Triglycerides, C16-18 (even numbered), reaction products with diethylenetriamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 September 2015 - 05 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Triglycerides, C16-18 (even numbered), reaction products with diethylenetriamine

Molecular formula:

not applicable (UVCB)

IUPAC Name:

Triglycerides, C16-18 (even numbered), reaction products with diethylenetriamine

Test material form:

solid: compact

Details on test material:

- Name of test material (as cited in study report): Amidoamine (UVCB)
- Substance type: Amidoamine
- Chemical name: Glycerides, C14-20, reaction products with diethylenetriamine (preliminary naming)/Amides, from diethylenetriamine and hydrogenated palm oil
- CAS 85409-11-6/1618093-67-6
- Physical state: pale yellowish solid at 20 °C
- Batch No.: K8 4309 L481
- Expiry date of batch: 09 March 2017
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions

Specific details on test material used for the study:

Test item without emulsifier was investigated.

Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
Physical state: pale yellowish solid at 20 °C
Batch No.: K8 4309 L481
Expiry date of batch: 09 March 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

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:

Approximately 10 mg (26.3 mg/cm2) of the test item was then applied to the epidermal surface.

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

The DBPS rinsed tissues were incubated at 37 °C, 5% CO2 in air for 42 hours.

Number of replicates:

Triplicate tissues were treated with the test item, positve and negative control.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

15-Minute exposure period - followed by 42-Hour post-exposure incubation period

Value:

105.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The relative mean tissue viability for the positive control treated tissues was 14.8% relative the negative control treated tissues and the standard deviation value of the viability was 5.4%. The positive control acceptance criteria were therefore satisfied.

The mean OD562 for the negative control treated tissues was 0.739 and the standard deviation value of the viability was 10.2%. The negative control acceptance criteria were thereforesatisfied.

The standard deviation calculated from individual tissue viabilities of the three identically item treated tissues was 10.5%. The test item acceptance criterion was therefore satisfied.

Assessment of Color Interference with the MTT endpoint:
The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.

Direct MTT Reduction:
The MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item showed no skin irritation potential using the EPISKIN Reconstructed Human Epidermis Model. The test item is therefore classified as “non-irritant” in accordance with UN GHS and EU CLP 'No Category'.

Executive summary:

In a Klimisch 1 GLP study from Warren (2015) the skin irritation potential using the EPISKIN Reconstructed Human Epidermis Model was investigated. The test item showed no skin irritation potential.

The relative mean  viability of the test item treated tissues was 105.2%  after a 15-Minute exposure period and 42-Hour post-exposure incubation period. It was considered  unnecessary to perform IL-alpha analysis as the results of the MTT test were unequivocal.