Glycerol trimyristate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Aug - 12 Sept 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

/ no purity of test substance specified

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)

Deviations:

yes

Remarks:

/ no purity of test substance specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol trimyristate

EC Number:

209-099-7

EC Name:

Glycerol trimyristate

Cas Number:

555-45-3

Molecular formula:

C45H86O6

IUPAC Name:

propane-1,2,3-triyl tritetradecanoate

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Limited, Wyton, Huntingdon, U.K.
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 145 - 155 g (males), 127 - 147 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: 5 animals of the same sex per cage in polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet (No. 1, Special Diet Services Limited, Witham, Essex, U.K.), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 52 - 73
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 23 Aug To: 12 Sept 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250 mg/mL in aqueous methyl cellulose (1%)
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: not given

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 hours after dosing and afterwards daily until the end of the observation period. Individual body weights were determined on Day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Results and discussion

Preliminary study:

No mortality or clinical signs indicative for systemic toxicity were observed during the range finding study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

In all animals abnormal body carriage (hunched posture) and pilo-erection was observed 1 h after dosing, which was fully reversible within 4 h after dosing.

Body weight:

No effect on body weight was noted.

Gross pathology:

Necropsy and macroscopic examination revealed no substance-related findings.

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