Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
28 June to 30 June 1994
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline available
Principles of method if other than guideline:
In vitro study of skin corrosion, conducted to accepted methodology but prior to development of current guideline.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
Details on test material:
clear, colourless to pale yellow
Specific details on test material used for the study:
Bulab 600
Lot: 3H-9275
Appearance: clear pale yellow liquid
Storage conditions: Room temperature protected from light

In vitro test system

Test system:
artificial membrane barrier model
Source species:
other: Synthetic
Cell type:
other: Hydrated collagen matrix and supporting filter membrane
Cell source:
other: Synthetic
Source strain:
other: Synthetic
Justification for test system used:
The Corrositex assay is a standardised and quantitative in vitro corrosivity test. It is based on the time that is required for the test sample to pass through a biobarrier membrane and produce a change in the Chemical Detection System. The Corrositex Biobarrier Membrane consists of a reconstituted collagen matrix.
unchanged (no vehicle)
Details on test system:
The experimental design consists of a pH determination, if possible, and a definitive Corrositex assay in the Chemical Detection System. The Corrositex assay is evaluated on the basis of the colour change of the Chemical Detection System. The time that a colour change is observed is recorded manually and the average of the six replicates is used to determine the Packing Group.
The biobarrier is prepared by adding the biobarrier diluent to the biobarrier matrix powder. This is warmed to 67-69 degrees C to aid solubility. Following this, 200 mcL of the matrix is pipetted onto the membrane discs which are refrigerated at 2-8 degrees C for at least 2 hours, up to 7 days.
Seven vials were used (six for the test material and one for the positive control); 22 mL of the Chemical Detection System was dispensed into each of these vials and 12 mL was dispensed into an eighth vial to serve as the blank control. A membrane disc was placed into one vial which contained 500 mcL of the test material. The vial was observed for three minutes. At one minute intervals, the remaining five membrane discs each containing 500 mcL of test material were added to five further vials. A membrane disc containing a pellet of sodium hydroxide was added to the seventh vial.
The vials were observed continuously for the first 10 minutes, and then at approximately 5 minutes intervals for 4 hours. The first indication of a colour change in the Chemical Detection System (as compared to the blank control) was recorded.
The mean time for the colour to change determined the packing group:
<3 minutes – Packing group I
3 mins to 1 hour – Packing group II
1 to 4 hours – Packing Group III
>4 hours – Non-corrosive
Control samples:
yes, concurrent positive control
Amount/concentration applied:
500 mcL for the test material.
Duration of treatment / exposure:
Up to 4 hours or until a colour change was noted.
Number of replicates:

Results and discussion

In vitro

Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
>= 40 - <= 43
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
Breakthrough time of 13 min 20 sec
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
Positive control response met the acceptance criteria (breakthrough time between 9 min 33 sec and 14 min 01 sec).

Any other information on results incl. tables

Test article

Breakthrough time (min)

Packing group


Vial 1

Vial 2

Vial 3

Vial 4

Vial 5

Vial 6


Bulab 600










Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
The test material was assigned to Packing Group II based on mean breakthrough time of 40 minutes. The results of this study indicate that TMEDA is corrosive to skin
Executive summary:

Bulab 600 was tested for potential corrosivity using the Corrositex continuous time monitor assay which is a calibrated biobarrier into a chemical detection system. The substance was tested in a single experiment with six replicates. The mean breakthrough time was determined to be 40 minutes and was therefore assigned to Packing Group II. The results of this study indicate that TMEDA is corrosive to skin.