Hexadecyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 February 1973 to 27 February 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not applicable

Principles of method if other than guideline:

Preparation containing 90 % test item administered to albino rats (five groups of two animals) with 14 day observation period.

GLP compliance:

no

Remarks:

investigation took place before the introduction of GLP

Test type:

other: similar to acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl acetate

EC Number:

211-103-7

EC Name:

Hexadecyl acetate

Cas Number:

629-70-9

Molecular formula:

C18H36O2

IUPAC Name:

hexadecyl acetate

Details on test material:

- Name of test material (as cited in study report): Acetulan
- Analytical purity: Declared by owner of study report to contain 90 % test item and to be equivalent to the substance described elsewhere in this dossier
- Lot/batch No.: 615F

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Five groups of albino rats (one male and one female per group) were set aside and observed for a period of one week to assure normalcy.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Animals were starved for 24 hours.
- Doses were determined for each animal and administered directly into the stomach by means of a stomach tube.
- Animals were allowed food and water ad libitum during a fourteen day observation period.

Doses:

2.5, 5.0, 10.0, 20.0 and 40.0 mL/kg

No. of animals per sex per dose:

One male and one female per dose group

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: no toxicity reported following oral administration

Mortality:

No mortality

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Other findings:

Not reported

Any other information on results incl. tables

Dose Level mL/kg	Number of rats dosed	Day														Mortality after 14 days
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
2.5	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
5.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
10.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
20.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
40.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was demonstrated to have an acute oral oral LD50 greater than 40.0 mL/kg in the rat.

Executive summary:

METHOD

A preparation declared to contain 90 % of test item was administered in a single dose by gavage to five groups of Sherman-Wistar rats consisting of one male and one female. Mortality after a fourteen day observation period was reported.

RESULTS

No mortality was observed in rats dosed with 2.5, 5.0, 10.0, 20.0 or 40.0 mL/kg of the test material.

CONCLUSION

The test material was demonstrated to have an acute oral LD50 greater than 40.0 mL/kg in the rat.