3-Furanol, tetrahydro-, (3S)-

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-090-2

EC Name:

-

Cas Number:

86087-23-2

Molecular formula:

C4 H8 O2

IUPAC Name:

(3S)-oxolan-3-ol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Method of administration:
Gavage

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 25 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 25 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:

Clinical observations:
No deaths occurred and no signs of toxicity were observed.

Laboratory findings:
There were no toxicologically significant effects on
haematology or blood clinical chemistry.

Effects in organs:
There were no treatment related histopathological changes in
the organs examined.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Administration of 1272W94 at doses up to and including 1000mg/kg/day for 28days in rats was not associated with any evident signs of toxicity

Executive summary:

Groups of five male and five female Alpk:APfSD (Wistar derived) rats were dosed orally by gavage with 0, 25, 150, 1000mg/kg/day of 1272W94 (using de-ionised water as the control substance and vehicle) for 28 consecutive days. Clinical observations, bodyweights and food consumption were measured and at the end of the scheduled period, the animals were killed and subjected to an examination post mortem. cardiac blood samples were taken for clinical pathology, selected organs were weighed and specific tissues were taken for histopathological examination. One female rat from the 1000mg/kg group was found dead on day 17 of the study but it's death was considered the result of mis-dosing. There were no clinical signs of toxicity, or any treatment related effects on bodyweight or food consumption. There were no treatment related effects on haematology or blood clinical chemistry. There were no treatment related histopathological changes in the organs examined.

Administration of 1272W94 at doses up to and including 1000mg/kg/day for 28days in rats was not associated with any evident signs of toxicity. The NOEL was determined to be >1000mg/kg/day.