Registration Dossier

Administrative data

Description of key information

A study was performed in accordance with GLP and OECD Guideline 429 to assess the skin sensitisation potential of Patchouli Essential Oil in the CBA/J strain mouse following topical applications of the test material to the dorsal surface of the ear (Robertet Grasse, 2008). The test material was considered not to be a sensitiser under the conditions of the test.

Additional information is available from two human repeat insult patch tests (Hill Top Research, Inc, 1971 and Harrison Research Laboratories, Inc, 1983) which demonstrate that the test material is not a skin sensitiser.

Therefore, the substance does not need any classification regarding the provided studies and data.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 March to 7 April 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Method of calculation different than proposed in OECD 429.
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
Different cell count method
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP certificates - Afssaps - signed the 5 July of 2007
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Patchouli essential oil
- Physical state: brown liquid
- Analytical purity: not applicable; considered as 100 % for the study
- Origin: Plantae (from Indonesia)
- Binomial family: Labiatae
- Binomial name: Pogostemon cablin
Species:
mouse
Strain:
CBA:J
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier, Le genest Saint Isle
- Age at study initiation: 8 weeks
- Weight at study initiation: 22-25 g
- Housing: Animals were housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet: Food, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 41-55 %
- Air changes: Approximately 15 changes/h
- Photoperiod: 12 h dark / 12 h light

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Preliminary screening test: 100 % w/w in acetone/olive oil 4:1
Main test: 10, 25, 50 % w/w in acetone/olive oil 4:1
No. of animals per dose:
Preliminary screening test: One animal/dose
Main test: 4 animals/dose
Details on study design:
RANGE FINDING TESTS:
- Using available information regarding the irritancy potential of the test item, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 μL of the test item at concentrations of 100% w/w in acetone/olive oil 4:1, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3).

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a 1.4 fold or greater increase in 3H Thymidine incorporation compared to control values. Any test item failing to produce a 1.4 fold or greater increase in 3HTdR incorporation will be classified as a "non sensitizer."

TREATMENT PREPARATION AND ADMINISTRATION:
25 µL of control or test material was applied topically on the dorsal surface of both ears using a micropipette daily for three consecutive days (Days 1-3).
Five hours later animals were killed with sodium pentobarbital and administration continued to fatal levels. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group.
A single cell suspension of the lymph cells of 4 mice of each group was prepared by gentle mechanical tissue disaggregation through a 200-mesh cell strainer in 4 mL of PBS containing 0.5% BSA into a well of a multi-well 6.
10 µL of this cell suspension was diluted in 10 mL of physiological saline solution. The lymphocytescell were counting using a cell counter (Beckman Coulter Z2).
For the run, the lower size selected was 5 µm and the upper size was 15 µm (average 8 µm).
The proliferation response of lymph node cells was expressed as the number of lymphocytes per lymph node and as the ratio of lymphocytes into lymph node cells of test nodes relatives to that recorded for the control nodes (Stimulation Index)(Stimulation Index).

The mouse was observed once daily on Days 1, 2, 3, 4, 5 and 6. Local skin irritation was scored daily. Any clinical signs of toxicity, if present, were also recorded. The body weight was recorded on Day 1 (prior to dosing) and on Day 6.
- The thickness of each ear was measured using a micrometer, pre-dose on Day 1 and on Day 6
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
The Stimulation Index (SI) was calculated from the formula SI = cell count of treated group / cell count of control group.
Positive control results:
A group of 4 mice received the vehicle alone and a further group of four mice received a positive control (alpha-Hexylcinnamaldehyde) diluted at 25% in the vehicle, in the same manner.
Parameter:
SI
Value:
1.01
Test group / Remarks:
Treated group 10%
Parameter:
SI
Value:
1.45
Test group / Remarks:
Test group 25%
Parameter:
SI
Value:
2.24
Test group / Remarks:
Test group 50%
Parameter:
SI
Value:
2.53
Test group / Remarks:
Test group 100%
Parameter:
other: Ec1.4
Value:
23.3

Clinical Observations and Mortality Data

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

 

Bodyweight

Body weight change of the test animals between Day 1 and Day 6 were comparable to that observed in the corresponding control group animals over the same period.

