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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
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 (1-generation reproduction study)
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 (Alpk: ApfSD)

Administration / exposure

Route of administration:
oral: unspecified
Details on exposure:
Method of administration or exposure: In diet
Frequency of treatment:
Dosing regime (males): 7 days/weekr
Dosing regime (females): 7 days/week
No. of animals per sex per dose:
Male: 26 animals at 0 mg/kg or mg/l
Male: 26 animals at 104 mg/kg or mg/l
Male: 26 animals at 526 mg/kg or mg/l
Male: 26 animals at 2127 mg/kg or mg/l
Female: 26 animals at 0 mg/kg or mg/l
Female: 26 animals at 111 mg/kg or mg/l
Female: 26 animals at 552 mg/kg or mg/l
Female: 26 animals at 2304 mg/kg or mg/l

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

No adverse treatment-related effects were observed. Orange staining of the fur/skin was noted in most males and all females in the lowest dose group, and all animals in the mid-, and top dose groups. Eleven pairs of animals (including controls) failed to produce a litter following mating. These animals were re-mated during week 18 of the study; overall with the exception of 3 females and 1 male rat, all the Fo parents which failed to oroduce a litter after the first mating were proven to be fertile after re-mating.

Effect levels (P0)

Remarks on result:
not determinable

Results: F1 generation

Details on results (F1)

Effects on F1 generation:
No toxicologically significant treatment-related effects on litter size, survival, growth or development of the offspring were observed. Orange staining of the skin and fur was noted in all pups of both sexes at all dose levels of the test substance. No treatment-related effects on survival and growth occurred throughout lactation.

Effect levels (F1)

Remarks on result:
not determinable

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

None.

Applicant's summary and conclusion