Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-990-4 | CAS number: 112-61-8
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: review article
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Review article
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission Flavouring Group Evaluation 2, Revision 1 (FGE.02Rev 1)
- Author:
- European Food Safety Authority
- Year:
- 2 008
- Bibliographic source:
- http://www.efsa.europa.eu/; The EFSA Journal (2008) 709-60
- Report date:
- 2007
- Reference Type:
- review article or handbook
- Title:
- Flavouring substances and natural sources of flavourings.
- Author:
- CoE (Council of Europe)
- Year:
- 1 992
- Bibliographic source:
- 4th Ed. vol. I. Chemically defined flavouring substances. Council of Europe, partial agreement in the social and public health field. Strasbourg.
- Reference Type:
- review article or handbook
- Title:
- Evaluation of certain food additives and contaminants.
- Author:
- JECFA
- Year:
- 1 999
- Bibliographic source:
- Forty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. Rome, 17-26 June 1997. WHO Technical Report Series, no. 884. Geneva.
- Reference Type:
- review article or handbook
- Title:
- First annual report on chemically defined flavouring substances.
- Author:
- SCF (Scientific Committee for Food)
- Year:
- 1 995
- Bibliographic source:
- May 1995, 2nd draft prepared by the SCF Working Group on Flavouring Substances (Submitted by the SCF Secretariat, 17 May 1995). CS/FLAV/FL/140-Rev.2. Annex 6 to Document III/5611/95, European Commission, Directorate-General III, Industry.
Materials and methods
- Type of study / information:
- The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 47 flavouring substances in the Flavouring Group Evaluation 2, Revision 1 (FGE.02Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 47 flavouring substances belong to chemical groups 1 and 2, Annex I of the Commission Regulation (EC) No 1565/2000.
Test material
- Reference substance name:
- Methyl stearate
- EC Number:
- 203-990-4
- EC Name:
- Methyl stearate
- Cas Number:
- 112-61-8
- Molecular formula:
- C19H38O2
- IUPAC Name:
- methyl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Methyl octadecanoate
- CAS-No. of test material (as cited in study report): 112-61-8
- FL-No. of test material (as cited in study report):09.651
Constituent 1
Results and discussion
Any other information on results incl. tables
According to the default MSDI ( Maximised Survey-derived Daily Intake) approach, the 47 flavouring substances in this group have intakes in Europe from 0.0012 to 6.7 µg/capita/day, which are below the threshold of concern value for a structural class I substance of 1800 µg/person/day.
Methyl octadecanoate has been reported to occur naturally in foods (0.009 mg/kg in milk powder).
The estimated intake based on the MSDI approach for Methyl octadecanoate was found to be 0.73 µg/capita/day.
The treshold of concern for Methyl octadecanoate was reported as 1800 µg/person/day.
It can be predicted that Methyl octadecanoate will be metabolised to innocuous products.
Based on intake calculated by the MSDI approach no safety concern for Methyl octadecanoate was found.
Applicant's summary and conclusion
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.
