Registration Dossier
Registration Dossier
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EC number: 203-835-0 | CAS number: 111-11-5
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: review
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: JECFA Monograph
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety evaluation of certain food additives and contaminants – esters of aliphatic acyclic primary alcohols with aliphatic linear saturated carboxylic acids.
- Author:
- WHO JECFA
- Year:
- 1 998
- Bibliographic source:
- WHO FOOD ADDITIVES SERIES 40, The forty-ninth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Materials and methods
- Type of study / information:
- Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives
Test material
- Reference substance name:
- Methyl octanoate
- EC Number:
- 203-835-0
- EC Name:
- Methyl octanoate
- Cas Number:
- 111-11-5
- Molecular formula:
- C9H18O2
- IUPAC Name:
- methyl octanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl octanoate
- Analytical purity: no data
- Other: Functional class: flavouring agent
Constituent 1
Results and discussion
Any other information on results incl. tables
Intake estimates (Europe): 9.7 µg / person per day
Latest evaluation: 1997
ADI: ACCEPTABLE
Comments: No safety concern at current levels of intake when used as a flavouring agent
Report: TRS 884-JECFA 49/52
Specifications: COMPENDIUM ADDENDUM 5/FNP 52 Add.5/224
Tox monograph: FAS 40-JECFA 49/297
Estimated daily per capita intake
The total annual volume of the 67 esters in this group is approximately 19 tonnes in the USA and 65 tonnes in Europe. In the USA
more than 70% of the total annual volume is accounted for by five substances, amyl butyrate, cis-3- & trans-2-hexenyl propionate,
and the acetate esters of propyl alcohol, isobutyl alcohol and 2-methylbutyl alcohol.
In Europe, more than 75% of the total annual volume is accounted for by seven substances, butyl butyrate, amyl butyrate and the acetate esters of methyl alcohol, butyl alcohol, hexyl alcohol, cis-3-hexenol and isobutyl alcohol. Based on the reported annual volumes in the USA and Europe, the total estimated daily per capita intake of the 67 esters of aliphatic acyclic primary alcohols and aliphatic linear saturated carboxylic acids used as flavouring agents is 3.8 mg per capita per day in the USA and 9.2 mg per capita per day in Europe. The use of 7 of the esters (heptyl formate, octyl propionate, decyl propionate, decyl butyrate, butyl heptanoate, butyl dodecanoate, cis-3- & trans-2-hexenyl propionate) has been reported in the USA but not in Europe.
Esters of aliphatic acyclic primary alcohols and aliphatic linear saturated carboxylic acids are principal components of alcoholic
beverages and a wide variety of fruits. Quantitative data on the natural occurrence in food have been reported for 37 substances in the
group. In the USA, it is indicated that intake of these substances from natural sources exceeds intake from their use as flavouring agents.
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.
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