A moderate (+15.2%) to important (+41.6%) increase in ear thickness was recorded respectively at the concentration of 50% and 100%. An important increase in ear weight (+60.3%) was recorded at the concentration of 100%.

Positive control:

A Stimulation Index (SI) of 2.22 was recorded for the positive control diluted at 25 % in the vehicle.

The SI result was more than 1.4 as expected.

Interpretation of results:
GHS criteria not met
Remarks:
Specific count
Conclusions:
In view of the results, under these experimental conditions, the test item Patchouli EO was not considered to be a sensitiser under the conditions of the test.
Executive summary:

A study was performed to assess the skin sensitisation potential of test material in the CBA/Ca (CBA/J) strain mouse following topical application to the dorsal surface of the ear. The method was conducted according to the OECD test guideline No 429 and in compliance with GLP.

 

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 10%, 5% or 25% w/w. A further group of four animals was treated with acetone/olive oil 4:1 alone. 

The Stimulation Index (SI) was calculated from the formula SI = cell count of treated group / cell count of control group. 

 

The historical positive control, α-Hexylcinnamaldehyde, gave a SI of 2.22, when tested at 25 % v/v. The test system was therefore considered to be more sensitive than planed (2.22 instead of 1.4).

 

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Body weight change of the test animals between Day 1 and Day 6 were comparable to that observed in the corresponding control group animals over the same period.

 

Under the test conditions, test material should not be classified as a skin sensitiser according to the annex VI of the Regulation EC No. 1272/2008 (CLP) .

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Human Repeat Insult Patch Test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August 30 to November 5, 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Adaptation of the method of Draize: Test materials were applied nine times under a patch to the upper arms of the panelists during 24 hours every 2/3 days (induction phase). Eight different samples were tested simultaneously on each panelist. Each patch is applied to the same area each time unless the severity of a reaction made this inadvisable. A two week rest period followed the induction phase.
For the final challenge application, duplicate patches were applied and readings were made.
GLP compliance:
no
Type of study:
other: Study with volunteers
Justification for non-LLNA method:
Available study on volunteers
Specific details on test material used for the study:
Date of receipt: July 24, 1971
Species:
other: Human
Strain:
other: non relevant
Sex:
male/female
Details on test animals and environmental conditions:
Panelists were recruited from: St. Aloysius Church, Bridgetown, Ohio; Sycamore United Presbyterian Church, Loveland, Ohio; Hill Top Research, Inc., Miamiville, Ohio.
- Number of subjects recruited: 22
- Number of subjects exposed: 22
- Sex: 3 men and 19 women
- Age: 21-30 yr: 1M/5F ; 31-40 yr: 0M/8F ; 41-50 yr: 0M/4F ; 51-60 yr: 2M/1F ; >60 yr: 0M/1F.
Positive control results:
No positive control
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted - group 90, BP-10-11
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
Twenty-two panelists showed little or no primary irritation. Two panel ists, Nos. 1 and 5, showed evidence of possible sensitization.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted - group 90, BP-10-11L
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
Twenty-one panelists showed little or no reaction. Panelists, No.5, showed moderate primary irritation. No evidence of sensitization was exhibited by the panelists.
Remarks on result:
no indication of skin sensitisation
Reading:
other: Non performed
Group:
negative control
Remarks on result:
not measured/tested
Reading:
other: non performed
Group:
positive control
Remarks on result:
not measured/tested

Table 7.10.4/2: Individual scores following Patch Application of Group 90, BP-10-11

PANELIST

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

1

0

0

-

*0

0

0

3Min

M

 

0

 

0

 

0

0

0

0

0

2

0

0

1C

1C

0

0

0

0

0

 

0

0

0

0

3

0

0

0

0

1

1

0

0

0

 

0

0

0

0

4

0

0

0

-

*0

1

1

1

0

 

0

0

0

0

5

0

0

1

1C

4

M

 

0

 

0

 

0

 

0

 

0

0

0

0

6

0

0

0

1C

0

-

*0

0

0

0

0

0

0

0

7

0

0

0

-

*0

0

0

0

0

0

0

0

0

0

8

0

1

M

 

