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Registration Dossier
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REACH
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
EC number: 415-350-3 | CAS number: - COLUMBIADUNKELBLAU R
Toxicological information
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- other: migrated information
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
- EC Number:
- 415-350-3
- EC Name:
- A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
- Molecular formula:
- C52H32N11Na5O17S5
- IUPAC Name:
- A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- rat, Wistar Mol: Wist
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: dest. 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: 9 animals at 0 mg/kg bw/day
Male: 9 animals at 50 mg/kg bw/day
Male: 9 animals at 250 mg/kg bw/day
Male: 9 animals at 1000 mg/kg bw/day
Female: 9 animals at 0 mg/kg bw/day
Female: 9 animals at 50 mg/kg bw/day
Female: 9 animals at 250 mg/kg bw/day
Female: 9 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- One group of the high dose and of the controls were observed
without application of test substance after the test period
as recovery groups.
One male of the intermediate dose group died during the test
due to a mistake during the application.
Clinical in all dose groups a black discolouration of the
faeces was observed which was reversible in the recovery
groups. - Other effects:
- not specified
- Description (incidence and severity):
- Laboratory findings:
The haematological examination revealed a reduction of the
number of the erythrocytes in the males of the high dose
group and in the recovery group.
Effects in organs:
The animal which died previously showed a black
discolouration of the stomache contents, of the lungs, of
the peritoneums and of the epicards. One male of the low
dose group, 3 males of the intermedium and 4 males of the
high dose group as well as 3 males of the recovery group
showed green-grey areals on the lung surface. The same
effects were observed in 3 females of the intermediate dose
group and in 7 females of the high dose group. Furthermore
in several animals haemorrhagies in the lungs were seen.
Microscopically in the animal which died previously a black
discolouration of the alveol septums and the existence of
dark coloured foreign material in the alveols was seen. At
the end of the test in some control animals predominantly
perivascular granulocytic infiltrats and alveolarephitel
proliferations (in 1 resp. 2 animals of each control group)
were observed. In some test animals of each treatment group
perivacular granulocytic infiltrats partly with
participation of eosinophile granulocytes, alveolarephitel
proliferations and occurance of (dark) granuled
alveolarphagocytes, haemorrhagien and emphysemes were found.
Further treatment related organ changes were not seen.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- ca. 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: not specified (migrated information)
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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