A mixture of cis- and trans-cyclohexadec-8-en-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

EC Number:

401-700-2

EC Name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

Cas Number:

3100-36-5

Molecular formula:

C16H28O

IUPAC Name:

(8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both sexes were investigated
- Age at study initiation: Not specified
- Weight at study initiation: Mean body weights of 205 g
- Fasting period before study: 16 hours before test started
- Housing: In groups of 5 males and 5 females in single cages
- Diet Ad libitum (laboratory standard diet Altromin)
- Water: Ad libitum
- Acclimation period: Not specified
- Microbiological status when known: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 45-55
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

The test item has been used undiluted after warmed up in a waterbath.

Details on oral exposure:

DOSAGE PREPARATION: The test item has been used undiluted after warmed up in a waterbath.

Doses:

5,000 mg/kg bw and 10,000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 hours, 48 hours, 7 days and 14 days after dosing
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: Appearance and behavior, reflexes, coat, cutaneous turgor, mucosae, faeces, body weights, food and water uptake, acute symptoms

Statistics:

LD50 oral according to Litchfield & Wilcoxon. 24-hours and 14-days LD50 slope function not measurable.

Results and discussion

Preliminary study:

Doses were chosen on account of an informational pre-test.

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured

Clinical signs:

other: In all dosage groups the preparation did not cause any remarkable symptoms.

Gross pathology:

Slight intestinal hyperaemia in 5 of 10 animals in the highest dosage in final autopsy could be
observed, possibly due to volume. No other macroscopical pathological changes could be observed.

Other findings:

No other findings were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats according to OECD guideline 401, the LD50 was higher than 10,000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 401 and GLP, the test item has been tested after one oral application in the rat. Under the conditions of the experiment, the following results have been determined: The 24 hour-LD₅₀ and 14 days LD₅₀ of the product has been found at higher than 10,000 mg/kg body weight. Body weights did not point to incompatibility. Clinical picture did not show alterations to normal findings. In the final autopsy, no clear anatomic pathological changes occurred. Slight intestinal hyperemia in 5 out of 10 animals in the highest dosage could be observed. Therefore, the product can be considered as nearly harmless (nontoxic).