Registration Dossier

Administrative data

specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: National test procedure. Valid study at the time to determine UN package group. Restrictions: test report not signed, and GHS classification determines proper transportation rules.

Data source


Materials and methods

Principles of method if other than guideline:
CORROSITEX test: The test item is separate d by a biological from a solution containing a chemical detection system which provides a visual change when the test item permeate sthrough the barrier. The permeation time is measued and used to classify teh test substance into UN Packin Groups.
GLP compliance:
Type of method:
in vitro
Endpoint addressed:
skin irritation / corrosion

Test material

Test material form:
liquid: viscous

Results and discussion

Any other information on results incl. tables

A summary of the results obtained after evaluating the test sample is presented in Table 2.

Table 2.Summary of CorrositexâTest Results

IVI#: C2345

Corrositex Time (minutes)


Replicate #1: 62.00

Conc. Tested: Neat

Replicate #2: 61.97

pHa: 12.02

Replicate #3: 61.93

Category: 1

Replicate #4: 61.90

Packing Group: III

Mean±SD:   61.95 ± 0.04

apH is taken at 10% aqueous solution.

Applicant's summary and conclusion

Executive summary:

In order to determine the UN package group, N,N-dimethyl-n-butylamine was subjected to the CORROSITEX test where the time until permeation though a biological membrane is determined. The package group is then defined according to the following table:


Designation of UN Packing Groups



Corrositex Time (minutes)

 Category 1

0 to 3 min.

>3 to 60 min.

>60 to 240 min.

>240 min.

 Category 2

0 to 3 min.

>3 to 30 min.

>30 to 60 min.

>60 min.






Packing Group I

Packing Group II

Packing Group III



With N,N-dimethyl-n-butylamine the mean Corrositex time was 61.95 ± 0.04 minutes. As this substance belongs to Category 1 (strong bases and acids; Category 2: weak bases and acids), the substance was designated the UN Packing Group III (Tang, 2002).


It should be mentioned that the new GHS classification (Cat IA) determines the proper transportation rules.