Registration Dossier

Administrative data

Endpoint:
other distribution data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
28.02.1994-06.06.1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study well documented, meets generally accepted scientific principles

Data source

Referenceopen allclose all

Reference Type:
other: petition
Title:
Unnamed
Year:
1999
Reference Type:
study report
Title:
Unnamed
Year:
1998
Reference Type:
publication
Title:
Rules and Regulation
Author:
Federal Register
Year:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The extraction study was conducted on paper towel to determine the potential migration of imidazolium quaternary ammonium compound (IQAC) from test materials into food-simulating solvents under exaggerated conditions of use. The IQAC levels in the paper towel test material were 0.15% and 0.36%, respectively. The extraction (paper towel: 124 in.²; 500 mL ethanol) was performed in triplicate using 8% and 50% ethanol as extracting solvents at approx. 250°F (ca. 121°C) for 10 minutes, then approx. 120°F (ca. 49°C) for 24 hours. A HPLC/UV method was developed and validated. The limit of determination is reported to be 0.403 µg/in.².
GLP compliance:
not specified
Type of study:
other: migration
Media:
other: paper towel/food simulating solvent

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Results of IQAC determination in 8% and 50% ethanol extracts of paper towels after 10 min at 250°F, then 24 h at 120°F

 Sample  8% ethanol (µg/in²)   50% ethanol (µg/in²)
 control  0.4  0.4
    0.4  0.4
    0.4  0.4
   mean: 0.4  mean: 0.4
 0.15% IQAC  0.8  0.4
   0.8   0.4
  0.4   0.4
   mean: 0.6* mean: 0.4
0.36% IQAC  1.5  0.7
   1.3  0.5
   0.9  0.4
   mean: 1.26 +/-0.3  mean: 0.5*

* when non-detects (0.4 µg/in²) are used in calculations, the assumed value used to calculate the mean is one-half the detection limit (0.2 µg/in²)

IQAC was not detected in ethanol extracts taken immediately after 10 min at 250°F.

Assuming that, on average, 10 grams of food contacts one square inch of paper, migration into aqueous food and fatty foods would be 0.13 and 0.05 ppm, respectively. As the extraction was not carried out with a IQAC concentration of 0.5% the migration was calculated. The aqueous food and the fatty food migration values, based on a use level of 0.5%, were calculated to be 0.18 ppm and 0.07 ppm, respectively.

Using the food distribution factors for uncoated paper (Recommendations for Chemistry Data for Indirect Food Additive Petitions, Chemistry Review Branch, Office of Premarket Approval, Center for Food Safety & Applied Nutrition, FDA, June 1995, page 29), the concentration in the daily diet is 6.7 ppb and the estimated daily intake would not exceed 0.020 mg/person/day.

The test compound was prepared using DMS (dimethyl sulfate) which is known to be a carcinogen on inhalation and is probably oral carcinogen. DMS was not found at a level of 4 ppm in Varisoft 3690. Based on various assumptions (DMS concentration in Varisoft 3690: 4 ppm; varisoft concentration: max. 0.5%, weight of paper: 100 mg/in²; all DMS migrates into food; 10 grams of food contacts 1 in²; the consumption factor is 0.05 for debonded paper) a dietary concentration of 0.01 ppb and a estimated daily intake of 0.03 µg/day can be calculated. This is 50 times lower than the Threshold of Regulation dietary limit of 0.5 ppb.

In 2000, the FDA appoved the use of IQAC at concentration up to 0.5% by weight of the dry paper and paperboard.

Applicant's summary and conclusion

Conclusions:
An extraction study was conducted on paper towel to determine the potential migration of imidazolium quaternary ammonium compound (IQAC) from test materials into food-simulating solvents under exaggerated conditions of use. The IQAC levels in the paper towel test material were 0.15% and 0.36%, respectively. The extraction (paper towel: 124 in.²; 500 mL ethanol) was performed in triplicate using 8% and 50% ethanol as extracting solvents at approx. 250°F (ca. 121°C) for 10 minutes, then approx. 120°F (ca. 49°C) for 24 hours. A HPLC/UV method was developed and validated. The limit of determination is reported to be 0.403 µg/in.².
IQAC was not detected in either the 8% or the 50% ethanol extracts taken immediately after 10 min at 250°F (LOD=0.403 µg/in²).
After further 24 h of extraction, mean values of 0.6 and <0.4 µg/in² (max.: 0.8 µg/in²), respectively were detected in 8 and 50% ethanol at an IQAC concentration of 0.15%. At an IQAC concentration of 0.36% mean values of 1.26 and <0.5 µg/in² were determined.
Based on the assumption that 10 grams of food contacts 1 in² of paper, migration into aqueous food and fatty foods would be 0.13 and 0.05 ppm, respectively. The aqueous food and the fatty food migration values, based on a use level of 0.5%, were calculated to be 0.18 ppm and 0.07 ppm, respectively. Using the food distribution factors for uncoated paper, the concentration in the daily diet is 6.7 ppb and the estimated daily intake would not exceed 0.020 mg/person/day.
The test compound was prepared using DMS (dimethyl sulfate) which is known to be a carcinogen. DMS was not found at a level of 4 ppm in oleic-acid based IQAC, DMS quaternised. Based on various assumptions a dietary concentration of 0.01 ppb and a estimated daily intake of 0.03 µg/day can be calculated. This is 50 times lower than the Threshold of Regulation dietary limit of 0.5 ppb for DMS.
In 2000, the FDA appoved the use of IQAC at concentration up to 0.5% by weight of the dry paper and paperboard.
Executive summary:

An extraction study was conducted on paper towel to determine the potential migration of imidazolium quaternary ammonium compound (IQAC) from test materials into food-simulating solvents under exaggerated conditions of use (IQAC levels: 0.15% and 0.36%). The extraction was performed in triplicate using 8% and 50% ethanol as extracting solvents at approx. 250°F for 10 minutes, then approx. 120°F for 24 hours. A HPLC/UV method was developed and validated (LOD: 0.403 µg/in.²). IQAC was not detected in either the 8% or the 50% ethanol extracts taken immediately after 10 min at 250°F. After further 24 h of extraction, mean values of 0.6 and <0.4 µg/in² were detected in 8 and 50% ethanol at an IQAC concentration of 0.15%. At an IQAC concentration of 0.36% mean values of 1.26 and <0.5 µg/in² were determined. Migration into aqueous food and fatty foods was estimated to be 0.13 and 0.05 ppm. The aqueous food and the fatty food migration values, based on a use level of 0.5%, were calculated to be 0.18 ppm and 0.07 ppm, respectively. Using the food distribution factors for uncoated paper, the concentration in the daily diet is 6.7 ppb and the estimated daily intake would not exceed 0.020 mg/person/day. The test compound was prepared using DMS (dimethyl sulfate) which is known to be a carcinogen. DMS was not found at a level of 4 ppm in oleic-acid based IQAC, DMS quaternised. Based on various assumptions a dietary concentration of 0.01 ppb and a estimated daily intake of 0.03 µg/day can be calculated. This is 50 times lower than the Threshold of Regulation dietary limit of 0.5 ppb for DMS.

In 2000, the FDA appoved the use of IQAC at concentration up to 0.5% by weight of the dry paper and paperboard.