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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago.

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
401-310-2
EC Name:
-
Cas Number:
93912-64-2
Molecular formula:
Hill formula: C37H23N10O22S7Cl.6Na CAS formula: C37H23N10O22S7ClNa6
IUPAC Name:
Hexasodium 2-[8-amino-7-[[5-[[4-chloro-6-[[3-[[2-(sulfato)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl] amino]-2 sulfonatophenyl]azo]-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]-naphthalene-1,5-disulfonate

Test animals

Species:
mouse
Strain:
ICR

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
No. of animals per sex per dose:
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative