Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
There were no abnormal clinical signs.
Body weight:
All rats administered an acute dose of MLCT at 5000 mg/kg showed typical body weight gain throughout the observation period, with no significant differences compared with the control group.
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