[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

publication

Title:

The effects of oats on the function of gut microflora in children with coeliac disease

Author:

Tjellström B, Stenhammar L, Sundqvist T, Fälth-Magnusson K, Hollén E, Magnusson KE, Norin E, Midtvedt T, Högberg L.

Year:

2014

Bibliographic source:

Aliment Pharmacol Ther., 39(10):1156-60

Report date:

2014

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Clinical study, randomised double-blind study on the effect of a gluten-free diet containing oats (GFD-oats) vs a standard GDF (GFD-std). Faecal samples were received from 34 children in the GFD-oats group and 37 in the GFD-std group at initial diagnosis and/or after 1 year on a GFD. Faecal short chain fatty acids (SCFAs) were analysed.

GLP compliance:

no

Test type:

other: clinical study

Test material

Test material information

Constituent 1

Reference substance name:

Oat, ext.

EC Number:

281-672-4

EC Name:

Oat, ext.

Cas Number:

84012-26-0

Molecular formula:

(C2H4O)n

IUPAC Name:

Avena Sativa (Oat) leaf/stem extract Avena sativa extract Oat, ext.

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Effect level:

> 93 000 mg/kg bw

Clinical signs:

other:

Other findings:

The GFD-std group had a significantly lower total faecal SCFA concentration at 12 months compared with 0 months (P < 0.05). In contrast, total SCFA in the GFD-oats group remained high after 1 year on the GFD. The children in the GFD-oats group had significantly higher acetic acid (P < 0.05), n-butyric acid (P < 0.05) and total SCFA concentration (P < 0.01) after 1-year diet treatment compared to the GFD-std group.
Good systemic tolerance at 50 and 93 g per day in 23 and 18 persons, except intestinal inflammation, which could occur in coealic patients - LD50 >93000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a clinical study, gluten-free diet containing oats (GFD-oats) had a good systemic tolerance at 50 and 93 g per day in 23 and 18 persons, except intestinal inflammation, which could occur in coealic patients.
LD50 can be estimated to be >93000 mg/kg.