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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocortisone
EC Number:
200-020-1
EC Name:
Hydrocortisone
Cas Number:
50-23-7
Molecular formula:
C21H30O5
IUPAC Name:
11,17,21-trihydroxypregn-4-ene-3,20-dione
Details on test material:
- Name of test material (as cited in study report): hydrocortisone (ZK5191)
- Lot/batch No.: 024H0502
- Expiration date of the lot/batch: 02 March 96

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
24 and 48 h
Frequency of treatment:
once
Post exposure period:
no
Doses / concentrations
Remarks:
Doses / Concentrations:
250, 500 and 1000 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
5/sex
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
bone marrow of femur,
Examination of incidence of micronucleated cells per 2000 polychromatic (PCE) and 1000 normochromatic (NCE) erythrocytes.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

After application more than half of the high dose animals showed slight apathy and incomplete eyelid closure.

Regarding micronucleated PCE and NCE counts as well as ratio PCE/NCE, there were neither biologically relevant nor statistically significant differences (p greater 0.05) at any sample time.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Hydrocortisone is negative for mutagenicity in the micronucleus test
Executive summary:

Mice (10/sex/group) were treated intraperitoneally with 250, 500 and 1000 mg/kg of hydrocotisone (ZK 5191). After 24 and 48 h 5 animals /sex were sacrificed. Hydrocotisone did not induce chromosome breakage and mis-distribution of chromosomes in erythrocytes of bone marrow of mice.