Soil Generic Assessment Criteria for Human Health Risk ... - ESdat

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Molybdenum CAS Number: 7439-98-7 Assessor A: Nick Struggles, Assessor B: Atkins Final review: Penl/SF
AECOM
Date 01/06/2009 Date 17/06/2009 Date 26/08/2009
Apply TDIoral to exposure routes
Apply IDoral to exposure routes
Apply TDIinh to exposure routes
Apply IDinh to exposure routes
Oral
Inhalation
Dermal
Yes Yes No
No No No
No No Yes
No No No
Combine Oral Justification
and Inhalation
TDIs
Insufficient data to assess non threshold effects - so
HCV based on threshold effects. TDIoral applied to
oral and dermal routes
Yes
Insufficient data to assess non threshold effects - so
HCV based on threshold effects. TDIinhal applied to
inhalation routes
TDI oral
Recommended
TDIoral
Units
10 ug.kg-1.d-1
Justification
Recommended by EFSA and RIVM. Both studies are more recent than the USEPA (which had a lower value).
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- Confidence rating Basis Value Units UF UF description Study type Description
1.d-1
European Food Safety Authority (EFSA) http://www.efsa.europa.eu/en.html 01/02/2006 01/06/2009 TDI oral 0.01 mg/kg bw/day 10 Medium NOAEL 0.9 mg/kg bw/day 100 10 for protecting sensitive human subpopulations
9 week study of
with inadequate
Cu intake or with deficient Cu
rats (diet and
drinking water)
metabolism in view of the species
differences in antagonism between
Mo and Cu, and another factor of 10
to cover the lack of knowledge about
reproductive effects of Mo
in humans and incomplete data on the
toxicokinetics in man.
A tolerable upper intake level (UL) can be
established using the 9-week study in the rat
(Fungwe et al,
1990).
a) is the tolerable upper intake level
b) is equivalent for adults
5 groups, each of 21 female weaning rats, were
given for 6 weeks a basic diet containing 0.025
mg Mo/kg diet as well as 6.3 mg Cu/kg diet, and
additionally in their drinking water doses of 0, 5,
10, 50 and 100 mg Mo/L as sodium molybdate
(Na2MoO4.2H2O) for 3 weeks until the 21st day
of gestation. Six animals in each group were
sacrificed after 6 weeks to determine the
oestrus cycle length. The remaining 15 animals
in each group were mated with untreated males
and allowed to continue gestation for 21 days.
WHO Guidelines for drinking water Quality
http://www.who.int/water_sanitation_healt
h/dwq/guidelines/en
No data 01/06/2009 DW a) 0.07
b) N/A
c) N/A
a) mg/L [Note
Units]
b) N/A
a) 70
b) N/A
a) NOAEL
b) N/A
c) NOAEL
a) 0.2
b) N/A
c) 2
a) mg/L
b) N/A
c)
mg/kg/bw/day
a) 3
b) N/A
c) none provided
a) Although an uncertainty factor of
10 would normally be applied to
reflect intraspecies variation, it is
recognized that molybdenum is an
essential element, and a factor of 3 is
therefore considered to be adequate
(provided in reference) (WHO)
b) N/A
c) None provided
a) 2 year study of a) There are some concerns about the quality of
humans exposed this study. This gives a guideline value of 0.07
via drinking water mg/litre (rounded figure), which is in the same
range as that derived on the basis of the results
of toxicological studies in animals and is
consistent with the essential daily requirement
for molybdenum
b) five pairs of Charles River CD mice received
10mg of molybdenum per litre (about
1.5mg/kg/bw/day) in deionised drinking-water
for up to 6 months.
c) The effects of dietary molybdenum on
reproductive ability and pup growth during
lactation were studied in Long-Evans rats fed
diets containing 0.1, 2, 8, or 14 mg of
molybdenum per kg of body weight per day and
either 5 or 20 mg of copper per kg for 13 weeks
(35).
Dutch National Institute for Public Health
and the Environment (RIVM) Maximum
Permissible Risk (MPR) levels.
USEPA Integrated Risk Information System
(IRIS)
http://www.rivm.nl/en/ March 2001 01/06/2009 TDI 10 ug/kg/bw/day 10 Medium TDI oral (based
on a NOAEL of
1mg/kg as seen in
rats)
10 (TDIoral) ug/kg bw/day Considered adequate for intrahuman
variation (RIVM)
http://epa.gov/iris/
28/10/2003 (based
on 1961 study)
01/06/2009 Oral RfD 0.005 mg.kg-1.d-1 5 Medium LOAEL 0.14 mg.kg-1.d-1 30 Quoted from IRIS. 3 for protection of
sensitive human populations and a
factor of 10 for the use of a LOAEL,
rather than a NOAEL, from a longterm
study in a human population. A
full factor of 10 is not used for the
protection of sensitive human
populations because the study was
conducted in a relatively large human
population (IRIS)
Chronic. Human
6-year to Lifetime
dietary exposure
study
TDI of 10
Koval'skiy, V.V., G.A. Yarovaya and D.M.
Shmavonyan. 1961. Changes of purine
metabolism in man and animals under
conditions of molybdenum biogeochemical
provinces. Zh. Obshch. Biol. 22:179-191.
(Russian trans.)
Notes to the value quoted: Dose determined
from study: molybdenum (Mo) concentration in
diet is 10-15 mg/day. Assumed body weight of
adult male is 70 kg; 10 mg molybdenum/70-kg
body weight = 0.14 mg/kg-day.
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