Short Chain Fructo Oligosaccharides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

short chain Fructo-Oligosaccharides

EC Number:

908-300-1

Molecular formula:

C6H11O5(C6H10O5)nOH

IUPAC Name:

short chain Fructo-Oligosaccharides

Test material form:

solid: particulate/powder

Details on test material:

CAS no. 308066-66-2
Composition (on dry basis):
- FOS 95.46%
a) 1-Kestose (GF2): 40.23%
b) Nystose (GF3): 47.15%
c) 1F-Fructofuranosylnystose (GF4) :8.08%
- Other sugars 4.50%
a) Glycerol: 1.40%
b) Fructose: 0.36%
c) Arabitol: 0.36%
d) Glucose: 0.63%
e) Sucrose: 1.75%
- Physical appearance: Fine white powder
- Moisture content (as per COA): 2.26%
- Heavy metals (Pb, As, Hg, and Cd) Below detection limits (Pb— 0.03 ppm, As—0.05 ppm, Hg— 0.01 ppm, and Cd—0.01 ppm)
- Microbial analysis Standard plate count: <10 cfu/g
Yeast count: <10 cfu/g
Mould count: <10 cfu/g
Enterobacteriaceae: 10 MPN/g
E.coli: Absent/10 g
Salmonella sp: Absent/100 g
Shigella sp: Absent/10g
- pH 5.48

Specific details on test material used for the study:

FOS (FOSSENCE TM) used for the experiments was provided by Tata Chemicals Limited (Tamilnadu, India) and stored at ambient conditions (>15°C to <25°C).

- CAS no. 308066-66-2
- Composition (on dry basis)
- FOS: 95.46%
a) 1-Kestose (GF2): 40.23%
b) Nystose (GF3):47.15%
c) 1F-Fructofuranosylnystose (GF4): 8.08%
- Other sugars 4.50%
a) Glycerol: 1.40%
b) Fructose: 0.36%
c) Arabitol: 0.36%
d) Glucose: 0.63%
e) Sucrose: 1.75%
- Physical appearance Fine white powder
- Moisture content (as per CoA): 2.26%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The test item was mixed in Milli-Q water and administered as a single oral dose at the dose levels of 2000, 5000, and 9000 mg/kg
5 Wistar rats of each sex were randomly assigned to 4 groups (control, 2000, 5000, and 9000 mg/kg).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Milli-Q water.

Details on oral exposure:

The highest dose of 9000 mg/kg was considered as maximum feasible dose from oral administration perspective considering high viscosity factor and dose volume.
The dose volume employed was 15 mL/kg body weight.

Doses:

2000, 5000, and 9000 mg/kg

No. of animals per sex per dose:

n= 5 rats/sex/group

Control animals:

yes

Remarks:

Milli-Q water was administered to control group rats.

Details on study design:

The rats were observed for clinical signs or mortality, and body weights and feed consumption were measured. All the rats were euthanized under isoflurane anesthesia on day 15, and gross pathological examinations were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 9 000 mg/kg bw

Based on:

test mat.

Mortality:

Oral gavage administration of test item i did not reveal any mortality at 2000, 5000, and 9000 mg/kg body weight.

Clinical signs:

other: other: other: Oral gavage administration of test item i did not reveal any clinical signs at 2000, 5000, and 9000 mg/kg body weight.

Gross pathology:

Necropsy at the end of study (day 15 post-dose) did not reveal any gross pathological abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, Wistar rats did not reveal any clinical signs, mortality, on body weight, and feed consumption at any dose level. No gross pathological abnormalities were also observed after necropsy. The MTD and the LD50 were > 9000 mg/kg bw (Highest dose tested).

Executive summary:

The objective of this study was to evaluate the toxicity of FOS product FOSSENCE^TM following a single oral administration in rats according to methods similar to OECD 420 guidelines. The study was GLP compliant.

The FOSSENCE^TM was mixed in Milli-Q water and administered as a single oral dose at the dose levels of 2000, 5000, and 9000 mg/kg (n=5 rats/sex/group). The highest dose of 9000 mg/kg was considered as maximum feasible dose from oral administration perspective considering high viscosity factor and dose volume.

 

Under the test conditions, Wistar rats did not reveal any clinical signs, mortality, on body weight, and feed consumption at any dose level. No gross pathological abnormalities were also observed after necropsy. The MTD (Maximum Tolerable Dose) and the LD50 were > 9000 mg/kg bw (Highest dose tested).