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EC number: 243-349-6
CAS number: 19819-98-8
Acute oral toxicity (read across from Etaphen, which is tested in an OECD TG 401): LD50 = 1609.3 mg/kg bw
An acute oral LD50 for females was not calculated as the data generated
were not suitable to be analysed with the statistical method chosen.
In this study, 5 groups of 10 rats (5 males
and 5 females) were administered Etaphen at dose levels of 1000, 1600,
2000, 2500 and 3200 mg/kg bw. Animals were observed for 14 days. None of
the 10 test animals died at 1000 mg/kg, 5 out of 10 died at 1600 mg/kg,
9 out of 10 died at 2000 mg/kg, and all rats died at the 2500 and 3200
mg/kg levels. Observed clinical signs included body drop, prostration,
exophthalmus, decreased activity, semi-prostration, abnormal gait,
dyspnea, tremors, ataxia, ptosis, diarrhea, decreased body tone,
hypersensitivity, hyperactivity and chromodacryorrhea. The
acute oral LD50 for the substance in male and female rats was determined
to be 1609.3 mg/kg bw with a 95% CI of 1399.6 to 1850.4 mg/kg bw and is
The acute oral toxicity is based on read across to Etaphen. First the
study with the analogue is described and thereafter the read across
justification is presented.
Acute oral toxicity with Etaphen:
In the key study, 5 groups of 10 rats (5 males and 5 females) were
administered Etaphen at dose levels of 1000, 1600, 2000, 2500 and 3200
mg/kg bw. The results are used for read-across to Peomosa. Animals were
observed for 14 days. None of the 10 test animals died at 1000 mg/kg, 5
out of 10 died at 1600 mg/kg, 9 out of 10 died at 2000 mg/kg, and all
rats died at the 2500 and 3200 mg/kg levels. Observed clinical signs
included body drop, prostration, exophthalmus, decreased activity,
semi-prostration, abnormal gait, dyspnea, tremors, ataxia, ptosis,
diarrhea, decreased body tone, hypersensitivity, hyperactivity and
chromodacryorrhea. The acute oral LD50 for the substance in male and
female rats was determined to be 1609.3 mg/kg bw with a 95% CI of 1399.6
to 1850.4 mg/kg bw and is considered harmful.
acute oral toxicity of Peomosa using read across from Etaphen
and hypothesis for the analogue approach
Peomosa is a primary alcohol, specifically a
phenylethanol. For this substance no acute oral toxicity data are
In accordance with Article 13 of REACH,
lacking information should be generated whenever possible by means other
than vertebrate animal tests, i. e. applying alternative methods such as
in vitro tests, QSARs, grouping and read-across. For assessing the acute
oral toxicity of Peomosa the analogue approach is selected because for
one closely related analogue the acute oral toxicity information is
available which can be used for read across.
has similar acute oral toxicity compared to Etaphen resulting in a
similar LD50 of 1609 mg/kg bw because the methyl group present in the
ortho position of the phenyl ring in Peomosa does not affect the organ
toxicity and the LD50.
source substance Etaphen has been tested in a well conducted acute
oral toxicity test (method similar to OECD TG 401 under GLP) with an
LD50 of 1609 mg/kg bw and the test result receives a reliability of 2.
chemical and source chemical(s)
Chemical structures of the target and the
source chemicals are shown in Appendix 1, including physico-chemical
properties and toxicological information, thought relevant for acute
oral toxicity, of all substances.
The purity and impurities of the target
chemical do not indicate acute oral toxicity potential other than
indicated by the parent substance. The impurities are all below < 10%.
According to Annex XI 1.5 read across can be
used to replace testing when the similarity can be based on a common
backbone and a common functional group. When using read across the
result derived should be applicable for C&L and/or risk assessment and
it should be presented with adequate and reliable documentation.
to ECHA guidance (RAAF, 2015) a clear documentation is needed on the
selection of potential source substances. In accordance with ECHA
Guidance (2015, RAAF), Etaphen was selected being the closest analogue
for which acute oral toxicity information was available. Etaphenwas
selected based on structural similarity and the presence of useful data
for read-across, out of all analogues identified in the OECD QSAR
toolbox and analogues identified in the RIFM database.
Structural similarities and differences:The
target and the source chemicals, have a similar backbone and functional
group consisting of phenylethanol, and differ in an additional methyl
group at the ortho position of the phenyl ring present in the target.
These differences between the target and source chemicals are not
expected to influence their acute oral toxicity.
source chemicals and the target chemicals indicate similar
toxico-kinetic characteristics based on the similarity in chemical
structure and physico-chemical properties: Mw, appearance, VP, WS and
log Kow. The
metabolism processes are similar. Etaphen will be metabolised into a
carboxylic acid (phenylacetic acid or benzoic acid) that will be
subsequently excreted to the urine after phase 2 conjugation. Peomosa
will be metabolised analogously to Etaphen (yielding the corresponding
ortho-methyl analogues), and there are no significant differences in
rates to be expected.
and Etaphen have similar reactivity because both have the alcohol as
their functional group.
Uncertainty of the prediction:There
are no remaining uncertainties, because of the reasons presented above.
Therefore, in the ECHA guidance (RAAF, 2015) terminology it receives a
score of 5 (acceptable with high confidence), because the rationale for
the selection of the analogues is clearly documented and there is
supporting evidence provided).
The relevant information on physico-chemical
properties and toxicological characteristics are presented in the Data
per endpoint for C&L
When using read across the result derived
should be applicable for C&L and/or risk assessment, cover an exposure
period duration comparable or longer than the corresponding method and
be presented with adequate and reliable documentation. For Etaphen a
well conducted acute oral toxicity test is available (Reliability 2)
with an LD50 of 1609 mg/kg bw which leads to classification for this
endpoint as Acute Tox. 4. Based on these data for Peomosa also an LD50
of 1609 mg/kg bw can be derived for the acute oral toxicity endpoint.
Final conclusion on hazard and C&L:
Peomosa has an LD50 of 1609 mg/kg bw. Classification and labeling for
this endpoint is assigned as Acute Tox. 4 according to CLP Regulation
(EC) No. 1272/2008 and its updates.
matrix with information on Peomosa and analogues
important for assessment of
acute oral toxicity properties.
Vapour pressure (Pa)
Water solubility (mg/l)
Acute oral tox
Read across to Etaphen
LD50 = 1609 mg/kg bw
Based on the LD50 of 1609.3 mg/kg bw as determined in the key study, the
substance should be classified as Acute Tox. Category 4 in accordance
with the criteria outlined in Annex I of the CLP Regulation
(1272/2008/EC) and its amendments.
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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