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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 15th to July 3rd, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- May 12th, 1981
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
- EC Number:
- 424-310-4
- EC Name:
- 3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
- Cas Number:
- 178452-66-9
- Molecular formula:
- Hill formula: C63 H83 N27 O17 S4 CAS formula: C60 H77 N27 O14 S4 . C3 H6 O3
- IUPAC Name:
- 2-hydroxypropanoic acid; 5-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-3-{2-[4-({4-[(4-{2-[8-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3,6-disulfonaphthalen-2-yl]diazen-1-yl}phenyl)amino]-6-{[3-(diethylamino)propyl]amino}-1,3,5-triazin-2-yl}amino)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Stable in polyethylene glycol and water fo 48 hours.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Total number of animals: 30 males, 30 females
Total number of animals per group: Groups 1 and 4: 10 males, 10 females; Groups 2 and 3: 5 males and 5 females
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG400 / bi-distilled water 1:1
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Duration of acclimatization period: 7 days
Duration of treatment: 28 days
Duration of recovery: 14 days - Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/Kg bw/day
Female: 5 animals at 50 mg/Kg bw/day
Female: 5 animals at 200 mg/Kg bw/day
Female: 10 animals at 1000 mg/Kg bw/day - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Clinical signs, food consumption and body weights were recorded periodically during the treatment and recovery periods. Ophthalmoscopic examinations were performed at the end of the treatment ad recovery periods.
At the end of the dosing period and the treatment-free period blood samples were withdrawn for haematology and plasma chemistry analysis, and urine samples were collected for biochemical and microscopic analyses. All animals were killed, examine post-mortem and necropsied. Samples of major organs from all group 0 mg/kg and 1000 mg/kg animals and gross lesions from all animals were processed as haematoxylin and eosin stained slides and examine by light microscopy.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no test substance-related clinical signs note in any group.
In one female treated with 100 mg/kg dose rales were noted on treatment days 11-12. No further clinical signs were observed in any other animal treated at 1000 mg/kg, therefore the rales were considered of no toxicological significance. - Description (incidence):
- All animals survived the scheduled study period. One control female and one female treated with 1000 mg/kg dose died after blood sampling on the day of the scheduled necropsy after 4 weeks of treatment.
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Ophthalmologic findings were noted in small proportion of animals from all groups. They included persistent pupillary membrane, corneal opacity, anterior synechia and vitrous floaters. These findings occurred at similar incidences in the control and treated groups at the end of the treatment period. Therefore, they are considered to be unrelated to treatment with the test substance.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The only change of note was a slightly increate uric acid, total bilirubin, sodium, total protein and globulin level, and a slightly decreased chloride level in males treated with 1000 mg/kg at termination of the treatment. These findings, which were of minor degree and within historical control data, suggest metabolic adaptive changes rather than to constitute toxic effects. At the termination of the treatment-free recovery period these findings were generally reversed and found to be similar to those of the controls. All other statistical differences in the results of the haematology, clinical biochemistry and urinalysis data were considered to be incidental and unrelated to the treatment, and of normal biological variation for rats of this strain and age data for untreated Wistar rats.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- see haematological findings.
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- see haematological findings.
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Higher absolute and relative ovaries weights after 6 weeks were recorded in females at 1000 mg/kg. Both statistically significant findings were not considered to be test articles-related, but due to the slightly higher body weight of animals at 1000 mg/kg
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The macroscopic findings recorded were unremarkable and within the range of spontaneous alterations which may be seen in rats of this age and strain. They included dilated renal pelves, reddish discoloration in various organs and diluted uterine horns. Bluish discoloration of the gastrointestinal tract was noted amongst treated animals and was considered due to passive coloration by the test substance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food efficiency
- gross pathology
- haematology
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food efficiency
- gross pathology
- haematology
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, 1000 mg/kg bw/day of the substance was established as the NOAEL and 200 mg/kg as the no-observed-effect-level NOEL.
- Executive summary:
The subacute 28-Day oral toxicity study was conducted according to OECD 407 (1981) and EU Method B.7 (1992).
Dose levels for a study of 28 days oral treatment were selected to be 0, 50, 200 and 1000 mg/kg bw/day.
In this subacute 28-day toxicity study, the test item was administered daily by gavage to SPF-bred Wistar rats, followed by a 14-day recovery period.
A NOEL was established at 200 mg/kg bw/day, and the NOAEL was established at 1000 mg/kg bw/day.
Based on findings, the test item is not classified for Repeated dose toxicity (oral) according to the CLP Regulation (EC) No.1272/2008.
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