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EC number: 701-068-0
CAS number: 2156592-58-2
Experimental studies with C12 -18 -(even numbered)-alkylamines on
fertility, respectively on reproductive function are not available.
However, data relevant for hazard assessment with regard to this
endpoint are available from an OECD TG 421 study as well as from
repeated oral dose toxicity studies with histopathological investigation
of the reproductive organs for related primary alkylamines which are
considered appropriate for extrapolation. In a study according to OECD
TG 421 with tallow alkylamines (CAS No. 61790 -33 -8), findings of
general toxicity in close accordance to the results from the 28 -day
repeated dose toxicity study with the same compound were obtained at
identical dose levels. Since severe general toxicity due to the strong
irritating / corrosive properties
There are no human data available on any primary alkylamine indicative of potential developmental toxicity.Tests in animals with C12-18-(even numbered)-alkylamines are also not available. However, concerning developmental toxicity data from animal studies with the oral route of exposure useful for read-across purposes are available for two species (rats, rabbits) on (Z)-octadec-9-enylamine which did not provide evidence for any embryo-/fetotoxic or teratogenic potential even at clearly maternally toxic dose levels. From the study with rabbits a NOAEL (development) of greater 30 mg/kg body weight per day is derived.
Experimental studies with C12 -18 -(even numbered)-alkylamines with
respect to the endpoint developmental toxicity are not available.
However, data from guideline according prenatal developmental toxicity
testing in two species (rats, rabbits) is available for the closely
related primary alkylamine (Z)-octacec-9 -enylamine (CAS No. 112 -90
-3). Read-across from these test results are considered adequate for
hazard assessment of C12 -18 -(even numbered)-alkylamines for this
endpoint. From the rat study a NOAEL (maternal toxicity) of 10 mg/kg
body weight per day and a NOAEL (developmental toxicity) of greater 80
mg/kg body weight was derived. In addition, a guideline conform
teratology study in rabbits with (Z)-octadec-9 -enylamine revealed
general findings of irritation in the gastrointestinal tract and
dose-dependent body weight loss or reduced weight gain during the
treatment in the 30 mg/kg dose group. Caesarean section data did not
reveal any significant differences in reproductive parameters and no
indications of an embryotoxic, fetotoxic or teratogenic effect at any
tested dose-level. A NOAEL (developmental toxicity) of greater 30 mg/kg
body weight per day was derived.
Reproductive toxicity studies on C12 -18 -(even numbered)-alkylamines
are not available. However, data relevant for hazard assessment with
respect to the endpoints fertility and developmental toxicity are
available for the closely related primary alkylamines (Z)-octadec-9
-enylamine (CAS No. 112 -90 -3) and tallow alkylamines (CAS No. 61790
-33 -8). In line with the existing EU risk assessment on primary
alkylamines it is considered approriate to extrapolate from these data
and therefore read-across is considered adequate for hazard assessment.
Also in line with the existing EU risk assessment, additional testing is
not regarded to be necessary. Thus, according to the results from the
available studies classification and labelling of C12 -18 -(even
numbered)-alkylamines with regard to reproductive toxicity is not
warranted as it is not for all other primary alkylamines of this
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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