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EC number: 215-089-3
CAS number: 1300-71-6
No available information
There are no reports of human
epidemiological studies which have investigated potential effects of xylenols,
ethyl phenols or cresol exposure on fertility or sexual function. Available
animal studies reported confirm fertility NOAEL in excess of 450 mg/kg/day
for all cresol isomer and >245mg/kg/day for both mixed xylenols and ethyl
7.8.2 Developmental Toxicity / Teratogenicity:Weight of evidence: m-cresol (rat developmenal study). CMA, 1988. KL.3. NOAEL general tox: 30 mg/kg/day; NOAEL maternal: 175 mg/kg/day; NOAEL developmental: >450 mg/kg/day; Weight of evidence: o, p-cresol (rat developmenal study). CMA, 1988. KL.3. NOAEL maternal and developmental: 175 mg/kg/day; Weight of evidence: m, p-cresols (rabbit, developmental study). CMA, 1988. KL.3. NOAEL maternal: 5 mg/kg/day; NOAEL developmental: 100 mg/kg/day; Weight of evidence: o-cresols (rabbit, developmental study). CMA, 1988. KL.3. NOAEL maternal:5 mg/kg/day; NOAEL developmental: 50 mg/kg/day;
three cresol isomers the NOAEL for both maternal and developmental
toxicity in the rat exceeds 100 mg/kg bw so use of this value as the
overall NOAEL is conservative. However, for all three isomers the NOAEL
for maternal toxicity in the rabbit is 5 mg/kg bw and the parental NOAEL
in the multigeneration study is 30 mg/kg bw. In addition the NOAEL for
developmental toxicity in the rabbit was 50 mg/kg bw for o-cresol.
the studies which established these NOAELs are not available to JSC and
only summaries can be used to assess whether these NOAELs are robust.
These show that the NOAEL for maternal toxicity in the rabbit is based
mainly on clinical signs such as audible respiration, hypoactivity and
ocular discharge in rabbits receiving 50 mg/kg bw of all three isomers.
There may have been some mortality (incidence not reported) in rabbits
given 50 mg/kg bw p-cresol but the summary of mortality data for this
study is ambiguous and, as no mortality was reported with either of the
other two isomers, even if there was a death at 50 mg/kg bw it was
probably not treatment related. As the clinical signs of toxicity were
not particularly adverse and there was no evidence of developmental
effects at any dose level of any isomer, 50 mg/kg bw can be considered a
NOEL and the NOAEL in all three developmental toxicity studies of the
cresol isomers should be ≥100 mg/kg bw.
NOAEL in the multi generation study of all three isomers is based on
observations of perioral wetness at 175 mg/kg. There was also a possible
increase in still births at this dose level but there was no clear dose
response suggesting that it was not treatment related. As the clinical
signs of toxicity were mild and there was a considerable spacing between
the LOAEL (30 mg/kg bw) and the NOAEL (175 mg/kg bw) it is likely that
the true NOAEL for this study is approximately 100 mg/kg bw which is the
overall NOAEL for xylenols.
only a very small component of the xylenols and its presence is
consequently unlikely to affect the NOAEL for any xylenol, the NOAEL of
50 mg/kg bw for developmental toxicity in the rabbit can therefore be
constitute <25% of xylenols and so would only affect NOAELs of mixtures
in which they were present if they were significantly more toxic than
xylenol isomers. Although the reports of reproductive and developmental
toxicity studies of cresol isomers are not available, the data discussed
above show they are probably of comparable toxicity to xylenol isomers
so NOAELs for xylenols can be used to derive DNEL for xylenols
containing cresols. This is also to be expected based on the similarity
of the structures.
As so few
studies have been conducted with ethyl phenols a read across approach
will be used to justify similar NOAELs to xylenol isomers.
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