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Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
EC Number:
816-324-8
Cas Number:
2044770-20-7
Molecular formula:
C19H44N4O2
IUPAC Name:
1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
Test material form:
liquid
Details on test material:
Storage conditions: room temperature

In vitro test system

Test system:
artificial membrane barrier model
Remarks:
Corrositex® biobarrier system
Source species:
other: Corrositex® biobarrier system
Cell type:
other: Corrositex® biobarrier system
Cell source:
other: Corrositex® biobarrier system
Source strain:
other: not applicable - Corrositex biobarrier system
Vehicle:
unchanged (no vehicle)
Details on test system:
Background
The Corrositex® test is a standardized and reproducible method that can be employed to determine the potential corrosivity and the Packing Group classification of specified categories of chemical compounds under the hazardous materials transportation regulations administered by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The Corrositex® test predicts the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the amount of time it
takes for a chemical to penetrate or destroy a synthetic biobarrier. A color change in a proprietary liquid Chemical Detection System (CDS) is used to indicate that the chemical has passed through the biobarrier.

Procedure
The Corrositex® test is a three-step procedure. First, each test article was qualified to ensure that it was compatible with the Corrositex® system, and then it was categorized according to pH to determine cut-off times. Finally, it was classified based on the mean time each test article took to penetrate the biobarriers.

Qualification
For each test article, 150 μl or 100 mg of the test article were added to the CDS reagent in a Qualify vial, and the vial was observed for any notable color change. An observable color change indicates that the test article is compatible with the Corrositex® system.

Categorization
Next, each test article was categorized, which determined cut-off times for the Packing Group designations. A 10% formulation of each test article was prepared and its pH was measured. If the pH of the 10% formulation was < 7.0, 150 μl or 100 mg of the neat test article were added to Vial A. The pH of Vial A was then measured, and if it was ≤ 5.0, the test article was assigned to Category 1, and if it was > 5.0, the test article was assigned to Category 2. If the pH of the 10% formulation was > 7.0, 150 μl or 100 mg of the neat test article were added to Vial B. The pH of Vial B was measured, and if the final pH was ≥ 9.0, the test article was Category 1, and if it was < 9.0, the test article was Category 2.

Classification
Finally, each test article was classified by adding 500 μl or 500 mg of the test article to four test vials containing biobarriers to determine the Packing Group. If the test article penetrates or destroys the biobarrier, it will come in contact with the CDS reagent in the vial and induce a color change similar to that observed in the Qualify vial. The amount of time required for the test article to penetrate or destroy each biobarrier was recorded and the mean time of the four replicates is used to designate the United Nations
(U.N.) Packing Group classification and GHS Sub-category as described below. A positive control was performed using 1.0 N sodium hydroxide. The result for the positive control is considered valid if it falls within the range of the MB Research historical mean ± 2 standard deviations. A negative control was performed using 1% citric acid; the result is considered valid if the breakthrough time is greater than 60 minutes.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
The test articles were analyzed using the Corrositex® test method to determine their dermal corrosivity potential and Packing Group designations.
The 1.0 N sodium hydroxide positive control had a breakthrough time of 18.00 minutes, which fell within the range allowed (>13.7 and <22.2 minutes).
The 1% citric acid negative control had a breakthrough time of >92.83 minutes, which met the acceptance criterion of >60 minutes.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Value:
81.54
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Mild corrosive; GHS subcategory: 1C
Executive summary:

The test articles were analyzed using the Corrositex® test method to determine their dermal corrosivity potential and Packing Group designations.
The 1.0 N sodium hydroxide positive control had a breakthrough time of 18.00 minutes, which fell within the range allowed (>13.7 and <22.2 minutes).

The 1% citric acid negative control had a breakthrough time of >92.83 minutes, which met the acceptance criterion of >60 minutes.

The results of this study indicated that the test articles were compatible with the Corrositex® system. The mean times required to penetrate the synthetic biobarriers and the Packing Group classification of the

test article is as follows:

Breakthrough time: 81.54 min

Packing Group: III

GHS subcategory: 1C
Mild corrosive

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