0

 

0

 

1

 

2C

 

0

 

0

 

0

 

0

0

0

0

9

0

0

0

0

0

0

0

0

0

 

0

0

0

0

10

0

0

0

0

0

0

0

0

0

 

0

0

0

0

11

0

0

0

0

0

0

0

0

0

 

0

0

0

0

12

1B

0

0

0A

1C

1

2C

1C

2C

 

0

0

0

0

13

0

0

0

0

0

0

0

0C

0

 

0

0

0

0

14

0

0

0

0

0

0

0

0

0

 

0

0

0

0

15

0

0

0

0

0

1C

1C

2F

M

 

1

 

0

0

0

0

16

0

0

0

0

0

0

0

0

-

 

0

0

0

0

17

0

0

0

0

0

0

0

0

0

 

0

0

0

0

18

0

0

0

0

0

0

0

0

0

 

0

0

0

0

19

0

0

0

0

0

0

0

0

0

 

0

0

0

0

20

0

0

0

0

0A

0A

0

0

0

 

0

0

0

0

21

0

0

0

0

0

0

0

0

0

 

0

0

0

0

22

0

0

0

0

0

0

0

0

0

 

0

0

0

0

M: applied to an adjacent site after strong test reaction

-: panelist absent

*: residual reaction to earlier application, after an absence, not included in score totals

Table 7.10.4/3: Score Totals for All Panelists Following Application of Group 90, BP-10-11

TOTALS

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

0

21

21

19

16

16

16

17

19

19

3

22

22

22

22

1

1

1

2

3

3

4

2

2

1

0

0

0

0

0

2

0

0

0

0

0

1

1

1

1

0

0

0

0

0

3

0

0

0

0

0

0

1

1

0

0

0

0

0

0

4

0

0

0

0

1

0

0

0

0

0

0

0

0

0

A

0

0

0

1

1

1

0

0

0

0

0

0

0

0

C

0

0

1

3

1

2

2

2

1

0

0

0

0

0

F

0

0

0

0

0

0

0

1

0

0

0

0

0

0

NP

0

0

1

3

2

1

1

0

1

0

0

0

0

0

NP: number of panelists not included in score total: (-, *)

Table 7.10.4/4: Individual scores following Patch Application of Group 90, BP-10-11L

PANELIST

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

1

0

0

-

*0

0

0

0

 0

 0

 0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

 

0

0

0

0

3

0

0

0

0

0

0

0

0

0

 

0

0

0

0

4

0

0

0

-

*0

0

0

0

0

 

0

0

0

0

5

0

0

3

M

(2)

0

(2)

1

 

0

 

0

 

0

 

0

 

0

0

0

0

6

0

0

0

1C

0

-

*0

0

0

0

0

0

0

0

7

0

0

0

-

*0

0

0

0

0

0

0

0

0

0

8

0

0

0

0

0

0

0

0

0

 

0

0

0

0

9

0

0

0

0

0

0

0

0

0

 

0

0

0

0

10

0

0

0

0

0

0

0

0

0

 

0

0

0

0

11

0

0

0

0

0

0

0

0

0

 

0

0

0

0

12

0

0

0

0

0

0

0

0

0

 

0

0

0

0

13

0

0

0

0

0

0

0

0

0

 

0

0

0

0

14

0

0

0

0

0

0C

0

0

0

 

0

0

0

0

15

0

0

0

0

0

0

0

0

0

 

0

0

0

0

16

0

0

0

0

0

0

0

0

-

 

0

0

0

0

17

0

0

0

0

0

0

0

0

0

 

0

0

0

0

18

0

0

0

0

0

0

0

0

0

 

0

0

0

0

19

0

0

0

0

0

0

0

0

0

 

0

0

0

0

20

0

0

0

0

0A

0A

0

0

0

 

0

0

0

0

21

0

0

0

0

0

0

0

0

0

 

0

0

0

0

22

0

0

0

0

0

0

0

0

0

 

0

0

0

0

M: applied to an adjacent site after strong test reaction

-: panelist absent

*: residual reaction to earlier application, after an absence, not included in score totals

( ): scores un ( ) are residual or flaring reactions on sites of earlier applications, recorded only when of special interest. Not included in score totals.

