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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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