Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2016
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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Deviations:
yes
Remarks:
minor deviations considered to have no impact on the conclusion of the study for more information see Details on study design
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)

Test animals / tissue source

Species:
human
Strain:
other: reconstructed human Cornea-like Epithelium
Details on test animals or tissues and environmental conditions:
EpiOcular TM tissue Model OCL-212 supplied by MatTek

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The test item was applied as supplied at the dose of 50 µl
Duration of treatment / exposure:
29 minutes
Duration of post- treatment incubation (in vitro):
A 12 -minute post exposure immersion period at room temperature and 2 hours and 5 minutes post exposure incubation at standard culture conditions.
Number of animals or in vitro replicates:
4 replicates.
Details on study design:
Deviations from the study plan:
- Incubator temperature: The temperature in the incubator reached 38.4°C which is +0.4°C higher than the 37+/-1°C as initially scheduled ==> Considering the results obtained, this deviation is considered to have no impact on the conclusion of the study
- Test system: RhCE tissue used was OCL-212 instead of OCL-200 ==> This reference corresponds to a 12-tissue kit whereas OCL-200 refers to individual tissues or 24-tissue kit. ==> This deviation is considered to have no impact on the conclusion of the study
- Treatment of the results: the true viability % of the tissues treated with the test item was calculated by subtracting the mean viability percents of the test item and the NSC living control instead of their ODs as scheduled in the study plan ==> This deviation is considered to have no impact on the conclusion of the study.
- In the first run, the mean tissue viability of the tissues treated with the positive control substance was slightly > 50% (50.58%), instead of <50% as initially scheduled in the study plan. ==> Considering the results obtained, this deviation is considered as without impact on the conclusion of the study.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: mean percent tissue viability
Run / experiment:
first run
Value:
63.14
Negative controls validity:
valid
Positive controls validity:
not valid
Remarks:
percent tissue viability = 50.58%
Irritation parameter:
other: mean percent tissue viability
Run / experiment:
Second run
Value:
48.72
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
mean percent tissue viability : 40.30%

In vivo

Irritant / corrosive response data:
Cistus oil is potentially irritating or corrosive to the eye.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: other experiment to class in category 1 or 2 need to be performed
Conclusions:
Cistus oil is potentially irritating or corrosive to the eye. It has to be identified as potentially requiring classification and labelling according to UN GHS category 2 or category 1.
Executive summary:

In a GLP study according to OECD 492 guideline the irritant and corrosive potential of Cistus oil was evaluated. The method is based on viability of Reconstructed Human Cornea-like Epithelium-(RhCE) when exposed to the test substance. In a first run, the mean tissue viability of the tissues treated with the positive control substance was slightly > 50% (50.58%), instead of < 50%. The positive control was not validated therefore a second run was performed. The mean percent tissue viability of the RhCE replicates treated with the test item was 48.72% versus 40.30% in the positive control (Methyl acetate). In conclusion, under experimental conditions adopted and in accordance with the Regulation EC N° 1272/2008 the test item has to be identified as potentially requiring classification and labelling according to UN GHS category 2 or category 1.