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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vivo

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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:
other: OECD Guideline and GLP compliant.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.12; OECD 474
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
EC Number:
403-830-5
EC Name:
6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
Cas Number:
89331-94-2
Molecular formula:
C35H36N2O3
IUPAC Name:
6'-(dibutylamino)-3'-methyl-2'-(phenylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one

Test animals

Species:
other: mus, Charles River CD-1

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
1% methylcellulose
No. of animals per sex per dose:
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours

Female: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
yes
Remarks:
(Doses producing toxicity: 5000 mg/kg produced severe lethargy, piloerection and moderate ptosis and hunched posture)
Additional information on results:
Observations:

No mortalities were observed.
The treatment induced clinical symptoms, but no cytotoxic effects (PCE/NCE in bone marrow).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative