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Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-08-19 to 2015-09-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
September 26, 2014 reconstructed human epidermis (RHE) test method
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of 2-[[2-(dimethylamino)ethyl]methylamino]ethanol di(hexanoate) and ethyl oxirane (1:2)
EC Number:
806-726-1
Cas Number:
1407168-93-7
Molecular formula:
C27 H58 N2 O7
IUPAC Name:
Reaction product of 2-[[2-(dimethylamino)ethyl]methylamino]ethanol di(hexanoate) and ethyl oxirane (1:2)
Test material form:
other: Brown, viscous liquid
Details on test material:
Reaction products of 2-[[2-(dimethylamino)ethyl]methylamino]ethanol di(hexanoate) and ethyl oxirane made by Evonik Degussa GmbH, Batch P 2323 of 2015-02-20

Test animals

Species:
other: in vitro
Details on test animals or test system and environmental conditions:
The following Reconstructed Human Epidermis Model was used:
EpiDermTM (EPI-200-SCT, Lot no. 21691) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.

Test system

Vehicle:
water
Remarks:
sterile deionised water
Amount / concentration applied:
- Test item: 25 mg of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface which was
moistened with sterile deionised water to ensure adequate contact with the skin.
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl
- At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline
Duration of treatment / exposure:
3 minutes and 1 hour
Details on study design:
Cell viability measurements
- MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1) reduction, which had been shown to give accurate and reproducible results, was used to measure cell viability
- Each skin sample was placed in an MTT assay solution of 1 mg/mL (37°C incubation temperature, 5% CO2, 95% humidity) for 3 hours
- The precipitated blue formazan product was extracted using the solvent propanol-27, and the concentration of the formazan was measured by
determining the optical density (OD) at a wavelength of 570 nm in a spectrophotometer
- Cell viability measurements were carried out at the end of the exposure period (1st period: 3 min; 2nd period: 60 min). The measurements were
made for each of the two tissues in triplicate.
- Previous checks for interference of the test item with the MTT assay or the tissues were performed. No discoloration or test item
interference with the vital dye was noted

ADMINISTRATION
- EpiDerm tissues were conditioned by pre-incubation (1 hour) for release of transport stress related compounds and debris in the incubator
(37°C, 5% CO2, 95% humidity)
- After pre-incubation tissues were transferred to fresh Maintenance Medium and topically exposed with test item and controls
- 25 mg of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface
- At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl
- Two tissues were used per treatment, negative and positive control and exposition time (12 Tissues in total)
- At the end of the exposure period, tissues were rinsed (with Dulbecco's phosphate buffered saline (D-PBS)), blotted and assay medium is
replaced by MTT assay medium (final concentration: 1 mg MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide,
Thiazolyl blue)/mL medium).
- After 3-h incubation, tissues were washed with Dulbecco's phosphate buffered saline (D-PBS), blotted and the blue formazan salt was extracted
with Isopropanol
- Optical density of the formazan extract was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as
% of the mean of the negative control tissues
- Skin corrosivity potential of the test materials was classified according to the remaining cell viability obtained after 3 minutes or 1 hour exposure
with the test chemical


Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
compared to the control % viability (3 min)
Value:
> 50
Vehicle controls validity:
not valid
Negative controls validity:
valid
Remarks:
aqua deion.
Positive controls validity:
valid
Remarks:
KOH 8N
Remarks on result:
other:
Remarks:
Remarks: Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.. (migrated information)
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
compared to the control % viability (1h)
Value:
< 15
Vehicle controls validity:
not valid
Negative controls validity:
valid
Remarks:
aqua deion.
Positive controls validity:
valid
Remarks:
KOH 8N
Remarks on result:
other:
Remarks:
Remarks: Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.. (migrated information)

Any other information on results incl. tables

Assay acceptability criteria

Assay acceptance criterion 1: Negative control

The absolute OD of the negative control (NC) tissues (treated withsterile deionised water) in the MTT test is an indicator of tissue viability obtained in the testing laboratory after shipping and storing procedures and under specific conditions of use.

The assay meets the acceptance criterion if the mean OD540of the NC tissues is ≥ 0.8 and ≤ 2.8.

Assay acceptance criterion 2: Positive control

A8N KOHwas used as positive control (PC) and tested concurrently with the test chemicals. Concurrent means here the PC has to be tested in each assay.

Tissues treated with the PC, should reflect the ability of the tissues to respond to a corrosive chemical under the conditions of the test method (viability after 1hour exposure: < 15%).

Assay acceptance criterion 3:variability between tissue replicates

Associated and appropriate measures of variability between tissue replicatesshould not exceed 30% (in the range of 20 – 100% viability).

Interpretation of results

The mean OD values obtained for the test item and the positive control were used to calculate percentage viability relative to the negative control, which is arbitrarily set at 100%. The cut-off percentage cell viability value distinguishing corrosive from non-corrosive test items was used to evaluate the results and identify corrosive materials and shown to be appropriate. The prediction of corrosivity associated with theEpiDermTMmodel is:

The test item is considered to be corrosive to skin:

If the viability after 3 minutes exposure was < 50%, or
if the viability after 3 minutes exposure was ≥ 50% and the viability after 1hour exposure was < 15%.

The test item is considered to be non-corrosive to skin:

If the viability after 3 minutes exposure was ≥ 50% and the viability after 1hour exposure was ≥ 15%.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was corrosive to skin in an experiment
employing an artificial three-dimensional model of human skin.
Executive summary:

The purpose of this study was to assess the corrosive properties of the test item to human skin, in an experiment with an artificial three-dimensional model of human skin. TheEpiDermTMmodel was employed.

Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.

Test item was applied topically as liquid test item supplied. Sterile deionised water was used as the negative control. 8N KOH was used as the positive reference item.The test item and the reference items were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.

In comparison to the negative controls, the mean viability of cells exposed to the test item was 113.5% after a 3-minute exposure period and 7.0% after a 1‑hour exposure.

The 3-minute exposure value was above the cut-off percentage cellviability value of 50%, the 1-hour exposure value was less than the cut of percentage cell viability value of 15%. Therefore, the test item was corrosive in this skin model and is predicted to be corrosive to human skin.

The mean optical density (OD) of the negative control of 2 tissues was 1.573 (3‑minute exposure) or 1.507 (1-hour exposure) and was well within the acceptable range of ≥ 0.8 to ≤ 2.8. The viability of cells treated with the positive reference item 8N KOH were 7.1% (3-minute exposure) and 5.4% (1-hour exposure) of the negative control and, hence well below the 15% cut-off value at the 1-h exposure. The standard deviation of all replicates determined (at 20 - 100% viability) was below the limit of acceptance of 30%. Hence, all acceptance criteria were fulfilled.

Conclusion

Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was corrosive to skin in an experiment employing an artificial three-dimensional model of human skin