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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 22, 1979 - November 5, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability 2 is assigned because the study is conducted similar to OECD TG 401 in compliance with GLP, with deviations that influence the quality of the results.

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:
yes
Remarks:
No details on test material, no purity, no details on environmental conditions.
Principles of method if other than guideline:
E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 17 - 25.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
Tetrahydro-3-pentyl-2H-pyran-4-yl acetate
EC Number:
242-640-5
EC Name:
Tetrahydro-3-pentyl-2H-pyran-4-yl acetate
Cas Number:
18871-14-2
Molecular formula:
C12H22O3
IUPAC Name:
tetrahydro-3-pentyl-2H-pyran-4-yl acetate
2
Chemical structure
Reference substance name:
Reaction mass of (3S,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate and (3R,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate
Molecular formula:
C12H22O3
IUPAC Name:
Reaction mass of (3S,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate and (3R,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate
Constituent 1
Chemical structure
Reference substance name:
(3S,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate
Molecular formula:
C12H22O3
IUPAC Name:
(3S,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate
Constituent 2
Chemical structure
Reference substance name:
(3R,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate
Molecular formula:
C12H22O3
IUPAC Name:
(3R,4S)-3-pentyltetrahydro-2H-pyran-4-yl acetate
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Wistar-strain albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Suitable licensed dealer
- Age at study initiation: approx. 6 to 8 weeks
- Weight at study initiation: 200 - 238 g
- Fasting period before study: approx. 18 hours
- Housing: Animals were housed in galvanized cages with indirect bedding
- Diet: Free access to diet consisted of a growth and maintenance ration from a commercial producer
- Water: Free access to water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Individual doses, calculated on the basis of bodyweight, were administered using a stainless steel intragastric feeding needle.
Doses:
5000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours after application and thereafter daily.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed, necropsied and subjected to complete gross necropsy, with all findings noted.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 14th day of the observation period.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Slight depression was oberserved among all animals at 3, 6 and 24 hours after application of the substance.
Body weight:
Normal bodyweight increases were observed on the 14th day of the observation period.
Gross pathology:
No gross changes were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not acutely orally toxic
Remarks:
according to CLP criteria 1272/2008 and its amendments
Conclusions:
The acute oral toxicity test showed an LD50 of >5000 mg/kg bw
Executive summary:

In this study performed equivalent to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. Slight depression was oberserved among all animals at 3, 6 and 24 hours after application of the substance. Normal bodyweight increases were observed on the 14th day of the observation period. No gross changes were observed. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

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