Peppermint, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across to cornmint oil. Test was performed as described by Kligman (1966) but not according to GLP. Limited details on test subjects and used methods available.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Kligman, JID 47: 393-409, 1966

Principles of method if other than guideline:

no data

GLP compliance:

no

Remarks:

pre-GLP test

Test material

Test material information

Constituent 1

Reference substance name:

Cornmint oil

IUPAC Name:

Cornmint oil

Details on test material:

no data

Method

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 22 volunteers completed the experiment
- Sex: male
- Age: no data
- Race: Black (1), Mexican (7), Caucasian (13), Chinese (1)
- Demographic information: no data

Clinical history:

No data on the clinical history of the subjects. According to the study report the volunteers were all healthy at the start of the study.

Controls:

Petrolatum control on right side of the back.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: no data
- Vehicle / solvent: unchanged (no vehicle)
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule:
Test material was applied under occlusion to the same sites on the volar aspect of the forearms of all subjects for 5 alternate day 48 periods. Patch sites were pretreated for 24 hours with 5% aqeous SLS under occlusion for the initial patch only. Following a 10 to 14 day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 1 hour exposure of 1% aqeous SLS under occlusion on the left side of the back, whereas the test material was applied without SLS treatment on the right side and an additional petrolatum control was placed on the right.
- Removal of test substance: Patches were removed and read after 24 hours and in some instances after 96 hours.
- Other: Some questionable reactions were biopsied and retests were applied one week later on fresh sites to reevaluate any questionable reaction.

EXAMINATIONS
- Grading/Scoring system: no data
- Statistical analysis: no data

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Test material produced questionable reactions in two subjects at sites pretreated with SLS. In one subject the test material produced a definite positive reaction at the test site pretreated with SLS.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 19
- Number of subjects with equivocal reactions: 2
- Number of subjects with irritating reactions: 0

OTHER RESULTS: Biopsies were obtained from one subject showing a questionable reaction and from the subject showing a positive reaction. The results of the biopsies indicated allergic contact sensitization in the two subjects. The other subject, showing questionable reactions, refused biopsy.

One week later, the test material was retested in the two subjects showing questionable reactions. The retest revealed increased reactivity in one subject (who cooperated with the biopsy), substantiating the fact that he was allergic to the test material. In the other subject (who refused the biopsy) the reaction again appeared questionable or irritant in nature and he was considered not to have become sensitized by the material.

The test material induced allergic reactions in two out of 22 male volunteers.

Any other information on results incl. tables

There was very little irritation at the 1% SLS treated site.

Applicant's summary and conclusion

Conclusions:

In a human maximisation test, two out of 22 volunteers showed sensitising reactions. This indicates that the test substance can induce a substantial positive skin sensitisation reaction in human. For this reason cornmint oil can be considered a skin sensitiser.

Executive summary:

The sensitising properties of Cornmint oil were investigated in a human maximisation test. Twenty-two healthy male volunteers completed the experiment. The test material was applied under occlusion to the forearms of all subjects for 5 alternate day 48 hour periods. SLS was used as pre-treatment. Following a 10 to 14 day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours, both with and without pretreatment of SLS, and an additional petrolatum control was applied. The challenge sites were read on removal of the patch 24 upto 96 hours later. Some questionable reactions were biopsied and, when needed, retests were applied one week later.

The test material produced a definite positive reaction in one subjec (#26) at the SLS treated site and questionable reactions at the SLS treated sites in two subjects (#10 and #22). Biopsies - from subject #22 and #26 - indicated allergic contact sensitistion. Retests in subject #10 and #22 showed increased reactivity in subject #22 and in subject #10 the reactions again appeared questionable or irritant in nature. He was considered not to have become sensitized by the test material.

The results indicate that the test substance can induce a positive skin sensitisation reaction in human. According to the criteria outlined in Annex I of 1272/2008/EC, Cornmint oil may be classified as skin sensitiser based on the fact that a substantial (10%) positive response is seen in human subjects.