Glycerides, C12-18 mono-, di- and tri-

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 Feb - 22 Feb 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: off-white coloured waxy solid
- Analytical purity: no data
- Lot/batch No.: 978
- Storage condition of test material: room temperature

Specific details on test material used for the study:

Physical state: off-white coloured waxy solid
Analytical purity: no data
Lot/batch No.: 978
Storage condition of test material: 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: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 145-160 g (males), 139-151 g (females)
- Fasting period before study: overnight
- Housing: groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diet Services Ltd., Witham, Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-65
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: For the purpose of the study, the test material was freshly prepared as a solution/suspension at the appropriate concentration in arachis oil B.P. The preparation was warmed to aid solubilisation.

Doses:

5000 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 observations and weighing: animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the day of treatment (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Effect levels

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:

No overt signs of toxicity were noted during the study.

Body weight:

All animals showed the expected gains in body weight over the study period.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified