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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: sufficient documented for evaluation

Data source

Reference
Reference Type:
publication
Title:
Allergic contact Dermatitis due to thymol in Listerine for treatment of paronychia
Author:
Fischer AA
Year:
1989
Bibliographic source:
Cutis 43, 531-532

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
closed patch test with tymol
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Subjects:
patient with chronic paronychia
Route of exposure:
dermal
Reason of exposure:
intentional

Results and discussion

Clinical signs:
positve patch test with Listerine and tymol

Any other information on results incl. tables

48-hour patch test with Listerine ingredients

Thymol 1 percent in petrolatum 2+
Eucalyptus oil 1 percent in alcohol 0
Methyl salicylate 2 percent in olive oil 0
Menthol 1 percent in petrolatum 0
Benzoic acid 5 percent in petrolatum 0

In 3 control patients there was no reaction to thymol 1 percent in petrolatum

Applicant's summary and conclusion

Executive summary:
A 43-year old man applied Listerine antiseptic solution, under occlusion, for 3 weeks to a chronic paronychia of his left big toe.
Listerine antiseptic solution has the following active ingredients: thymol 0.6 percent,
eucalyptol 0.9 percent, methyl salicylate 0.6 percent, menthol 0.4 percent,benzoic acid trace. The package insert states that Listerine antiseptic also contains water, alcohol 26.9 percent, and poloxamer 407 and caramel.
A 48-hour closed patch test with Listerine, as is, produced a positive reaction in the patient
and none in three controls. A further patch test in the patient with pure thymol was also positve