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EC number: 629-765-4
CAS number: 1226892-44-9
Tall oil diethylenetriamine imidazoline was
administered by daily oral gavage to male and female Wistar Han rats at
dose levels of 10, 30 and 100 mg/kg/day. The males were exposed for 2
weeks prior to mating, during mating, and up to termination (for 28
days). There was a 2 week recovery period for 5 animals of Group 1 and
4. The females were exposed for 2 weeks prior to mating, during mating,
during post-coitum, and at least 4 days of lactation.
Formulation analysis showed that the
formulations were prepared accurately and homogeneously and were stable
for at least 6 hours at room temperature.
The changes in clinical biochemistry
parameters in animals at 100 mg/kg/day at the end of the treatment
period were generally slight in nature (i.e. mostly within the normal
range) and were fully reversible after a 14-day recovery period in
males. Moreover, no morphological changes were observed that would
support these changes which included higher alanine and aspartate
aminotransferase activity and creatinine level in males, and lower total
protein and urea level in males and females respectively. Therefore,
these changes were not considered to be of toxicological relevance.
The lower prostate and seminal vesicle
weight, and lower prostate to body weight ratio at the end of the
treatment period in males at 100 mg/kg/day were absent at the end of the
recovery period in males, and were not supported by any
histopathological lesions or reproductive toxicity. No toxicological
relevance was ascribed to these findings.
Histopathology revealed foamy macrophage
foci in the ileum of all selected males and females at 100 mg/kg/day, a
slightly increased incidence and degree of macrophage foci in the
mesenteric lymph node of both sexes at 100 mg/kg/day, and increased
incidence of lymphoid atrophy in the thymus of females at 100 mg/kg/day.
At the end of the 14-day recovery period for males, foamy macrophage
foci in the ileum had completely resolved, whilst macrophage foci in the
mesenteric lymph node persisted at higher severity than observed at the
end of treatment. Given the persistence of this finding it was
considered to be of an adverse nature.
No toxicologically significant changes were
noted in any of the remaining parental parameters investigated in this
study (i.e. clinical appearance, functional observations, body weight,
food consumption, haematology and macroscopic examination).
No reproductive/developmental toxicity was
observed at any dose level.
Based on the increased incidence/severity of
macrophage foci in the mesenteric lymph node at both the end of
treatment and recovery period in males, a parental No Observed Adverse
Effect Level (NOAEL) of 30 mg/kg/day was derived.
A reproductive/developmental NOAEL of 100
mg/kg/day was derived.
As explained in the category
justification, For cross-reading in general use is made with data of
same or lower EA-length where available, and that of Tall oil + DETA
representing the worst case.This
dossier is for the substance "Fatty acids C18 unsat, reaction products
with triethylenetetramine" (or TO + TETA). As for the substance itself
no toxicological information is available, cross-reading has been
applied to TO + DETA.
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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