Glycerides, C16-18 mono-

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:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

publication

Title:

Safety evaluation of a medium- and long-chain triacylglycerol oil produced from medium-chain triacylglycerols and edible vegetable oil

Author:

Matulka, R.A. et al.

Year:

2006

Bibliographic source:

Food Chem Toxicol. 44(9):1530-8.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only basic data given

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

medium- and long-chain triacylglycerol oil produced from medium-chain triacylglycerols

IUPAC Name:

medium- and long-chain triacylglycerol oil produced from medium-chain triacylglycerols

Details on test material:

- Name of test material (as cited in study report): MLCT
- Details of test material composition see tables 1 and 2
- Other: Medium-chain triacylglycerol (MCT) and rapeseed oil (as a source of LCT) were purchased commercially (Nisshin Oillio Group, Ltd., Tokyo, Japan). Medium- and long-chain triacylglycerol (MLCT) was produced by transesterification of MCT and rapeseed oil with bacteriaderived lipase, and bleached by activated clay and deodorized by steam distillation. The MLCT contains approximately 13 % Medium-chain fatty acids (MCFA), consisting of caprylic acid and capric acid.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan SLC Co., Ltd., Hamamatsu, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 102 - 105 g for females and males
- Diet: typical rat diet (Oriental Yeast Co., Ltd., Tokyo, Japan) ad libitum
- Water: sterilized tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 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: daily
- Frequency of weighing: Body weights were obtained on the day of test administration and on days 1, 2, 3, 4, 7, and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: rat

Mortality:

All rats administered an acute dose of MLCT at 5000 mg/kg survived.

Clinical signs:

other: There were no abnormal clinical signs.

Gross pathology:

There were no gross pathological abnormalities in any organ/tissue in the external, cephalic, thoracic or abdominal regions in any of the male or female rats in the 5000 mg/kg groups following the observation period.

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