Registration Dossier

Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The test was not performed according to recognised standardised guidelines. Not enough details for assessment.

Data source

Reference
Reference Type:
publication
Title:
Depigmentation of skin with 4-isopropylcatechol, mercaptoamines, and other compounds.
Author:
Bleehen S.S., Pathak M.A., Hori Y., Fitzpatrick T.B.
Year:
1968
Bibliographic source:
The Journal of Investigative Dermatology, 50 (2), 103-117.

Materials and methods

Principles of method if other than guideline:
Depigmentation study
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrocatechol
EC Number:
204-427-5
EC Name:
Pyrocatechol
Cas Number:
120-80-9
Molecular formula:
C6H6O2
IUPAC Name:
pyrocatechol
Details on test material:
no data

Test animals

Species:
guinea pig
Strain:
other: Black
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: vanishing creams
Details on exposure:
The control area referred to in this publication included unepilated and epilated skin of black guinea pigs. Three different unscented vanishing creams, differing in the pH and the type of emulsifier, were used as placebo. The effects of these mixtures were evaluated in 6 animals. The bases were applicated once daily, five times a week, for a month on the wax-depilated backs of these animals.
Catechol was applied daily, on the wax-depilated backs and the unepilated skin of the ear of black guinea pigs, in concentrations ranging from 1% to 10%. The compounds were applied once daily, five times a week, for periods up to one month. At weekly intervals, the back of each animal was epilated, and the effect of the compound was assessed for the degree of resulting depigmentation and any irritation of the skin.  To evaluate the morphologic changes and the reactivity of the melanocytes 11 animals were tested.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
1 month
Frequency of treatment:
5 times a week
Doses / concentrations
Remarks:
Doses / Concentrations:
1%, 3%, 5% 7% and 10% in creams
Basis:
no data
No. of animals per sex per dose:
11 animals treated for the study.
Control animals:
no

Results and discussion

Results of examinations

Details on results:
Absence of depigmentation and irritation at 1%, definite but weak action at 3%, characterised by small spots or speckles of depigmentation, definite but moderate action at 5%, characterised by an uniform hypopigmentation, and a very strong (complete) depigmentation at 7 and 10%.
Catechol was irritating at 7 and 10%.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 other: %
Sex:
not specified
Basis for effect level:
other: Depigmentation
Dose descriptor:
LOAEL
Effect level:
3 other: %
Sex:
not specified
Basis for effect level:
other: Depigmentation

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion