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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium sodium 3,3'-(3(or4)-methyl-1,2-phenylenebis(imino(6-chloro)-1,3,5-triazine-4,2-diylimino(2-acetamido-5-methoxy)-4,1-phenylenazo)dinaphthalene-1,5-disulfonate
EC Number:
403-810-6
EC Name:
Potassium sodium 3,3'-(3(or4)-methyl-1,2-phenylenebis(imino(6-chloro)-1,3,5-triazine-4,2-diylimino(2-acetamido-5-methoxy)-4,1-phenylenazo)dinaphthalene-1,5-disulfonate
Cas Number:
140876-13-7
Molecular formula:
C51H42Cl2N16O16S4
IUPAC Name:
3-{2-[4-({4-chloro-6-[(2-{[4-chloro-6-({4-[2-(4,8-disulfonaphthalen-2-yl)diazen-1-yl]-5-acetamido-2-methoxyphenyl}amino)-1,3,5-triazin-2-yl]amino}-5-methylphenyl)amino]-1,3,5-triazin-2-yl}amino)-2-acetamido-5-methoxyphenyl]diazen-1-yl}naphthalene-1,5-disulfonic acid; 3-{2-[4-({4-chloro-6-[(2-{[4-chloro-6-({4-[2-(4,8-disulfonaphthalen-2-yl)diazen-1-yl]-5-acetamido-2-methoxyphenyl}amino)-1,3,5-triazin-2-yl]amino}-6-methylphenyl)amino]-1,3,5-triazin-2-yl}amino)-2-acetamido-5-methoxyphenyl]diazen-1-yl}naphthalene-1,5-disulfonic acid

Test animals

Species:
other: Rat (Wistar-derived)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Deionised water
Details on oral exposure:
Method of administration: gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
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 250 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 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No deaths and no signs of toxicity were observed. Orange-staining of faecal pellets was apparent in top-dose animals. There were sporadic, statistically significant but generally small changes in some haematological and clinical chemistry parameters. In the absence of any clear dose or sex-related trends, or effects in organs, they were considered to be of no toxicological significance.

Effects in organs:
No treatment-related gross or microscopic findings were observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified