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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2012-05-14 to 2012-08-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl 3-cyclohexylpropionate
EC Number:
220-292-5
EC Name:
Allyl 3-cyclohexylpropionate
Cas Number:
2705-87-5
Molecular formula:
C12H20O2
IUPAC Name:
prop-2-en-1-yl 3-cyclohexylpropanoate

Test animals

Details on test animals or test system and environmental conditions:
not relevant

Test system

Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
15 min treatment + 42 h incubation
Number of animals:
not relevant
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with PBS
- Time after start of exposure: 15 min

SCORING SYSTEM:
In vitro result: In vivo prediction:
mean tissue viability ≤ 50 % → irritant (I), H315 (category 2)
mean tissue viability > 50 % → non-irritant (NI)

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean of 3 runs
Value:
93.9
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

 Results after treatment with the test item and controls


















































Dose group



Treat-ment interval



Absor-bance


540 nm Tissue 1*



Absor-bance


540 nm Tissue 2*



Absor-bance


540 nm Tissue 3*



Mean Absorbance of 3 Tissue



Relative absor-bance


[%] Tissue


1, 2+3**



Stan-dard


De-viation [%]



Rel. Absor-bance / Tissue Viability


[% of negative control]***



Negative Control



15 min



1.154



1.047



1.032



1.077



107.1


97.2


95.8



6.2



100.0



Positive Control



15 min



0.175



0.142



0.154



0.157



16.3


13.2


14.3



1.6



14.6



Test Item



15 min



1.157



0.941



0.938



1.012



107.3


87.3


87.1



11.6



93.9



*Mean of two replicate after blank correction


**Relative absorbance per tissue [rounded values]: 100xabsorbance (tissue)/mean absorbance (negative control)


***Relative absorbance per treatment group [rounded values]: 100xmean absorbance (test item)/mean anbsorbance (negative control)


 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It can be stated that in this study and under the experimental conditions reported, the test item is non irritant to skin according to UN GHS and EU CLP regulation.
Executive summary:

This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test according to OECD TG 439. Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. 10 μL of the liquid test item were applied to each tissue, spread to match the tissue size. 10 μL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 till ≤ 1.5 for the 15 minutes treatment interval thus showing the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 15 minutes treatment interval thus ensuring the validity of the test system. Compared to the value of the negative control, after exposure of the test item the test item the mean relative absorbance value decreased to 93.9%. This value is well above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item the test item is non irritant to skin according to UN GHS and EU CLP regulation.