Matricaria recutita, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Study performed in humans, in the Department of Dermatology of St John's Hospital for Diseases of the Skin in London.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Not reported

GLP compliance:

no

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:
- first group: 200 consecutive patients with dermatitis
- second group: 50 other subjects positive to one or more of four balsms (which comprised balsam of Peru, wood tars, colophony and turpentine)

Clinical history:

Dermatitis patients and other subjects positive to one or more of four balsms (which comprised balsam of Peru, wood tars, colophony and turpentine)

Route of administration:

dermal

Details on study design:

All the patients were tested with the 35 essential oils which were used at a concentration of 2 % in yellow soft paraffin.

Results of examinations:

- From the among 35 essential oils tested on 200 consecutive patients, 28 (14%) gave positive results. The largest number of patients was sensitive to citronella oil (5) and in diminishing order to ylang ylang (4), bitter orange, bergamot, Himalayan cedarwood, eucalyptus, geranium and litsea cubeba oil (3). One or to patients reacted to the remaining oils.
- In addition, frequent reactions were observed to star anis oil; but on account of some of its properties this oil will be the subject of a separate communication. Of the remaining seven oils to which the patients did not react, four (sandalwood,lavender, thyme and guaiac wood oil) gave positive results in the additional group of subjects sensitive to balsams.
- No patient reacted to calamus, sassafras or rosemary oil. It should be stressed that sandalwood, thyme and guaiac wood oils are used in Polish cosmetics in relatively small amounts, whereas lavender and sassafras oils are used in large quantities.
- Of the 200 consecutive patients, 187 were negative to all four balsams. Among the latter, 11 were positive to 1, 2, or 3 oils. This could not be suspected on the basis of tests with the standard series. Nevertheless, all subjects who were positive to more than three oils (5, 7 and 15) were also positive to balsams.
About half of the patients who are positive to each of the four balsams are also positive to one or several essential oils (Tables 2 to 5), the positive results with these oils showing a somewhat better agreement with the reaction to turpentine (Table 3) than with balsam of Peru (Table 2).
- Of the 20 patients positive to balsam of Peru and negative to other balsams, 12 reacted to one or more essential oils; seven were positive to cassia oil (Table 2). This may have been because 80-90 % of this oil consists of cinammic aldehyde noted that 68 % of persons positive to balsam of Peru reacted to 5 % cinammic aldehyde and 21 % of such subjects to a 2 % concentration. Thus, cinammic aldehyde could be the cause of simultaneous reactions to these substances. Subjects sensitive to balsam of Peru react less frequently to the remaining essential oils, with the exception of clove oil to which three patients were positive (Table 2).
- Of the 23 patients positive to turpentine and negative to other balsams, 15 reacted to some oils (Table 3). Twelve of these 15 reacted to pine needle oil and eight to abies alba oil. Both these oils contain alphapinene, but only pine needle oil contains delta-3-carene which is interesting in the light of views on turpentine allergens.
See 'any other information on results incl. tables'.

Table 7.10.4/1: Positive reactions to essential oil in 200 patients related to the 187 negative reactors to balsams

Essential oils	Number of positive reactions in 200 patients	Number of positive reactions in 187 patients with negative reactions to balsam
Cassia	2	1
Oak moss	1	1
Juniper	1	0
Zdrawetz	1	1
Coriander	2	0
Sweet orange	1	0
Petitgrain bigarade	1	0
Peppermint	1	1
Clary sage	1	0
Petitgrain Paraguay	1	0
Abies alba	2	0
Cananga	1	1
Lavandin	1	0
Pine needle	4	0
Vetiver	1	0
Spike	1	0
Clove	2	1
Angelica	2	1
Bitter orange	3	1
Bergamot	3	2
Chamomile	1	0
Lemon	1	0
Cedarwood	3	1
Eucalyptus	3	1
Geranium	3	2
Citronella	5	4
Litsea cubeba	3	1
Ylang-ylang	4	3

Table 7.10.4/2: Positive tests to essential oils related to positive reactions to balsam of Peru

