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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Version / remarks:
The Corrositex® - InVitro International, Placentia, CA
Principles of method if other than guideline:
The Corrositex® (InVitro International, Placentia, CA) 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 predicts1,2 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 permeate 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. This assay system is depicted below.

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, they were 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 Tube A. The pH of Tube 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 Tube B. The pH of Tube 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 mixture permeates 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 tube. The amount of time required for the test article to permeate 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. Classifications are as follows: Packing Group I (severe
corrosivity), Packing Group II (moderate corrosivity), Packing Group III (mild corrosivity), or Non-Corrosive. 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.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

In vitro test system

Test system:
artificial membrane barrier model
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
> 71.8
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
2
Value:
> 71.7
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
3
Value:
> 71.5
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
4
Value:
> 71.3
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2-hydroxyethyliminodi(acetic acid) was found to be non-corrosive in Corrositex study.
Executive summary:

2-hydroxyethyliminodi(acetic acid) was found to be non-corrosive in Corrositex study.