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

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1-Methylnaphthalene CAS Number: 90-12-0 Assessor A: Andreas Neymeyer,
Buro Happold
Assessor B:
Mike Rogers, OPUS
JOYNES PIKE Ltd
Final review:
Panel/SF
Date 16/04/2009 Date 16/04/2009 Date 28/08/2009
Oral Dermal Inhalation Combine Oral and
Inhalation TDIs
Justification
Apply TDIoral to exposure routes
Apply IDoral to exposure routes
No No No
Yes Yes No
NR
Chronic dietary studies with 1- or 2-
methylnaphthalene provided limited evidence for
carcinogenicity. Recommended IDoral is lower than
TDIoral, therefore Idoral adopted as oral HCV and
applied to oral and dermal exposure.
Apply TDIinh to exposure routes
Apply IDinh to exposure routes
No No No
No No No
No inhalation route health criteria value. Likely to be
similar to naphthalene, i.e. inhalation orders of
magnitude more toxic than oral
TDI oral
Recommended
TDIoral
Units
7 ug.kg-1.d-1
Justification
USEPA PPRTV concluded that there was insufficient data to derive a provisional RfD but derived a provisional toxicity screening value that may be of limited use
to risk assessors. Despite these uncertainties, the facts that (1) the PPRTV report is more recent than the ATSDR report, (2) the PPRTV screening value is more
conservative and (3) the PPRTV screening value is closer to the EIC proposed HCVoral for 2-methyl naphthalene , results in the PPRTV screening value being
recommended as the TDIoral.
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
US EPA Provisional Peer Reviewed Toxicity http://rais.ornl.gov/tox/unauthorized.shtml Jul-09 15/07/2009 Provisional toxicity
0.007 mg/kg/day 7 LOAEL 71.6 mg/kg body
Values (PPRTV)
screening value
weight per day
Confidence rating Basis Value Units UF UF description Study type
10000 Composite uncertainty factor (UF) of
10,000, which includes factors of 10
for extrapolating from a LOAEL to a
NOAEL, 10 for interspecies
extrapolation, 10 for interindividual
variability,
and 10 for database deficiencies.
animal (mice)
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
http://www.atsdr.cdc.gov/ Aug-05 27/03/2009 MRL (substancespecific
Minimal Risk
Level)
0.07 mg/kg/day 70 LOAEL 71.6 mg/kg body
weight per day
1000 10 for using a LOAEL, 10 for
extrapolating from animals to
humans, and 10 for human variability
animal (mice)
TDI inhal
Recommended
TDIinhal
n/a
Units
Justification
No inhalation route health criteria value. [The reasonable presumption of 1-methylnaphtalene to be similar to naphthalene (regarding its chemical and
toxicological properties) would suggest risks from 1-methylnaphtalene to be dominated by the inhalation pathway. However, no human or animal data are
available regarding the toxicity of
1-methylnaphthalene following repeated inhalation exposure.]
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
Confidence rating Basis Value Units UF UF description Study type
US EPA Provisional Peer Reviewed Toxicity
Values (PPRTV)
http://rais.ornl.gov/tox/unauthorized.shtml
No human or animal data are available regarding the toxicity of 1-methylnaphthalene following repeated inhalation exposure, thus precluding the derivation of provisional subchronic or chronic RfC values
for 1-methylnaphthalene.
ID oral Recommended IDoral Units
2.3 ug.kg-1.d-1
Justification
Derived from BMDL10 for incidence of lung adenomas and carcinomas from Mutata et al 1993 study divided by uncertainty factor of 10,000, as recommended
in Environment Agency SC050021/SR2 report, 2009
Organisation Web Link Last Updated Date Web Checked Non threshold
effects
Basis
Health criteria
type
Value Units Confidence rating
Basis
Study type
US EPA Provisional Peer Reviewed Toxicity
Values (PPRTV)
http://rais.ornl.gov/tox/unauthorized.shtml Jan-08 15/07/2009 Cancer risk Lung adenomas or
carcinomas observed
during 81-week mice
study
Slope factor 0.029 (mg/kg/d) -1 Calculated based on a derived BMDL10 of 22.91 mg/kg/d
animal (mice)
ID inhal
Recommended IDinhal Units
n/a
Justification
Chronic dietary studies with 1- or 2-methylnaphthalene provided limited evidence for carcinogenicity.
Organisation Web Link Last Updated Date Web Checked Non threshold
effects
Basis
Health criteria
type
Value Units Confidence rating
Basis
Study type
US EPA Provisional Peer Reviewed Toxicity
Values (PPRTV)
http://rais.ornl.gov/tox/unauthorized.shtml
There are no appropriate human or animal data from from which to derive an inhalation unit risk for 1-methylnaphthalene
Page 1 of 2 EIC proforma 1-methylnaphthalene.xls 28/08/2009