Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity

Justification for type of information:

According to Annex IX of REACH Regulation, the extended one-generation reproductive toxicity study (EOGRTS) is required, if the 28 day or 90 day study or the screening study indicates adverse effects on reproductive organs or tissues.
For the target substance C1618FA-TEPA-compound further testing on reproductive toxicity is considered not necessary because in studies conducted with the source substance Partially unsaturated IQAC, DMS quaternised up to 1000 mg/kg bw/day there were no indications for substance-related effects regarding reproduction organ weights (ovary) and histopathology of uterus from a 91-day repeated dose toxicity study. Observed effects in the repeated dose toxicity study were a decreased liver weight and serum protein level which occurred simultaneously with an increased SGOT and SGPT activity at the highest dose level of 1000 mg/kg bw. However, these findings were without histopathological correlate. Based on these findings there are no indications for reproductive toxicity.
In addition this is substantiated by the absence of effects on maternal reproduction, embryo lethality or embryotoxicity in the developmental toxicity study in rats with doses of up to 1000 mg/kg bw/day.
The substance has no genotoxic toxicity potential as proven by a full set of genetic toxicity studies required by REACH Regulation. Beside the classification for skin and eye irritation there is no additional classification required for the target substance. Furthermore, the target and source substances exhibit a low bioavailability as determined by toxicokinetic studies, thus, even after unintended high exposure systemic toxic effects, including effects on reproduction are unlikely.
In conclusion, no trigger for reproductive toxicity has been identified within a detailed review of the available data. Accordingly, based on the proven low toxicity of the substance and in order to avoid unnecessary animal testing the conduct of an EOGRTS is not justified.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified