Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP non-guideline, available as unpublished report, limitations in design and/or reporting (no information on duration of treatment) but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rabbits were exposed to the test substance by oral gavage.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,5-Dihydrofuran
- Purity: 94%
- Physical state: colorless clear liquid

Test animals

Species:
rabbit
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 2.9 and 2.7 - 2.9 kg, for females and males respectively

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- 2 animals dosed 0.4 mL/kg; 2 times per week
- 2 animals dosed 0.4 mL/kg; first week ones, thereafter 2 times per week
- 1 animal dosed 0.4 mL/kg; first week ones, thereafter 3 times per week treated with 0.2 mL/kg
- 1 animal dosed 0.4 mL/kg; first week ones, thereafter 4 times per week treated with 0.2 mL/kg
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
- not specified
Control animals:
no

Examinations

Observations and examinations performed and frequency:
Clinical observations
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY: Diarrhea was observed in all exposed animals. All exposed animals died.
PATHOLOGY: Autopsy revealed in 4 out of 6 animals a mild to moderate edema in the lungs. No effects on liver, kidneys and hematological parameters were observed. In one exposed animal kidney damage was histologically detectable.

Effect levels

Dose descriptor:
NOAEL
Basis for effect level:
other: No NOAEL derivation was possible
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion