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EC number: 211-185-4
CAS number: 632-79-1
TBPA has caused skin sensitization in the Buehler guinea pig test. Using
the criteria in REACH Guidance R.8, Table R.8-24, TBPA would be
considered "moderate". Quantiation of this endpoint for purposes of a
DNEL was not attempted. Rather, the DNEL for inhalation was based on an
oral 90-d study of tetrachlorophthalic anhydride in rats. The rat NOAEL
in that study was 94 mg/kg bw administered by gavage, based on renal
toxicity. Mice did not experience renal toxicity at any of the doses
tested. This study was selected for derivation of the DNEL over the rat
21 d inhalation study due to the serious nature of the effects seen in
rats in the 13 wk tetrachlorophthalic anhydride study and repeated dose
studies by the dermal and oral routes of TBPA indicating similar
effects. The NOAEL of 94 mg/kg bw was corrected to an inhalatory NOAEC
by multiplying the NOAEL of 94 mg/kg by (1/0.38 m3/kg/d)(1/1)(6.7 m3
(8h)/10 m3 (8h) as indicated in the REACH Guidance Figure R.8-3. The
corrected inhalatory NOAEC-worker = 166. Assessment factors were 2.5 for
remaining species differences, 5 for worker intraspecies differences, 2
for subchronic to chronic, 1 for dose-response and quality of database.
AF=25. The DNEL worker inhalation was calculated to be 0.64 mg/m3 This
value is highly conservative.
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