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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: special study and only one dose used, no dose-response relationship can be derived and thus no NOAEL or LOAEL can be deduced.

Data source

Reference
Reference Type:
publication
Title:
p-Cresol: cause of ink-induced hair depigmentation in mice
Author:
Shelley WB
Year:
1974
Bibliographic source:
British Journal of Dermatology 90, 9-174 (1974)

Materials and methods

Principles of method if other than guideline:
Hair pigmentation was studied following plucking or clipping the caudal half of the back and repeated application of laundry ink or its pure component chemicals incl. p-cresol in a concentration of 0.5% in acetone.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: p-cresol, purity not noted

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
migrated dataset

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on exposure:
Route of Administration: dermal
Details on analytical verification of doses or concentrations:
migrated dataset
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
3x/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0 or 0.5 % in acetone
Basis:

No. of animals per sex per dose:
no data
Control animals:
yes, concurrent vehicle
Details on study design:
Post-exposure period: 6 months
Positive control:
migrated dataset

Examinations

Observations and examinations performed and frequency:
migrated dataset
Sacrifice and pathology:
migrated dataset
Other examinations:
migrated dataset
Statistics:
migrated dataset

Results and discussion

Results of examinations

Details on results:
migrated dataset

Effect levels

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Dose descriptor:
NOAEL
Effect level:
< 0.5
Sex:
female
Dose descriptor:
LOAEL
Effect level:
<= 0.5
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Topical application caused hair depigmentation.  No microscopic changes were noted.

Applicant's summary and conclusion

Executive summary:

p-Cresol was applied to the skin of five female Agouti mice three times weekly for 6 weeks. Hair colour was observed weekly for the subsequent 6 months. Microscopic examinations of post-treatment hairs and skin biopsies of areas of non-pigmented and normally pigmented hair were made. Control groups of animals received acetone.

No hair depigmentation and no microscopic changes were noted.