Registration Dossier
Registration Dossier
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EC number: 201-944-8 | CAS number: 89-83-8
Direct observations: clinical cases, poisoning incidents and other
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:
- 1 989
- 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 substance name:
- Thymol
- EC Number:
- 201-944-8
- EC Name:
- Thymol
- Cas Number:
- 89-83-8
- Molecular formula:
- C10H14O
- IUPAC Name:
- 5-methyl-2-(propan-2-yl)phenol
- Details on test material:
- no data
Constituent 1
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
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