Registration Dossier
Registration Dossier
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EC number: 203-764-5 | CAS number: 110-40-7
Endpoint summary
Administrative data
Description of key information
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 oral LD50 is used (14470 mg/kg bw).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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)
- 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
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14 470 mg/kg bw
- Based on:
- not specified
- Mortality:
- not specified
- 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).
Reference
Nothing is specified on animals (mortality, clinical sign, body weight, gross pathology)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 14 470 mg/kg bw
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
