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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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

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