Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP but the method followed is similar to a recognised guideline; limited test material characeterisation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one
EC Number:
251-201-7
EC Name:
Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one
Cas Number:
32764-98-0
Molecular formula:
C10H16O2
IUPAC Name:
tetrahydro-6-(3-pentenyl)-2H-pyran-2-one
Test material form:
other: clear liquid
Details on test material:
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8 weeks
- Weight at study initiation: 198-235g
- Fasting period before study: not reported
- Housing: housed 5 per cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Rat chow ad libitum except for 16-20 hours prior to dosing.
- Water (e.g. ad libitum): ad libitum except for 16-20 hours prior to dosing.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was given orally by syringe and 13 gauge blunt end needle. One group of ten male rats were dosed at 5g/kg of body weight. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity. The vehicle, if any, was chosen because of its lack of known toxicity, lack of physiological effect and because it is relatively unreactive with other chemical substances.
Doses:
5g/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 3-4 hours after dosing and once daily for 14 days.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Mortality:
All animals survived.
Clinical signs:
Lethargy was noted in five or more animals 3-4 hours post dose. Isolated instances of prostration, diarrhea, eyes bulging, and chromorhinorrhea were also noted 3-4 hours post dose. One instance of chromorhinorrhea was noted on Day 1. All animals were normal on Days 2 thru 5. One instance of lethargy was noted on Day 6. All animals were normal on Days 7 and 8. Isolated instance of chromorhinorrhea was noted on Days 9 and 10. All animals were normal on Days 11 and 12. An isolated instance of chromorhinorrhea was noted on Day 1 Isolated instances of lethargy, piloerection, and ptosis were noted on Day 14.
Body weight:
Not measured
Gross pathology:
Not measured

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute oral median lethal dose (LD50) of the test material in male Wistar rats was estimated to be greater than 5000 mg/kg body weight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Wistar strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, after fasting for 16 -20 hours, once only by gavage. 10 male test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were not subjected to gross necropsy after an observation period of 14 days. There were no deaths but lethargy was noted in five or more animals 3-4 hours post dose. Isolated instances of prostration, diarrhea, eyes bulging, and chromorhinorrhea were also noted 3-4 hours post dose. One instance of chromorhinorrhea was noted on Day 1. All animals were normal on Days 2 through to 5. One instance of lethargy was noted on Day 6. All animals were normal on Days 7 and 8. Isolated instance of chromorhinorrhea was noted on Days 9 and 10. All animals were normal on Days 11 and 12. An isolated instance of chromorhinorrhea was noted on Day 1 Isolated instances of lethargy, piloerection, and ptosis were noted on Day 14. The acute oral median lethal dose (LD50) of the test material in the male Wistar strain rat was estimated to be greater than 5000 mg/kg bodyweight.