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EC number: -
CAS number: -
No other studies are available.
The parental NOEL for fatty acids,
C18-unsaturated dimers in rats was considered to be 2,000 ppm
(approximately 180 mg/kg/day) and for reproductive parameters the NOEL
was considered to be 20,000 ppm (approximately 1,858 mg/kg/day).
A supporting long-term and multigenerational
study with rats feed with medium chain triclycerides (MCT) (75% octanoic
acid, 25% decanoic acid) showed normal reproduction, as indicated by
litter size and number. After weaning, growth of the rats fed MCT was
similar to animals on the oleo oil diet. No specific toxic effects in
mice were observed.
No studies on the toxicity to reproduction
of 400160 are available. However studies on the developmental toxicity
are available for 2-ethylhexanol applied orally to mice and dermally to
rats. These studies were used as read-across to structural analogues. In
accordance with REACH Annex VIII, column 2 (8.7.1) a screening test for
reproductive/developmental toxicity does not need to be conducted if a
pre-natal developmental toxicity study (Annex IX, 8.7.2) or a
two-generation reproductive toxicity study (Annex IX, section 8.7.3) is
Information on developmental toxicity is available for 2-ethylhexanol, a raw material of 400160. The NOAEL of dermal application was 840 and ≥ 2520 mg/kg/day for maternal and developmental toxicity. For oral application the NOAEL for maternal and developmental toxicity was each 191 mg/kg bw/day. A lower NOAEL of 130 mg/kg/day was determined in another oral study with 2-ethylhexanol in rats. This study showed significant maternal toxicity at higher doses and a lower number of animals were used as recommended in the guideline.A supporting feeding study of cuphea oil to three generations showed no effects on reproduction in mice.
2-ethylhexanol (2 -EH) (0%, 0.009%, 0.03%, or 0.09% in feed, corresponding
to an average intake of 0, 17, 59, and 191 mg/kg/day)
was provided on gestational days 0 to 17 ad libitum to timed-mated CO-1
mice (28/group). At sacrifice (gestational day 17), the number of
ovarian corpora lutea and uterine implantation sites, including
resorptions, and dead or live fetuses, were recorded. Live and dead
fetuses were weighed. Live fetuses were sexed and examined for external,
visceral and skeletal malformations and variations.
dams died, delivered early or were removed from the study. Pregnancy
rate was high and equivalent across all groups. There was no
treatment-related maternal toxicity observed in this study.
were no effects of exposure to dietary 2-EH on any gestational
parameter. The number of corpora lutea, uterine implantation sites, pre-
and postimplantation loss, sex ratio and live fetal body weight per
litter were all equivalent across all groups. There were also no
treatment-related changes in the incidence of individual, external,
visceral, skeletal or total malformations or variations. In conclusion,
there were no maternal or developmental toxic effects of 2-EH dietary
exposure throughout gestation up to a concentration of 191 mg/kg/day.
2-EH is essentially without developmental or
teratogenic effects in the presence of demonstrable maternal toxicity,
when administered by dermal route to pregnant F344 rats on gestational
days 6 through 15. Maternal toxicity was limited to reduced body weight
gain at 1680 and 2520 mg/kg/day and to mild or moderate skin irritation
at 840 and 2520 mg/kg/day. Both effects occurred during treatment and
were transient or ameliorated after treatment ceased. There were no
other clinical findings and no effects on selected organs at necropsy.
There were no effects on gestational parameters and no significant
differences from controls in the incidence of fetal malformations and
Therefore, the NOAEL for maternal systemic
toxicity was 840 mg/kg bw/day, based on the effects on body weight gain;
the NOAEL for skin irritation was 252 mg/kg bw/day. The NOAEL for
developmental toxicity and teratogenicity was 2520 mg/kg bw/day.
Several pivotal studies have been
performed with structural analogues of UVCB 400160 (CAS No. 68334-05-4;
typically consisting of 16% diesters, 43.3% monoesters, and 40.7%
C18–unsaturated fatty acid dimers), in particular with 2-ethylhexanol
(2-EH), the alcoholic moiety of the mono- and diesters included in
400160 as well as with medium-chain fatty acids.
Originally, fatty acids (e.g. C16-C18
and C18-unsatturated) (CAS No. 67701-08-0) were exempted from the
obligations to register in accordance with article 2(7)(a) according to
Annex IV of Regulation (EC) No 1907/2006. However, a review of the
criteria for inclusion in Annex IV (“sufficient information is
known about these substances that they are considered to cause minimum
risk because of their intrinsic properties”) in 2008 led to the
deletion of fatty acids in Annex IV because some of the substances did
not fulfil all criteria for inclusion (Commission of the European
Communities, 2009). For saturated C16-C18 and C18-unsatturated fatty
acids this decision was mainly based on ecotoxicological concerns and a
slight skin and eye-irritating potential (DHI 2009). Data available on
reproductive toxicity were considered sufficient to fulfil the Annex IV
inclusion criteria. In particular, a three-generation reproductive study
on a C10 fatty acid did not reveal any safety effects concerning
reproduction (Hendrich et al. 1993).
In view of the available reproductive
toxicity data, the long history of safe use of fatty acids in diet, and
the fact that available reproductive toxicity data were considered
sufficient to fulfil the Annex IV inclusion criteria of regulation (EC)
No 1907/2006, no
further developmental toxicity study with 400160 is justified.
No concern arises from both raw materials of
400160 (2-ethylhexanol and dimer fatty acids) on sexual function and
fertility or on development.
Therefore no classification is required for
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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