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

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-06-02

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

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Version / remarks:

1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

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:

Wistar

Remarks:

KFM-Han SPF

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: dest. Wasser + 4 % CMC-Na-Salz

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/da

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

mortality

Target system / organ toxicity

Critical effects observed:

no

Any other information on results incl. tables

No mortalities occurred.

Yellow colouration of the skin in the neck and back region and of the mucous membrane of some animals from the medium and high-dose groups was a substance-related change. However, it was interpreted as non-toxic. The comparison between all of the examined parameters did not reveal any significant differences between the controls and the treatment groups.

Applicant's summary and conclusion

Conclusions:

The NOAEL of the test material was 1000 mg/kg/day.