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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
In vitro Membrane Barrier Test Method for Skin Corrosion
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 June 2018 - 10 January 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
July 28, 2015, adopted

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
July 28, 2015, adopted
Deviations:
yes
Remarks:
• included change of consistency in “Quality Test" • NaOH included as Cat. 1B classified positive control • 1 replicate for positive and negative control
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of 2,3-epoxypropyl phenyl ether and 2,2'-iminodi(ethylamine)
EC Number:
948-518-4
Molecular formula:
(C13H23N3O2 . C31H43N3O6)x
IUPAC Name:
Reaction products of 2,3-epoxypropyl phenyl ether and 2,2'-iminodi(ethylamine)
Test material form:
liquid
Details on test material:
PGE-DETA adduct
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Olin Corporation Batch: 17-09-502-04 QM 14K17-54
- Expiration date of the lot/batch: 30 October 2019
- Purity test date: Approx. 97% (including the oligomeric isomers)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: N/A

Test Item Preparation: Used without dilution (neat)

In vitro test system

Test system:
artificial membrane barrier model
Source species:
other: synthetic macromolecular bio-barrier
Justification for test system used:
Corrositex™ is a validated and accepted in vitro method to assess if a test item can produce skin corrosion, and to distinguish between GHS corrosivity categories 1A, 1B and 1C. The test method may be used for solids, liquids, and emulsions, but may have limitations depending on the pH range. No prior treatment of the sample is required. This method can be used to meet certain regulatory uses, e.g. UN Packaging Group classifications and has been accepted by regulatory authorities.
Vehicle:
unchanged (no vehicle)
Details on test system:
Name: Corrositex™
Supplier: ROMER Labs Deutschland GmbH, 35510 Butzbach, Germany
Lot No.: CT100217
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 150 ul
- Concentration (if solution): neat

VEHICLE
- Amount(s) applied (volume or weight with unit): None

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Citric Acid (10%) 500 ul

POSITIVE CONTROL
- Amount(s) applied (volume or weight): Sulfuric Acid (95 - 97%): 500 ul; NaOH; 110mg
Duration of treatment / exposure:
60 minutes
Number of replicates:
4 replicates

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
Classification Test
Value:
> 60
Negative controls validity:
valid
Remarks:
No penetration for >90 minutes
Positive controls validity:
valid
Remarks:
Penetration: 53 sec (Sulfuric acid); 18 min.55 sec (NaOH)
Remarks on result:
other: non corrosive

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive
Conclusions:
Test Items was demonstrated to be Non-corrosive.
Executive summary:

This in vitro study was performed to assess the corrosive potential of 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl Ph ether by means of the In Vitro Membrane Barrier Test for Skin Corrosion (OECD TG 435) using the Corrositex™ test kit.

Following an initial determination of the compatibility of the test item with the test system (qualify test) and a test system-specific categorisation (categorisation test), 500 μL of the test item were applied on quadruplicate bio-barriers for the classification test. The bio-barriers were placed atop vials containing the chemical detection system (CDS). The time needed to possibly corrode the bio-barrier and to induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.

No change of colour of the CDS reagent after treatment of the bio-barriers with the test item was observed after 60 minutes. According to the classification criteria given in chapter 3.7 the test item is, therefore, classified as non-corrosive.

The test item, the negative and positive controls met acceptance criteria.

In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl Ph ether is non-corrosive to skin.