Registration Dossier
Registration Dossier
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EC number: 224-403-8 | CAS number: 4345-03-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Scientific opinion on the re-evaluation of tocopherol-rich extract (E 306), α-tocopherol (E 307), γ-tocopherol (E 308) and δ-tocopherol (E 309) as food additives
- Author:
- EFSA
- Year:
- 2 015
- Bibliographic source:
- EFSA Journal 2015;13(9):4247
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- α-tocopheryl hydrogen succinate
- EC Number:
- 224-403-8
- EC Name:
- α-tocopheryl hydrogen succinate
- Cas Number:
- 4345-03-3
- Molecular formula:
- C33H54O5
- IUPAC Name:
- 4-oxo-4-{[2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-chromen-6-yl]oxy}butanoic acid
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
Administration / exposure
- No. of animals per sex per dose:
- 10 animals/sex/group
- Details on study design:
- 14 d
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 7 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the LD50 for the test substance was greater than 7000 mg/kg bw.
- Executive summary:
A study was conducted to determine acute oral toxicity of the test substance. Mature CD rats (10 animals/sex/group) were fasted for 16 hours before being given the test substance at 7000 mg/kg bw. All animals were observed for clinical signs of toxicity for 14 days, after which, gross necropsies were conducted. After an initial transient 24-hour period of listlessness and diarrhoea, no further adverse effects were observed. Under the study conditions, the LD50 for the test substance was greater than 7000 mg/kg bw (efsa, 2015).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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