4-[(4-chloro-6-{[(3 or 4)-sulfophenyl]amino}-1,3,5-triazin-2-yl)amino]-2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazenyl}benzenesulfonic acid, lithium sodium salts

Genetic toxicity: in vivo

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

Test material information

Constituent 1

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.