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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
26 August 2015 - 28 August 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

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

Constituent 1
Chemical structure
Reference substance name:
Amides, from diethylenetriamine and hydrogenated palm oil
EC Number:
810-543-2
Cas Number:
1618093-67-6
Molecular formula:
n/a
IUPAC Name:
Amides, from diethylenetriamine and hydrogenated palm oil
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:
water
Details on test system:
After pre-incubation of the EpiDerm tissues, the medium was aspirated and replaced with 0.9 mL of fresh assay medium. The 6-well plate for the 3-Minute exposure period was returned to the incubator, while the other was being dosed for the 60-Minute exposure. For the 60-Minute exposure period, 50 µL of sterile distilled water (negative control) was added to the first two tissues. The tissues were dosed at regular intervals to allow for the time taken to rinse each
tissue following exposure and to ensure that each tissue gets an equal exposure time. 25 mg of the test item and 50 µL of 8.0 N Potassium Hydroxide (positive control) were also applied to the corresponding tissues in turn. 25 µL of sterile water was added for wetting of the test item. The plate was returned to the incubator (37 °C, 5% CO2) for the 60-Minute exposure period. When dosing for the 60-Minute exposure period was complete, the same procedure was repeated
for the 3-Minute exposure period.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Duration of treatment / exposure:
3-Minute and 60-Minute exposure period
Duration of post-treatment incubation (if applicable):
Not applicable, the tissues were dosed at regular intervals to ensure that each tissue received an equal exposure time and to allow
for the time taken to rinse each tissue with DPBS following exposure.
Number of replicates:
Triplicate tissues were treated with the test item, positve and negative control.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Relative Mean Viability (%) - 3 minutes exposure period
Value:
97.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Relative Mean Viability (%) - 60 minutes exposure period
Value:
83.7
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 mean OD562 for the negative control treated tissues was 2.145 for the 3 Minute exposure period and 2.127 for the 60 Minute exposure period. The negative control acceptance criteria were therefore satisfied.

The relative mean tissue viability for the positive control treated tissues was 3.2% relative to the negative control following the 60 Minute exposure period. The positive control acceptance criterion was therefore satisfied.

In the range 20-100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The 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 was considered to be non-corrosive to the skin.
Executive summary:

In a Klimisch 1 GLP study from Warren (2015) the corrosivity potential using the EpiDerm Human Skin Model after treatment periods of 3 and 60 minutes were investigated. The test item showed no skin corrosivity potential.

The relative mean  viability of the test item treated tissues was 97.5%  after a 3-Minute exposure period and 83.7% after a 60-Minute exposure period. The test item was considered to be non-corrosive to the skin.

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