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Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
1 000 mg/kg bw/day
Additional information
In a one-generation screening assay according to OECD 421, the test substance (APG C12–C14 fatty alcohol from renewable sources, n = 1.43) was applied to 40 males and 40 females Sprague-Dawley rats prior to mating, throughout the gestation and lactation period until post partum day 3.

Treatment by gavage with 0, 100, 300 and 1000 mg/kg bw/day began 7 days after allocation for both males and females. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum). Matings were monogamous.

During the study, parameters of general toxicity like clinical signs, food consumption and body weight gain were recorded in the parental generation and in the pups. Effects related to reproduction and hormone balance such as oestrous cycle, mating performance, pregnancy rates and the number of embryo resorptions were registered. Pup losses were recorded and the filial generation was examined for behavioural abnormalities and external growth abnormalities.

No effects on the fertility were observed up to the highest dose of 1000 mg/kg bw/day.

Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day. The lack of major toxicity was further confirmed by a subchronic toxicity study in Sprague–Dawley rats that did not show any substance related systemic toxic effects in either gender up to the limit dose of 1000 mg/kg bw (Potokar et al., 1989).

Teratogenic effects potentially induced by APG were investigated in an OECD compliant developmental toxicity study. The dams tolerated the applied dose levels of up to 1000 mg/kg bw/day without any signs of clinical toxicity. Maternal body weight gain was not affected by the treatment. For maternal toxicity, embryo toxicity and teratogenicity, a NOAEL of 1000 mg/kg bw was deduced. From the studies presented, there is no indication for any impairment of reproduction, either with regard to the development of the progeny or to the effects on fertility both of the structural and functional level. Therefore, a hazard of reproductive toxicity for APG is not expected.

However, it must be noted that a one-generation screening study assay is not suitable to exclude for sure the presence of toxic effects to reproduction if it comes out negative. Nevertheless, together with the results of the subchronic toxicity investigations (no effects on male or female reproductive organs), it can be concluded that APG are substances of no concern with regard to toxicity to reproduction.

Short description of key information:
A one-generation screening assay revealed a NOAEL for reprotoxicity of 1000 mg/kg/day.

Effects on developmental toxicity

Description of key information
A developmental toxicity study revealed a NOAEL of 1000 mg/kg/day.
Effect on developmental toxicity: via oral route
Dose descriptor:
1 000 mg/kg bw/day
Additional information

Alkyl glucoside (C10–14, n = 1.4) was tested according to OECD 414 at dose levels of 0, 100, 300 and 1000 mg/kg bw/day in 96 female Sprague-Dawley rats. The test substance was administered orally by gavage once daily from day 6 to day 15 of gestation. Control animals receive the vehicle alone (aqua dest.) for the entire test period. Clinical conditions and reactions to treatment were recorded at least once daily. Body weights were reported for days 0, 6, 16 and 20 of gestation. All surviving females were sacrificed on day 20 of gestation and the foetuses were removed by caesarean section. At necropsy, the females were examined macroscopically and live foetuses were weighted, sexed, and examined for visceral and skeletal abnormalities. Gross macroscopic examinations include all maternal organs with emphasis on the uterus, uterine contents, position of foetuses in the uterus and number of corpora lutea. Number and distribution of intrauterine implantations were classified as live or dead foetuses, late intrauterine deaths (resorptions), early intrauterine deaths (resorption sites). The foetuses were removed from the uterus, were sexed, weighted individually and examined for gross external abnormalities and placentae were weighted separately. The brains and viscera of half of the foetuses of each litter were examined as well as skeletal abnormalities in the other half of the litter.

Skeletal and visceral investigations did not detect any treatment-related malformations. For the embryo/fetotoxicity, the teratogenicity and the maternal toxicity a NOAEL of 1000 mg/kg was deduced.

Justification for classification or non-classification

Classification criteria according to 67/548/EEC and (EC)1272/2008 are not fulfilled. No data available on breastfed babies.

Additional information