Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Adequacy of study:
weight of evidence
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The repeated dose toxicity study from Casterton et al. (see 7.5.1) was a 90-day Wistar rat feeding study with in utero exposure of refined arachidonic acid-rich oil (RAO). RAO consists among other things of stearic acid and palmitic acid, the both main components of the fatty acid C16-18, sodium salt. The in utero phase of the study involved dietary exposure to RAO, covered four-weeks prior to mating, through mating, gestation and lacation until offspring (F1) weaning. There were no treatment-related fertility, reproductive or developmental index observations. Therefore, it is assumed that the fatty acid C16-18, sodium salt does not affect fertility. Because of the existing developmental toxicity study according OECD 414, which shows that the fatty acid has no developmental toxicity properties, an additional OECD 421 study is not justified with regard to avoid animal testing.
Executive summary:

The repeated dose toxicity study from Casterton et al. (see 7.5.1) was a 90-day Wistar rat feeding study with in utero exposure of refined arachidonic acid-rich oil (RAO). RAO consists among other things of stearic acid and palmitic acid, the both main components of the fatty acid C16-18, sodium salt. The in utero phase of the study involved dietary exposure to RAO, covered four-weeks prior to mating, through mating, gestation and lacation until offspring (F1) weaning. There were no treatment-related fertility, reproductive or developmental index observations. Therefore, it is assumed that the fatty acid C16-18, sodium salt does not affect fertility. Because of the existing developmental toxicity study according OECD 414, which shows that the fatty acid has no developmental toxicity properties, an additional OECD 421 study is not justified with regard to avoid animal testing.