Registration Dossier
Registration Dossier
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EC number: 201-678-2 | CAS number: 86-52-2
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Remarks:
- Epicutanous pathch test
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1995
- Reliability:
- 3 (not reliable)
Data source
Reference
- Reference Type:
- publication
- Title:
- An Erythema Multiforme-like Eruption Caused by Exposure to 1-Chloromethylnaphthalene
- Author:
- Urano, S., Tokura, Y.
- Year:
- 1 997
- Bibliographic source:
- The Journal of Dermatology Vol. 25:13-18, 1998
Materials and methods
- Principles of method if other than guideline:
- One hundered microliters of test solution containing 1-chloromethylnaphthalene (1-CMN), its derivates of methylnaphthalene or naphthalene, or an oinment of gentamycin sulfate were applied to a normal skin site and occluded for 48 hours.
- GLP compliance:
- no
- Type of method:
- in vitro
- Endpoint addressed:
- skin sensitisation
Test material
- Specific details on test material used for the study:
- no data given
Test animals
- Species:
- other: Humans
- Sex:
- not specified
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- not specified
- Details on exposure:
- dermal application and occluded for 48 hours
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 48 hours
- Frequency of treatment:
- once
- Post exposure period:
- no
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: %
- Dose / conc.:
- 0 other: %
- Dose / conc.:
- 0 other: %
- Dose / conc.:
- 0.001 other: %
- Details on study design:
- 11 humans
Examinations
- Examinations:
- after 48 and 72 hours of
- Positive control:
- no
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- One hundered microliters of test solution containing 1-chloromethylnaphthalene, its derivates of methylnaphthalene or naphthalene, or an oinment of gentamycin sulfate were applied to a normal skin site and occluded for 48 hours. Concentrations of 0, 0,00001%, 0,0001%, 0,001% were used with naphtalene and its derivatives, the concentration of gentamycin sulfate is not given. 10 healthy voluteers and one person with previous exposure to 1-Chloromethylnaphthalene were investigated.
Only at the highest concentration the person with previous exposure to 1-CMN showed an erythema at the application site. Because of the lack of further data it is not clear whether the observed reaction is a consequence of an irritation or an sensibilisation or a toxic reaction of the skin. - Executive summary:
One hundered microliters of test solution containing 1-chloromethylnaphthalene, its derivates of methylnaphthalene or naphthalene, or an oinment of gentamycin sulfate were applied to a normal skin site and occluded for 48 hours. Concentrations of 0, 0,00001%, 0,0001%, 0,001% were used with naphtalene and its derivatives, the concentration of gentamycin sulfate is not given. 10 healthy voluteers and one person with previous exposure to 1-Chloromethylnaphthalene were investigated.
Only at the highest concentration the person with previous exposure to 1-CMN showed an erythema at the application site. Because of the lack of further data it is not clear whether the observed reaction is a consequence of an irritation or an sensibilisation or a toxic reaction of the skin.
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