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Toxicological information

Acute Toxicity: oral

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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

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
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.