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

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2-Methylnaphthalene CAS Number: 91-57-6 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
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 No
No No No
Combine Oral
and Inhalation
TDIs
NR
Justification
Chronic dietary studies with 1- or 2-methylnaphthalene
provided limited evidence for carcinogenicity.
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
4 ug.kg-1.d-1
Justification
Lowest literature oral Reference Dose (RfD) [USEPA Integrated Risk Information System (IRIS)]
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
http://www.atsdr.cdc.gov/ 09/03/2009 27/03/2009 MRL (substancespecific
Minimal Risk
Level)
0.04 mg/kg/day 40 LOAEL
Confidence rating Basis Value Units UF UF description Study type
BMDL05
50.3 mg/kg body
weight per day
4
100 Based on the lower 95% confidence animal (mice)
limit on a benchmark dose associated
with 5% extra risk (BMDL05=4
mg/kg/day) for pulmonary alveolar
proteinosis in male mice exposed to
2-methylnaphthalene in the diet for 81
weeks and an uncertainty factor of 100
(10 for extrapolation from animals to
humans and 10 for human variability)
USEPA Integrated Risk Information System
(IRIS)
http://epa.gov/iris/ 09/03/2009 27/03/2009 RfD 0.004 mg/kg/day 4 BMDL05 3.5 mg/kg body
weight per day
1000 A total uncertainty factor of 1000 was animal (mice)
applied to the BMDL05 of 3.5 mg/kgday:
10 for extrapolation for
interspecies differences (UFA: animal to
human); 10 for consideration of
intraspecies variation (UFH: human
variability); and 10 for deficiencies in
the database (UFD).
US EPA Provisional Peer Reviewed Toxicity
Values (PPRTV)
http://rais.ornl.gov/tox/unauthorized.shtml Sep-07 15/07/2009 p-RFD 0.004 mg/kg/day 4 BMDL05 3.5 mg/kg body
weight per day
1000 A total UF of 1000 was applied to this animal (mice)
effect level: 10 for interspecies
differences (UFA: animal to human); 10
for intraspecies variation (UFH: human
variability); and 10 for deficiencies in
the database (UFD).
TDI inhal Recommended TDIinhal Units
n/a
Justification
Insufficient data for the assessment of chronic risk to humans
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
1.d-1
USEPA Integrated Risk Information System http://epa.gov/iris/
Insufficient data for the assessment of chronic risk to humans with respect to the inhalation pathway
(IRIS)
US EPA Provisional Peer Reviewed Toxicity
Values (PPRTV)
http://rais.ornl.gov/tox/unauthorized.shtml
ID oral Recommended IDoral 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
US EPA Provisional Peer Reviewed Toxicity http://rais.ornl.gov/tox/unauthorized.shtml
Values (PPRTV)
Basis Health criteria type Value Units Confidence rating Basis Study type
Quantitative estimates of cancer risk for 2-MN could not be derived because no data demonstrating carcinogenicity associated with 2-MN exposure were identified.
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
US EPA Provisional Peer Reviewed Toxicity http://rais.ornl.gov/tox/unauthorized.shtml
Values (PPRTV)
Basis Health criteria type Value Units Confidence rating Basis Study type
Page 1 of 2 EIC proforma 2-methylnaphthalene.xls 28/08/2009