Table 7.10.4/5: Score Totals for All Panelists Following Application of Group 90, BP-10-11L

TOTALS

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

0

22

22

20

18

19

21

21

22

21

3

22

22

22

22

1

0

0

0

1

1

0

0

0

0

0

0

0

0

0

3

0

0

1

0

0

0

0

0

0

0

0

0

0

0

A

0

0

0

0

1

1

0

0

0

0

0

0

0

0

C

0

0

0

1

0

1

0

0

0

0

0

0

0

0

NP

0

0

1

3

2

1

1

0

1

0

0

0

0

0

NP: number of panelists not included in score total: (-, *)

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material can be considered as non-sensitizing.
Executive summary:

In a Human Repeated Insult Patch Test, the primary irritation and sensitization propoerties of the test sample was tested on 22 volunteers.

The procedure used was an adaptation of the method of Draize. Before application to the skin, 0.5 mL of the sample was applied to the Webril swatch by means of a calibrated dropper. The test patches were applied to the upper arms of the panelists, 3 times per week for 3 weeks. Eight different samples from the group number 90 were tested simultaneously on each panelist. The order of application was varied so that each test material occupied each of the possible positions with approximately equal frequency. The panelists were instructed to remove the patches 24 hours after application.

Each patch was applied to the same area each time unless the severity of a reaction made this inadvisable. In such cases, subsequent application was made to an adjacent site or omitted. For the final challenge application after a 2-week rest period, duplicate patches were applied, one to the original site and one to a skin which had not previously received any patches.

Reactions to the test material were scored after removal of each patch.

Results:

- group 90, BP-10-11: twenty-two panelists showed little or no primary irritation. Two panelists, Nos. 1 and 5, showed evidence of possible sensitization.

- group 90, BP-10-11L: Twenty-one panelists showed little or no reaction. Panelists, No.5, showed moderate primary irritation. No evidence of sensitization was exhibited by the panelists.

Under the test conditions, the test material tested undiluted can be considered as non-sensitizing.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Human Repeat Insult Patch Test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
HRL Standard Operating Procedures: 0.2mL of test material was applied nine times under occlusive patchs to the left upper back area of panelists during 24 hours for a period of three weeks on Mondays, Wednesdays and Fridays (induction phase).
Each patch is applied to the same area each time. A two week rest period followed the induction phase. For the final challenge application, the patch was applied to a virgin site and readings were made after 24, 48 and 72h using the (modified) scoring scale of the International Contact Dermatitis Research Group System as per HRL SOP.
GLP compliance:
no
Type of study:
other: Study with volunteers
Justification for non-LLNA method:
Available study on volunteers
Specific details on test material used for the study:
Date of receipt: February 8, 1983
Species:
other: Human
Strain:
other: non relevant
Sex:
male/female
Details on test animals and environmental conditions:
- Number of subjects recruited: 58
- Sex: 14 men and 44 women
- Age: from 18 to 58: 18-30 yr: 34 ; 31-45 yr: 13 ; 45-65 yr: 11

- Number of subjects completed the tests: 51
- Sex: 14 men and 37 women
Positive control results:
No positive control
Key result
Reading:
other: 1st, 2nd and 3rd
Hours after challenge:
72
Group:
test group
Dose level:
0.2mL at 2%
No. with + reactions:
0
Total no. in group:
51
Clinical observations:
None
Remarks on result:
other: no indication of skin sensitisation
Remarks:
after 24, 48 and 72h
Reading:
other: Non performed
Group:
negative control
Remarks on result:
not measured/tested
Reading:
other: Non performed
Group:
positive control
Remarks on result:
not measured/tested

Table 7.10.4/1: Summary of Reactions

 

Induction reading

Challenge reading

Reaction grade

1

2

3

4

5

6

7

8

9

24

48

72

C1

C2

C3

0

55

54

53

53

53

51

51

51

51

51

51

51

±

 

 

 

 

 

 

 

 

 

 

 

 

1+

 

 

 

 

 

 

 

 

 

 

 

 

2+

 

 

 

 

 

 

