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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
Potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
EC Number:
414-100-0
EC Name:
Potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
Cas Number:
154336-20-6
Molecular formula:
C56H42Cl2K4N16Na4O32S10
IUPAC Name:
potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate

Test animals

Species:
rat

Administration / exposure

Vehicle:
water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Mortality:
Male: 0 mg/kg bw; Number of animals: 5; Number of deaths: 0. Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0. Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0. Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0. Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0.
Clinical signs:
Signs of toxicity related to dose levels: At the administration of 5000 mg/kg was observed consistently at both sexes a blue staining of the faeces and one blue staining of the extremities.
Gross pathology:
Effects on organs:
The overall pathology showed a blue staining of the kidneys and the testicles in males as well as the kidneys and the uterine horns in females when administered with 1000 mg/kg. When administered at 5000 mg/kg the staining extended to many other organs in both genders. A histopathological examination recognises a gray-blue pigmentation in the kidneys in 2
male and 4 female rats of the 5000 mg/kg group, but in none of the rats of the 1000 mg/kg group.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU