Registration Dossier

Administrative data

Description of key information

Eye irritant (OECD 492, GLP, K, Rel. 1)

Skin irritant (OECD 439, GLP, K, Rel. 1)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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 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
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%
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
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
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
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.
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%
Irritant / corrosive response data:
Cistus oil is potentially irritating or corrosive to the eye.

None

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

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.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available information and typical composition provided by the Lead Registrant, the registered substance is classified as skin irritant: Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).

Based on the available data on the registered substance, the registered substance is classified as eye irritant: eye irritant Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).

None of the constituents of the registered susbtance are known to have corrosive properties to the skin or to cause irreversible damages to the eyes therefore the registered substance is considered to be irritating to skin and eyes only.

No information was available regarding respiratory irritation.