 

 

 

 

 

 

3+

 

 

 

 

 

 

 

 

 

 

 

 

4+

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL

55

54

53

53

53

51

51

51

51

51

51

51

No. Of subj. In Panel

55

54

53

53

53

51

51

51

51

51

51

51

0: no visible reaction

±: faint, minimal reaction

1+: erythema

2+: erythema, induration

3+: erythema, induration, vesicles

4+: severe reaction with erythema, induration, vesicles (may be weeping), pustules

Table 7.10.4/2: RIPT - Individual scores

 

 

 

 

Induction reading

Challenge reading

Subj. #

HRL Subj. #

Sex

Age

1

2

3

4

5

6

7

8

9

24

48

72

C1

C2

C3

1

1697

F

51

0

0

0

0

0

0

0

0

0

0

0

0

2

1698

M

21

0

0

0

0

0

0

0

0

0

0

0

0

3

1107

F

53

0

0

0

0

0

0

0

0

0

0

0

0

4

1699

F

57

DISCONTINUED

5

1128

F

58

0

0

0

0

0

0

0

0

0

0

0

0

6

628

F

32

0

0

0

0

0

0

0

0

0

0

0

0

7

1320

M

22

0

0

0

0

0

0

0

0

0

0

0

0

8

1118

M

27

0

0

0

0

0

0

0

0

0

0

0

0

9

1119

F

23

0

0

0

0

0

0

0

0

0

0

0

0

10

1700

M

19

0

0

0

0

0

0

0

0

0

0

0

0

11

942

F

18

0

0

0

0

0

0

0

0

0

0

0

0

12

940

F

19

0

0

0

0

0

0

0

0

0

0

0

0

13

939

F

22

0

0

0

0

0

DISCONTINUED

14

1404

F

22

0

0

0

0

0

0

0

0

0

0

0

0

15

1701

M

48

0

0

0

0

0

0

0

0

0

0

0

0

16

1702

F

36

0

0

0

0

0

0

0

0

0

0

0

0

17

1703

F

30

0

0

0

0

0

0

0

0

0

0

0

0

18

1704

F

29

0

0

0

0

0

0

0

0

0

0

0

0

19

1529

F

32

0

0

DISCONTINUED

20

1130

F

37

0

0

0

0

0

0

0

0

0

0

0

0

21

1705

F

44

0

0

0

0

0

0

0

0

0

0

0

0

22

1706

M

29

DISCONTINUED

23

562

F

30

0

0

0

0

0

0

0

0

0

0

0

0

24

913

F

25

0

0

0

0

0

0

0

0

0

0

0

0

25

1511

F

43

0

0

0

0

0

0

0

0

0

0

0

0

26

574

F

28

0

0

0

0

0

0

0

0

0

0

0

0

27

1115

F

48

0

0

0

0

0

0

0

0

0

0

0

0

28

1149

F

56

0

0

0

0

0

0

0

0

0

0

0

0

29

1068

F

46

0

0

0

0

0

0

0

0

0

0

0

0

30

326

F

20

0

0

0

0

0

0

0

0

0

0

0

0

31

325

F

20

0

0

0

0

0

0

0

0

0

0

0

0

32

598

F

29

0

0

0

0

0

0

0

0

0

0

0

0

33

1707

F

26

0

0

0

0

0

0

0

0

0

0

0

0

34

1519

F

39

0

DISCONTINUED

35

1456

M

23

0

0

0

0

0

0

0

0

0

0

0

0

36

1323

F

20

0

0

0

0

0

0

0

0

0

0

0

0

37

1322

M

20

0

0

0

0

0

0

0

0

0

0

0

0

38

1158

F

47

0

0

0

0

0

0

0

0

0

0

0

0

39

961

F

35

0

0

0

0

0

0

0

0

0

0

0

0

40

1180

M

30

0

0

0

0

0

0

0

0

0

0

0

0

41

1708

F

32

DISCONTINUED

42

1432

F

38

0

0

0

0

0

DISCONTINUED

43

1709

F

19

0

0

0

0

0

0

0

0

0

0

0

0

44

1710

F

18

0

0

0

0

0

0

0

0

0

0

0

0

45

1711

F

47

0

0

0

0

0

0

0

0

0

0

0

0

46

1064

M

27

0

0

0

0

0

0

0

0

0

0

0

0

47

1712

M

32

0

0

0

0

0

0

0

0

0

0

0

0

48

674

M

29

0

0

0

0

0

0

0

0

0

0

0

0

49

546

F

29

0

0

0

0

0

0

0

0

0

0

0

0

50

1713

F

18

0

0

0

0

0

0

0

0

0

0

0

0

51

1714

F

18

0

0

0

0

0

0

0

0

0

0

0

0

52

1715

F

19

0

0

0

0

0

0

0

0

0

0

0

0

53

1069

M

29

0

0

0

0

0

0

0

0

0

0

0

0

54

1070

F

28

0

0

0

0

0

0

0

0

0

0

0

0

55

1181

F

27

0

0

0

0

0

0

0

0

0

0

0

0

56

1182

F

56

0

0

0

0

0

0

0

0

0

0

0

0

57

852

M

42

0

0

0

0

0

0

0

0

0

0

0

0

58

1230

F

33

0

0

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the test material is considered as non-sensitizing.
