Registration Dossier
Registration Dossier
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A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)
EC number: 404-540-1 | CAS number: 159405-95-5 BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
NOAEL for maternal and teratogenic effects is 1000 mg/kg/day. NOEL for developmental effects is 1000 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study is GLP conform according to OECD414.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A dose-range finding study was run on pregnant female rats. Doses of 0, 100, 300 and 1000 mg/kg bw/day were administered by gavage to rats (5 per group) from day 6 to 19 post-coitum. The dose of 1000 mg/kg bw/day was selected as highest dose for the main study.
The developmental toxicity study on test substance was conducted in rats, following OECD guideline 414. Doses of 0, 100, 300 and 1000 mg/kg/day were administered by gavage from day 6 post coitum until day 19 post coitum.
Slight reduction in body weight gain was recorded at 300 and 1000 mg/kg/day. No toxicological relevant findings were seen in fetuses. All findings noted, such as exencephaly and delay of ossification, were considered to be spontaneous variations.
Overall:
NOAEL for maternal toxicity = 1000 mg/kg bw/day
NOAEL for teratogenic effects = 1000 mg/kg bw/day
NOEL for developmental effects = 1000 mg/kg bw/day
NOEL for maternal toxicity = 100 mg/kg/day.
Justification for classification or non-classification
Based on the above stated assessment of the reproduction toxicity potential, the test substance does not need to be classified according to the CLP Regulation (EC 1272/2008).
Additional information
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