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EC number: 417-070-7
CAS number: 151006-62-1
1-DODECENE TRIMER, HYDROGENATED; ALKANE 4
Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer.
were no identified key studies for repeated oral, dermal, or inhalation
exposure for dec-1-ene, dimers, hydrogenated. Read-across
studies within poly alpha olefins were used to assess repeated dose
toxicity through oral exposure. There were, however, no studies
identified within category for repeated dose toxicity for either
inhalation or dermal exposure.
Dose Oral Toxicity
28-day studies and three 90-day repeated dose studies for oral exposure
were identified. For the 28-day repeated dose studies, studies were
identified from 1-decene, homopolymer, hydrogenated; 1-dodecene dimer
with 1-decene, hydrogenated, and 1 -dodecene trimer, hydrogenated, a
structural analog. For 90-day exposures, studies were identified from
1-decene, homopolymer, hydrogenated and 1 -dodecene, trimer All studies
were considered robust and of good quality.
the 28-day exposure studies produced no mortalities or significant
clinical or systemic toxicity when the respective poly alpha olefins
were administered orally. For
one of the 28-day repeated dose studies, 1-decene, homopolymer,
hydrogenated, was administered to F-344 rats (5 sex/dose) in the diet
for four weeks at nominal concentrations of 0, 8000; 20,000; or 50,000
ppm (equivalent overall mean daily intakes were 1039, 2538, or 6245
mg/kg/day for males and 995, 2481, or 6771 mg/kg/day for females)
(Cooper, 1994). Dietary administration of 1 -decene, homopolymer,
hydrogenated to male and female F-344 rats at levels up to 50,000 ppm
for 4 weeks did not produce toxicologically significant effects.
Therefore, the subacute oral NOAEL for 1 -decene, homopolymer,
hydrogenated is 6245 mg/kg/day in males and 6771 mg/kg/day in females.
In the second 28-day repeated dose study conducted with 1-dodecene dimer
with 1-decene, hydrogenated was administered to 6 Sprague-Dawley
rats/sex/dose at dose levels 0, 200, 500, or 1000 mg/kg bw/day for 29
days (Cooper, 1989). A recovery group (6 rats), dosed with 0 or 1000
mg/kg/day of the test substance, was observed for two weeks post-dosing.
No mortality, compound-related systemic toxicity or pathological changes
were observed in the study or recovery groups at the limit dose of 1000
mg/kg 1 -dodecene, dimer with 1 -decene. Statistically significant
changes occurred in food consumption, haematology, serum chemistry, and
organ weights; however, none of the changes were considered to be of
toxicological significance. No
LOAEL could be determined due to lack of any affects. The NOAEL was
reported as 1000 mg/kg/day. Lastly,
a short-term oral exposure study conducted with 1 -dodecene, trimer, a
structural analogue for poly alpha olefins, found no compound-related
effects in mortality, clinical signs, body weight, food consumption,
haematology, clinical chemistry, organ weights, or gross and histologic
pathology when 1 -dodecene, trimer was administered to 5 Sprague-Dawley
CD rats/sex/dose at dose levels 0 or 1000 mg/kg bw/day for 28
consecutive days (Coles, 1995). The
NOAEL was reported as 1000 mg/kg/day.
a 90-day study followed by a 4 week recovery with 1 -dodecene,
homopolymer, hydrogenated (Cooper, 1995), rats were dosed with 0, 1000,
7000, or 50,000 ppm (equivalent to 77.5, 553.7, or 4159.4 mg/kg,
respectively, in males and 85.5, 611.5, and 4619.9 mg/kg, respectively,
in females). No mortalities were observed in any treated group. Clinical
signs observed in the 50,000 ppm group included oily and ungroomed coats
as well as a slight increase in food consumption, including during the
four week recovery period. Increased erythrocyte counts and hemoglobin
concentrations (dose-response relationship) were reported for treated
males. Marginally high packed cell volumes were reported for males
treated at 7000 and 50,000 ppm. Platelet
counts were slightly higher 50,000 ppm animals and slightly reduced
liver weights were reported in males at end of treatment. All
effects were not present at the end of the 4 week recovery period and
therefore considered reversible. In
a 90-day one-generation reproduction study with subchronic toxicity with
1 -dodecene, trimer, a structural analogue for poly alpha olefins (Knox
et al., 2007, OECD 415/OECD 408), there were no signs of clinical
toxicity, changes in body weight, haematological or clinical chemistry
NOAEL was reported as 1000 mg/kg bw. In
a 91-day oral repeated dose study (Daniel, 1994), rats exposed to
Ethylflo 166 in utero were treated with Ethylflo 166 at doses of 0, 250,
500, or 1000 mg/kg/day. Transient changes in body weight, body weight
gain, food consumption, haematology, and organ weights were observed but
were not considered treatment-related. The
NOAEL was reported as 1000 mg/kg bw/day.
significant or enduring toxicological effects were reported from these
studies; therefore classification and labelling was not required for
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.
read-across information from studies performed with poly alpha olefins
within category or from a structural analogue, it can be assumed that
dec-1-ene, dimers, hydrogenated would
not produce significant systemic toxicity following repeated exposure.
Therefore, dec-1-ene, dimers, hydrogenated is
not classified under EU Dangerous Substances Directive 67/548/EEC or CLP
EU Regulation 1272/2008 for repeated dose toxicity.
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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