Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: Weight of evidence approach
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
The weight of Evidence is justified in the attached Justification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 432, OECD 129 and ECVAM 139
GLP compliance:
not specified

Test material

1
Reference substance name:
Polysaccharids of kernel Avena sativa, Poaceae
EC Number:
944-507-3
IUPAC Name:
Polysaccharids of kernel Avena sativa, Poaceae

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these different information, the applicant concludes that the substance Polysaccharides of Avena Sativa kernel do not show acute oral systemic toxicity potentially up to 2000 mg/kg bw.Therefore, no classification for acute oral toxicity is needed.