Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive 93/8/EEC
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Coating No 1:

Solvent Extraction  (methanol 2 h reflux)   Benzoguanamine  [mg/dm2]
     
1. extraction   0,16
2. extraction   0,02
3. extraction   n.d.
total   0,18
     
Migration tests    
     
dist. Water 30 min (121°C) + 10 d (40°C) 0,04
3 % acetic acid 30 min (121°C) + 10 d (40°C) 0,53
15 % ethanol 30 min (121°C) + 10 d (40°C) 0,14
50 % ethanol 30 min (121°C) + 10 d (40°C) 0,24

Coating No 2:

Solvent Extraction  (methanol 2 h reflux)   Benzoguanamine  [mg/dm2]
     
1. extraction   0,02
2. extraction   0,02
3. extraction   n.d.
total   0,04
     
Migration tests    
     
dist. Water 30 min (121°C) + 10 d (40°C) 0,04
3 % acetic acid 30 min (121°C) + 10 d (40°C) 0,05
15 % ethanol 30 min (121°C) + 10 d (40°C) 0,03
50 % ethanol 30 min (121°C) + 10 d (40°C) 0,07

Coating No 3:

Solvent Extraction  (methanol 2 h reflux)   Benzoguanamine  [mg/dm2]
     
1. extraction   0,02
2. extraction   0,01
3. extraction   n.d.
total   0,03
     
Migration tests    
     
dist. Water 30 min (121°C) + 10 d (40°C) 0,04
3 % acetic acid 30 min (121°C) + 10 d (40°C) 0,29
15 % ethanol 30 min (121°C) + 10 d (40°C) 0,05
50 % ethanol 30 min (121°C) + 10 d (40°C) 0,03

Applicant's summary and conclusion

Conclusions:
As the values has been determined by an guideline study it can be considered as reliable.
Executive summary:

According to the results of the examination the dried films of the coating formulation show migration of benzoguanamine with aqueous food simulants and fat simultan (50% Ethanol).