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Physical & Chemical properties

Storage stability and reactivity towards container material

Administrative data

Endpoint:
storage stability and reactivity towards container material
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Principles of method if other than guideline:
Where possible the test methods used in this Study are internationally recognised (e.g. CTP AC methods); where internal BASF methods have been used, a copy of the latest version of the method as used in the Study is attached for reference (Appendix 4).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Substance type: organic
- Physical state: liquid

Results and discussion

Results:
6.2 Chemical Stability
The storage data presented in Table 2 for the stability of the active substance show no significant change in active substance content after storage with hexahydrotriazine remaining >98% of initial.
The pH characteristics showed no marked change over the storage period (Table 3).

6.3 Physical Stability
6.3. l The product showed no change in appearance over the storage period, remaining as a clear liquid with no foreign matter present (Table 1 ).
6.3.2 The product showed excellent cold stability, as shown by the freeze/thaw data presented in Tables 1 to 4 and the 7 days at 0°C data in Table 6.
These results indicate that the product would give satisfactory chemical and physical properties under use conditions.

6.4 Packaging
The data given in Table 5 show the HDPE packs to remain in good condition throughout the test, with no evidence of product leakage or penetration.

Transformation products:
no

Any other information on results incl. tables

Table 1 - Product Appearance

Method: RLA 11803

Temperature
[°C]

Storage
(weeks)

Appearance

 

initial

Colourless, clear liquid free from foreign mattter

20

12

as initial

 

26

as initial

 

52

as initial

50

4

Light brown, clear liquid free from foreign matter

 -18/20

5 cycles

as initial

Conclusion: Product shows no significant change in appearance on storage.

Table 2 - Active Substance Content

Method: RLA 12660 for hexahydrotriazine and formaldehyde content; RLA 12659 for monoethanolamine content.

Temperature

Storage

% w/w

[°C]

(weeks)

Hexahydrotriazine

Formaldehyde

Monoethanolamine

 

initial

76.4, 76.9

31.4, 31.6

66.2, 66.0

20

12

75.5, 75.3

31.0, 30.9

66.5, 67.2

 

26

75.0, 76.0

30.8, 31.2

67.2, 67.3

 

52

75.7, 75.7

31.1, 31.1

66.8, 66.9

50

4

75.9, 76.6

31.2, 31.5

67.1, 66.6

 -18/20

5 cycles

76.4, 76.3

31.4, 31.3

67.1, 66.9

Conclusion: Hexahydrotriazine content remains > 98% of initial after 52 weeks storage

Table 3 - pH

Method: CIPAC MT 75.2

Temperature

 [°C]

Storage

(weeks)

pH (0.2% v/v dilution)

 -

initial

9.9

 

20

12

10.3

26

10.4

52

10.2

50

4

10.3

 -18/20

5 cycles

10.3

Conclusion: pH characteristics show no marked change on storage.

Table 4 - Specific Gravity

Method: CIPAC MT 3.1

Temperature
[°C]

Storage
[weeks]

Specific Gravity

 

initial

1.156

20

12

1.154

 

26

1.154

 

52

1.154

50

4

1.156

 -18/20

5 cycles

1.155

Conclusion: Essentially no change in Specific Gravity throughout the storage period.

Table 5 - Pack Appearance / Weight Check

Method: AGF 0065

Temperature
[°C]

Storage
[weeks]

Pack Appearance

Weight Change [%]

 

initial

No leakage, penetration or distortion

 -

20

12

as intitial

0

 

26

as intitial

0

 

52

as intitial

-0.1

50

4

as intitial

0

 -18/20

5 cycles

as intitial

0

Conclusion: The HDPE packs remained in good condition throughout the storage period.

Table 6 - Low Temperature Stability

Method: CIPAC MT 39.1

Temperature
[°C]

Storage
[weeks]

Specific Gravity

0

1

No visible separation

Conclusion: The product shows good low temperature stability

Applicant's summary and conclusion

Conclusions:
- The product shows good chemical and physical stability after 52 weeks storage.
- The HDPE packs remained in good condition.
- A minimum shelf life of 2 years can be recommended for this product.