Oils, cinnamon

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was performed according to method described by Kligman (1966), but not under GLP. Although the report is concise the test seems reliable, with a well-described method and results section and a table with individual results reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: J.I.D., vol. 47, No. 5; 1966; 393-406

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

An LLNA is not performed because other reliable information is available.

Test material

Test material information

Constituent 1

Reference substance name:

Essential oil of Cinnamon bark obtained from the bark of Cinnamomum zeylanicum, Lauraceae by distillation

EC Number:

943-043-9

Cas Number:

8015-91-6

IUPAC Name:

Essential oil of Cinnamon bark obtained from the bark of Cinnamomum zeylanicum, Lauraceae by distillation

Details on test material:

- Name of test material (as cited in study report): cinnamon bark oil, RIFM 72-8-99
- Physical state: liquid

In vivo test system

Test animals

Species:

human

Strain:

other: caucasian and african

Sex:

male

Details on test animals and environmental conditions:

Not applicable

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

no data

Induction 2

Concentration / amount:

No data (test article assumed to be applied unchanged)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

no data

Challenge 2

Concentration / amount:

No data (test article assumed to be applied unchanged)

No. of animals per dose:

25 subjects were tested

Details on study design:

PRE-TESTING
The test material was pre-tested on five subjects in order to determine whether SLS pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from these materials and it was decided to use SLS pre-treatment in the test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 48 hours
- Test groups: 1 (25 subjects)
- Control group: No
- Site: Forearm
- Frequency of applications: Alternate days
- Duration: 10 days
- Concentrations: No data (test article applied as such)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 10 days after completion of induction phase
- Exposure period: 48 hours
- Test groups: 1 (25 subjects)
- Control group: No
- Site: Fresh sites (forearm)
- Concentrations: No data (test article applied as such)
- Evaluation (hr after challenge): Upon removal of patch and 24 hours later

OTHER: Before induction and challenge, pre-treatment with 5% and 10% SLS for 24 hours and 1 hour (occluded) was performed, respectively.

Challenge controls:

None

Positive control substance(s):

no

Results and discussion

Positive control results:

Not performed

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

No data (unchanged test article used)

No. with + reactions:

18

Total no. in group:

25

Clinical observations:

Subjects with score of 1 or more (strong sensitizer)

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: No data (unchanged test article used). No with. + reactions: 18.0. Total no. in groups: 25.0. Clinical observations: Subjects with score of 1 or more (strong sensitizer).

Results 2

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

No data (unchanged test article used)

No. with + reactions:

18

Total no. in group:

25

Clinical observations:

Subjects with score of 1 or more (strong sensitizer)

Remarks on result:

other: see Remark

Remarks:

Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: No data (unchanged test article used). No with. + reactions: 18.0. Total no. in groups: 25.0. Clinical observations: Subjects with score of 1 or more (strong sensitizer).

Any other information on results incl. tables

Subject	Age	Race	48 hrs.	72 hrs.
1	45	B	4	4
2	25	B	3	3
3	31	B	1	1
4	32	B	2	2+
5	24	B	4	3
6	25	B	0	0
7	29	B	0	0
8	22	B	1	1
9	22	B	0	0
10	45	B	2 +	2
11	22	B	2	2+
12	38	B	3	3
13	29	B	1	2
14	22	B	1	1
15	21	B	0	0
16	26	B	2 +	2
17	30	W	0	0
18	29	W	1	2
19	21	W	1	1
20	24	W	3	3
21	25	W	2	2
22	28	W	0	0
23	32	W	2 +	2
24	21	W	0	0
25	27	W	1	1

Results after exporsue for all test subjects

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Under the conditions of this study, testing resulted in 18 out of 25 cases of contact sensitisation. Based on these results, cinnamon bark oil can be considered a skin sensitizer and should be classified as such based on the criteria outlined in 1272/2008/EC (CLP).

Executive summary:

In this maximization test according to a human assay developed by Kligman (1966), 25 volunteers were exposed to cinnamon bark oil as supplied via an occlusive patch. Test subjects were induced for 5 intermittend days in a 10 day period. After a recovery period, volunteers were exposed to the test substance for 24 hours. Challenge application was preceded by a 1 hour application of a 10% aqueous solution of sodium lauryl sulfate under occlusion. The effects were scored after removal of the patch and 24 hours later.

18 out of 25 volunteers exposed to cinnamon bark oil showed skin sensitisation directly and 24 hours after removal of the patch (48 and 72 hours after challenge).