Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
The structure of the read-across substance is the para form of the CJ301 without the meta form. However, this difference does not influence the toxicity of the CJ301. CJ301 contains Li/Na salt form and the read-across substances contains only Na salt. This will not lead to difference on the toxicity results.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium sodium 5-(5-(4-chloro-6-(4-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinemethanesulfonate
Cas Number:
111850-26-1
Molecular formula:
C24H23ClN8O11S3.xK.yNa
IUPAC Name:
Potassium sodium 5-(5-(4-chloro-6-(4-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinemethanesulfonate

Test animals

Species:
rat
Strain:
other: OF-1 SPF

Administration / exposure

Route of administration:
oral: unspecified
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 44 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 20 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 44 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 68 hours

Female: 0 mg/kg; No. of animals: 5; Sacrifice time: 44 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 20 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 44 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 68 hours

Results and discussion

Any other information on results incl. tables

Der Test wurde für einen Meldevorgang nach der 6. Änderung der Richtlinie 67/548/EWG durchgeführt

Applicant's summary and conclusion

Conclusions:
No symtoms of toixicty oberserved at the 5000 mg/kg/bw dose.