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EC number: 215-089-3
CAS number: 1300-71-6
Acute oral toxicity: Key study -mixed ethylphenols. York, 2005. KL.1. LD50 980.62mg/kg; NOEL 175mg/kg; Supporting study: mixed xylenols. York, 2005. KL.1 LD50 980.62mg/kg; NOEL 175mg/kg; Supporting study: m-cresol. IBTL, 1969. KL.3. NOEL not identified. LOAEL 147mg/kg; Supporting study: o-cresol. IBTL, 1969. KL.3. NOEL not identified. LD50 121mg/kg; LOAEL 68mg/kg; Supporting study: p-cresol. IBTL, 1969. KL.3. NOEL not identified. LD50 207mg/kg; LOAEL 100mg/kg; Acute inhalation toxicity: No key or supporting studies identified; Acute dermal toxicity: No key or supporting studies identified;
study on ethyl phenols and the supporting study on xylenols both confirm
the LD50 at 980.62 mg/kg and the NOEL at 175 mg/kg. These studies
performed were available to review and the robustness of the NOEL
three cresol isomers the data summaried was already provided and
therefore reports were not available to enable complete evaluation and
suitability for the LD50 / LOAEL values set. These studies are in excess
of 40 years old and consequently not conducted to any guideline, with
data absent. The LOAEL determined have been dictated by the dose levels
set, with clinical signs of toxicity observed at the LOAEL similar to
that observed at higher doses in both the guideline compliant studies on
ethylphenols and xylenols. It is likely that the true NOEL for the
cresols if conducted to modern day guideline compliant protocol would be
similar to that observed for the xylenols and ethylphenols.
it is important to note that Cresols will only constitute <25% of
xylenol / ethylphenol mixture and so would only affect NOAEL / NOEL of
mixtures in which they were present if they were significantly more
toxic than xylenol /ethylphenol isomers.
study available on 3,5 xylenol confirms an LD50 value in
excess of 2400 mg/kg for a study conducted nearly 30 years ago. This
value is reinforced by similar LD50 vaules ranging from 2000
to 2325 mg/kg for the 2,4 and 2,6 isomers. Whilst the cresols data
reports are in excess of 40 years old, the LD50 values
reported for m and p cresol (2050 and 138 mg/kg, respectively) reinforce
the data obtained for the xylenols. Based on structural similarities,
one would assume that the ethyl phenols would give similar values. It
should be noted that the LD50 value for o-cresol was 301
mg/kg. As o-cresol is only a very small component of the mixture (if
present) is unlikely to affect the overall NOAEL.
reported (with the exclusion of 3,5 xylenol where no clinical signs of
toxicity or skin reactions were noted) clinical signs were attributed to
local irritant effects. With transient signs of increased salivation and
available acute dermal toxicity data is limited, but consistently shows
that local irritant effects are the endpoint of concern which persisted
under EU Directive 67/548 EEC both xylenols and cresols are classified
as corrosive, with the R phrases of R24 'toxic in contact with skin and
R34 'cause burns' applied. Therefore in accordance with REACH R7.A
guidance no further testing is warranted. DNEL setting for the dermal
route will be extrapolated form the oral route. The dermal studies
reported are limited in respect of the data available; therefore route
to route extrapolation has been undertaken from the oral data inorder to
derive a acute dermal systemic DNEL.
No key or
supporting studies were identified. What information is available
reports LC50 values 0.29 mg/L through to 30 mg/m3
where no mortality was observed. The
exposure duration is either 1 hour or unknown and therefore not
compliant with the required 4hr exposure.
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