Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 minute exposure

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study 2018 to GLP.
All quality crieteria met

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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

EC Number:

264-867-9

EC Name:

Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Cas Number:

64396-12-9

Molecular formula:

C16H28O4.C6H15NO3

IUPAC Name:

Succinic acid, dodecenyl-, triethanolamine salt (1:1)

Test material form:

liquid

Details on test material:

Commercial grade containing approximately 45% actives

Specific details on test material used for the study:

PAH 330/132/1A
The sample had been partly concentrated up to ca 50% (repored 49.38) to prepare as concentrated form of the material as possible for testing.
Attempts to concentrate further appeared to impact on stability.

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 vehicle

Amount/concentration applied:

The test item was applied topically to the corresponding tissues ensuring uniform covering.
10 µL (26.3 µL/cm2) of the test item was applied to the epidermis surface

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Average

Value:

ca. 66.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

No other effects reported
The solution containing the test item was a yellow color. This color was attributed to the intrinsic color of the test item itself. It was therefore unnecessary to run color correction tissues

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considered non-classified

Executive summary:

The relative mean viability of the test item treated tissues was66.6% after the 15‑Minute exposure period and 42‑Hours post‑exposure incubation period.