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Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
LPT Hamburg
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
EC Number:
947-436-6
Molecular formula:
not applicable for UVCB
IUPAC Name:
Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
CD® / Crl:CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
Route of administration Oral, via gavage
Frequency of administration Once daily, from TD 15 until TD 50 (males) or LD 14 (females)
Administration volume 2 mL/kg b.w./day
Doses / concentrationsopen allclose all
Dose / conc.:
10 mg/kg bw/day (nominal)
Dose / conc.:
30 mg/kg bw/day (nominal)
Dose / conc.:
90 mg/kg bw/day (nominal)
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
Control
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
effects observed, non-treatment-related
Description (incidence and severity):
At 90 mg test item/kg b.w./day, breathing sounds were noted in 2 of 10 males and 3 of 9 dams.
Mortality:
no mortality observed
Description (incidence):
No premature deaths of male or female animals
were noted.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No test item-related differences were noted.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No test item-related differences were noted.
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
No test-item related changes were noted.
Immunological findings:
effects observed, non-treatment-related
Organ weight findings including organ / body weight ratios:
no effects observed

Reproductive function / performance (P0)

Reproductive performance:
no effects observed
Description (incidence and severity):
No test item-related influence was noted on the mean number of implantation sites per dam, the mean number of pups born (alive and dead) per dam and the percentages of post-implantation loss.

Details on results (P0)

Fertility No test item-related influences were noted on the fertility indices of the female animals.
Pre-coital time No test item-related influence was noted.
Gestation length No test item-related influence was noted.

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
10 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
clinical biochemistry
Dose descriptor:
NOAEL
Effect level:
90 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive performance

Results: P1 (second parental generation)

General toxicity (P1)

Description (incidence):
No test item-related influence was noted.

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Description (incidence and severity):
No test item-related influence was noted.
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
At 90 mg test item/kg b.w./day, a reduced body weight was noted on LD 13.
Gross pathological findings:
no effects observed
Description (incidence and severity):
The external macroscopic examination after sacrifice revealed no test item-related gross abnormalities.
Other effects:
no effects observed
Description (incidence and severity):
Thyroid HormoneT4 serum levels No test item-related differences were noted for the male and female pups on LD 13.

Effect levels (F1)

open allclose all
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
30 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: adverse effects on postnatal development (pup)
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
90 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: adverse effects on prenatal development (conceptus to birth)

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion