Tetrahydrofuran

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:

2014-07-21 to 2014-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 455: “Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists”, adopted 02. Oct. 20121

Deviations:

yes

Remarks:

The stock solution of the test item in DMSO: The concentration of the stock solution was 0.045 mol/L instead of 0.01 mol/L. This can be seen as uncritical because the higher concentrated solutions of the test item showed no endocrine 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

1

Reference substance name:

Tetrahydrofuran

EC Number:

203-726-8

EC Name:

Tetrahydrofuran

Cas Number:

109-99-9

Molecular formula:

C4H8O

IUPAC Name:

tetrahydrofuran

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:

Origin
The YES-YAS Assay Kit including Saccharomyces cerevisiae was obtained from Xenometrix AG, Gewerbestrasse 25, CH-4123 Allschwil, Switzerland.
Batch no.: N05-2785, expiry date: Mar. 2015

Culture
Three days before the start of the experiment, the yeast cultures (YES and YAS) were prepared and incubated at 32 ± 1 °C for 72 hours, until the cultures were clearly turbid. After incubation, the optical density was measured with a microplate reader. The cultures were diluted appropriately and then used for the experiment.

Administration / exposure

Duration of treatment / exposure:

72h at 32°

Frequency of treatment:

once

Duration of test:

3 days before test, ca. 3 days during test

Doses / concentrations

Remarks:

8 different concentrations: 1.43*10-7, 4.52*10-7, 1.43*10-6, 4.52*10-6, 1.43*10-5, 4.52*10-5, 1.43*10-4, 4.52*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.

Any other information on results incl. tables

After incubation with test item and yeast cells, no cytotoxicity was observed.

The test item Tetrahydrofuran showed no positive result in any assay: The values for galactosidase activity and induction ratio of all test item dilutions lay in the same range as the values of the respective control. No dose-response correlation was visible.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this test system, the test item Tetrahydrofuran is considered to have no estrogenic and androgenic agonistic and antagonistic activity in the YES YAS Assay.