Glycerol trimyristate

Endpoint summary

Description of key information

Oral: LD50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Specific details on test material used for the study:

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

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

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

Preliminary study:

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

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.

Interpretation of results:

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

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

CAS 555-45-3

The acute oral toxicity of glycerol trimyristate was assessed in a study performed with a protocol similar to OECD guideline 401 (Key, 1985). A total of 7 Wistar rats/sex were exposed to a limit dose of 5000 mg/kg bw in aqueous methyl cellulose (1%) via gavage, in a range-finding study and a main study. No mortality was observed up to the end of the 14-day observation period. Hunched posture and piloerection were noted in all the animals 1-4 h after administration on Day 1 of the observation period. All animals showed the expected gain in body weights during the study and necropsy revealed no substance-related findings. Based on the results, the oral LD50 value for female Sprague Dawley rats is > 5000 mg/kg bw.

Justification for classification or non-classification

The available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.