Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Oct 2017 - 20 Oct 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study completed according to OECD 435 Guidelines, and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Type:
impurity
Test material form:
liquid: viscous

In vitro test system

Test system:
other: Corrositex Kit Biobarriers
Source species:
other:
Cell type:
other:
Cell source:
other:
Vehicle:
water
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Test animals

Species:
other: N/A - Macromolecular Barrier

Test system

Type of coverage:
other: In vitro
Vehicle:
water
Remarks:
Tissue culture water
Controls:
yes, concurrent vehicle
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
500 μl of the test article to each of four test vials containing biobarriers
Duration of treatment / exposure:
Single Exposure
Observation period:
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
Details on study design:
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 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, the 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 the test article took to penetrate the biobarriers.

Qualification
150 μl 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, the test article was categorized, which determined cut-off times for the Packing Group designations. A 10% formulation of the test article was prepared and its pH was measured. If the pH of the 10% formulation was <7.0, 150 μl of the neat test article were added to Vial A. The pH of Vial A was then measured, and if it was lower or equal to 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 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 greater or equal than 9.0, the test article was Category 2.

Classification
Finally, the test article was classified to determine the Packing Group by adding 500 μl of the test article to each of four test vials containing biobarriers. If the test article 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.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
> 85.21
Vehicle controls validity:
valid
Negative controls validity:
valid
Remarks:
Citric acid
Positive controls validity:
valid
Remarks:
1.0 N Sodium hydroxide
Remarks on result:
no indication of irritation
Remarks:
Non Corrosive

Any other information on results incl. tables

The 1.0 N sodium hydroxide" positive control had a breakthrough time of 16.15 minutes, which fell within the range allowed (>13.7 and <22.2 minutes). The 1% citric acid negative control had a breakthrough time of 68 minutes, which met the acceptance criterion of >60 minutes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
The material was considered non-corrosive.
Conclusions:
The material was considered non-corrosive.
Executive summary:

Benzene, tetrapropylene-, distn. residues, sulfonated, sodium salt was analyzed using the Corrositex® test method to determine its dermal corrosivity potential and U.N. Packing Group classification and GHS Sub-category. The 1.0 N sodium hydroxide" positive control had a breakthrough time of 16.15 minutes, which fell within the range allowed (>13.7 and <22.2 minutes). The 1% citric acid negative control had a breakthrough time of 68 minutes, which met the acceptance criterion of >60 minutes. The results of this study indicated that the test article was compatible with the Corrositex® system. Based on the pH of the test article, it was assigned as a Corrositex® Category 2 test article. The results obtained from the evaluation of four replicate tests demonstrated that a mean time of >85.21 minutes was required to penetrate the synthetic biobarriers. These findings lead to the classification of this test article as a Non-Corrosive material.