Pentyl valerate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30. Jun. 2016 to 20. Oct. 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

The test substance may interact with the endocrine system of humans and cause damage.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Genetically modified yeast (Saccharomyces cerevisiae) cultures can interact with the human estrogen or andregen receptors hERa and hAR and a plasmid containing a reporte gene (lacZ, encoding ß-galactosidase) and estrogen (YES) or androgen (YAS) responsive elements. Upon binding of a ligand, the hERa and hAR interact with the corresponding response element on the expression plasmid, leading to secretion of ß-galactosidase, which converts a yellow dyestoff into a red product. The red colour (red-ß-galactopyranoside) can be quantified by colorimetry at 570 nm. The measured OD570 correlates derictly with the activity of the substance which binds to the corresponding receptor.
The XeoScreen XL YES/YAS Assay system can indentify both activating (agonistic) and inhibitory (antagonistic) activities of the test substance. For the determination of the antagonistic activities, the samples are incubated with a fixed concentration of a reference agonist (17-ß estradiol for YES or 5a-dihydrotestosterone for YAS). Inhibition of the response relative to the fixed agonist concentration is a sign of antagonistic activity.

GLP compliance:

yes (incl. QA statement)

Remarks:

certified by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, D-55116 Mainz, Germany

Type of method:

in vitro

Remarks:

genetically modified Saccharomyces cerevisiae used

Test material

Test material information

Constituent 1

Reference substance name:

Pentyl valerate

EC Number:

218-528-7

EC Name:

Pentyl valerate

Cas Number:

2173-56-0

Molecular formula:

C10H20O2

IUPAC Name:

pentyl valerate

Test material form:

liquid

Test animals

Species:

other: Yeast (Saccharomyces cerevisae)

Strain:

other: Yeast, genetically modified with human genes

Remarks:

hERa and hAR receptor, Expression plasmid carrying response elements and reporter gene lacZ

Details on test animals or test system and environmental conditions:

Saccharomyces cerevisiae (yeast) was grown in test vessels. All yeast cultures, media, chemicals and solutions necessary for this assay were included in the YES YAS Assay KIt. All solutions and media were obtained sterilized and at highest quality grade from Xenometrix AG, Gewerbestraße 25, CH-4123 Allschwil, Switzerland.

Administration / exposure

Route of administration:

other:

Duration of treatment / exposure:

47.5h (YES), 51.5h (YAS) at 32^C with agitation (100rpm)

Frequency of treatment:

once

Duration of test:

3 days before test, ca. 3 days during test

Doses / concentrations

Remarks:

8 different concentrations between 3.16 * 10^-8 and 1 * 10^-4 mol/L

Control animals:

yes

Details on study design:

The yeast cultures were prapared 3 days before the experiment. On the day of the assay, the cultures were checked for growth with a microplate reader. Then the plates were prepared according to the XenoScreen kit: There are YES Agonist, YAS Agonist, Yes Antagonist and YAS Antagonist plates. For each sort of plates 8 different concentrations of the test substance or positive controls were added in duplicate. After ca. 50h the absorption values at 570nm (for detection of the ß-galactosidase activity and therefore agonistic or antagonistic activity of the test substance) and at 690nm (for cell density and therefore cell growth) were taken by a microplate reader. Then growth factor, ß-galactosidase activity and induction rate are calculated and dose response curves were drawn. A dilution of a test substance is considered to have an agonistic effect if the induction rate is

Statistics:

not made

Results and discussion

Effect levels

Key result

Basis for effect level:

other:

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

No endocrine activity observed in this test system.

Applicant's summary and conclusion

Conclusions:

No adverse effects on the endocrine system were detected in this test system.