Reaction products of amines, polyethylenepoly-, triethylenetetramine fraction and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1st June 2017 to 6th July 2017

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

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

yes

Remarks:

See Other information

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[propane-2,2-diylbis(benzene-4,1-diyloxy)]bis(1-{[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amino}propan-2-ol)

Molecular formula:

C33H60N8O4

IUPAC Name:

3,3'-[propane-2,2-diylbis(benzene-4,1-diyloxy)]bis(1-{[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amino}propan-2-ol)

Constituent 2

Reference substance name:

1,16-bis(4-{2-[4-(3-{[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amino}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)-4,7,10,13-tetraazahexadecane-2,15-diol

Molecular formula:

C60H102N12O8

IUPAC Name:

1,16-bis(4-{2-[4-(3-{[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amino}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)-4,7,10,13-tetraazahexadecane-2,15-diol

Constituent 3

Reference substance name:

3-(4-{2-[4-(3-{[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amino}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propane-1,2-diol

Molecular formula:

C27H44N4O5

IUPAC Name:

3-(4-{2-[4-(3-{[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amino}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propane-1,2-diol

Constituent 4

Reference substance name:

Polymeric adducts of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis-oxirane and N1,​N2-​bis(2-​aminoethyl)​-​2-​ethanediamine

IUPAC Name:

Polymeric adducts of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis-oxirane and N1,​N2-​bis(2-​aminoethyl)​-​2-​ethanediamine

Constituent 5

Reference substance name:

Unknown components

IUPAC Name:

Unknown components

Specific details on test material used for the study:

Identification:
4,4’-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with triethylenetetramine
Short Name:
BADGE-TETA
Trade Name:
Aradur® 3985 BD
Batch:
# 01725
CAS No.:
38294-69-8
Purity:
Not indicated by the Sponsor
Appearance:
Light yellow, liquid, highly viscous
Expiry Date:
01 September 2021
Storage Conditions:
At room temperature
Purpose of Use:
Industrial chemical

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on test system:

Epi-200 kits and MTT-100 assays were purchased from MatTek Corporation (Bratislava, Slovakia). The EpiDerm™ tissue consisted of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consisted of organised basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.63 cm²) are cultured on specially prepared cell culture inserts (MILLICELL, 10 mm ∅).
EpiDerm™ tissues were shipped on cool packs and on medium-supplemented agarose gels in a 24-well plate and reached Envigo CRS GmbH on 04 July 2017. On day of receipt the pre-incubation phase of the EpiDerm™ tissues started.

Control samples:

other: Positive and Negative Controls

Duration of treatment / exposure:

Duplicate EpiDermTM tissues were treated with the test item, positive control or negative control for the following exposure times:
• Test Item: 3 ± 0.5 minutes, 60 ± 5 minutes
• Negative Control: 3 ± 0.5 minutes, 60 ± 5 minutes
• Positive Control: 3 ± 0.5 minutes, 60 ± 5 minutes

Duration of post-treatment incubation (if applicable):

After the pre-incubation of the EpiDermTM tissues was completed the DMEM-based medium in each well was replaced with 0.9 mL fresh assay medium. The 6-well plates for the 3 ± 0.5 minutes exposure periods stayed at room temperature in the sterile bench, the 6-well plates for the 60 ± 5 minutes exposure period were placed into an incubator (37 ± 1.5 °C, 5 ± 0.5% CO2).

Number of replicates:

Duplicate EpiDermTM tissues were treated with the test item, positive control or negative control.

Test system

Details on study design:

Controls
Concurrent controls were used for several Envigo CRS GmbH studies performed simultaneously. Each 50 μL were applied to each set of duplicate tissues for the 3 min and 1 hour exposure periods.
Negative Control
Name: Deionised water (produced in-house)
Positive Control
Name: 8.0 N Potassium Hydroxide (Sigma)

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

90.3

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 Minute exposure

Value:

73.6

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is considered to be non-corrosive to skin:
• since the corrected viability after 3 minutes exposure is greater than 50% and
• the corrected viability after 1 hour exposure is greater than 15%.