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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
Study period:
2017-05-05 to 2017-06-09
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:
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:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

In vitro test system

Test system:
artificial membrane barrier model
Justification for test system used:
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.
Vehicle:
unchanged (no vehicle)
Details on test system:
TEST SYSTEM
Identity : Corrositex® Kit
Supplied by : InVitro International, Placentia, CA
Lot Numbers : CT 060115 and CT 120516
Dates Received : 06 Oct 2015 and 14 Feb 2017
Expiration Dates : Jun 2017 and Dec 2018
Storage : Refrigerated at 2-8ºC
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
100 μl of the test article were added to
900 μl of tissue culture water and mixed to yield a 10%
formulation. The test article was also used as received.
Number of replicates:
4

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
48.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
2
Value:
48.35
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
3
Value:
48.37
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
4
Value:
48.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
5
Value:
48.38
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Skin irritation/corrosion properties of the test material benzylated polyamine was determined using Corrositex® method. The test material showed a break through time of 48.38 min.
Executive summary:

The objective of the test was to determine dermal corrosivity and assign U.N. Packing Group classification for chemicals or mixtures. This study is designed to comply with the standards set forth in the OECD Guideline for the Testing of Chemicals No. 435.The test article was qualified and found to be compatible with the Corrositex® test system. The test article was then categorized by pH. Then 500 μl of the test article were added to each of four Corrositex® test vials containing biobarriers and the times required for each test article to penetrate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) were tested concurrently. The mean breakthrough time, which predicts the in vivo corrosive potential, was used to designate the United Nations (U.N.) Packing Group classifications and GHS Sub-category.

The 1.0 N sodium hydroxide positive control had a breakthrough time of 18.00 minutes, which fell within the range allowed. The 1% citric acid negative control had a breakthrough time of >92.83 minutes, which met the acceptance criterion of >60 minutes. The benzylated poly amine has a mean breakthrough time of 48.38 min and was therefore classified as skin corrosive Cat. 1B and assigned to packing group 2.