Essential oils	Positive reactions of patients positive to balsam of Peru only (20)	Positive reactions of all patients positive to balsam of Peru (31)
Cassia	7	9
Thyme	1	1
Oak moss	1	1
Juniper	1	1
Zdrawetz	0	1
Coriander	1	1
Peppermint	0	1
Clary sage	1	2
Abies alba	1	2
Pine needle	1	4
Vetiver	0	1
Spike	0	1
Clove	3	5
Chamomile	0	1
Lemon	0	1
Geranium	1	1
Citronella	0	3
Litsea cubeba	0	1
Ylang-ylang	1	1

Table 7.10.4/3: Positive tests to essential oils related to turpentine reactions

Essential oils	Positive reactions in patients positive to turpentine only (23)	Positive reactions in all patients positive to turpentine (31)
Lavender	1	1
Cassia	3	5
Oak moss	1	1
Juniper	1	1
Coriander	1	1
Sweet orange	1	1
Petitgrain bigarade	2	2
Abies alba	8	9
Cananga	1	1
Pine needle	13	14
Guaiac wood	1	1
Vetiver	1	1
Spike	1	1
Clove	0	1
Angelica	1	1
Bitter orange	3	3
Bergamot	1	1
Chamomile	1	2
Lemon	1	2
Cedarwood	3	3
Eucalyptus	2	2
Geranium	1	1
Citronella	1	2
Litsea cubeba	1	1
Ylang-ylang	1	1

Table 7.10.4/4: Positive tests to essential oils related to colophony reactions

Essential oils	Positive reactions to essential oils in patients positive to colophony only (4)	Positive reactions to essential oils in all patients positive to colophony (7)
Sandalwood	1	1
Cassia	0	2
Zdrawetz	0	1
Sweet orange	1	1
Peppermint	0	1
Clary sage	1	2
Pine needle	1	2
Guaiac wood	1	1
Vetiver	1	2
Spike	0	1
German chamomile	1	1
Citronella	0	1
Litsea cubeba	1	2

Table 7.10.4/5: Positive tests to essential oils related to wood tars sensitivity

Essential oils	Nuumber of positive reactions to essential oils in patients positive to wood tars only (4)	Number of positive reactions to essential oils in all patients positive to wood tars (11)
Cassia	0	1
Coriander	2	2
Clary sage	2	2
Petitgrain Paraguay	1	1
Lavandin	1	1
Pine needle	0	1
Clove	0	1
Citronella	1	2
Ylang-ylang	1	1
Other oils	0	0

Table 7.10.4/6: Number of patients reacting to none or more than one of the 35 essential oils tested related to the various groups of balsam reactors

	Patients positive to none or more than one oil
200 + 50 patients	0	1	2	3	4	5	6	7	8	9	15 oils
200 patients	183	6	2	6	0	1	0	1	0	0	1
Negative to balsams (187)	176	5	1	5	0	0	0	0	0	0	0
All balsam of Peru reactors (31)	13	12	3	0	0	1	1	0	0	1	0
Positive to balsam of Peru only (20)	8	9	2	0	0	0	1	0	0	0	0
All turpentine reactors (31)	12	8	4	2	0	3	0	1	0	0	1
Positive to turpentine only (23)	8	5	4	2	0	2	0	1	0	0	1
All wood tars reactors (11)	6	2	1	1	0	1	0	0	0	0	0
Positive to wood tars only (4)	2	0	0	1	0	1	0	0	0	0	0
All colophony reactors (7)	3	1	0	1	0	1	0	0	0	1	0
Positive to colophony only (4)	2	0	0	1	0	1	0	0	0	0	0

Conclusions:

In this study, German chamomile essential oil at concentration of 2% is a potential skin sensitiser for humans.

Executive summary:

Two hundred consecutive patients and 50 subjects positive to balsams were tested with the 35 essential oils most frequently used in Polish cosmetics. The essential oils were tested at concentration of 2% in yellow soft paraffin.

The frequency of sensitivity to the particular oils is noted and the index of sensitization calculated as the amount of oil/kg used annually for the production of Polish cosmetics per one patient positive to this oil.

The correlation of positive tests to essential oils with positive tests to four balsams of the standard series is shown.

The fact that the amount of oils per one positive test is smallest in the case of German camomile oil may be the result of frequent application in Poland of camomile compresses. An example of 'false cross-reaction' is probably responsible for simultaneous sensitivity to turpentine and pine needle oil.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Not reported

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Matricaria recutita, ext.

