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

Endpoint summary

Description of key information

BADGE-TETA should be considered corrosive to the skin and eyes.

Studies were carried out on BADGE-DETA, BADGE-TETA and BADGE-EDA. The most conservative end point will be used for classification due to the similarity and read across information.

An In vitro skin corrosion test using Reconstructed human Epidermis was carried out according to OECD guideline 431 and EU method B. 40. It can be stated that in this study and under the reported experimental conditions, BADGE-DETA is corrosive to skin according to EU CLP and UN GHS and therefore BADGE-TETA should also be considered corrosive to the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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)

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

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.

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)

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

90.3

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 Minute exposure

Value:

73.6

Negative controls validity:

valid

Positive controls validity:

valid

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%.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Justification for classification or non-classification

According to the read across approach used, BADGE-EDA, BADGE-DETA and BADGE-TETA should be considered corrosive to the skin (Category. 1) according to EU CLP and UN GHS.

Under the experimental conditions reported, BADGE-EDA, BADGE-DETA and BADGE-TETA should be considered seriously eye damaging (CLP/EPA/GHS (Cat 1)