Registration Dossier

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
84/449/EWG, B.12
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Read 239

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
deionised water
Duration of treatment / exposure:
animals were killed after 24, 48 or 72 hours after administration of the test compound
Frequency of treatment:
The test compound was given in two equal parts within two hours
Doses / concentrations
Remarks:
Doses / Concentrations:
6250 mg/kg
Basis:
nominal in water
No. of animals per sex per dose:
Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 6250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 6250 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 6250 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Positive control(s):
endoxane, 50 mg/kg BW

Results and discussion

Additional information on results:
The incidence of micronucleated polychromatic erythrocytes in the dose groups of Reaktiv-Rot F-52167 FW was within the normal range of the negative control groups. No statistically significant increase of micronucleated polychromatic erythrocytes has been observed.
Due to the colour of the test compound urine, faeces and skin were red coloured.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
not mutagenic
Executive summary:

Reaktiv-Rot F-52 167 FW was tested in the micronucleus test. The test compound was administered orally by gavage to male and female mice. The following doses were tested: 0 and 6250 mg Reaktiv-Rot F-52 167 FW per kg bodyweight. The 6250 mg per kg bodyweight dose level was chosen since a preliminary study had shown it to be the maximal applicable dose.

The test compound was given in two equal parts within two hours and according to the test procedure the animals were killed 24, 48, 72 hours after administration of the test compound.

Endoxan was used as positive control substance and was administered orally at a dose of 50 mg per kg bodyweight.

The incidence of micronucleated polychromatic erythrocytes of the animals treated with Reaktiv-Rot F-52 167 FW was within the normal range of the negative control. The number of normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with Reaktiv-Rot F-52 167 FW and was statistically not different form the control values.

Endoxan induced in both males and females a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity of the system. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extend.

The results indicated that, under the conditions of the present study, Reaktiv-Rot F-52 167 FW is not mutagenic in the micronucleus test.