5-cyclohexadecen-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 September - 11 October 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(E)-cyclohexadec-5-enone

Cas Number:

35951-24-7

Molecular formula:

C16H28O

IUPAC Name:

(E)-cyclohexadec-5-enone

Constituent 2

Reference substance name:

(Z)-cyclohexadec-5-enone

Cas Number:

21944-95-6

Molecular formula:

C16H28O

IUPAC Name:

(Z)-cyclohexadec-5-enone

Specific details on test material used for the study:

Name (as stated in the report): Ambretone
Batch: V910002

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Microbial grade SPF

Sex:

male

Details on test animals or test system and environmental conditions:

Animals were purchased to Charles River Japan.
Acclimatation period: 5 days
Age of 7 week year old

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was administered in a single dose by gavage using a stomach suitable incubation cannula.

Doses:

Limit test at one dose level of 2000 mg/Kg Body weight

No. of animals per sex per dose:

5 rats with one dose of test substance per animal
5 rats with one dose of solvent (control) per animal

Control animals:

yes

Remarks:

Corn oil (solvent)

Details on study design:

10 animals were assigned to each group (5 animals in the test group and 5 animals in control group)
Following a bodyweight was carried out in group (5 males each).
Following an overnight fast, the animals were weighed and then the test item was administered in a single dose by gavage using a stomach suitable incubation cannula.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal treated with 2000 mgKg body weight died within 30 minutes after the administration. In other animals, no mortaility occured.

Clinical signs:

other: One animal treated with 2000 mgKg body weight died during the study. A necropsy was performed. Abnormalities noted at the necropsy of the animal was a lot of hemorrhage bleeding in abdomen. No abnormalities were noted at necropsy of animals sacrified at

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Acute Oral toxicity of the test item, Ambretone, at 2000 mg/Kg body weight produced no evidences in the Wistar strain male rat No signs of system toxicity were noted
Therefore the LD50 is > 2000 mg/Kg body weight.

Executive summary:

The Acute oral toxicity of Ambretone was tested in this test according to the OECD 420 guideline.

One animal treated with 2000 mgKg body weight  died during the study. A necropsy was performed. Abnormalities noted at the necropsy of the animal was a lot of hemorrhage bleeding in abdomen. No abnormalities were noted at necropsy of animals sacrified at the end of the study. In other animals, no mortaility occured.

Therefore,Acute Oral toxicity of the test item, Ambretone, at 2000 mg/Kg body weight produced no evidences in the Wistar strain male rat  No signs of system toxicity were noted

Therefore the LD50 is > 2000 mg/Kg body weight.