Registration Dossier

Physical & Chemical properties

Storage stability and reactivity towards container material

Administrative data

Endpoint:
storage stability and reactivity towards container material
Type of information:
other: company data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Experience in use

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Guideline:
other: no data
GLP compliance:
not specified
Type of method:
testing for reactivity towards container material

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Myacide BT (crystalline Bronopol)

Results and discussion

Results:
Crystalline Bronopol (Myacide BT) in the dry state is not corrosive per se to metals and other packing materials. However, concentrated solutions of Bronopol are corrosive to a range of metals including mild steel, copper, brass and aluminium. These same solutions have been shown to be compatible with plastics used widely in packaging such as Low and High Density Polyethylene (LDPE and HDPE), Rigid PVC and Polypropylene.

These factors together have dictated the design of commercial packs and the recommendations for storage and transportation of the crystalline solid. Thus the Myacide BT is supplied in Fibreboard Casks with double internal polythene bag liners with plastic security straps securing each liner. A desiccant sachet is also included within the inner bag to maintain dry conditions.

As a consequence it is not technically justified to generate corrosion data on the crystalline solid.

Applicant's summary and conclusion