Essential oil of Cistus ladaniferus L (Cistaceae) obtained from stems and leaves by distillation

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

23 October 2015

Test material

Test material information

Constituent 1

Reference substance name:

Pin-2(3)-ene

EC Number:

201-291-9

EC Name:

Pin-2(3)-ene

Cas Number:

80-56-8

Molecular formula:

C10H16

IUPAC Name:

2,6,6-trimethylbicyclo[3.1.1]hept-2-ene

Constituent 2

Reference substance name:

2,2,6-trimethylcyclohexan-1-one

EC Number:

219-309-9

EC Name:

2,2,6-trimethylcyclohexan-1-one

Cas Number:

2408-37-9

Molecular formula:

C9H16O

IUPAC Name:

2,2,6-trimethylcyclohexanone

Constituent 3

Reference substance name:

(1α,3α,5α)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol

EC Number:

216-813-0

EC Name:

(1α,3α,5α)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol

Cas Number:

1674-08-4

Molecular formula:

C10H16O

IUPAC Name:

6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol

Constituent 4

Reference substance name:

Endo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate

EC Number:

200-964-4

EC Name:

Endo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate

Cas Number:

76-49-3

Molecular formula:

C12H20O2

IUPAC Name:

1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate

Constituent 5

Reference substance name:

[1aR-(1aα,7α,7aβ,7bα)]-1a,2,3,5,6,7,7a,7b-octahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulene

EC Number:

244-565-3

EC Name:

[1aR-(1aα,7α,7aβ,7bα)]-1a,2,3,5,6,7,7a,7b-octahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulene

Cas Number:

21747-46-6

Molecular formula:

C15H24

IUPAC Name:

(1aR,7R,7aS,7bR)-1,1,4,7-tetramethyl-1a,2,3,5,6,7,7a,7b-octahydro-1H-cyclopropa[e]azulene

Constituent 6

Reference substance name:

1aR,4R,4aS,7R,7aS,7bS)-1,1,4,7-tetramethyl-2,3,4a,5,6,7,7a,7b-octahydro-1aH-cyclopropa[e]azulen-4-ol

Cas Number:

577-27-5

Molecular formula:

C15H26O

IUPAC Name:

1aR,4R,4aS,7R,7aS,7bS)-1,1,4,7-tetramethyl-2,3,4a,5,6,7,7a,7b-octahydro-1aH-cyclopropa[e]azulen-4-ol

Constituent 7

Reference substance name:

[1aR-(1aα,4β,4aβ,7α,7aβ,7bα)]-decahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulen-4-ol

EC Number:

209-003-3

EC Name:

[1aR-(1aα,4β,4aβ,7α,7aβ,7bα)]-decahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulen-4-ol

Cas Number:

552-02-3

Molecular formula:

C15H26O

IUPAC Name:

(1aR,4S,4aS,7R,7aS,7bS)-1,1,4,7-tetramethyl-2,3,4a,5,6,7,7a,7b-octahydro-1aH-cyclopropa[e]azulen-4-ol

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.