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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Acid Red 423
IUPAC Name:
Acid Red 423
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
other: OF-1 albino mice
Sex:
male/female
Details on test animals or test system and environmental conditions:
Weight: male/female 25g
Supplier: from a SPF colny IFFA-CREDO, L'Arbresie France
Quarantine period of 1 week, the animals were allowed a libitum access to food (Aliment Rats-Souris Charles River, produced by U.A.R, Villemoisson/Orge France) and drinking water.
Animals were housed 5 of the same sex per cage in Makrolon type III cages.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
deionised water
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
Control
Dose / conc.:
1 500 mg/kg bw/day (nominal)
Remarks:
Doses / Concentrations:
1500 mg/kg bw
No. of animals per sex per dose:
5 mice / sex / Group
Control animals:
yes, concurrent vehicle

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
At low magnification of the microscope no neticeable differences in bone marros nucleated cells were observed between tested animals and negative control.
In the positive control group (Thio-TEPA) decreased numbers of nucleated bone marrow cells were noted.

There was no statistically significant increase in the number of micronucleated polychromatic erythrocytes in animals exposed to 500 mg/kg of the tested substance compared to negative controls. In animals treated with positive control there was a statistically significant increased number of micronucleated cells.
The ration of polychromatic to normochromatic erythrocytes was markedly decreased in mice treated with positive control. There is no difference between animals treated with the tested substance and the negative control for this ratio.

Applicant's summary and conclusion

Conclusions:
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore the tested substance is considered to be non-mutagenic in this micronucleus assay.
Executive summary:

The tested substance is considered to be non-mutagenic in this micronucleus assay.