2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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:

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

EC Number:

278-031-6

EC Name:

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Cas Number:

74931-55-8

Molecular formula:

C10H23NO3

IUPAC Name:

2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)

Test material form:

liquid

Details on test material:

- Density: 0.999 g/cm3

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: Single topical application of 50µl of neat test item

NEGATIVE CONTROL
- Amount applied: 50µl
- Lot/batch no.: RNBG4913

POSITIVE CONTROL
- Amount applied: 50µl
- Lot/batch no.: SLBD3295V

Duration of treatment / exposure:

3 and 60 minutes

Number of replicates:

Triplicate

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3-minute

Value:

97.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60-minute

Value:

8.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

In the reported study, mean tissue viability (as a percentage of the negative control) was 8.6 % after a 60-minute exposure and 97.6 % after a 3-minute exposure. 2-Ethylhexanoic acid, compound with 2-aminoethanol (1:1) subsequently required classification as corrosive to skin (Skin Corr. 1B/1C) according to CLP Regulation (EC) No. 1272/2008.

Executive summary:

An in vitro skin corrosion study was performed for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) in line with OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method). The test was compliant with GLP. 2-Ethylhexanoic acid, compound with 2-aminoethanol (1:1) was applied neat at 50µl to reconstructed human epidermal model Epiderm™. A negative (sterile water) and positive control (potassium hydroxide) was prepared and run in parallel. Exposure was permitted for a 3- and 60-minute period at 37 °C, 5 % CO2, 95 % RH. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are then used to make a prediction of the corrosivity potential of the test item.

All controls were valid and demonstrated the reliability of the test system. Mean tissue viability, calculated as a percentage of the negative control, was 8.6 % after a 60-minute exposure and 97.6 % after a 3-minute exposure. A classification for skin corrosion (Skin Corr. 1B/1C) is subsequently required for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) according to CLP Regulation (EC) No. 1272/2008.