Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
not specified
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: safe use as food addidive

Data source

Reference
Reference Type:
publication
Title:
No information
Author:
Federal Register, Vol.68, No 109/Friday, June 6, 2003/Rules and Regulations
Year:
2003
Bibliographic source:
Federal Register, Vol.68, No 109/Friday, June 6, 2003/Rules and Regulations

Materials and methods

Type of study / information:
Type of experience: Human - Exposure through Food
Endpoint addressed:
not applicable
Principles of method if other than guideline:
safe use of tyol in food additives
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Details on study design:
no data

Results and discussion

Results:
see: Any other information on results incl. tables

Any other information on results incl. tables

Thymol is found naturally occuring in thyme herb. Thyme is used as a food  
seasoning ingredient, and is generally recognized as a safe natural  
seasoning by FDA. Thyme oil also is recognized as a GRAS essential oil by  
FDA. Thymol may safely used in food as as a synthetic flavoring substance  
when used in the minimum quantity to produce the intended effect. Levels  
of thymol reported in foods where it is permitted as a direct food  additive 
have been stated as 44 ppm in ice cream, ices, etc., 2.5 ppm to  11 ppm 
in non-alcoholic beverages; 9.4 ppm in candy, 5ppm to 6.5 ppm in  baked 
goods, and 100 ppm in chewing gum.

Applicant's summary and conclusion

Executive summary:
Thymol is found naturally occuring in thyme herb. Thyme is used as a food seasoning ingredient, and is generally recognized as a safe naturalseasoning by FDA. Thyme oil also is recognized as a GRAS essential oil byFDA. Thymol may safely used in food as as a synthetic flavoring substance when used in the minimum quantity to produce the intended effect. Levelsof thymol reported in foods where it is permitted as a direct food additivehave been stated as 44 ppm in ice cream, ices, etc., 2.5 ppm to 11 ppmin non-alcoholic beverages; 9.4 ppm in candy, 5ppm to 6.5 ppm in bakedgoods, and 100 ppm in chewing gum.