
A NOAEL of 250 mg/kg/day was selected from a
90-day repeat dose oral study with rats.
Oral absorption rat – oral/dermal absorption
human: Assume 25% absorption based on the physical-chemical properties
(water solubility, liquid nature, low molecular weight) in accordance
with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12).
Therefore, a dose descriptor of 1000
mg/kg/day was derived as the starting point. See discussion for route to
route extrapolation caluculations.
134.1 g/mol, liquid
Freely soluble (>500 g/L) (measured, OECD 105)
1.1 (measured, OECD 117)
6.28 Pa at 20oC (measured, OECD 104)
In a 90-day oral gavage study with rats a
No-Observed-Adverse-Effect-Level (NOAEL) of 250 mg/kg bw/d was
to low vapor pressure, inhalation is not expected to be a major route of
exposure. For the DNEL covering local effects of inhalation,
route-specific data need to be available (Guidance on information
requirements and chemical safety assessment R 22.214.171.124). Exposure to a
repeated oral high dose is not expected under normal occupational
settings and there are no consumer uses of this substance. Human
exposure, via the environment, is unlikely due to the instability of the
The test substance is a skin sensitizer,
which is considered a systemic effect. Therefore, a qualitative risk
assessment, for dermal systemic effects will be conducted based on its
classification as a Category 1 sensitizer which is considered as a high
hazard (ECHA Guidance on information requirements and chemical safety
assessment Part E, Table E.3 -1). However, DNELs were derived for
non-sensitizing systemic effects.
DNEL dermal-systemic-worker for
CAS 37187 -22 -7
A NOAEL of 250 mg/kg/day was selected
from a 90-day repeat dose oral study with rats.
Oral absorption rat – oral/dermal
absorption human: Assume 25% absorption based on the physical-chemical
properties (water solubility, liquid nature, low Log Pow value) in
accordance with Endpoint Specific Guidance Chapter 8 and 7c (R.7.12).
250 mg/kg/day / 0.25 = 1000 mg/kg/day
= dermal dose descriptor
Applying assessment factors in
accordance with Endpoint Specific Guidance Chapter 8:
Correction for interspecies
differences (apply factor for allometric scaling 4 for rat x 2.5 for
additional factors): 10
= 1000 mg/kg/day/10 = 100 mg/kg/day
Correction for intraspecies
100 mg/kg/day/5 = 25 mg/kg/day
Correction for duration between
sub-acute to chronic: 4
100 mg/kg/day/4 = 5 mg/kg/day
Correction for dose-response: 1 due to
5 mg/kg/day/1 = 5 mg/kg/day
Correction for whole database: 1 due
to quality of study
Total AF = 200
5 mg/kg/day DNEL
The dose descriptor of 250 mg/kg/day
was selected from a 90-day repeat dose oral study in rats.
Assume ABSoral-rat/ABSinh-human is
50/100 = 0.5 based on phys-chem properties and Endpoint Specific
Guidance chapters 8 and 7c (R.7.12)
Corrected inhalatory NOAEC from oral
Oral NOAEL x (1/sRVrat) x
(ABSoral-rat/ABSinh-human) x (sRVhuman/wRV)
[ABS: absorption; sRV: standard
Respiratory Volume; wRV: worker Respiratory Volume]
Corrected NOAEC = 250 mg/kg/day x
(1/0.38 m3/kg/day) x (0.5) x 6.7m3/10m3
= 220.4 mg/m3 = inhalation
Applying remaining assessment factors
in accordance with Endpoint Specific Guidance Chapter 8:
Correction for interspecies
220.4 mg/m3/2.5 = 88.16 mg/m3
88.16 mg/m3/5 = 17.63 mg/m3
17.63 mg/m3/4 = 4.41 mg/m3
Correction for dose-response: 1
4.41 mg/m3/1 = 4.41 mg/m3
Total AF = 50
4.41 mg/m3 DNEL
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