Registration Dossier
Registration Dossier
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EC number: 203-764-5 | CAS number: 110-40-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Flavouring Group Evaluation 10 Revision1 (FGE.10 Rev1)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- Version / remarks:
- This report is an evaluation of flavouring substances from the European Food Safety Authority and regroup experiments on these substances. Therefore, this report does not detail experiments and gives results on LD50 and NOAEL.
- Principles of method if other than guideline:
- This report is an evaluation of flavouring substances from the European Food Safety Authority and regroup experiments on these substances. Therefore, this report does not detail experiments and gives results on LD50 and NOAEL.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl sebacate
- EC Number:
- 203-764-5
- EC Name:
- Diethyl sebacate
- Cas Number:
- 110-40-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- diethyl sebacate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- not specified
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14 470 mg/kg bw
- Based on:
- not specified
- Mortality:
- not specified
Any other information on results incl. tables
Nothing is specified on animals (mortality, clinical sign, body weight, gross pathology)
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Three studies were reported in this evaluation. Therefore, three LD50 were determined. The first experiment was on rats (male/female) and LD50 was 14470mg/kg bw. The second experiment was also on rats (female) and LD50 was 32000 mg/kg bw. The third experiment was on mouse (sex not reported) and LD50 was >32000 mg/kg bw.
Therefore, the smallest LD50 is used (14470 mg/kg bw). - Executive summary:
Three studies were reported in this evaluation. Therefore, three LD50 were determined. The first experiment was on rats (male/female) and LD50 was 14470mg/kg bw. The second experiment was also on rats (female) and LD50 was 32000 mg/kg bw. The third experiment was on mouse (sex not reported) and LD50 was >32000 mg/kg bw.
Therefore, the smallest LD50 is used (14470 mg/kg bw).
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