Isopropyl benzoate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

other: review article

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliable and appropriate for risk assessment according to the JECFA Expert Committee.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Type of study / information:

Risk assessment of human ingestion of substance as a food additive

Endpoint addressed:

other: risk assessment

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Risk assessment of food additives

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl benzoate

EC Number:

213-361-6

EC Name:

Isopropyl benzoate

Cas Number:

939-48-0

Molecular formula:

C10H12O2

IUPAC Name:

propan-2-yl benzoate

Constituent 2

Reference substance name:

13-361-6

IUPAC Name:

13-361-6

Constituent 3

Reference substance name:

propan-2-yl benzoate

IUPAC Name:

propan-2-yl benzoate

Method

Details on study design:

Review of existing safety data and risk assessment

Exposure assessment:

estimated

Details on exposure:

Estimated daily intake in the EU and USA

Results and discussion

Results:

The estimated daily intake of isopropyl benzoate in the EU is 0.004 and in the US is 0.3 microgram/d. Benzoate esters are hydrolysed to benzoic acid (and alcohols). There is no safety concern for use of this substance as a flavouring in food for human consumption.

Any other information on results incl. tables

The estimated daily per capita intakes of 33 of the flavouring agents in this group are below the threshold of concern for structural class I (1800 microgram). the committee concluded that these substances would not be expected to be of safety concern at current estimated levels of use as flavouring agents. The ADI (acceptable daily intake) of the group of benzoic acid, the benzoate salts, benzaldehyde, benzyl acetate and benzyl alcohol (expressed as benzoic acid equivalents) is 0 -5 mg/kg bw/d.

The safety of benzoates have been evaluated by JECFA numerous times since 1961:

Table 1: JECFA Evaluations of the Safety of Benzoic Acid

JECFA Meeting/ No.	Year	Comment
6	1961
9	1965
14	1970
17	1973
27	1983	Report 48
46	1996	5 benzyl derivatives as a group
	2002	33 benzyl derivatives Report 99
48	2004	37 benzyl derivatives Report 909

The Scientific Committee on Food (SCF) has evaluated the safety of benzoate additives at least twice, in 1994 and 2002.

Applicant's summary and conclusion

Conclusions:

Benzoate esters are hydrolysed to benzoic acid (and alcohols). There is no safety concern for use of isopropyl benzoate as a flavouring in food for human consumption.