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EC number: 701-068-0
CAS number: 2156592-58-2
No data are available for the primary alkylamine C12-18-(even numbered)-alkylamines with regard to repeated dose toxicity. However, the 28-day oral toxicity test with (Z)-octadec-9-enylamines (Genamin OL 100 D) can be used based on read-across principles. This approach is in line with the existing EU risk assessment on primary alkylamines. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. In accordance with the existing EU risk assessment on primary alkylamines, this value is considered to be valid also for C12-18-(even numbered)-alkylamines and will be used for all relevant exposures by route-to-route extrapolation for this category of chemicals.
The term `primary alkylamines` stands for a group of substances which
share essential chemical key aspects. From a toxicological point of
view, this category of chemicals exhibite a closely related effect
spectrum not only related to qualitative but also quantitative aspects.
On that basis, read across of data from one primary alkylamine to
another is scientifically accepted and has been used in the existing EU
risk assessment on primary alkylamines. Hence, the same principles are
There are no human data available on repeated dose toxicity of C12 -18
-(even numbered)-alkylamines as for the whole class of primary
alkylamines. Likewise no data from repeated dose studies are available
for the inhalatory route of exposure. For the dermal route of exposure
limited data exist from non-guideline studies which, however, do not
allow to establish a dermal systemic NOAEL but which can be used to
support the practicability of read-across principles. Additionally, the
available data from these studies do allow the derivation of an overall
minimal concentration (LOAEC local) for primary alkylamines of 0.3 %
that induces skin irritation.
For the oral route of exposure information from guidline-compliant
subacute 28 -day studies are available for (Z)-octadec-9 -enylamine
(CAS-No. 112 -90 -3) and tallow alkylamines (CAS-No. 61790 -33 -8) which
demonstrated a closely related toxicity profile. Additional data in form
of a chronic feeding studies in rats and dogs exist for octadecylamine
(CAS-No. 124 -30 -1). However, due to limitations in quality, these are
not used as key studies but do support the derived conclusions. Based on
validity considerations therefore the available data for (Z)-octadec-9
-enylamine and for tallow alkylamines are used for the assessment and
read-across is applied for all primary alkylamines considered in this
category approach. Leading health effects after oral exposure were
mortalities at higher dose-levels associated with precedent bad general
health status and gait abnormalities, erosions of the mucosa of the
gastrointestinal tract, accumulation of histiocytes in the submucosa of
the distal parts of the small intestine and in the mesenteric lymph
nodes, and mild toxic effects in liver and kidneys. With respect to
local effects, the available data clearly demonstarte that primary
alkylamines cause damage along the exposure route, i.e. the mucosa of
the gastrointestinal tract. The data also indicate a cytotoxic potential
at any site of contact along the exposure route and can be explained by
the strong dermal irritative / corrosive nature of the primary
Taking the approach of applying read-across implies that the most
sensitive NOAEL for the endpoint `repeated dose toxicity` is used for
the assessment which was derived from the valid oral 28 -day study on
(Z)-octadec-9 -enylamine (CAS-No. 112 -90 -3). The NOAEL from this study
was 3.25 mg/kg body weight per day which will be also used as starting
point for the route-to-route evaluations with regard to the inhalative
and dermal exposure patterns. This approach is supported by findings
from a 2 -year chronic toxicity study in rats and a 1 -year chronic
feeding study in dogs which yielded in oral NOAELs of about 10 and 3
mg/kg body weight per day respectively. Based hereupon, additional
testing was not considered necessary in the existing EU risk assessment
on primary alkylamines. For the dermal route, however, a local LOAEC for
effects on the dermis of 0.3 % can be applied.
The category approach for primary alkylamines is also applied for
classification considerations, and a `Xn (harmful) with R48/22 - danger
of serious damage to health by prolonged exposure if swallowed` is
proposed for C12 -18 -(even numbered)-alkylamines which is in line with
the proposed classification from the EU risk assessment on primary
alkylamines. However, it should be noted that the available data
consistently points to a primarily local mode of action due to the
strong irritative / corrosive properties of primary alkylamines which,
however, leads to secondary effects with relevance of systemic 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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