Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 614-345-5
CAS number: 68155-40-8
There is 28 Day oral dosing study available for 2, 2’-(Octadec-9-enylimino) bisethanol CAS No 25307-17-9, dose level where 250mg/kg/day reduced to 150mg/kg/day , 100mg/kd/day and 30 mg/kg/day. The no-observed-adverse-effect-level (NOAEL), is regarded as 30 mg/kg/day. This study has now been followed by an OECD408 90 day oral (gavage) dosing study in rats. This study which used dose levels of 5, 30 and 150 mg/kg bodyweight, confirmed a 30mg/kg NOAEL despite the longer duration of dosing.
is a 90 day oral (gavage) dosing study available for 2,
2’-(Octadec-9-enylimino) bisethanol CAS No 25307-17-9. The
5, 30 and 150 mg/kg bodyweight were
selected based on the effects seen in the 28 day study, which were
mainly local irritant effects in the stomach, small intestines and foamy
macrophages in the mesenteric lymph nodes.
main treatment related effects where limited to the 150mg/kg bodyweight
top dose group.
were no macroscopic findings observed at necropsy examination that were
considered to be associated with treatment.
addition to some haematological, clinical chemistry and organ weight
differences the only histopathological findings were limited to
irritant/.corrosive effects in the stomach and small intestines.
150 mg/kg bw/day histopathological examination showed minimal or mild
diffuse epithelial hyperplasia and hyperkeratosis of the forestomach
were observed in most animals with minimal or mild focal erosion of the
forestomach, minimal or mild submucosal inflammatory cell infiltration,
submucosal oedema and minimal focal dyskeratosis being present in the
forestomach for a few animals. In addition, minimal to marked foamy
macrophages were present in the lamina propria of the small intestine
(principally the jejunum but also in the duodenum and ileum) and also in
the sinuses of the mesenteric lymph node for both sexes.
30 mg/kg bw/day treatment-related changes were restricted to incidences
of minimal focal epithelial hyperplasia, minimal focal erosion,
submucosal oedema and minimal or mild submucosal inflammatory cell
infiltration of the forestomach. No treatment-related changes were
observed in the small intestine or mesenteric lymph node.
150 mg/kg bw/day, the extent of microscopic changes to the fore stomach
and gastro-intestinal tract apparent for both sexes was considered to
exclude this dosage from being a No Observed Adverse Effect Level
(NOAEL). At 30 mg/kg bw/day, microscopic changes were restricted to the
fore stomach and were considered to represent a local irritancy effect
of the test item rather than systemic toxicity.
such, a dosage of 30 mg/kg bw/day may be considered the NOAEL for
systemic toxicity. A dosage of 5mg/kg
bw/day was considered to represent the No Observed Effect Level (NOEL).
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
This is a full GLP Klimisch 1 study carried out with the substance to be registered to the current OECD408 90 day study in rats guideline and EU B.26.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The low vapour pressure of the substance means inhalation is not considered to be relevant route of
exposure so no testing is required. An Inhalation DNEL can be calculated based on the oral NOAEL following REACH guidelines.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
The low vapour pressure of the substance means inhalation is not considered to be relevant route of exposure so no testing is required.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The corrosive properties of this substance mean the repeated dose dermal studies are not scientifically justified due to concerns for animal welfare. A dermal systemic DNEL, based on the oral NOAEL can be calculated following the REACH guidelines.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Local effects would be expected to be irritation/corrosion which are local concentration rather than dose dependent. Specific testing is not scientifically justified due to concerns for animal welfare. The classification as corrosive will ensure dermal exposure is well controlled.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: duodenum; digestive: ileum; digestive: jejunum; digestive: stomach
toxic effects seen can be attributed to oral dosing with a
corrosive/irritant test substance which caused effects due to the direct
contact with the forestomach and to a much lesser extent the
gastrointestinal tract (small intestines). The
effects were seen at dose levels in the range of 30 -150mg/kg/day and
therefore potentially classifiable as Category 2 (10 -100mg/kg) for
specific target organ toxicity after repeated exposure, when based on a
90 day study. However
there were no indications of any specific systemic toxic effects such as
serious organ damage even at 150mg/kg. Therefore
as the only effects seen at 150mg/kg of 2, 2’-(Octadec-9-enylimino)
bisethanol CAS No 25307-17-9 were direct irritant effects, with limited
local effects only in the forestomach at 30mg/kg, it does not meet the
CLP(GHS) criteria for classification for specific target organ 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.
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again