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EC number: 417-070-7
CAS number: 151006-62-1
1-DODECENE TRIMER, HYDROGENATED; ALKANE 4
No other concerns identified.
read-across studies were identified for poly alpha olefins and their
structural analogue, 1 -dodecene, trimer: a 91-day study which assessed
the systemic toxicological effects of treatment with 1-decene,
homopolymer, hydrogenated on rats previously treated in utero with the
same chemical and a 90-day study 1 -dodecene, trimer which assessed
fertility and developmental effects in a one-generation study (OECD
415). Details of the studies are presented below.
a one-generation reproduction study, 1-decene, homopolymer, hydrogenated
was administered to 30 Sprague-Dawley Crl: CD®BR VAF/Plus® rats/sex/dose
by gavage at dose levels of 0, 100, 500, or 1000 mg/kg bw/day (Daniel,
males and females were treated for 4 weeks prior to mating and through
the end of mating, males were sacrificed. Females
were treated through gestation and until lactation day 21.
were no treatment-related effects on clinical signs, mortality, body
weight, or gross pathology in the parental generation or in the pups
through lactation day 21. There
were no treatment related effects on reproduction or pup viability. Some
pups were used further in a subchronic study with the remainder
sacrificed on lactation day 21. There
is no parental or offspring systemic or reproduction LOAEL, based n the
lack of effects. The
parental systemic and reproduction NOAEL is 1000mg/kg bw/day in males
and females. The offspring NOAEL is 1000 mg/kg bw/day even after the
additional 91 day subchronic exposure.
a one-generation reproduction study, 1 -dodecene, trimer was
administered orally, once daily, by gavage to three groups each of
twenty-four male and twenty-four female Sprague-Dawley Crl: CD® (SD) IGS
BR strain rats, at dose levels of 1000, 250 and 50 mg/kg/day (Knox et
al., 2007). A further group of twenty-four male and twenty-four female
rats received the vehicle alone to serve as a control.
were two unscheduled deaths on the study, occurring in the control and
250 mg/kg/day dosage groups, neither of which was associated with
treatment. There were no signs of clinical toxicity observed in either
sex at any of the doses tested. Behavioural and functional performance
remained unaffected in male and female rats treated with 1 -dodecene,
trimer. Sensory reactivity, body weight, food and water consumption were
unaffected as were fertility and mating performance. Haematological and
clinical chemistry assessments revealed no significant treatment-related
effects on male and female rats.
treatment-related effects on offspring growth or development were
detected. Litter sizes from birth to weaning were essentially similar
across all dose groups. Gross necroscopy did not reveal any remarkable
findings and neither did histopathology.
oral administration of 1 -dodecene, trimer to rats by gavage at a
maximum dose level of 1000 mg/kg/day, throughout maturation, mating,
gestation and lactation resulted in no treatment related effects. Thus,
the NOAEL for adult toxicity and reproductive and developmental toxicity
was considered to be 1000 mg/kg/day.
adverse fertility effects were reported in a one-generation study with 1
-dodecene, trimer; a structural analogue of dec-1-ene, dimers,
at the limit dose of 1000 mg/kg/day (Knox et al., 2007). No
treatment-related effects were reported in rats treated in utero and
then subsequently treated an additional 91 days after birth with
1-decene homopolymer, hydrogenated (Daniel, 1994).
The NOAEL was 1000 mg/kg/day for both
studies (highest dose tested). The weight of evidence presented by these
studies suggests that poly alpha olefins, as a group, are unlikely to
present a significant hazard potential to fertility; therefore a DNEL
for this endpoint is not necessary.
for Read Across
criteria justify the use of the read across approach to fill data gaps
for poly alpha olefins using 1 -dodecene, trimer as an analogue. 1
-dodecene, trimer, like other compounds in this category, is a poly
alpha olefin, i. e., highly branched isoparaffinic chemicals produced by
oligomerization of oct-1-ene, dec-1-ene, and/or dodec-1-ene. Therefore
its physiochemical and toxicological properties are expected to be
similar to those of other poly alpha olefins.
Short description of key
Two read-across studies were
identified for poly alpha olefins and its structural analogues: a 91-day
study which assessed the systemic toxicological effects of treatment
with 1-decene, homopolymer, hydrogenated on rats previously treated in
utero with the same chemical and a 90-day study with 1 -dodecene, trimer
which assessed fertility and developmental effects in a one-generation
study (OECD 415). Neither study showed any treatment-related effects on
fertility or reproductive endpoints in rats. Both studies reported a
NOAEL of 1000 mg/kg bw.
Not expected to cause developmental toxicity.
developmental or 2-generation reproductive toxicity data were available
for dec-1-ene, dimers, hydrogenated.
Two one-generation reproduction toxicity studies from 1-decene,
homopolymer, hydrogenated and structural analogues related to dec-1
-ene, dimers, hydrogenated
showed no effects on reproductive parameters. Although results from
these studies showed no reproductive or developmental effects at the
highest dose tested, and while the data in combination present a
reasonable weight of evidence upon which to judge the reproductive and
developmental toxicity of poly alpha olefins, these study results cannot
meet the requirement for results from a complete developmental or
two-generation reproductive study. Nonetheless, the results are
considered adequate do not raise concern with regard to classification
of dec-1-ene, dimers, hydrogenated as
toxic for reproduction or a development toxicant under EU Dangerous
Substances Directive 67/548/ECC or CLP EU Regulation 1272/2008 (GHS
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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