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EC number: 905-562-9
CAS number: -
PNECs were derived for freshwater, saltwater, sediment, and soil using
the experimental data or equilibrium partitioning calculations. The
latter where experimental data was lacking.
The screening criteria for environmental toxicity in the PBT assessment
is that a substance with an acute L(E)C50 <0.1 mg/L is considered to
potentially meet the T criterion and an L(E)C50 <0.01 mg/L indicates a
substance is definitely T. A chronic fish study is available for mixed
xylenes and acute and chronic ecotoxicity data are available from
studies conducted with m, p and o-xylene. The most conservative results
are: 96 hour LC50 for fish is 2.6 mg/L for p-xylene (Galassi et al.
1988), 24 hour EC50 for invertebrates of 1 mg/L for o-xylene (Galassi et
al. 1988), 73 hour EC50 for algae of 4.36 mg/L for p-xylene (TNO 2004),
35 day NOEC for fish of 0.714 mg/L for p-xylene (Noack 2017), 7 day NOEC
for invertebrates of 1.17 mg/L for m-xylene (Niederlehner et al. 1998)
and 73 hour NOEC for algae of 0.44 mg/L for p-xylene (TNO 2004). All of
the acute toxicity values are greater than the screening criteria and
the chronic toxicity values are greater than the criteria in Annex XIII
of the REACH regulations. Therefore, the xylene isomers are not
considered to meet the environmental T criteria.
96 hour LC50 for fish is 2.6 mg/L. The lowest 48 hour EC50 for Daphnia
magna is 3.82 mg/L. The lowest 72 or 96 hour ErC50 for algae is 3.2
mg/L. These values would not result in a classification for acute hazard
to the environment.
24 hour EC50 for Daphnia magna of 1mg/L is reported for o-xylene.
Four other studies are available with Daphnia magna, which report
a 48 hour EC50 of 3.82 mg/L (o-xylene), a 48 hour EC50 of >5.3 mg/L
(p-xylene data from chronic study), a 24 hour EC50 of 3.6 mg/L
(p-xylene) and a 24 hour EC50 of 4.7 mg/L (m-xylene). These studies are
all considered valid and are conducted with the same test organism. A
geometric mean of 3.2 mg/L has been calculated from these five values.
None of the LC or EC50 from the acute ecotoxicity tests conducted with
the xylene isomers are less than 1 mg/L and therefore on balance of the
data a classification for acute hazard to the environment is not
data indicate that xylene isomers are readily biodegradable and that
they will partition to the air from water, further reducing their
potential for exposure. An experimentally determined BCF for mixed
xylenes in fish gave a result of 29 L/kg, indicating a low potential for
bioaccumulation. Taken together with the acute toxicity results, these
results would not result in a classification for chronic hazard to the
on 10th March 2011, Commission Regulation (EC) No 1272/2008 [CLP
Regulations] was amended. The new criteria for environmental
classification state that if chronic data are available these results
should be used to determine the chronic classification. The xylene
isomers have a complete chronic data set, with the lowest chronic effect
being a 72 hour NOEC of 0.44 mg/L for algae. This results in a chronic
Category 3 classification under the CLP Regulations. This has been added
as a self classification to the dossier.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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