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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern GLP study conducted to the appropriate guidelines.

Data source

Reference
Reference Type:
other: Interim results
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
CIPAC MT 46.3 (Storage Stability)
GLP compliance:
yes
Type of method:
other: accelerated and ambient testing

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Paper
Details on test material:
Batch No.: LOT 07.15
Active Substance (a.s.): 0.233 % Transfluthrin
Mode of product: Paper
Packaging material: PET/PE-foil
Manufacturer: Reckhaus GmbH & Co. KG
Industriestraße 53
33689 Bielefeld, Germany
Production date: 2015-05-26
Expiry date: 2019-05-25
Specific details on test material used for the study:
The purpose of the study is to generate stability data for the test item after 48 months at 20 °C, 18 weeks at 30 °C and 8 weeks at 40 °C.

The appearance (visual), pH (CIPAC MT 75.3), weight loss, active substance content (MV122) and density (EU method A.3) will be determined before and after storage.

The stability of the packaging will be assessed before and after storage according to SOP-PR-029.

Results and discussion

Results:
The results obtained before storage are tabulated below. The study is currently ongoing and results are expected in December 2015 for the accelerated study and October 2017 for the ambient study. Study plan attached.

Any other information on results incl. tables

 

Before Storage

After Storage for 8 weeks at 40 °C

After Storage for 48 months at 20 °C

Content (MV122)

0.207%

*

*

Appearance

White, yellow paper with paper odour

*

*

Packaging stability

Test Item in sound condition, sealed and without leakages, paneling, ballooning or any other damages

*

*

Weight range

30.579-32.057 g

*

*

pH value 1% (MT 75.3)

pH 9.6

*

*

Density (A.03)

1.279 g/cm3

*

*

* Study ongoing

Applicant's summary and conclusion

Conclusions:
The content of transfluthrin in the mothpaper was determined to be 0.207% before storage. The study is currently ongoing and results are expected in December 2015 for the accelerated study and October 2017 for the ambient study. Study plan attached.
Executive summary:

The stability of the mothpaper after storage was determined using CIPAC MT 46.3. The content of transfluthrin in the mothpaper was determined to be 0.207% before storage. The study is currently ongoing and results are expected in December 2015 for the accelerated study and October 2017 for the ambient study. Study plan attached.