Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20/07/2015-14/08/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
B46 BIS
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Designation in Test Facility: 15070801G
Date of Receipt: 08. Jul. 2015
Condition at Receipt Room temperature, in proper conditions

Batch no. 100026324
Appearance Colourless liquid
Composition 2-(3,3-DIMETHYLCYCLOHEX-1-ENYL)-2,5,5-TRIMETHYL-1,3-DIOXANE
Purity Sum of isomers: 98.5%
Homogeneity: Homogeneous
Solubility H2O: < 0.1 g/l; EtOH: > 1 g/l; acetone: > 1 g/l; CH3CN: unknown; DMSO: < 0.1 g/l
Production date Mar. 2015
Expiry date Mar. 2016
Storage Room temperature: 20 ± 5 °C, keep away from light

In vitro test system

Test system:
human skin model
Remarks:
Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from multiple donors
Source strain:
other: Keratinocyte 21685
Details on animal used as source of test system:
Lot numer : 21685
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Test material: 30 µL
Duration of treatment / exposure:
60 minutes
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 / test item
Value:
ca. 100.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
After the treatment, the relative absorbance values were increased to 100.9%. This value
is well above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion
of 0.8 ≤ mean OD ≤ 2.8, OD was 1.8. The positive control induced a decrease in the
relative absorbance as compared to the negative control to 3.3 % (required: £ 20%) for
thus ensuring the validity of the test system. Variation within replicates was within the accepted
range for negative control, positive control and test item.
For these reasons, the result of the test is considered valid.

Applicant's summary and conclusion

Executive summary:

The skin irritation/corrosion test was performed according to the OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method). The test item is considered as not skin irritant.