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Toxicological information

Specific investigations: other studies

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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:
1997
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.