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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Contribution a l'etude analytique toxicologique et biochimique de l'isophorone.
Author:
Dutertre-Catella H
Year:
1976
Bibliographic source:
Thesis, Universite Rene Descartes, Paris.

Materials and methods

Principles of method if other than guideline:
Method: other: see Reference
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: Elf Atochem S.A.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Details on exposure:
Route of Administration: dermal
Duration of treatment / exposure:
8 weeks
Frequency of treatment:
daily on shaved skin
Doses / concentrations
Remarks:
Doses / Concentrations:
0.1 ml; 0.2 ml
Basis:

Control animals:
yes, concurrent no treatment
Details on study design:
Post-exposure period: yes, duration not reported

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: 
- Mortality and time to death: 
  females: no mortalities
  males: 1/5 in all groups including control
- Body weight gain: 
  males: similar in treated and untreated animals
  females: reduced by approximately 8 % in treated animals as compared to  controls
- Gross pathology: formation of erythema and crust on skin after 5-6  weeks of treatment was completely reversed after end of treatment
- Histopathology: confirmation of complete disappearance of erythema and  crust; no differences between exposed and untreated animals were observed  in any organ

Applicant's summary and conclusion