Registration Dossier

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:
other: GLP study according to OECD TG 439

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Details on test animals 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:
other:
Value:
105.3
Remarks on result:
other:
Remarks:
Basis: other: Test item on EpiSkin. Max. score: 100.0. Reversibility: no data. Remarks: % of negative control. (migrated information)

Any other information on results incl. tables

Results after treatment with menthyl acetate racemic 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

[% 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

1.175

1.050

1.178

1.134

109.0

97.5

109.4

6.8

105.3

*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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean relative absorbance value of the test item, corresponding to the cell viability, did not decrease (105.3%; threshold for irritancy: ≤ 50%), consequently the test item was non irritant to skin.
Executive summary:

This in vitro study was performed to assess the irritation potential of Menthyl Acetate racemic 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 Menthyl Acetate racemic the mean relative absorbance value did not decrease (105.3%; 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 Menthyl Acetate racemic is non irritant to skin according to UN GHS and EU CLP regulation.