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EC number: 627-034-4 | CAS number: 1213789-63-9
Experimental studies with (Z)-octadec-9 -enylamines 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. However, concerning developmental toxicity data from animal studies with the oral route of exposure 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. In accordance with the EU risk assessment on primary alkylamines, this NOAEL will also used for read-across purposes for the whole category of primary alkylamines.
Data from guideline according prenatal developmental toxicity testing in two species (rats, rabbits) are available for (Z)-octacec-9 -enylamine (CAS No. 112 -90 -3). 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. However, 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 (Z)-octadec-9 -enylamines and tallow alkylamines are available which are considered relevant for hazard assessment with respect to the endpoints fertility and developmental toxicity. 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 (Z)-octadec-9 -enylamine with regard to reproductive toxicity is not warranted as it is not for all other primary alkylamines of this category.
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