Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate,Erythorbic Acid, and sodium Erythorbate
Author:
F. Alan Andersen
Year:
1999
Bibliographic source:
International Journal of Toxicology

Materials and methods

Principles of method if other than guideline:
No guideline available. However, this substance has been fully evaluated by JECFA. And the data was also reviewed by peers.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-didehydro-D-erythro-hexono-1,4-lactone
EC Number:
201-928-0
EC Name:
2,3-didehydro-D-erythro-hexono-1,4-lactone
Cas Number:
89-65-6
Molecular formula:
C6H8O6
IUPAC Name:
(5R)-5-[(1R)-1,2-dihydroxyethyl]-3,4-dihydroxy-2,5-dihydrofuran-2-one

Test animals

Species:
rat
Sex:
male

Administration / exposure

Route of administration:
oral: feed

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
18 000 mg/kg bw
Based on:
not specified

Applicant's summary and conclusion