N,N,N',N'-tetramethylethylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetramethylethylenediamine

EC Number:

203-744-6

EC Name:

N,N,N',N'-tetramethylethylenediamine

Cas Number:

110-18-9

Molecular formula:

C6H16N2

IUPAC Name:

[2-(dimethylamino)ethyl]dimethylamine

Test material form:

liquid

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.

Vehicle:

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:

Six

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

1

Value:

>= 40 - <= 43

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks:

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	pH
	Vial 1	Vial 2	Vial 3	Vial 4	Vial 5	Vial 6	Mean
Bulab 600	43	40	40	41	41	40	40	II	11.0

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

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.