Glycerides, C14-18

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

May 20th, 1988 - June 3rd, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Purity of test substance not given.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C12-18

EC Number:

266-944-2

EC Name:

Glycerides, C12-18

Cas Number:

67701-26-2

IUPAC Name:

67701-26-2

Details on test material:

- Name of test material (as cited in study report): C10-18 Triglyceride;
- Name of test material: Hydrogenated Coco-Glycerides
- Physical state: white, waxy solid
- Analytical purity: no data
- Storage condition of test material: room temperature
- Stability under test conditions: not determined

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CFY strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Ltd., Cambridgeshire, U.K.
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 120-137 g; females 120-136 g.
- Fasting period before study: yes
- Housing: goups of up to five in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd., Essex, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
The test material was ground to a waxy paste and freshly prepared, as required, as a suspension in arachis oil B.P.

Doses:

2000 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: Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy
- Other examinations performed: body weights were recorded on days 0, 7 and 14

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: rat

Mortality:

No deaths occured during the study period.

Clinical signs:

other: No evidence of systemic toxicity were noted during the study period.

Gross pathology:

No abnormalities occured.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU