Amines, N-C12-14-alkyltrimethylenedi-

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because a pre-natal developmental toxicity study is available

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
No studies are available on N-C12,14 alkyl-1,3-diaminopropane (CAS 90640-43-0), also referred to as C12-14-diamine.
Cross-reading to data available on other diamines and polyamines is acceptable on the basis of identical alkyl-diamine structure, resulting to the same functional groups with similar properties leading to common biological activity, and common metabolic degradation. Further information on the applicability of the read-across from various diamines to Coco-diamine can be obtained from the document "Category polyamines - 20170518.pdf" added to IUCLID Ch. 13.

No adverse effects on reproductive organs were identified in the 90 day study in rats on C12-14-diamine. This study was performed according to OECD 408 and does not include detailed reproductive parameters as indicated in OECD 416. Nevertheless, the 90 day study did not indicate any effects on weight of testes, prostate, seminal vesicles, ovaries, and uterus. Histological examination of these tissues also confirmed no treatment-related effects. There was a very slight increase in relative weight of the epididymis in the high dose animals but there were no corresponding histological changes. There was also no indication of a dose-response relationship. Accordingly, the effect on epididymis is not believed to be treatment related.

Additional data is available from a developmental toxicity study performed on Oleyl-diamine, which also included endpoints relevant to assessing an effect on fertility. No effects on pre/post implantation rate, late/early resorptions, corpora lutea or number of live fetuses were seen in this study. Although the available data on Oleyl-diamine does not include information on sperm parameters and oestrus cycle, it supports the conclusion that there are no indications of an effect of diamines on fertility.

On overall, there are various reproduction screening studies, a full 2-generation study and various developmental toxicity studies available, covering the range of Polyamines, which show a clear lack for concern for reproduction toxicity.

In addition, there is no consumer exposure to C12-14-diamine. Further, manufacture and use are highly controlled. Its use is limited to industrial and professional users where following its severe corrosive properties the applied protection measures will provide for sufficient protection to prevent exposure

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified