Glycerol monomyristate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Mar - 27 Mar 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with accepatble restrictions. Lack of details on test material.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of details on test material

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol monomyristate

EC Number:

248-329-0

EC Name:

Glycerol monomyristate

Cas Number:

27214-38-6

Molecular formula:

C17H34O4

IUPAC Name:

2-hydroxy-1-(hydroxymethyl)ethyl myristate

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: white pellets
- Analytical purity: no data
- Lot/batch No.: 00010271
- Expiration date of the lot/batch: 10 years
- Storage condition of test material: ambient temperature and out of light

Test animals

Species:

mouse

Strain:

other: NMRI-Han albino mice

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Test Facility breeding, Blanquefort, France
- Age at study initiation: 5 weeks
- Weight at study initiation: 19.4 - 21.9 g
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: 5 animals per cage in polypropylene cages with stainless steel lid on wood shavings bedding.
- Diet: sterilized pelleted diet (UAR, Epinay sur Orge, France), ad libitum
- Water: tap water (periodically analyzed), ad libitum
- Acclimation period: none, as breeded in test facility

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: T,he vehicle was chosen according to the nature of the test substance and producing no painful effect in agreement with the rules of animal ethics.

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION: The test substance was crushed and homogenized with a pestle in a mortar, and then diluted in corn oil.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical observations: animals were observed daily
- Frequency of weighing: on Days 1, 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Slight piloerection was observed in male and female animals within the first h after test substance application. No other clinical signs of toxicity occured.

Gross pathology:

No abnormalities were observed in all treated animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified
DSD: not classified