Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

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

Constituent 1
Reference substance name:
no data available
IUPAC Name:
no data available
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