Executive summary:

In a Human Repeated Insult Patch Test, the primary irritation and sensitization propoerties of the test sample was tested on volunteers.

In 58 subjects enrolled, 51 completed the study (14 men and 37 women).

The study was performed following the HRL Standard Operating Procedures: 0.2mL of test material was applied nine times under occlusive patchs to the left upper back area of panelists during 24 hours for a period of three weeks on Mondays, Wednesdays and Fridays. If a missed patching was unable to be made-up during the same week, the subject was re-patched at the end of the Induction Phase (tenth visit). Additional absences necessitated dropping the subject from the panel. Subjects were instructed that each patch was to remain in place, and the area was to be kept dry for 24 hours, at which time the patch was to be removed. A 24-hr rest period, during which no test material was applied, followed the removal of the Monday and Wednesday patch applications; a 48-hr rest period followed the Friday patch application. Each patch is applied to the same area each time. A two week rest period followed the induction phase. The Challenge patch was applied to a virgin site and readings were made after 24, 48 and 72h.

Reading ans recordings during induction and challenge phases were done using the (modified) scoring scale of the International Contact Dermatitis Research Group System as per HRL SOP.

The original patch sites exhibited no reactions during rest or at the Challenge.

No reactions were observed during the Induction Phase nor at the Challenge Phase.

 

Under the test conditions, the test material at concentration of 2% is considered as non-sensitizing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A study was performed in accordance with GLP and OECD Guideline 429 to assess the skin sensitisation potential of Patchouli Essential Oil in the CBA/J strain mouse following topical applications of the test material to the dorsal surface of the ear (Robertet Grasse, 2008). Four groups, each of four animals, were treated for three consecutive days with 50 μL (25 μL per ear) of the undiluted test item and the test item as a solution in Acetone/ Olive oil (4:1) at concentrations of 10%, 25%, 50% and 100% (v/v). The Stimulation Index, when using the pooled approach, is expressed as the cell count for each treatment group divided by the cell count of the control group and was 1.01, 1.45, 2.24 and 2.53 at concentrations of 10%, 25%, 50% and 100%, respectively. Therefore, the test material was considered not to be a sensitiser under the conditions of the test.

Additional information is available from two human repeat insult patch tests (Hill Top Research, Inc, 1971 and Harrison Research Laboratories, Inc, 1983) which demonstrate that the test material is not a skin sensitiser. In the Harrison Laboratories study (1983), a total of 51 subjects completed the study in which 0.2 mL of a 2% solution of Patchouli was applied to the skin in a series of nine induction patches for a period of three weeks. During both the induction and challenge phases, the test areas were observed and the reaction scored and recorded. The original patch sites exhibited no reactions during rest or at the challenge and no reactions were observed during the induction or challenge phases of the study. In the study performed at Hill Top Research (1971) 22 subjects were treated with 0.5 mL of a 9.25% solution of Patchouli oil, light. All 22 subjects showed little or no primary irritation and two subjects showed evidence of possible sensitisation.