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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
12.5 mg/kg bw/day
Additional information

Experimental studies with octadecylamines 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

appears to be the predominating substance-related toxic effect, and since no histological compound-related changes were observed on testes, epididymides and ovaries, neither in the OCED 421 nor in the OECD 407 study, even at the highest dose of 150 mg/kg body weight per day tested, a specific substance-related effect on reproduction performance is not deducible. Signs of general toxicity without indications on the reproductive behaviour was also noted at the intermediate dose-level of 50 mg/kg body weight per day. No toxic effects were observed at the low-dose treatment with 12.5 mg/kg body weight per day which therefore can be considered to be a NOAEL (fertility). This conclusion is in line with the evaluation coming from the existing EU risk assessment on primary alkylamines. Additionally, according to the EU risk assessment further testing of primary alkylamines with regard to the endpoint fertility was not considered necessary.

Short description of key information:
No human data are available for any primary alkylamine indicative of potential toxicity to reproduction. Additionally, no animal data on this endpoint are available for octadecylamines. However, data from closely related primary alkylamines can be used as read-across tor assessment purposes. The results from an OECD TG 421 study with tallow alkylamines as well as from detailled histopathology of the reproductive organs of repeated-dose toxicity studies did not provide evidence for adverse effects on the gonads or any indications for a specific toxic potential adverse to fertility. Based on the results from these studies a NOAEL for fertility of 12.5 mg/kg body weight per day is derived on a read-across basis for octadecylamines, which is in line with the conclusion from the existing EU risk assessment on primary alkylamines in general.

Effects on developmental toxicity

Description of key information
There are no human data available on any primary alkylamine indicative of potential developmental toxicity.Tests in animals with octadecylamines 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.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
30 mg/kg bw/day
Additional information

Experimental studies with octadecylamines 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.

Justification for classification or non-classification

Reproductive toxicity studies on octadecylamines 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 octadecylamines with regard to reproductive toxicity is not warranted as it is not for all other primary alkylamines of this category.