Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
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:
- 2 017
- 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 (incl. QA statement)
Test material
- Reference substance name:
- {2-[(2-aminoethyl)amino]ethyl}(benzyl)amine
- Cas Number:
- 39549-34-3
- Molecular formula:
- C11H19N3
- IUPAC Name:
- {2-[(2-aminoethyl)amino]ethyl}(benzyl)amine
- Reference substance name:
- benzyl(2-{[2-(benzylamino)ethyl]amino}ethyl)amine
- Cas Number:
- 17327-80-9
- Molecular formula:
- C18H25N3
- IUPAC Name:
- benzyl(2-{[2-(benzylamino)ethyl]amino}ethyl)amine
- Reference substance name:
- Piperazine-1,4-diethylamine
- EC Number:
- 229-428-8
- EC Name:
- Piperazine-1,4-diethylamine
- Cas Number:
- 6531-38-0
- Molecular formula:
- C8H20N4
- IUPAC Name:
- 2,2'-piperazine-1,4-diyldiethanamine
- Reference substance name:
- 2-piperazin-1-ylethylamine
- EC Number:
- 205-411-0
- EC Name:
- 2-piperazin-1-ylethylamine
- Cas Number:
- 140-31-8
- Molecular formula:
- C6H15N3
- IUPAC Name:
- 2-piperazin-1-ylethanamine
- Reference substance name:
- N-(2-aminoethyl)-N'-[2-(benzylamino)ethyl]ethylenediamine
- EC Number:
- 244-734-1
- EC Name:
- N-(2-aminoethyl)-N'-[2-(benzylamino)ethyl]ethylenediamine
- Cas Number:
- 22029-44-3
- Molecular formula:
- C13H24N4
- IUPAC Name:
- N-(2-aminoethyl)-N'-[2-(benzylamino)ethyl]ethane-1,2-diamine
- Reference substance name:
- 2-{4-[(benzylamino)methyl]piperazin-1-yl}ethan-1-amine
- Molecular formula:
- C14H24N4
- IUPAC Name:
- 2-{4-[(benzylamino)methyl]piperazin-1-yl}ethan-1-amine
- Reference substance name:
- [2-(benzylamino)ethyl][2-(piperazin-1-yl)ethyl]amine
- Molecular formula:
- C15H26N4
- IUPAC Name:
- [2-(benzylamino)ethyl][2-(piperazin-1-yl)ethyl]amine
- Reference substance name:
- 1,12-diphenyl-2,5,8,11-tetraazadodecane
- Cas Number:
- 140840-03-5
- Molecular formula:
- C20H30N
- IUPAC Name:
- 1,12-diphenyl-2,5,8,11-tetraazadodecane
- Reference substance name:
- benzyl(2-{4-[2-(benzylamino)ethyl]piperazin-1-yl}ethyl)amine
- Cas Number:
- 176906-02-8
- Molecular formula:
- C22H32N4
- IUPAC Name:
- benzyl(2-{4-[2-(benzylamino)ethyl]piperazin-1-yl}ethyl)amine
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
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.
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