Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male

Administration / exposure

Duration of treatment / exposure:
28 day
Frequency of treatment:
daily
Doses / concentrations
Dose / conc.:
0.5 other: g/animals

Results and discussion

Results of examinations

Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
In the control and treated group both the intact and scarified skin surfaces were symptom-free during the treatment. No primary irritation was observed. In all animals a slight exfoliation occurred on both the intact and abraded skin surfaces, otherwise, the animals were free of symptoms. At histopathological evaluation signs of secondary irritation (lesion) was found in samples taken from the intact and scarified skin surfaces treated with Tolperione 15%gel.The change was reversible.
Mortality:
no mortality observed

Effect levels

Remarks on result:
other: not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion