Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
23 October 2015

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
Name Cistus Organic Oil
Batch no. 1215/2
CAS No. 89997-74-0
EINECS-No. 289-711-7
Purity 100%wt (UVCB substance)
Appearance: orange-yellow mobile liquid
Production date 23. Dec. 2015
Expiry date 22. Dec. 2017
Storage: Room Temperature (20 ± 5°C)

In vitro test system

Test system:
human skin model
Remarks:
Episkin
Source species:
other: reconstructed epidermises
Cell source:
other: reconstructed epidermises
Details on animal used as source of test system:
Reconstructed epidermis: Episkin SA, RHE/S/17
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16µL of the test item was applied
Duration of treatment / exposure:
42 minutes of exposure at room temperature
Duration of post-treatment incubation (if applicable):
Incubation post exposure: 41 hours in fresh medium at 37°C, 5% CO2
Number of replicates:
5

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
1.6
Negative controls validity:
valid
Remarks:
% tissue viability: 100%
Positive controls validity:
valid
Remarks:
% tissue viability : 1.7%

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In accordance with the Regulation (EC) 1272/2008 the test item has to be classified in Category 2 "Irritant to Skin".
Executive summary:

In a GLP study according to OECD 439 guideline the irritant potential of Cistus oil for skin was evaluated. The mean percent tissue viability of the epidermises replicates treated with the test item was 1.6 % versus 1.7% in the positive control (SDS). In conclusion, under experimental conditions adopted and in accordance with the Regulation EC N° 1272/2008 the test item has to be identified and classified in Category 2 as skin irritant. The hazard statement "H315 Causes skin irritation" with the signal word "Warning" are required.