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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 28, 2020 - 2021, March 3, 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
July, 2015
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
methylbis({2-[methyl(propan-2-yl)amino]ethyl})amine
EC Number:
950-627-7
Cas Number:
1042950-30-0
Molecular formula:
C13H31N3
IUPAC Name:
methylbis({2-[methyl(propan-2-yl)amino]ethyl})amine
Test material form:
liquid
Specific details on test material used for the study:
Batch No.: UW20226411
Purity: 98%
Expiry Date: 14 February 2022
Storage conditions: Room Temperature

In vitro test system

Test system:
artificial membrane barrier model
Remarks:
The test system CORROSITEX® is composed of two components, a synthetic macromolecular bio-barrier and a CDS (Chemical Detection System);
Vehicle:
unchanged (no vehicle)
Details on test system:
SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: yes, CORROSITEX®, in vitro INTERNATIONAL (17751 Sky Park East, Ste. G. Irvin -
California 92614 - US), batch: CT110419
- Components: two components: a proteinaceous macromolecular aqueous gel and a permeable supporting membrane

- Apparatus and preparation procedures: The permeable supporting membrane provides mechanical support to the proteinaceous gel during the gelling process and exposure to the test item. The supporting membrane prevents
sagging or shifting of the gel and is readily permeable to all test substances. The proteinaceous gel serves as the target for the test item and is placed on the surface of the supporting membrane and allowed to gel, prior to placing the membrane barrier over the indicator solution. The proteinaceous gel should be of equal thickness and density on the entire surface, and with no air bubbles or defects that could affect its functional integrity. The biobarrier will be supplied in the form of a powder to be reconstituted, prepared over a supporting membrane and stored according to the manufacturer’s instructions.

WAS THE COMPATIBILITY TEST PERFORMED: Yes. A Qualify test tube was supplied with the test system, containing the same indicator solution used in theMain Assay. An aliquot of 150 μL of test item was added to the Qualify test tube (amber solution). The tube was shaken to dissolve the test item and the vial was let stand for 1 minute. Colour change (e.g. from amber to red, orange, lightening) or consistency modification (flaking or precipitation) of the CDS was evaluated. In case no change occurred, the substance should not be considered idoneous to proceed with the test.

WAS THE TIMESCALE CATEGORY TEST PERFORMED: Yes. Components of the test item timescale category test (Test Tube A, Test Tube B, Colour Chart and one bottle of Confirmr eagent) were supplied with the test system. An aliquot of 150 μL of test item was added to Tube A (yellow solution) and Tube B (clear solution). Tubes were shaken to mix substances. The colour change in each tube was assigned and recorded according to the Colour chart. Each colour in the colour chart was associated to a letter (Addendum 1). The substance is classified as Category 1 or 2 (time scale category), on the basis of the colour changes and according to the manufacturer’s instructions. When a colour change is not detected either in Tube A or B, a confirm reagent is added to Tube B to confirm the test system suitability.

METHOD OF DETECTION
- Chemical or electrochemical detection system: The indicator solution, which is the same solution used for the compatibility test (qualification), responds to the presence of a test substance. A pH indicator combination of dyes willshow a colour change in response to the presence of the test substance or other types of chemical or electrochemical reactions. The measurement system will be visual.

METHOD OF APPLICATION:
Treatment
A Main Assay was carried out including test item, positive and negative controls. The pre-filled CDS vials were kept at room temperature (17-25°C) before use. A cold biobarrier disc, kept on crushed ice on the bench, was added to the top of each vial. A fixed amount of samples was added to the top within 2 minutes from putting the biobarrier at room temperature /

NUMBER OF REPLICATES: 4 (test item, 500 µL), 1 (negative and positive control, 500 µL)

NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 (Preliminary test and Main Test)

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
The time (in minutes) elapsed between application of the test item to the membrane barrier and barrier penetration was used to classify the test item in terms of corrosivity according to the following formula: CORROSITEX® Time = Detection Time – Start Time Means and standard deviations of CORROSITEX® Time were calculated for replicates of the same sample. Cut-off time values for each of the three corrosive subcategories are to find in the section Any other information on materials and methods incl. tables

Control samples:
yes, concurrent negative control
Duration of treatment / exposure:
A fixed amount of samples was added to the top within 2 minutes from putting the biobarrier at room
temperature

Test animals

Species:
other: not relevant: in vitro study

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
500 µL for test item and controls
Observation period:
Detection intervals (minutes): 0-5, 55-65,235-245 for test item. Negative control vial was observed at 60 minutes.
Details on study design:
not relevant: in vitro study

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
main experiment
Value:
237.8
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: indication of corrosion
Other effects / acceptance of results:
Preliminary test: Results of Qualification and Categorisation tests are shown in the attachment under Overall remarks. The test item issuitable for this test system since red colour was recorded after adding the test item. The ime category was 1 since Tube B content changed the colour to deep purple, after the addition of the test item.

Main Assay: After addition of the test item to the bio-barrier, a colour change to red was observed in the Chemical Detection System after a mean time of 237.8 minutes. Negative control was not corrosive within 60 minutes. Positive controls gave the expected
penetration response time (13 minutes and 32 seconds), within the range based on historical control data.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The skin corrosion potential of the test item was assessed with an in vitro membrane barrier assay, using the validated commercial kit CORROSITEX®.
The test item penetrated the bio-barrier after 237.8 minutes. Positive and negative control
results met the acceptance criteria indicating a good functioning of the test system.
According to OECD guideline for testing of chemicals No. 435, the test item is classified as corrosive to the skin, sub-category 1C, based on UN GHS, corresponding to
UN packing group III.