2-hexylcyclopentan-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-09-03 to 1980-09-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This method is similar to OECD guideline 401, and the study was conducted to GLP. Only male rats used and limited details on test substance.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Limit test using only male rats (group of 10) and details on test substance (e.g. purity) not included in report.

GLP compliance:

yes

Remarks:

Report states that "this study was conducted in compliance with the FDA's Good Laboratory Practices effective 6/20/79" [i.e. 20 June 1979]. No certificate of GLP compliance was included

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hexylcyclopentan-1-one

EC Number:

235-970-6

EC Name:

2-hexylcyclopentan-1-one

Cas Number:

13074-65-2

Molecular formula:

C11H20O

IUPAC Name:

2-hexylcyclopentan-1-one

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 80-75, hexyl cyclopentanone
- Physical state: clear liquid
- Analytical purity: no data in study report
- Impurities (identity and concentrations): no data in study report
- Composition of test material, percentage of components: no data in study report
- Isomers composition: not applicable
- Purity test date: no data in study report
- Lot/batch No.: no data in study report
- Expiration date of the lot/batch: no data in study report
- Stability under test conditions: no data in study report
- Storage condition of test material: no data in study report
- Other: specific gravity 0.86 [g/mL]

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 200 to 232 g
- Fasting period before study: 16 to 20 hours
- Housing: 5/cage in suspended wire mesh cages
- Diet (e.g. ad libitum): fresh Purina rat chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: "at least one week"

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data, although study report states that the room was "temperature controlled"
- Humidity (%): no data in study report
- Air changes (per hr): no data in study report
- Photoperiod (hrs dark / hrs light): no data in study report

IN-LIFE DATES: no data in study report

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: not applicable

MAXIMUM DOSE VOLUME APPLIED: no data in study report

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed 3 to 4 hours after dosing, and once daily for 14 days
- Necropsy of survivors performed: yes. At 14 days the survivors were sacrificed. All animals were examined for gross pathology
- Other examinations performed: no data in study report

Statistics:

Not applicable

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Only dose tested (limit test). 95% confidence levels not relevant as no deaths occurred

Mortality:

All animals survived to the end of the 14-day observation period

Clinical signs:

other: 9/10 animals had diarrhoea on day 1. On days 2-5, there were isolated instances of prostration, tachypnea, piloerection, lethargy, flaccid muscle tone, ptosis, emaciation and brown staining of the anogenital area. All animals were normal from day 5 until

Gross pathology:

9/10 animals were normal. One animal had white nodules (3-6 mm) on all lobes of the left lung

Other findings:

No data in study report

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity of hexyl cyclopentanone was determined to be greater than 5000 mg/kg bw (limit test).

Executive summary:

In an acute oral toxicity study, conducted according to GLP, and similar to OECD TG401 (not available at time of study), a group of 10 male Wistar rats was administered a single dose of neat hexyl cyclopentanone by gavage. Animals were observed for clinical signs of toxicity for 14 days. All survivors were examined for gross pathological changes.

No deaths occurred during the observation period. On day 1, 9/10 animals had diarrhoea. There were isolated instances of clinical signs in the early part of the observation period, but the animals were generally healthy on days 5 through 14. One animal was found at necropsy to have white nodules (3-6 mm) on all lobes of the left lung.

From the results of this study, the acute oral LD50 of hexyl cyclopentanone in rats was determined to be greater than 5000 mg/kg bw (limit test).