Bis[2-(diethylamino)ethyl] adipate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis[2-(diethylamino)ethyl] adipate

EC Number:

240-610-6

EC Name:

Bis[2-(diethylamino)ethyl] adipate

Cas Number:

16545-00-9

Molecular formula:

C18H36N2O4

IUPAC Name:

1,6-bis[2-(diethylamino)ethyl] hexanedioate

impurity 1

Reference substance name:

2-diethylaminoethanol

EC Number:

202-845-2

EC Name:

2-diethylaminoethanol

Cas Number:

100-37-8

Molecular formula:

C6H15NO

IUPAC Name:

2-(diethylamino)ethanol

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: epidermal keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized 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 EpiDermTM tissues are cultured on specially prepared cell cultures inserts.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 µL

Duration of treatment / exposure:

3 minutes and 1 hour

Duration of post-treatment incubation (if applicable):

3 hours

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3min

Value:

ca. 79.9

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

ca. 8.7

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Negative Control		Test Item		Positive Control		Incubation
Tissue 1	Tissue 2	Tissue 1	Tissue 2	Tissue 1	Tissue 2
1.906	1.857	1.479	1.509	0.394	0.392	3 min
1.875	1.815	1.465	1.509	0.386	0.389
1.869	1.807	1.464	1.467	0.389	0.386
1.987	1.956	0.806	0.806	0.176	0.165	1 h
1.975	1.929	0.793	0.797	0.178	0.163
1.984	1.928	0.800	0.788	0.176	0.162
Mean		Mean		Mean
1.855		1.482		0.389		3 min
2.2%		1.2%		0.1%		SD
1.960		0.798		0.170		1 h
1.6%		0.2%		5.5%		SD

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test item is considered non-corrosive to skin. After 3 minutes treatment, the relative absorbance values were decreased to 79.9%. This value is well above the threshold for corrosivity (50%). After 1 hour treatment relative ab-sorbance values were reduced to 40.7%. This value is well above the threshold for corrosivity (15%). In the guideline values greater or equal to the threshold are considered as “non-corrosive to skin”. The values of the negative control met the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals, thus showing the quality of the tissues. The positive control has met the validity criterion too, thus ensuring the validity of the test system. For these reasons, the result of the test is considered valid.

Executive summary:

One valid experiment was performed. Two tissues of the human skin model EpiDerm^TMwere treated with Bis[2-(diethylamino)ethyl]adipate for 3 minutes and 1 hour, respectively. The test item was applied to each tissue and spread to match the tissue size. Demineralised water was used as negative control. 8 M KOH was used as positive control. After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was evaluated by measuring the optical density (OD) of the resulting solution.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals thus showing the quality of the tissues. The OD was 1.9 (3 minutes experiment) and 2.0 (1 hour experiment). The positive control showed clear corrosive effects for both treatment intervals. The relative absorbance value was reduced to 8.7 % for the 1 hour treatment. After 3 minutes treatment with the test item, the relative absorbance value was reduced to 79.9 %. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, relative absorbance value was reduced to 40.7 %. This value, , is also above the threshold for corrosion potential (15%). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”. Therefore, Bis[2-(diethylamino)ethyl]adipate is considered as non-corrosive to skin in the Reconstructed human Epidermis (RhE) Test Method.