Registration Dossier

Diss Factsheets

Administrative data

Description of key information

N-benzylethylenediamine shows a corrosive potential (OECD 435)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
28 July 2015
GLP compliance:
yes
Specific details on test material used for the study:
Name of test substance: N-benzylethylenediamine
Test-substance No.: 17/0503-2
Batch identification: R1640 Fr.16/199/17-18
CAS No.: 4152-09-4
Content: 98.8 corrected area %
Identity: Confirmed
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this
responsibility. The test facility is organizationally independent from the BASF SE sponsor division.
Expiry date: 01 Mar 2020
pH-value: Ca. 11.9
Physical state / color: LIquid / colorless, clear
Storage conditions: Room temperature
Test system:
artificial membrane barrier model
Remarks:
reconstituted collagen matrix
Vehicle:
unchanged (no vehicle)
Details on test system:
The Corrositex® assay is a standardized in vitro corrosion test. The Corrositex® assay kit is commercially available from InVitro International.
The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). The Corrositex® assay is used to determine the corrosive potential of test substances. The assay is limited to testing those materials which cause detectable pH changes in the CDS.

Experimental procedure
The experimental design of this study consisted of a qualification screen with the CDS(to determine if a color change can be detected) and a categorization screen (to categorize
weak acids/bases and strong acids/bases), which were performed as a pretest (experimentalconduct in accordance with GLP, but without a GLP status) and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time until a color change was observed was recorded manually, and the breakthrough times of the four replicates were used to determine the corrosive potential of the test substance.

Test substance compatibility with the assay (qualification screen)
For the qualification screen, 150 μL of the test substance were added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required.

Categorization screen
The categorization screen was used to assess the appropriate scoring scale for the test substance. The categorization screen was performed by adding 150 μL of test substance to tube A and B each. Each tube was mixed, and the resulting color was observed. If required, 2 drops of the "confirm" reagent were added to tube B, the tube was mixed, and the resulting color was observed. The categorization kit and color chart provided by InVitro International were used to determine the category.
The test substance was scored as category 1 (high acid/alkaline reserve) or category 2 (low acid/alkaline reserve)

Bio barrier preparation
The vial containing the bio barrier matrix powder was placed in a water bath at 64 – 68ºC. The entire content of the bio barrier diluent vial was added slowly to the matrix powder. The stir bar rotated slowly enough to avoid foaming of the solution. 200 μL solubilized matrix were pipetted into each of the membrane discs. The membrane discs were then refrigerated for at least 2 hours at 2 – 8°C.
The bio barriers were wrapped and stored at 2 – 8°C for a maximum of 7 days.
Any remaining matrix solution was stored at 2 – 8°C for up to 30 days in order to prepare
additional bio barrier membrane discs.

Corrositex® assay
Following the acceptance of the positive control, the Corrositex® assay was performed for the test substance. Four vials containing the CDS were used for the test substance.
In addition, one vial was used for the PC, the NC and the color (blank) control each. A membrane disc coated with the bio barrier matrix was placed into one vial containing the
CDS. 500 μL undiluted test substance were added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three
minutes for any change in the CDS.
If no color change was observed within three minutes, the remaining membranes were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter, the vials were observed for approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance occurred. The elapsed time between test substance application and the first change in the indicator solution (i.e. barrier penetration) was
recorded.
The positive control vial was prepared as described above and contained one pellet of sodium hydroxide on top of the membrane disc. This vial was monitored continuously until
breakthrough occurred.
The negative control vial was prepared as described above and contained 500 μL 10% citric acid. This vial was observed for 60 minutes and evaluated as “non-corrosive” if no reaction
could be observed.

Acceptance criteria
The Corrositex® assay was accepted if the breakthrough time for the positive control substance was in the historic control range (mean ± 2-3x standard deviations, In order to demonstrate the functional integrity of the membrane barrier, the acceptance criterium for the negative control was to not induce membrance breakthrough within a 60 min observation period.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
500 µL of undiluted test substance
Duration of treatment / exposure:
60 minutes
Number of replicates:
4
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
mean
Value:
54.11
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore, the membrane barrier test method was

determined to be suitable for the evaluation of the corrosive potential of the test substance.

A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 1 (having a high acid/alkalinereserve;

Test substance Break Through Time [min:s]
Vial 1 Vial 2 Vial 3 Vial 4 Mean
17/0503 -2 56:07 50:17 56:40 53:40 54:11
Controls:          
PC:
Sodium hydroxide, solid
14:45 - - - -
NC:
10% citric acid
NB - - - -

NB = no breakthrough within maximum observation period (60 min)

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Based on the results observed and by applying the evaluation criteria it was concluded that N-benzylethylenediamine shows a corrosive potential in the Corrositex® Skin Corrosion Test under the test conditions chosen. The mean breakthrough time determined in the in vitro membrane barrier test was 54 minutes and 11 seconds. The breakthrough time indicates that the test substance has an intermediate corrosive potential and should be assigned to UN GHS skin corrosivity subcategories 1B or UN Transport Packing Group II as specified in OECD TG 435 and Instruction Manual.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The Corrositex® bio barrier membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that the test substance requires to penetrate through the Corrositex® bio barrier membrane and produce a change in the Chemical Detection System (CDS).

In addition to the test substance, a positive and a negative control were assessed.

The Corrositex® assay showed the following results:

The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore, the membrane barrier test method was

determined to be suitable for the evaluation of the corrosive potential of the test substance.

A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 1 (having a high acid/alkaline

reserve.

In the main test, four Corrositex® bio barrier membranes were treated with the undiluted testsubstance.

The mean breakthrough time of the test substance determined in the actual Corrositex® assay was 54 minutes and 11 seconds.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin corrosity GHS, cat.1B and for serious eye damage/eye irritation Cat1, H314 under Regulation (EC) No. 1272/2008.

Categories Display