EC Number:

282-006-5

EC Name:

Matricaria recutita, ext.

Cas Number:

84082-60-0

Molecular formula:

Not relevant, UVCB substance

IUPAC Name:

Essential oil of Matricaria recutita (Asteraceae) obtained from flower tops by steam distillation of Egypt origin

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

Among the 5315 consecutive patients tested with the ICDRG perfume mixture:
- 86 tested with 35 essential oils
- 42 tested with the individual ingredients

Clinical history:

Not specified

Route of administration:

dermal

Details on study design:

Tests were performed with the ICDRG perfume mixture containing 1 essential oil and 7 other fragrance substances in 5315 consecutive patients at St John's Hospital for Diseases of the Skin in London and the results were positive in 299 (5.6%).
Among these 299 persons, 86 were tested with 35 essential oils (Rudzki et al., 1976).
The 42 patients positive to the perfume mixture were then tested with the individual ingredients.

Results and discussion

Results of examinations:

- Of the 86 persons tested with 35 essentiel oils, 49 (56.9%) reacted to 1 or more essential oils, and 15 (30.6%) reacted to more than 3 oils. Positive tests were observed most frequently with cassia oil (24), oak-moss absolute (14), and clove oil (12 subjects). 3 subjects were positive to German chamomile essential oil. None were positive to bergamot or sassafras oils. The results are shown in Table 1
- Of the 42 patients positive to perfume mixture tested with the individual ingredients, most of the patients had a positive reaction to eugenol, isoeugenol and cinnamic aldehyde.
- Among the patients tested recently (1640 subjects: 890 women and 750 men) from January 1985 to May 1986, the % positive to the perfume mixture was higher than in previous years. 9.32% of all patients were positive (10.6% women and 7.7% men). In these 1640 persons, tests with balsam of Peru, turpentine, wood tar, colophony, propolis and the mixture of cassia and citronella oils are much more frequent in patients positive to the perfume mixture than in those who are negative.
See 'any other information on results incl. tables'.

Any other information on results incl. tables

Table 7.10.4/1: Sensitivity to essential oils in perfume mixture - positive patients

Essential oils	No. Positive	% of positives
Sandalwood	2	2.3
Lavender	3	3.4
Cassia	24	27.9
Thyme	4	4.6
Oak-moss absolute	14	16.2
Juniper berries	6	6.9
Calamus	7	8.1
Coriander	3	3.4
Zdrawetz concrete	4	4.6
Sweet orange	3	3.4
Petitgrain bigarade	7	8.1
Peppermint	6	6.9
Clary sage	4	4.6
Petitgrain Paraguay	4	4.6
Abies alba	2	2.3
Cananga	10	11.6
Lavandin	4	4.6
Pine needle	3	3.4
Guaiac wood	1	1.1
Vetiver	9	10.4
Spike	8	9.3
Clove	12	13.3
Angelica root	2	2.3
Rosemary	3	3.4
Bitter orange	2	2.3
German chamomile	3	3.4
Lemon	2	2.3
Himalayan cedarwood	3	3.4
Eucalyptus	1	1.1
Geranium	2	2.3
Citronella	1	1.1
Litsea cubeba	7	8
Ylang-ylang	8	9.3
Sassafras	0	-
Bergamot	0	-

Table 7.10.4/2: Sensitivity to ingredients of the perfume mixture in 42 persons

Ingredient	Positive
Eugenol	25
Isoeugenol	19
Cinnamic aldehyde	16
Geraniol	10
Cinnamic alcohol	10
Oakmoss absolute	7
Hydroxycitronellal	6
Amyl cinnamic alcohol	6

Applicant's summary and conclusion

Conclusions:

In this study, German chamomile essential oil is a potential skin sensitizer for humans (3.4% positive tests).

Executive summary:

After a first experiment using a perfume mixture (ICDRG) containing 1 essential oil and 7 other fragrance substances, a group of 86 humans were tested with essential oils and 42 with individual ingredients at St John's Hospital for Diseases of the Skin in London.

Among the 86 positive patients to the perfume mixture, 3 (3.4%) showed a positive response to German chamomile.