 6.
Does DBP pose risks to human health?
6.1 Are workers at risk
from exposure to DINP and DIDP?
6.2 Are consumers at
risk from exposure to DBP?
6.1
Are workers at risk from exposure to DINP
and DIDP?
Workers
Assuming that oral exposure
is prevented by personal hygienic measures,
the risk characterisation for workers
is limited to the dermal and respiratory
routes of exposure. Furthermore, it is
assumed that adequate risk reduction measures
are taken to prevent accidental exposure.
If applicable, quantitative risk characterisation
is performed by calculation of the MOS
(ratio between NOAEL/LOAEL
and exposure levels) and comparison of
this value with the minimal MOS. The minimal
MOS is established via assessment factors,
taking into account inter- and intraspecies
differences, differences between experimental
conditions and the exposure pattern of
the worker, type of critical effects,
dose-response relationship, confidence
of the database and correction for route-to-route
extrapolation. A risk is indicated when
the MOS is significantly lower than the
minimal MOS.
Acute toxicity, irritation
and sensitisation
Given the low toxicity
observed in the acute oral, inhalation,
and dermal studies, the effects observed
in the irritation and sensitisation studies
and the anticipated occupational exposure
levels it is concluded that DBP
is of no concern for workers with respect
to acute effects, irritation, and skin
sensitisation (conclusion (ii)).
There are no data available on the possible
respiratory sensitisation.
Repeated dose toxicity
There are no suitable
dermal repeated dose toxicity
studies available. The risk assessment
for dermal repeated exposure is therefore
based on route-to-route extrapolation.
Based on the MOSs (10-20) between the
NOAEL
from the repeated dose study by inhalation
in rats (146.6 mg/kg bw/day calculated
based on the NOAEC of 509 mg/m3)
and the anticipated dermal exposure levels
(420-975 mg/day) it is concluded that
for occupational exposure Scenario 3 (use
of products containing DBP;
subscenario “aerosol
forming activities”) adverse systemic
health effects due to repeated dermal
exposure cannot be excluded (minimal MOS
3.6) (conclusion (iii)).
No concern for systemic health effects
is indicated for other occupational scenarios.
There is no suitable information available
to determine the risk for local skin effects
after repeated dermal exposure.
Based on the MOSs (51-102)
between the NOAEC for systemic effects
from the repeated dose study by inhalation
in rats (509 mg/m3) and the
anticipated inhalation exposure levels
(5-10 mg/m3) it is concluded
that there is no concern for systemic
health effects due to repeated inhalation
occupational exposure in all scenarios
(minimal MOS 90) (conclusion (ii)).
Based on the MOSs (0.1-0.2) between the
NOAEC for local effects from the repeated
dose study by inhalation in rats (1.18
mg/m3) and the anticipated
inhalation exposure levels (5-10 mg/m3)
it is concluded that there is concern
for local effects due to repeated inhalation
occupational exposure in all scenarios
(minimal MOS 27) (conclusion (iii)).
The conclusions about
the risk for systemic health effects derived
for the individual routes of exposure
are also applicable after combined occupational
exposure (i.e. conclusion (iii) for Scenario
3 (use of products containing DBP;
subscenario “aerosol
forming activities”) after dermal
exposure and conclusion (ii) for all other
occupational scenarios). A risk assessment
for combined exposure is not applicable
for local toxicity.
Mutagenicity and carcinogenicity
From the results of the
mutagenicity studies it is concluded that
DBP
may be considered as a non-genotoxic
substance (conclusion (ii)).
No adequate carcinogenicity
studies with DBP are available. There
are no urgent reasons for concern for
workers with regard to carcinogenicity
(conclusion (ii)).
Toxicity for reproduction
Based on the MOSs (3.7-8.6)
between the LOAEL
for reproductive toxicity
(52 mg/kg bw/day) and the anticipated
dermal exposure levels (420-975 mg/day)
and the MOSs (36-73) between the LOAEL
for reproductive toxicity (52 mg/kg bw/day)
and the anticipated inhalation
exposure levels (5-10 mg/m3)
it is concluded that there is no concern
with respect to reproduction toxicity
due to repeated dermal or inhalation exposure
for any occupational scenario (minimal
MOS 7.2 and 80, respectively) (conclusion
(ii)).
Occupational limit values
The available current
occupational exposure limit values for
DBP
amount to 5 mg/m3, and are
based on different oral toxicity
studies. However, in the present report
reference is made to additional oral and
inhalation toxicity studies in which among
others a LOAEC for local respiratory effects
below the present OELs of 5 mg/m3
was established, based on which there
is a need to reconsider the current occupational
exposure limits.
Source
& © : IPCS
"Environmental
Health Criteria for Fluorides", (EHC
227),
Summary
of the Report, Chapter 1.8: Effects on
other organisms
in the laboratory and field
For more information,
see the full IPCS document,
Chapter
9: Effects on other organisms in the laboratory
and field
|
"Summary
Risk Assessment Report on DBP"
