Fatty acids, C18 unsaturated, C12-14 (even numbered) alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

the analytical purity of the test substance is not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecyl myristate

EC Number:

221-787-9

EC Name:

Tetradecyl myristate

Cas Number:

3234-85-3

Molecular formula:

C28H56O2

IUPAC Name:

tetradecyl myristate

Details on test material:

- Name of test material (as cited in study report): [only trade name given]
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 176-296 g
- Fasting period before study: overnight
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:

5000 mg/kg bw

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 and weighing: observations of mortality and signs of toxicity were made 1, 3, 4, 6 and 24 h after administration and daily thereafter; animals were weighed prior to dosing and prior to necropsy.
- Necropsy of survivors performed: yes

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:

One male rat died on day 4 after administration. No information on the cause of death was provided.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

No substance-related findings were noted during the necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg bw

Executive summary:

The acute oral LD50 of tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance, in rats of both sexes observed over a period of 14 days is > 5000 mg/kg bw.

Based on the result of this study the substance not subject for labelling and classification requirements according to regulatory requirements.